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A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

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ClinicalTrials.gov Identifier: NCT03255382
Recruitment Status : Completed
First Posted : August 21, 2017
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Fumaderm
Drug: risankizumab
Enrollment 120
Recruitment Details Intent-to-treat (ITT) analysis set included all participants enrolled in the study (N = 120). Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).
Pre-assignment Details A total of 120 participants were enrolled and included in the ITT population; 3 randomized participants discontinued prior to receiving any study drug and were excluded from the safety population.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows. Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Period Title: Overall Study
Started 60 60
Completed 47 60
Not Completed 13 0
Reason Not Completed
Adverse Event             3             0
Lost to Follow-up             2             0
Withdrawal by Subject             2             0
Not specified             6             0
Arm/Group Title Fumaderm Risankizumab Total
Hide Arm/Group Description Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows. Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16. Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
Intent to Treat (ITT) analysis set: all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
42.5  (12.71) 42.0  (13.75) 42.3  (13.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female 22 27 49
Male 38 33 71
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Hispanic or Latino 1 0 1
Not Hispanic or Latino 59 60 119
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
American Indian or Alaska Native 0 0 0
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 60 59 119
More than one race 0 0 0
Unknown or Not Reported 0 0 0
1.Primary Outcome
Title Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
Hide Description The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set: all participants who were randomized.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
10.0 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 73.3
Confidence Interval (2-Sided) 95%
61.3 to 85.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
6.7 53.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 46.8
Confidence Interval (2-Sided) 95%
32.8 to 60.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
28.3 91.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 63.4
Confidence Interval (2-Sided) 95%
50.2 to 76.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
46.7 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 53.1
Confidence Interval (2-Sided) 95%
40.4 to 65.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
60.0 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 39.6
Confidence Interval (2-Sided) 95%
27.3 to 51.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
63.3 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 36.3
Confidence Interval (2-Sided) 95%
24.1 to 48.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
53.3 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 46.4
Confidence Interval (2-Sided) 95%
33.7 to 59.0
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
3.3 13.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
0.1 to 19.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
8.3 75.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 66.6
Confidence Interval (2-Sided) 95%
53.8 to 79.5
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
20.0 86.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 66.6
Confidence Interval (2-Sided) 95%
53.3 to 79.9
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
26.7 93.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 66.6
Confidence Interval (2-Sided) 95%
53.8 to 79.5
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
38.3 95.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 56.5
Confidence Interval (2-Sided) 95%
43.0 to 70.0
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
33.3 98.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 64.8
Confidence Interval (2-Sided) 95%
52.5 to 77.2
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 4
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
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Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
0 1.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.392
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-2.1 to 5.4
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 8
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
1.7 38.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 36.6
Confidence Interval (2-Sided) 95%
23.8 to 49.3
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 12
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
5.0 61.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 56.6
Confidence Interval (2-Sided) 95%
43.2 to 70.0
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 16
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
11.7 76.7
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Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 64.9
Confidence Interval (2-Sided) 95%
51.5 to 78.3
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 20
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
16.7 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 66.6
Confidence Interval (2-Sided) 95%
53.3 to 79.8
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 4
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.991
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.0 to 2.1
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 8
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
1.7 5.0
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Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-3.2 to 9.8
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 12
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
1.7 23.3
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Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 21.5
Confidence Interval (2-Sided) 95%
10.4 to 32.6
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
1.7 35.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 33.1
Confidence Interval (2-Sided) 95%
20.7 to 45.5
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 20
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
6.7 48.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 41.3
Confidence Interval (2-Sided) 95%
27.3 to 55.3
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
5.0 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 44.7
Confidence Interval (2-Sided) 95%
30.9 to 58.5
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.37  (0.669) -9.56  (0.673)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.19
Confidence Interval (2-Sided) 95%
-8.82 to -5.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.825
Estimation Comments [Not Specified]
26.Secondary Outcome
Title PASI: Change From Baseline to Week 8
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.61  (0.759) -15.18  (0.763)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.58
Confidence Interval (2-Sided) 95%
-11.43 to -7.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.936
Estimation Comments [Not Specified]
27.Secondary Outcome
Title PASI: Change From Baseline to Week 12
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.69  (0.788) -16.49  (0.793)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -8.80
Confidence Interval (2-Sided) 95%
-10.72 to -6.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.972
Estimation Comments [Not Specified]
28.Secondary Outcome
Title PASI: Change From Baseline to Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
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ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.11  (0.777) -16.89  (0.782)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.78
Confidence Interval (2-Sided) 95%
-9.68 to -5.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.958
Estimation Comments [Not Specified]
29.Secondary Outcome
Title PASI: Change From Baseline to Week 20
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time Frame Baseline, Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.46  (0.894) -17.35  (0.899)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.89
Confidence Interval (2-Sided) 95%
-10.07 to -5.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.101
Estimation Comments [Not Specified]
30.Secondary Outcome
Title PASI: Change From Baseline to Week 24
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.31  (0.953) -17.69  (0.959)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -8.39
Confidence Interval (2-Sided) 95%
-10.71 to -6.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.175
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
3.3 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 29.7
Confidence Interval (2-Sided) 95%
17.1 to 42.4
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
15.0 81.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 66.7
Confidence Interval (2-Sided) 95%
53.4 to 80.0
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
33.3 90.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 56.8
Confidence Interval (2-Sided) 95%
42.7 to 70.8
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
31.7 91.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 59.9
Confidence Interval (2-Sided) 95%
46.3 to 73.6
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
48.3 93.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 44.9
Confidence Interval (2-Sided) 95%
30.8 to 59.1
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
38.3 93.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 55.0
Confidence Interval (2-Sided) 95%
41.2 to 68.8
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear at Week 4
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
0 1.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.392
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-2.1 to 5.4
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear at Week 8
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
1.7 10.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 8.4
Confidence Interval (2-Sided) 95%
0.1 to 16.7
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear at Week 12
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
3.3 21.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 18.3
Confidence Interval (2-Sided) 95%
7.1 to 29.5
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear at Week 16
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
3.3 36.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 33.0
Confidence Interval (2-Sided) 95%
20.2 to 45.9
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear at Week 20
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
6.7 48.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 41.3
Confidence Interval (2-Sided) 95%
27.3 to 55.3
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Percentage of Participants Achieving sPGA Score of Clear at Week 24
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
5.0 51.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 46.4
Confidence Interval (2-Sided) 95%
32.6 to 60.1
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16
Hide Description The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
5.0 25.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 19.8
Confidence Interval (2-Sided) 95%
7.6 to 31.9
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Percentage of Participants With PSS Score of 0 at Week 24
Hide Description The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
3.3 41.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percentage difference
Estimated Value 38.3
Confidence Interval (2-Sided) 95%
25.0 to 51.5
Estimation Comments [Not Specified]
45.Secondary Outcome
Title PSS Total Score: Change From Baseline to Week 16
Hide Description The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 55 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.5  (0.52) -8.7  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated by stratified van Elteren test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method van Elteren test
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-4.5 to -2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
46.Secondary Outcome
Title PSS Total Score: Change From Baseline to Week 24
Hide Description The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 55 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.6  (0.49) -9.5  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated by stratified van Elteren test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method van Elteren test
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-5.1 to -2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.59
Estimation Comments [Not Specified]
47.Secondary Outcome
Title Summary of Patient Benefit Index (PBI) at Week 16
Hide Description The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for “did not apply to me” (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 54 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.970  (1.1971) 3.118  (0.8246)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.146
Confidence Interval (2-Sided) 95%
0.764 to 1.528
Estimation Comments [Not Specified]
48.Secondary Outcome
Title Summary of PBI at Week 24
Hide Description The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for “did not apply to me” (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 54 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.997  (1.2710) 3.316  (0.7487)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.320
Confidence Interval (2-Sided) 95%
0.936 to 1.704
Estimation Comments [Not Specified]
49.Secondary Outcome
Title Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16
Hide Description The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 56 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.51) -2.7  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-3.6 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
50.Secondary Outcome
Title NAPPA-CLIN Total Score: Change From Baseline to Week 24
Hide Description The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 56 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.7  (0.53) -3.7  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-4.3 to -1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
51.Secondary Outcome
Title Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16
Hide Description The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 56 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.76  (0.251) -1.04  (0.249)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.352
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.90 to 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.307
Estimation Comments [Not Specified]
52.Secondary Outcome
Title PPASI: Change From Baseline to Week 24
Hide Description The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 56 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.87  (0.242) -1.17  (0.240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.88 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.296
Estimation Comments [Not Specified]
53.Secondary Outcome
Title Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: percentage estimated body surface area
-0.3  (0.86) -5.2  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-6.9 to -2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.06
Estimation Comments [Not Specified]
54.Secondary Outcome
Title BSA Affected by Psoriasis: Change From Baseline to Week 8
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: percentage estimated body surface area
-3.5  (1.33) -12.8  (1.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.3
Confidence Interval (2-Sided) 95%
-12.6 to -6.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.64
Estimation Comments [Not Specified]
55.Secondary Outcome
Title BSA Affected by Psoriasis: Change From Baseline to Week 12
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: percentage estimated body surface area
-6.0  (1.22) -16.2  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-13.2 to -7.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.51
Estimation Comments [Not Specified]
56.Secondary Outcome
Title BSA Affected by Psoriasis: Change From Baseline to Week 16
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: percentage estimated body surface area
-8.2  (1.22) -18.0  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.8
Confidence Interval (2-Sided) 95%
-12.8 to -6.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.51
Estimation Comments [Not Specified]
57.Secondary Outcome
Title BSA Affected by Psoriasis: Change From Baseline to Week 20
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: percentage estimated body surface area
-9.7  (1.13) -19.3  (1.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fumaderm, Risankizumab
Comments P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.6
Confidence Interval (2-Sided) 95%
-12.4 to -6.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.39
Estimation Comments [Not Specified]
58.Secondary Outcome
Title BSA Affected by Psoriasis: Change From Baseline to Week 24
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Fumaderm Risankizumab
Hide Arm/Group Description:
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
Overall Number of Participants Analyzed 58 60
Least Squares Mean (Standard Error)
Unit of Measure: percentage estimated body surface area
-9.8  (1.19) -19.8  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection