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A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis (ECLIPSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090100
Recruitment Status : Completed
First Posted : March 24, 2017
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Guselkumab
Drug: Placebo
Drug: Secukinumab
Enrollment 1048
Recruitment Details  
Pre-assignment Details Out of total 1,048 randomized participants, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Period Title: Overall Study
Started 534 514
Treated 534 511
Completed 507 466
Not Completed 27 48
Reason Not Completed
Adverse Event             9             11
Pregnancy             1             1
Lack of Efficacy             2             7
Lost to Follow-up             2             2
Withdrawal by Subject             7             19
Protocol Violation             2             6
Non-compliance             2             0
Other             2             2
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg Total
Hide Arm/Group Description Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. Total of all reporting groups
Overall Number of Baseline Participants 534 514 1048
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants randomized at Week 0.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 514 participants 1048 participants
<=18 years
6
   1.1%
2
   0.4%
8
   0.8%
Between 18 and 65 years
474
  88.8%
467
  90.9%
941
  89.8%
>=65 years
54
  10.1%
45
   8.8%
99
   9.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 534 participants 514 participants 1048 participants
46.3  (13.67) 45.3  (13.57) 45.8  (13.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 514 participants 1048 participants
Female
169
  31.6%
172
  33.5%
341
  32.5%
Male
365
  68.4%
342
  66.5%
707
  67.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 514 participants 1048 participants
Hispanic or Latino
27
   5.1%
36
   7.0%
63
   6.0%
Not Hispanic or Latino
502
  94.0%
472
  91.8%
974
  92.9%
Unknown or Not Reported
5
   0.9%
6
   1.2%
11
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 514 participants 1048 participants
American Indian or Alaska Native
2
   0.4%
2
   0.4%
4
   0.4%
Asian
18
   3.4%
12
   2.3%
30
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   0.6%
3
   0.3%
Black or African American
5
   0.9%
11
   2.1%
16
   1.5%
White
499
  93.4%
480
  93.4%
979
  93.4%
More than one race
4
   0.7%
0
   0.0%
4
   0.4%
Unknown or Not Reported
6
   1.1%
6
   1.2%
12
   1.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 514 participants 1048 participants
AUSTRALIA
35
   6.6%
36
   7.0%
71
   6.8%
CANADA
81
  15.2%
77
  15.0%
158
  15.1%
CZECH REPUBLIC
27
   5.1%
28
   5.4%
55
   5.2%
FRANCE
28
   5.2%
30
   5.8%
58
   5.5%
GERMANY
66
  12.4%
56
  10.9%
122
  11.6%
HUNGARY
25
   4.7%
20
   3.9%
45
   4.3%
POLAND
119
  22.3%
119
  23.2%
238
  22.7%
SPAIN
35
   6.6%
33
   6.4%
68
   6.5%
UNITED STATES
118
  22.1%
115
  22.4%
233
  22.2%
1.Primary Outcome
Title Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
84.5 70.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority margin of 10%
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.2
Confidence Interval (2-Sided) 95%
9.2 to 19.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
Hide Description Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Week 12 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or 48 were considered as non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
84.6 80.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority margin of 10%
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-0.2 to 8.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-90 Response at Week 12
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
69.1 76.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-12.2 to -1.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-75 Response at Week 12
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
89.3 91.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-6.0 to 1.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-100 Response at Week 48
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
58.2 48.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
3.8 to 15.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
Hide Description The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
62.2 50.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.6
Confidence Interval (2-Sided) 95%
5.8 to 17.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
Hide Description The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
85.0 74.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
4.9 to 14.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
Hide Description Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Time Frame Week 16 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or 48 were considered as non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
72.3 64.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
2.3 to 13.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-75 Response at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
92.7 92.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-3.5 to 3.1
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-90 Response at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 90 non-responders at Week 16.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
78.5 79.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-6.2 to 3.4
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.
Time Frame Week 24 up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through 48 were considered as non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
71.0 61.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
4.2 to 15.3
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
Hide Description The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
86.7 86.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-4.2 to 3.9
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
Hide Description The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
85.6 86.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab 100 mg + Placebo, Secukinumab 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-5.0 to 3.3
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0 and who achieved PASI 75 response at Week 12. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 477 471
Measure Type: Number
Unit of Measure: Percentage of participants
94.8 87.5
15.Secondary Outcome
Title Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0 and who achieved PASI-90 response at Week 16. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 419 409
Measure Type: Number
Unit of Measure: Percentage of participants
92.1 80.9
16.Secondary Outcome
Title Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
Hide Description PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.
Time Frame Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1: 100% improvement 0 0
Week 1: >=90% improvement 0 0
Week 1: >=75% improvement 2.1 1.8
Week 1: >=50% improvement 10.7 12.8
Week 2: 100% improvement 0.2 0.6
Week 2: >=90% improvement 1.1 2.7
Week 2: >=75% improvement 6.4 11.5
Week 2: >=50% improvement 30.9 42.0
Week 3: 100% improvement 1.7 1.6
Week 3: >=90% improvement 5.6 8.6
Week 3: >=75% improvement 19.5 28.4
Week 3: >=50% improvement 56.4 66.9
Week 4: 100% improvement 4.1 5.1
Week 4: >=90% improvement 13.1 21.8
Week 4: >=75% improvement 39.3 50.2
Week 4: >=50% improvement 73.4 85.4
Week 8: 100% improvement 20.0 27.2
Week 8: >=90% improvement 48.7 62.1
Week 8: >=75% improvement 76.4 86.2
Week 8: >=50% improvement 95.3 96.9
Week 12: 100% improvement 37.8 42.0
Week 12: >=90% improvement 69.1 76.1
Week 12: >=75% improvement 89.3 91.6
Week 12: >=50% improvement 96.8 96.1
Week 16: 100% improvement 47.8 46.1
Week 16: >=90% improvement 78.5 79.6
Week 16: >=75% improvement 92.7 92.8
Week 16: >=50% improvement 97.6 96.3
Week 20: 100% improvement 51.3 48.6
Week 20: >=90% improvement 80.1 81.1
Week 20: >=75% improvement 93.6 92.4
Week 20: >=50% improvement 97.6 95.1
Week 24: 100% improvement 54.7 50.4
Week 24: >=90% improvement 83.1 78.2
Week 24: >=75% improvement 94.2 90.3
Week 24: >=50% improvement 97.8 93.0
Week 28: 100% improvement 57.1 51.0
Week 28: >=90% improvement 85.4 77.2
Week 28: >=75% improvement 94.0 90.3
Week 28: >=50% improvement 97.2 93.0
Week 32: 100% improvement 57.5 50.2
Week 32:>=90 % improvement 84.8 77.4
Week 32: >=75% improvement 94.0 89.3
Week 32: >=50% improvement 97.0 93.0
Week 36: 100% improvement 58.6 50.0
Week 36: >=90% improvement 84.5 75.7
Week 36: >=75% improvement 93.6 87.0
Week 36: >=50% improvement 97.2 92.2
Week 40: 100% improvement 58.2 48.6
Week 40: >=90% improvement 84.6 73.7
Week 40: >=75% improvement 92.9 85.8
Week 40: >=50% improvement 95.9 90.9
Week 44: 100% improvement 58.6 49.4
Week 44: >=90% improvement 84.1 72.6
Week 44: >=75% improvement 92.3 85.2
Week 44: >=50% improvement 94.2 91.4
Week 48: 100% improvement 58.2 48.4
Week 48: >=90% improvement 84.5 70.0
Week 48: >=75% improvement 92.1 83.5
Week 48: >=50% improvement 94.0 89.3
Week 56: 100% improvement 50.4 27.0
Week 56: >=90% improvement 77.3 51.4
Week 56: >=75% improvement 88.0 70.4
Week 56: >=50% improvement 91.0 82.1
17.Secondary Outcome
Title Percentage of Participants With IGA Responses Through Week 56
Hide Description The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1: cleared (0) 0 0
Week 1: cleared (0) or minimal (1) 3.4 2.5
Week 1: mild or better (=<2) 27.2 34.2
Week 2: cleared (0) 0.2 0.8
Week 2: cleared (0) or minimal (1) 12.4 20.2
Week 2: mild or better (=<2) 54.1 63.8
Week 3: cleared (0) 2.6 3.3
Week 3: cleared (0) or minimal (1) 27.2 39.9
Week 3: mild or better (=<2) 75.3 82.5
Week 4: cleared (0) 6.7 9.7
Week 4: cleared (0) or minimal (1) 44.2 59.3
Week 4: mild or better (=<2) 85.6 92.2
Week 8: cleared (0) 29.2 35.8
Week 8: cleared (0) or minimal (1) 76.6 83.5
Week 8: mild or better (=<2) 96.3 96.3
Week 12: cleared (0) 46.3 50.2
Week 12: cleared (0) or minimal (1) 85.6 86.4
Week 12: mild or better (=<2) 96.8 95.3
Week 16: cleared (0) 55.4 53.5
Week 16: mild or better (=<2) 96.8 94.7
Week 16: cleared (0) or minimal (1) 86.7 86.6
Week 20: cleared (0) 56.9 53.9
Week 20: cleared (0) or minimal (1) 87.8 85.6
Week 20: mild or better (=<2) 95.3 93.2
Week 24: cleared (0) 61.0 56.0
Week 24: cleared (0) or minimal (1) 88.6 82.7
Week 24: mild or better (=<2) 96.3 91.6
Week 28: cleared (0) 62.2 56.2
Week 28: cleared (0) or minimal (1) 87.8 82.9
Week 28: mild or better (<=2) 95.5 90.9
Week 32: cleared (0) 63.1 54.5
Week 32: cleared (0) or minimal (1) 88.6 81.5
Week 32: mild or better (=<2) 95.5 90.5
Week 36: cleared (0) 60.7 53.7
Week 36: cleared (0) or minimal (1) 86.5 79.6
Week 36: mild or better (=<2) 95.5 88.9
Week 40: cleared (0) 63.1 52.3
Week 40: cleared (0) or minimal (1) 86.3 78.0
Week 40: mild or better (=<2) 93.6 87.9
Week 44: cleared (0) 62.2 51.9
Week 44: cleared (0) or minimal (1) 86.0 76.5
Week 44: mild or better (=<2) 92.3 87.5
Week 48: cleared (0) 62.2 50.4
Week 48: cleared (0) or minimal (1) 85.0 74.9
Week 48: mild or better (=<2) 92.7 86.8
Week 56: cleared (0) 54.3 29.4
Week 56: cleared (0) or minimal (1) 78.8 58.2
Week 56: mild or better (=<2) 87.5 76.3
18.Secondary Outcome
Title Percent Improvement From Baseline in PASI Through Week 56
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all the participants randomized at Week 0. Here 'n' signifies the number of participants analyzed at specified point. Zero percent improvement was assigned from the point when participants met treatment failure criteria and no other data imputation was applied.
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description:
Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Number of Participants Analyzed 534 514
Mean (Standard Deviation)
Unit of Measure: Percent improvement
Week 1 Number Analyzed 531 participants 510 participants
20.30  (20.743) 24.72  (20.711)
Week 2 Number Analyzed 533 participants 509 participants
37.85  (23.567) 44.56  (23.600)
Week 3 Number Analyzed 531 participants 507 participants
52.76  (24.186) 60.57  (21.871)
Week 4 Number Analyzed 531 participants 507 participants
64.63  (22.862) 72.80  (19.478)
Week 8 Number Analyzed 531 participants 506 participants
84.36  (17.278) 89.40  (13.579)
Week 12 Number Analyzed 527 participants 505 participants
90.85  (14.484) 92.60  (13.703)
Week 16 Number Analyzed 526 participants 501 participants
93.65  (12.849) 93.94  (12.123)
Week 20 Number Analyzed 525 participants 495 participants
94.35  (11.525) 94.41  (12.152)
Week 24 Number Analyzed 525 participants 490 participants
95.27  (9.848) 93.75  (14.314)
Week 28 Number Analyzed 521 participants 492 participants
95.58  (9.663) 92.96  (16.835)
Week 32 Number Analyzed 521 participants 491 participants
95.74  (9.336) 92.95  (16.641)
Week 36 Number Analyzed 523 participants 487 participants
95.45  (11.119) 92.40  (17.125)
Week 40 Number Analyzed 516 participants 484 participants
95.78  (10.456) 91.77  (17.733)
Week 44 Number Analyzed 511 participants 486 participants
95.45  (12.293) 91.34  (18.246)
Week 48 Number Analyzed 508 participants 478 participants
95.76  (11.629) 90.87  (19.181)
Week 56 Number Analyzed 499 participants 469 participants
93.35  (16.116) 81.67  (27.627)
Time Frame Up to Week 56
Adverse Event Reporting Description Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
 
Arm/Group Title Guselkumab 100 mg + Placebo Secukinumab 300 mg
Hide Arm/Group Description Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
All-Cause Mortality
Guselkumab 100 mg + Placebo Secukinumab 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/534 (0.00%)   0/511 (0.00%) 
Hide Serious Adverse Events
Guselkumab 100 mg + Placebo Secukinumab 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   33/534 (6.18%)   37/511 (7.24%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/534 (0.19%)  1/511 (0.20%) 
Atrioventricular Block Complete * 1  0/534 (0.00%)  1/511 (0.20%) 
Cardiac Failure Congestive * 1  0/534 (0.00%)  1/511 (0.20%) 
Coronary Artery Occlusion * 1  1/534 (0.19%)  0/511 (0.00%) 
Wolff-Parkinson-White Syndrome * 1  1/534 (0.19%)  0/511 (0.00%) 
Eye disorders     
Macular Fibrosis * 1  1/534 (0.19%)  0/511 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  1/534 (0.19%)  0/511 (0.00%) 
Crohn's Disease * 1  0/534 (0.00%)  1/511 (0.20%) 
Haemorrhoids * 1  0/534 (0.00%)  1/511 (0.20%) 
Leukoplakia Oral * 1  1/534 (0.19%)  0/511 (0.00%) 
Umbilical Hernia * 1  1/534 (0.19%)  0/511 (0.00%) 
General disorders     
Chest Pain * 1  0/534 (0.00%)  1/511 (0.20%) 
Exercise Tolerance Decreased * 1  0/534 (0.00%)  1/511 (0.20%) 
General Physical Health Deterioration * 1  1/534 (0.19%)  0/511 (0.00%) 
Non-Cardiac Chest Pain * 1  1/534 (0.19%)  1/511 (0.20%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/534 (0.00%)  1/511 (0.20%) 
Cholecystitis Acute * 1  1/534 (0.19%)  0/511 (0.00%) 
Cholelithiasis * 1  1/534 (0.19%)  1/511 (0.20%) 
Drug-Induced Liver Injury * 1  0/534 (0.00%)  1/511 (0.20%) 
Immune system disorders     
Anaphylactoid Reaction * 1  0/534 (0.00%)  1/511 (0.20%) 
Infections and infestations     
Abscess Limb * 1  0/534 (0.00%)  1/511 (0.20%) 
Appendicitis * 1  1/534 (0.19%)  0/511 (0.00%) 
Cellulitis * 1  1/534 (0.19%)  1/511 (0.20%) 
Labyrinthitis * 1  1/534 (0.19%)  0/511 (0.00%) 
Neuroborreliosis * 1  0/534 (0.00%)  1/511 (0.20%) 
Pneumonia * 1  1/534 (0.19%)  1/511 (0.20%) 
Pyelonephritis * 1  0/534 (0.00%)  1/511 (0.20%) 
Injury, poisoning and procedural complications     
Clavicle Fracture * 1  1/534 (0.19%)  0/511 (0.00%) 
Femoral Neck Fracture * 1  0/534 (0.00%)  1/511 (0.20%) 
Foot Fracture * 1  0/534 (0.00%)  1/511 (0.20%) 
Ligament Rupture * 1  1/534 (0.19%)  0/511 (0.00%) 
Meniscus Injury * 1  1/534 (0.19%)  0/511 (0.00%) 
Skull Fracture * 1  1/534 (0.19%)  0/511 (0.00%) 
Tendon Rupture * 1  0/534 (0.00%)  1/511 (0.20%) 
Upper Limb Fracture * 1  0/534 (0.00%)  1/511 (0.20%) 
Investigations     
Electrocardiogram Repolarisation Abnormality * 1  1/534 (0.19%)  0/511 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion * 1  0/534 (0.00%)  2/511 (0.39%) 
Osteoarthritis * 1  1/534 (0.19%)  1/511 (0.20%) 
Rotator Cuff Syndrome * 1  1/534 (0.19%)  0/511 (0.00%) 
Spinal Column Stenosis * 1  0/534 (0.00%)  1/511 (0.20%) 
Spinal Osteoarthritis * 1  0/534 (0.00%)  1/511 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Invasive Ductal Breast Carcinoma * 1  1/534 (0.19%)  0/511 (0.00%) 
Non-Small Cell Lung Cancer * 1  0/534 (0.00%)  1/511 (0.20%) 
Nervous system disorders     
Cerebrovascular Accident * 1  0/534 (0.00%)  1/511 (0.20%) 
Headache * 1  1/534 (0.19%)  0/511 (0.00%) 
Syncope * 1  0/534 (0.00%)  1/511 (0.20%) 
Psychiatric disorders     
Anxiety * 1  1/534 (0.19%)  1/511 (0.20%) 
Depression * 1  0/534 (0.00%)  1/511 (0.20%) 
Mixed Anxiety and Depressive Disorder * 1  0/534 (0.00%)  1/511 (0.20%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  1/534 (0.19%)  1/511 (0.20%) 
Nephrolithiasis * 1  0/534 (0.00%)  1/511 (0.20%) 
Reproductive system and breast disorders     
Bartholin's Cyst * 1  1/534 (0.19%)  0/511 (0.00%) 
Benign Prostatic Hyperplasia * 1  0/534 (0.00%)  1/511 (0.20%) 
Endometriosis * 1  1/534 (0.19%)  0/511 (0.00%) 
Prostatomegaly * 1  0/534 (0.00%)  1/511 (0.20%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial Lung Disease * 1  1/534 (0.19%)  0/511 (0.00%) 
Nasal Cyst * 1  1/534 (0.19%)  0/511 (0.00%) 
Nasal Polyps * 1  1/534 (0.19%)  0/511 (0.00%) 
Pneumonia Aspiration * 1  1/534 (0.19%)  0/511 (0.00%) 
Pulmonary Embolism * 1  0/534 (0.00%)  1/511 (0.20%) 
Skin and subcutaneous tissue disorders     
Chronic Cutaneous Lupus Erythematosus * 1  1/534 (0.19%)  0/511 (0.00%) 
Drug Eruption * 1  1/534 (0.19%)  0/511 (0.00%) 
Psoriasis * 1  0/534 (0.00%)  1/511 (0.20%) 
Rash Morbilliform * 1  1/534 (0.19%)  0/511 (0.00%) 
Surgical and medical procedures     
Finger Amputation * 1  0/534 (0.00%)  1/511 (0.20%) 
Vascular disorders     
Arteriosclerosis * 1  1/534 (0.19%)  0/511 (0.00%) 
Deep Vein Thrombosis * 1  0/534 (0.00%)  1/511 (0.20%) 
Hypotension * 1  1/534 (0.19%)  0/511 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Guselkumab 100 mg + Placebo Secukinumab 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   249/534 (46.63%)   254/511 (49.71%) 
Gastrointestinal disorders     
Diarrhoea * 1  27/534 (5.06%)  20/511 (3.91%) 
Infections and infestations     
Nasopharyngitis * 1  118/534 (22.10%)  125/511 (24.46%) 
Upper Respiratory Tract Infection * 1  83/534 (15.54%)  92/511 (18.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  30/534 (5.62%)  25/511 (4.89%) 
Back Pain * 1  29/534 (5.43%)  18/511 (3.52%) 
Nervous system disorders     
Headache * 1  48/534 (8.99%)  48/511 (9.39%) 
1
Term from vocabulary, MedDRA Version 21.0
*
Indicates events were collected by non-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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03090100    
Other Study ID Numbers: CR108278
2016-002995-29 ( EudraCT Number )
CNTO1959PSO3009 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: March 22, 2017
First Posted: March 24, 2017
Results First Submitted: August 1, 2019
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019