Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis (NCT NCT03573323)
NCT ID: NCT03573323
Last Updated: 2020-07-28
Results Overview
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1027 participants
Primary outcome timeframe
Week 12
Results posted on
2020-07-28
Participant Flow
The study consists of a combined blinded treatment (trt) period with a 24-week duration followed by a post treatment follow-up (PTFU) period with a minimum of a 12-week duration. The Induction Dosing Period (12 Weeks) and Extension Period (12 Weeks) were combined for analysis and referred to as the blinded treatment periods.
Participant milestones
| Measure |
Ixekizumab
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Guselkumab
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
|---|---|---|
|
Blinded Treatment Period (Weeks 0-24)
STARTED
|
520
|
507
|
|
Blinded Treatment Period (Weeks 0-24)
Received at Least One Dose of Study Drug
|
519
|
506
|
|
Blinded Treatment Period (Weeks 0-24)
COMPLETED
|
465
|
459
|
|
Blinded Treatment Period (Weeks 0-24)
NOT COMPLETED
|
55
|
48
|
|
Post-Treatment Follow Up (Weeks 25-36)
STARTED
|
465
|
456
|
|
Post-Treatment Follow Up (Weeks 25-36)
COMPLETED
|
406
|
399
|
|
Post-Treatment Follow Up (Weeks 25-36)
NOT COMPLETED
|
59
|
57
|
Reasons for withdrawal
| Measure |
Ixekizumab
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Guselkumab
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
|---|---|---|
|
Blinded Treatment Period (Weeks 0-24)
Screen Failure
|
1
|
1
|
|
Blinded Treatment Period (Weeks 0-24)
Adverse Event
|
15
|
8
|
|
Blinded Treatment Period (Weeks 0-24)
Protocol Violation
|
3
|
8
|
|
Blinded Treatment Period (Weeks 0-24)
Withdrawal by Subject
|
17
|
9
|
|
Blinded Treatment Period (Weeks 0-24)
Lack of Efficacy
|
2
|
3
|
|
Blinded Treatment Period (Weeks 0-24)
Pregnancy
|
1
|
2
|
|
Blinded Treatment Period (Weeks 0-24)
Physician Decision
|
1
|
0
|
|
Blinded Treatment Period (Weeks 0-24)
Lost to Follow-up
|
14
|
13
|
|
Blinded Treatment Period (Weeks 0-24)
Sponsor Decision
|
0
|
1
|
|
Blinded Treatment Period (Weeks 0-24)
Alkaline Phosphatase (ALP) level reached
|
0
|
1
|
|
Blinded Treatment Period (Weeks 0-24)
Noncompliant to protocol procedures
|
1
|
2
|
|
Post-Treatment Follow Up (Weeks 25-36)
Withdrawal by Subject
|
22
|
12
|
|
Post-Treatment Follow Up (Weeks 25-36)
Lack of Efficacy
|
8
|
19
|
|
Post-Treatment Follow Up (Weeks 25-36)
Physician Decision
|
4
|
3
|
|
Post-Treatment Follow Up (Weeks 25-36)
Did not wish to return to study
|
3
|
2
|
|
Post-Treatment Follow Up (Weeks 25-36)
Discontinued Trt and Completed Follow Up
|
14
|
8
|
|
Post-Treatment Follow Up (Weeks 25-36)
Not Compliant to Protocol Procedures
|
8
|
11
|
|
Post-Treatment Follow Up (Weeks 25-36)
Sponsor Decision
|
0
|
1
|
|
Post-Treatment Follow Up (Weeks 25-36)
Repeat Infections
|
0
|
1
|
Baseline Characteristics
All randomized participants who received at least one dose of study drug and had baseline Age data.
Baseline characteristics by cohort
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Total
n=1027 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 13.90 • n=519 Participants • All randomized participants who received at least one dose of study drug and had baseline Age data.
|
49.0 years
STANDARD_DEVIATION 14.88 • n=506 Participants • All randomized participants who received at least one dose of study drug and had baseline Age data.
|
49.0 years
STANDARD_DEVIATION 14.39 • n=1025 Participants • All randomized participants who received at least one dose of study drug and had baseline Age data.
|
|
Sex: Female, Male
Female
|
182 Participants
n=520 Participants
|
193 Participants
n=507 Participants
|
375 Participants
n=1027 Participants
|
|
Sex: Female, Male
Male
|
338 Participants
n=520 Participants
|
314 Participants
n=507 Participants
|
652 Participants
n=1027 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
127 Participants
n=520 Participants
|
120 Participants
n=507 Participants
|
247 Participants
n=1027 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
383 Participants
n=520 Participants
|
379 Participants
n=507 Participants
|
762 Participants
n=1027 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=520 Participants
|
8 Participants
n=507 Participants
|
18 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=520 Participants
|
6 Participants
n=507 Participants
|
13 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=520 Participants
|
35 Participants
n=507 Participants
|
66 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=520 Participants
|
2 Participants
n=507 Participants
|
4 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=520 Participants
|
29 Participants
n=507 Participants
|
67 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
White
|
439 Participants
n=520 Participants
|
431 Participants
n=507 Participants
|
870 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=520 Participants
|
4 Participants
n=507 Participants
|
6 Participants
n=1027 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=520 Participants
|
0 Participants
n=507 Participants
|
1 Participants
n=1027 Participants
|
|
Region of Enrollment
Canada
|
103 Participants
n=520 Participants
|
106 Participants
n=507 Participants
|
209 Participants
n=1027 Participants
|
|
Region of Enrollment
United States
|
417 Participants
n=520 Participants
|
401 Participants
n=507 Participants
|
818 Participants
n=1027 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
|
41.3 percentage of participants
Interval 37.1 to 45.6
|
24.9 percentage of participants
Interval 21.1 to 28.6
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 75
|
22.9 percentage of participants
Interval 19.3 to 26.5
|
5.1 percentage of participants
Interval 3.2 to 7.0
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 90
|
21.0 percentage of participants
Interval 17.5 to 24.5
|
7.9 percentage of participants
Interval 5.5 to 10.2
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 100
|
6.7 percentage of participants
Interval 4.6 to 8.9
|
1.4 percentage of participants
Interval 0.4 to 2.4
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 90
|
58.5 percentage of participants
Interval 54.2 to 62.7
|
35.9 percentage of participants
Interval 31.7 to 40.1
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)
|
41.9 percentage of participants
Interval 37.7 to 46.2
|
25.2 percentage of participants
Interval 21.5 to 29.0
|
SECONDARY outcome
Timeframe: Week 1Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 50
|
27.5 percentage of participants
Interval 23.7 to 31.3
|
9.3 percentage of participants
Interval 6.7 to 11.8
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 100
|
29.6 percentage of participants
Interval 25.7 to 33.5
|
13.6 percentage of participants
Interval 10.6 to 16.6
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Outcome measures
| Measure |
Ixekizumab
n=520 Participants
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
Guselkumab
n=507 Participants
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
|
|---|---|---|
|
Percentage of Participants Achieving PASI 100
|
50.0 percentage of participants
Interval 45.7 to 54.3
|
52.3 percentage of participants
Interval 47.9 to 56.6
|
Adverse Events
Ixekizumab
Serious events: 18 serious events
Other events: 113 other events
Deaths: 0 deaths
Guselkumab
Serious events: 16 serious events
Other events: 73 other events
Deaths: 0 deaths
Ixekizumab Post-Treatment Follow Up
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Guselkumab Post-Treatment Follow Up
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixekizumab
n=519 participants at risk
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Guselkumab
n=506 participants at risk
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Ixekizumab Post-Treatment Follow Up
n=465 participants at risk
Participants who received ixekizumab in the blinded treatment periods entered the post treatment follow up period.
|
Guselkumab Post-Treatment Follow Up
n=456 participants at risk
Participants who received guselkumab in the blinded treatment periods entered the post treatment follow up period.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
2/506 • Number of events 2 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/456 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/465 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/465 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
2/506 • Number of events 3 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/465 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infection
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/465 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/465 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/456 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage iv
|
0.00%
0/182 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
1/193 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/164 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/170 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/465 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Myxoedema coma
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.39%
2/519 • Number of events 2 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/456 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/337 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/313 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/301 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.35%
1/286 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.19%
1/519 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/506 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/519 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
1/506 • Number of events 1 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/456 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Ixekizumab
n=519 participants at risk
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Guselkumab
n=506 participants at risk
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
|
Ixekizumab Post-Treatment Follow Up
n=465 participants at risk
Participants who received ixekizumab in the blinded treatment periods entered the post treatment follow up period.
|
Guselkumab Post-Treatment Follow Up
n=456 participants at risk
Participants who received guselkumab in the blinded treatment periods entered the post treatment follow up period.
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
9.4%
49/519 • Number of events 80 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
6/506 • Number of events 9 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/465 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/456 • Number of events 2 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
34/519 • Number of events 41 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
27/506 • Number of events 29 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
5/465 • Number of events 5 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.44%
2/456 • Number of events 2 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
40/519 • Number of events 44 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.1%
41/506 • Number of events 50 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
6/465 • Number of events 6 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
6/456 • Number of events 6 • Up to 48 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60