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Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02203851
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Risankizumab
Enrollment 110
Recruitment Details Analyses were performed using the intent-to-treat (ITT) population defined as all participants who received at least 1 dose of study drug. As predefined, the demographics, disposition and safety results were summarized for ITT population. Efficacy results were summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).
Pre-assignment Details Participants completing lead-in study and met eligibility for this study were enrolled; demographic/disposition were not collected by dose level. Some participants in extension study had dose escalation due to lack of efficacy, predefined selected safety analysis were broken down by groups: participants remaining at 90mg and those receiving 180mg.
Arm/Group Title Risankizumab 90 mg or 180 mg
Hide Arm/Group Description Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Period Title: Overall Study
Started 110
Completed 99
Not Completed 11
Reason Not Completed
Lost to Follow-up             4
Withdrawal by Subject             6
Other             1
Arm/Group Title Risankizumab 90 mg or 180 mg
Hide Arm/Group Description Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
Intent to Treat (ITT) Population: All participants that received at least one dose of study drug in the extension study who either remained at 90 mg throughout the study or who received 180 mg were summarized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
49.0  (13.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female 44
Male 66
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Hispanic or Latino 18
Not Hispanic or Latino 92
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
American Indian or Alaska Native 1
Asian 3
Native Hawaiian or Other Pacific Islander 2
Black or African American 2
White 101
More than one race 1
Unknown or Not Reported 0
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
Time Frame From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, which is the same as the Intent to Treat (ITT) population for this study (defined as all participants who received at least one dose of study drug in the study), summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg
Arm/Group Title Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.
Overall Number of Participants Analyzed 87 23
Measure Type: Number
Unit of Measure: participants
67 18
2.Primary Outcome
Title Number of Participants With Drug-related TEAEs
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
Time Frame From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg
Arm/Group Title Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.
Overall Number of Participants Analyzed 87 23
Measure Type: Number
Unit of Measure: participants
12 3
3.Primary Outcome
Title Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
Time Frame From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg
Arm/Group Title Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.
Overall Number of Participants Analyzed 87 23
Measure Type: Number
Unit of Measure: participants
12 2
4.Primary Outcome
Title Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period
Hide Description 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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: defined as all participants who received at least one dose of study drug in the study and summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).
Arm/Group Title Risankizumab 18 mg/Risankizumab Risankizumab 90 mg/Risankizumab Risankizumab 180 mg/Risankizumab Ustekinumab/Risankizumab
Hide Arm/Group Description:
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Participants Analyzed 22 27 32 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.7
(54.1 to 91.3)
77.8
(62.1 to 93.5)
71.9
(56.3 to 87.5)
74.1
(57.5 to 90.6)
5.Secondary Outcome
Title Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period
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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population summarized by the 4 treatment groups from the lead-in study
Arm/Group Title Risankizumab 18 mg/Risankizumab Risankizumab 90 mg/Risankizumab Risankizumab 180 mg/Risankizumab Ustekinumab/Risankizumab
Hide Arm/Group Description:
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Participants Analyzed 22 27 32 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.6
(43.5 to 83.7)
70.4
(53.1 to 87.6)
68.8
(52.7 to 84.8)
66.7
(48.9 to 84.4)
6.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period
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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population summarized by the 4 treatment groups from the lead-in study
Arm/Group Title Risankizumab 18 mg/Risankizumab Risankizumab 90 mg/Risankizumab Risankizumab 180 mg/Risankizumab Ustekinumab/Risankizumab
Hide Arm/Group Description:
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeksfor approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Participants Analyzed 22 27 32 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.5
(86.8 to 100.0)
96.3
(89.2 to 100.0)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
7.Secondary Outcome
Title Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period
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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population summarized by the 4 treatment groups from the lead-in study
Arm/Group Title Risankizumab 18 mg/Risankizumab Risankizumab 90 mg/Risankizumab Risankizumab 180 mg/Risankizumab Ustekinumab/Risankizumab
Hide Arm/Group Description:
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Participants Analyzed 22 27 32 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.4
(72.0 to 100.0)
92.6
(82.7 to 100.0)
90.6
(80.5 to 100.0)
96.3
(89.2 to 100.0)
8.Secondary Outcome
Title Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period
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 a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population summarized by the 4 treatment groups from the lead-in study
Arm/Group Title Risankizumab 18 mg/Risankizumab Risankizumab 90 mg/Risankizumab Risankizumab 180 mg/Risankizumab Ustekinumab/Risankizumab
Hide Arm/Group Description:
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Participants Analyzed 22 27 32 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.5
(33.7 to 75.4)
55.6
(36.8 to 74.3)
50.0
(32.7 to 67.3)
55.6
(36.8 to 74.3)
9.Secondary Outcome
Title Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period
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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population summarized by the 4 treatment groups from the lead-in study
Arm/Group Title Risankizumab 18 mg/Risankizumab Risankizumab 90 mg/Risankizumab Risankizumab 180 mg/Risankizumab Ustekinumab/Risankizumab
Hide Arm/Group Description:
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Number of Participants Analyzed 22 27 32 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.5
(33.7 to 75.4)
63.0
(44.7 to 81.2)
56.3
(39.1 to 73.4)
55.6
(36.8 to 74.3)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
All-Cause Mortality
Risankizumab 90 mg Risankizumab 180 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)      0/23 (0.00%)    
Hide Serious Adverse Events
Risankizumab 90 mg Risankizumab 180 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/87 (13.79%)      2/23 (8.70%)    
Cardiac disorders     
Myocardial infarction  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Endocrine disorders     
Goitre  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Eye disorders     
Glaucoma  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Macular degeneration  1  1/87 (1.15%)  1 0/23 (0.00%)  0
General disorders     
Non-cardiac chest pain  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Infections and infestations     
Cystitis  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Pneumonia  1  0/87 (0.00%)  0 1/23 (4.35%)  1
Pyelonephritis  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Sepsis  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Lower limb fracture  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/87 (1.15%)  2 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Intervertebral disc protrusion  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/87 (1.15%)  1 1/23 (4.35%)  1
Papilloma  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Squamous cell carcinoma of skin  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Nervous system disorders     
Carpal tunnel syndrome  1  0/87 (0.00%)  0 1/23 (4.35%)  1
Syncope  1  1/87 (1.15%)  1 0/23 (0.00%)  0
Transient ischaemic attack  1  2/87 (2.30%)  3 0/23 (0.00%)  0
Ulnar neuritis  1  0/87 (0.00%)  0 1/23 (4.35%)  1
Psychiatric disorders     
Psychotic disorder  1  0/87 (0.00%)  0 1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/87 (0.00%)  0 1/23 (4.35%)  1
1
Term from vocabulary, MedDRA version 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Risankizumab 90 mg Risankizumab 180 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/87 (52.87%)      15/23 (65.22%)    
Infections and infestations     
Bronchitis  1  5/87 (5.75%)  6 2/23 (8.70%)  2
Influenza  1  7/87 (8.05%)  7 0/23 (0.00%)  0
Nasopharyngitis  1  16/87 (18.39%)  33 3/23 (13.04%)  8
Sinusitis  1  3/87 (3.45%)  5 3/23 (13.04%)  3
Tooth abscess  1  6/87 (6.90%)  6 0/23 (0.00%)  0
Upper respiratory tract infection  1  11/87 (12.64%)  16 4/23 (17.39%)  5
Urinary tract infection  1  8/87 (9.20%)  9 1/23 (4.35%)  1
Injury, poisoning and procedural complications     
Muscle strain  1  2/87 (2.30%)  2 2/23 (8.70%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/87 (10.34%)  10 2/23 (8.70%)  2
Pain in extremity  1  4/87 (4.60%)  4 2/23 (8.70%)  2
Skin and subcutaneous tissue disorders     
Dermal cyst  1  2/87 (2.30%)  2 2/23 (8.70%)  2
Dermatitis contact  1  2/87 (2.30%)  2 3/23 (13.04%)  3
Vascular disorders     
Hypertension  1  6/87 (6.90%)  6 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA version 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02203851    
Other Study ID Numbers: M16-009
2014-001687-36 ( EudraCT Number )
1311.13 ( Other Identifier: Boehringer Ingelheim )
First Submitted: July 29, 2014
First Posted: July 30, 2014
Results First Submitted: May 10, 2019
Results First Posted: November 8, 2019
Last Update Posted: November 8, 2019