Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011) (NCT NCT01729754)
NCT ID: NCT01729754
Last Updated: 2022-03-08
Results Overview
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1090 participants
Primary outcome timeframe
Week 12
Results posted on
2022-03-08
Participant Flow
The tables below present the Participant Flow for the Base Study only (Weeks 0 to 52: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 24 weeks).
Participant milestones
| Measure |
Tildrakizumab 200 mg (Parts 1 & 2)
Participants received tildrakizumab 200 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 200 mg (Parts 1, 2, & 3)
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3)
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 100 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1 & 2)
Participants received tildrakizumab 100 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3)
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Placebo (Part 1)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 plus etanercept PBO twice weekly until Week 12 (Part 1).
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
20
|
184
|
110
|
18
|
21
|
268
|
14
|
72
|
70
|
313
|
|
Part 1
COMPLETED
|
6
|
184
|
110
|
6
|
21
|
268
|
0
|
72
|
70
|
289
|
|
Part 1
NOT COMPLETED
|
14
|
0
|
0
|
12
|
0
|
0
|
14
|
0
|
0
|
24
|
|
Part 2
STARTED
|
6
|
184
|
110
|
5
|
21
|
268
|
0
|
72
|
70
|
289
|
|
Part 2
COMPLETED
|
0
|
184
|
110
|
0
|
21
|
268
|
0
|
69
|
66
|
277
|
|
Part 2
NOT COMPLETED
|
6
|
0
|
0
|
5
|
0
|
0
|
0
|
3
|
4
|
12
|
|
Part 3
STARTED
|
0
|
170
|
110
|
0
|
21
|
237
|
0
|
69
|
66
|
121
|
|
Part 3
COMPLETED
|
0
|
165
|
105
|
0
|
17
|
224
|
0
|
66
|
65
|
114
|
|
Part 3
NOT COMPLETED
|
0
|
5
|
5
|
0
|
4
|
13
|
0
|
3
|
1
|
7
|
Reasons for withdrawal
| Measure |
Tildrakizumab 200 mg (Parts 1 & 2)
Participants received tildrakizumab 200 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 200 mg (Parts 1, 2, & 3)
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3)
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 100 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1 & 2)
Participants received tildrakizumab 100 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3)
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Placebo (Part 1)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 plus etanercept PBO twice weekly until Week 12 (Part 1).
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
Adverse Event
|
2
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
5
|
|
Part 1
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 1
Lost to Follow-up
|
1
|
0
|
0
|
2
|
0
|
0
|
3
|
0
|
0
|
3
|
|
Part 1
Non-compliance with Study Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Part 1
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 1
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 1
Protocol Violation
|
2
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1
Withdrawal by Subject
|
5
|
0
|
0
|
7
|
0
|
0
|
5
|
0
|
0
|
6
|
|
Part 1
Other Protocol Specified Criteria
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
4
|
|
Part 2
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Part 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Part 2
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Part 2
Non-Compliance with Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2
Withdrawal by Subject
|
3
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
1
|
4
|
|
Part 2
Other Protocol Specified Criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 3
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
5
|
0
|
0
|
0
|
3
|
|
Part 3
Death
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 3
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
4
|
|
Part 3
Lost to Follow-up
|
0
|
1
|
2
|
0
|
0
|
3
|
0
|
0
|
1
|
0
|
|
Part 3
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3
Withdrawal by Subject
|
0
|
4
|
1
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
|
Part 3
Other Protocol Specified Criteria
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Analysis populations includes randomized participants with PASI value at baseline.
Baseline characteristics by cohort
| Measure |
Tildrakizumab 200 mg (Part 1)
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1).
|
Tildrakizumab 100 mg (Part 1)
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1).
|
Placebo (Part 1)
n=156 Participants
Participants received tildrakizumab placebo SC at Weeks 0 and 4 and etanercept placebo SC twice weekly until Week 12 (Part 1).
|
Etanercept 50 mg (Part 1)
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Total
n=1090 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.6 Years
STANDARD_DEVIATION 13.62 • n=314 Participants
|
44.6 Years
STANDARD_DEVIATION 13.59 • n=307 Participants
|
46.4 Years
STANDARD_DEVIATION 12.20 • n=156 Participants
|
45.8 Years
STANDARD_DEVIATION 13.97 • n=313 Participants
|
45.2 Years
STANDARD_DEVIATION 13.52 • n=1090 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=314 Participants
|
87 Participants
n=307 Participants
|
44 Participants
n=156 Participants
|
91 Participants
n=313 Participants
|
311 Participants
n=1090 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=314 Participants
|
220 Participants
n=307 Participants
|
112 Participants
n=156 Participants
|
222 Participants
n=313 Participants
|
779 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=314 Participants
|
1 Participants
n=307 Participants
|
0 Participants
n=156 Participants
|
1 Participants
n=313 Participants
|
2 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=314 Participants
|
9 Participants
n=307 Participants
|
3 Participants
n=156 Participants
|
10 Participants
n=313 Participants
|
36 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=314 Participants
|
0 Participants
n=307 Participants
|
1 Participants
n=156 Participants
|
0 Participants
n=313 Participants
|
1 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=314 Participants
|
7 Participants
n=307 Participants
|
1 Participants
n=156 Participants
|
8 Participants
n=313 Participants
|
24 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
White
|
284 Participants
n=314 Participants
|
279 Participants
n=307 Participants
|
144 Participants
n=156 Participants
|
289 Participants
n=313 Participants
|
996 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=314 Participants
|
7 Participants
n=307 Participants
|
3 Participants
n=156 Participants
|
3 Participants
n=313 Participants
|
15 Participants
n=1090 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=314 Participants
|
4 Participants
n=307 Participants
|
4 Participants
n=156 Participants
|
2 Participants
n=313 Participants
|
16 Participants
n=1090 Participants
|
|
Body weight
<=90 kg
|
180 Participants
n=314 Participants
|
176 Participants
n=307 Participants
|
90 Participants
n=156 Participants
|
180 Participants
n=313 Participants
|
626 Participants
n=1090 Participants
|
|
Body weight
>90 kg
|
134 Participants
n=314 Participants
|
131 Participants
n=307 Participants
|
66 Participants
n=156 Participants
|
133 Participants
n=313 Participants
|
464 Participants
n=1090 Participants
|
|
Prior exposure to biologic therapy for psoriasis
Yes
|
38 Participants
n=314 Participants
|
39 Participants
n=307 Participants
|
20 Participants
n=156 Participants
|
37 Participants
n=313 Participants
|
134 Participants
n=1090 Participants
|
|
Prior exposure to biologic therapy for psoriasis
No
|
276 Participants
n=314 Participants
|
268 Participants
n=307 Participants
|
136 Participants
n=156 Participants
|
276 Participants
n=313 Participants
|
956 Participants
n=1090 Participants
|
|
Psoriasis Area Sensitivity Index (PASI)
|
19.8 Score on a scale
STANDARD_DEVIATION 7.52 • n=314 Participants • Analysis populations includes randomized participants with PASI value at baseline.
|
20.5 Score on a scale
STANDARD_DEVIATION 7.63 • n=307 Participants • Analysis populations includes randomized participants with PASI value at baseline.
|
20.0 Score on a scale
STANDARD_DEVIATION 7.57 • n=155 Participants • Analysis populations includes randomized participants with PASI value at baseline.
|
20.2 Score on a scale
STANDARD_DEVIATION 7.36 • n=312 Participants • Analysis populations includes randomized participants with PASI value at baseline.
|
20.1 Score on a scale
STANDARD_DEVIATION 7.51 • n=1088 Participants • Analysis populations includes randomized participants with PASI value at baseline.
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)
|
65.6 Percentage of participants
|
61.2 Percentage of participants
|
5.8 Percentage of participants
|
48.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)
|
59.2 Percentage of participants
|
54.7 Percentage of participants
|
4.5 Percentage of participants
|
47.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)
|
49.4 Percentage of participants
|
44.3 Percentage of participants
|
55.1 Percentage of participants
|
54.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
1.3 Percentage of participants
|
1.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Analysis population includes all participants randomized to tildrakizumab or etanercept in Part 1 who received at least one dose of study medication in Part 2.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=299 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=294 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=289 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)
|
72.6 Percentage of participants
|
73.5 Percentage of participants
|
53.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 40Population: Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=107 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=108 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=67 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=64 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=114 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)
|
96.3 Percentage of participants
|
92.6 Percentage of participants
|
97.6 Percentage of participants
|
63.3 Percentage of participants
|
66.7 Percentage of participants
|
61.9 Percentage of participants
|
82.1 Percentage of participants
|
68.8 Percentage of participants
|
57.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=105 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=104 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=204 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=66 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=63 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=113 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)
|
97.1 Percentage of participants
|
94.2 Percentage of participants
|
93.6 Percentage of participants
|
66.7 Percentage of participants
|
78.9 Percentage of participants
|
68.4 Percentage of participants
|
92.4 Percentage of participants
|
85.7 Percentage of participants
|
81.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 28Population: Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in Part 2.
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=299 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=294 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=289 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)
|
69.2 Percentage of participants
|
64.6 Percentage of participants
|
45.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 40Population: Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40.
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=107 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=106 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=59 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=66 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=64 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=112 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)
|
83.2 Percentage of participants
|
79.2 Percentage of participants
|
84.9 Percentage of participants
|
57.6 Percentage of participants
|
38.1 Percentage of participants
|
57.1 Percentage of participants
|
75.8 Percentage of participants
|
62.5 Percentage of participants
|
50.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52.
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=105 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=103 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=204 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=59 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=66 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=63 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=111 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)
|
84.8 Percentage of participants
|
77.7 Percentage of participants
|
79.4 Percentage of participants
|
50.8 Percentage of participants
|
42.1 Percentage of participants
|
57.9 Percentage of participants
|
77.3 Percentage of participants
|
55.6 Percentage of participants
|
68.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis population includes randomized participants who received at least one dose of study medication in study Part 1.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)
|
36.6 Percentage of participants
|
38.8 Percentage of participants
|
1.3 Percentage of participants
|
21.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in study Part 2.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=293 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=290 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=277 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)
|
57.7 Percentage of participants
|
55.5 Percentage of participants
|
30.7 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 40Population: Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=107 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=108 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=67 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=64 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=114 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)
|
76.6 Percentage of participants
|
73.1 Percentage of participants
|
78.8 Percentage of participants
|
28.3 Percentage of participants
|
23.8 Percentage of participants
|
42.9 Percentage of participants
|
64.2 Percentage of participants
|
48.4 Percentage of participants
|
24.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=105 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=104 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=204 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=66 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=63 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=113 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)
|
81.9 Percentage of participants
|
68.3 Percentage of participants
|
78.4 Percentage of participants
|
31.7 Percentage of participants
|
26.3 Percentage of participants
|
42.1 Percentage of participants
|
63.6 Percentage of participants
|
47.6 Percentage of participants
|
41.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis population includes randomized participants who received at least one dose of study medication in study Part 1 and with valid PASI value at baseline and Week 12.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=313 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)
|
11.8 Perentage of participants
|
12.4 Perentage of participants
|
0 Perentage of participants
|
4.8 Perentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in study Part 2.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=293 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=290 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=277 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)
|
27.0 Percentage of participants
|
22.8 Percentage of participants
|
11.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 40Population: Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=107 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=108 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=67 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=64 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=114 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)
|
39.3 Percentage of participants
|
38.9 Percentage of participants
|
33.5 Percentage of participants
|
11.7 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
29.9 Percentage of participants
|
28.1 Percentage of participants
|
5.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=105 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=104 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=204 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=66 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=63 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=113 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)
|
46.7 Percentage of participants
|
37.5 Percentage of participants
|
35.3 Percentage of participants
|
10.0 Percentage of participants
|
5.3 Percentage of participants
|
31.6 Percentage of participants
|
39.4 Percentage of participants
|
23.8 Percentage of participants
|
15.9 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=312 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=312 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Baseline Dermatology Life Quality Index (DLQI)
|
13.2 Score on a scale
Standard Deviation 7.03
|
14.8 Score on a scale
Standard Deviation 7.24
|
13.7 Score on a scale
Standard Deviation 6.98
|
14.5 Score on a scale
Standard Deviation 7.20
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=312 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=156 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=312 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the DLQI at Week 12 (Part 1)
|
-10.3 Score on a scale
Interval -11.0 to -9.7
|
-10.2 Score on a scale
Interval -10.9 to -9.6
|
-2.0 Score on a scale
Interval -2.9 to -1.1
|
-8.9 Score on a scale
Interval -9.6 to -8.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: Analysis population includes randomized participants who received at least one dose of study medication and with baseline or post-baseline DLQI values in Part 1 or Part 2.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=299 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=294 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=289 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the DLQI at Week 28 (Part 2)
|
-11.7 Score on a scale
Interval -12.3 to -11.1
|
-11.2 Score on a scale
Interval -11.8 to -10.5
|
-9.5 Score on a scale
Interval -10.1 to -8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 40Population: Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=108 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=107 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=58 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=69 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=65 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=114 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the DLQI at Week 40 (Part 3)
|
-11.6 Score on a scale
Standard Deviation 6.61
|
-12.0 Score on a scale
Standard Deviation 7.11
|
-13.2 Score on a scale
Standard Deviation 6.92
|
-9.7 Score on a scale
Standard Deviation 5.62
|
-9.0 Score on a scale
Standard Deviation 7.76
|
-9.8 Score on a scale
Standard Deviation 7.25
|
-10.4 Score on a scale
Standard Deviation 6.66
|
-10.1 Score on a scale
Standard Deviation 6.08
|
-10.8 Score on a scale
Standard Deviation 6.81
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=105 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=104 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=205 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=58 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=65 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=63 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=114 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the DLQI at Week 52 (Part 3)
|
-11.3 Score on a scale
Standard Deviation 6.16
|
-11.5 Score on a scale
Standard Deviation 7.26
|
-13.1 Score on a scale
Standard Deviation 6.80
|
-9.2 Score on a scale
Standard Deviation 6.18
|
-9.4 Score on a scale
Standard Deviation 8.47
|
-9.3 Score on a scale
Standard Deviation 7.22
|
-11.1 Score on a scale
Standard Deviation 6.45
|
-10.4 Score on a scale
Standard Deviation 6.38
|
-11.5 Score on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with a valid DLQI value at Week 12.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=306 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=296 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=150 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=304 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)
|
47.4 Percentage of participants
|
40.2 Percentage of participants
|
8.0 Percentage of participants
|
35.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Analysis population includes randomized participants to tildrakizumab 200 mg, tildrakizumab 100 mg or etanercept in Part 1, who received at least one dose of study medication in Part 2 and with a valid DLQI value at Week 28.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=297 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=290 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=282 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)
|
65.0 Percentage of participants
|
54.1 Percentage of participants
|
39.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 40Population: Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=108 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=108 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=69 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=66 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=116 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)
|
72.2 Percentage of participants
|
68.5 Percentage of participants
|
71.2 Percentage of participants
|
41.7 Percentage of participants
|
9.5 Percentage of participants
|
19.0 Percentage of participants
|
50.7 Percentage of participants
|
51.5 Percentage of participants
|
38.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=105 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=105 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=205 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=19 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=65 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=64 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=116 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)
|
72.4 Percentage of participants
|
71.4 Percentage of participants
|
68.8 Percentage of participants
|
40.0 Percentage of participants
|
10.5 Percentage of participants
|
42.1 Percentage of participants
|
60.0 Percentage of participants
|
57.8 Percentage of participants
|
48.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4, Week 8 or Week 12Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 4, 8 and 12).
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=155 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=312 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in PASI Score Over Time (Part 1)
Week 4
|
-8.1 Scores on a scale
Standard Deviation 6.54
|
-7.9 Scores on a scale
Standard Deviation 6.83
|
-2.3 Scores on a scale
Standard Deviation 6.18
|
-7.0 Scores on a scale
Standard Deviation 7.15
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in PASI Score Over Time (Part 1)
Week 8
|
-13.1 Scores on a scale
Standard Deviation 7.71
|
-12.8 Scores on a scale
Standard Deviation 7.57
|
-3.1 Scores on a scale
Standard Deviation 7.18
|
-11.4 Scores on a scale
Standard Deviation 8.77
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in PASI Score Over Time (Part 1)
Week 12
|
-15.4 Scores on a scale
Standard Deviation 7.77
|
-15.1 Scores on a scale
Standard Deviation 7.94
|
-3.4 Scores on a scale
Standard Deviation 6.77
|
-13.5 Scores on a scale
Standard Deviation 8.29
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16, Week 22 or Week 28Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 2 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 16, 22 and 28).
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=312 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=72 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=68 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in PASI Score Over Time (Part 2)
Week 16
|
-16.2 Scores on a scale
Standard Deviation 7.70
|
-15.9 Scores on a scale
Standard Deviation 7.87
|
-14.2 Scores on a scale
Standard Deviation 8.20
|
-11.6 Scores on a scale
Standard Deviation 6.97
|
-9.6 Scores on a scale
Standard Deviation 6.71
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in PASI Score Over Time (Part 2)
Week 22
|
-17.1 Scores on a scale
Standard Deviation 7.66
|
-16.7 Scores on a scale
Standard Deviation 7.88
|
-14.5 Scores on a scale
Standard Deviation 8.32
|
-15.1 Scores on a scale
Standard Deviation 6.55
|
-13.7 Scores on a scale
Standard Deviation 7.18
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in PASI Score Over Time (Part 2)
Week 28
|
-17.0 Scores on a scale
Standard Deviation 7.81
|
-16.5 Scores on a scale
Standard Deviation 7.71
|
-14.8 Scores on a scale
Standard Deviation 7.85
|
-17.3 Scores on a scale
Standard Deviation 7.62
|
-14.5 Scores on a scale
Standard Deviation 8.46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 32, 36, 40, 46 and 52).
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=108 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=110 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=68 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=65 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=121 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in PASI Score Over Time (Part 3)
Week 32
|
-19.0 Scores on a scale
Standard Deviation 7.13
|
-19.0 Scores on a scale
Standard Deviation 8.03
|
-18.7 Scores on a scale
Standard Deviation 6.83
|
-14.0 Scores on a scale
Standard Deviation 5.72
|
-15.0 Scores on a scale
Standard Deviation 6.69
|
-15.5 Scores on a scale
Standard Deviation 7.08
|
-16.9 Scores on a scale
Standard Deviation 7.68
|
-16.4 Scores on a scale
Standard Deviation 8.02
|
-10.5 Scores on a scale
Standard Deviation 6.25
|
|
Mean Change From Baseline in PASI Score Over Time (Part 3)
Week 36
|
-18.9 Scores on a scale
Standard Deviation 7.11
|
-19.0 Scores on a scale
Standard Deviation 8.17
|
-18.9 Scores on a scale
Standard Deviation 7.18
|
-14.5 Scores on a scale
Standard Deviation 5.92
|
-15.7 Scores on a scale
Standard Deviation 8.09
|
-16.0 Scores on a scale
Standard Deviation 8.13
|
-17.6 Scores on a scale
Standard Deviation 6.80
|
-16.7 Scores on a scale
Standard Deviation 8.19
|
-12.9 Scores on a scale
Standard Deviation 6.64
|
|
Mean Change From Baseline in PASI Score Over Time (Part 3)
Week 40
|
-18.8 Scores on a scale
Standard Deviation 7.04
|
-18.5 Scores on a scale
Standard Deviation 7.56
|
-18.7 Scores on a scale
Standard Deviation 6.95
|
-14.4 Scores on a scale
Standard Deviation 6.00
|
-16.0 Scores on a scale
Standard Deviation 8.73
|
-16.5 Scores on a scale
Standard Deviation 8.59
|
-17.9 Scores on a scale
Standard Deviation 7.03
|
-16.9 Scores on a scale
Standard Deviation 7.99
|
-14.6 Scores on a scale
Standard Deviation 6.42
|
|
Mean Change From Baseline in PASI Score Over Time (Part 3)
Week 46
|
-19.0 Scores on a scale
Standard Deviation 7.13
|
-18.1 Scores on a scale
Standard Deviation 7.45
|
-18.7 Scores on a scale
Standard Deviation 6.76
|
-14.5 Scores on a scale
Standard Deviation 5.99
|
-16.2 Scores on a scale
Standard Deviation 8.76
|
-15.8 Scores on a scale
Standard Deviation 9.72
|
-17.9 Scores on a scale
Standard Deviation 6.24
|
-17.1 Scores on a scale
Standard Deviation 7.30
|
-15.6 Scores on a scale
Standard Deviation 7.16
|
|
Mean Change From Baseline in PASI Score Over Time (Part 3)
Week 52
|
-18.9 Scores on a scale
Standard Deviation 7.13
|
-18.4 Scores on a scale
Standard Deviation 7.66
|
-18.4 Scores on a scale
Standard Deviation 6.65
|
-14.6 Scores on a scale
Standard Deviation 5.72
|
-15.5 Scores on a scale
Standard Deviation 9.00
|
-16.3 Scores on a scale
Standard Deviation 9.55
|
-18.1 Scores on a scale
Standard Deviation 7.00
|
-17.0 Scores on a scale
Standard Deviation 7.30
|
-16.2 Scores on a scale
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Baseline and Week 4, Week 8 or Week 12Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 4, 8 and 12).
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=155 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=312 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
Week 4
|
-40.2 Percent change
Standard Deviation 27.86
|
-39.3 Percent change
Standard Deviation 30.02
|
-11.7 Percent change
Standard Deviation 30.37
|
-33.9 Percent change
Standard Deviation 33.55
|
—
|
—
|
—
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
Week 8
|
-65.7 Percent change
Standard Deviation 26.58
|
-63.8 Percent change
Standard Deviation 29.65
|
-15.3 Percent change
Standard Deviation 35.95
|
-55.7 Percent change
Standard Deviation 35.10
|
—
|
—
|
—
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
Week 12
|
-78.0 Percent change
Standard Deviation 22.31
|
-74.8 Percent change
Standard Deviation 28.11
|
-17.4 Percent change
Standard Deviation 32.95
|
-66.7 Percent change
Standard Deviation 30.78
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16, Week 22 or Week 28Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 2 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 16, 22 and 28).
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=314 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=307 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=312 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=72 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=68 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
Week 28
|
-85.7 Percent change
Standard Deviation 17.44
|
-82.5 Percent change
Standard Deviation 22.33
|
-73.5 Percent change
Standard Deviation 24.40
|
-84.0 Percent change
Standard Deviation 16.89
|
-72.9 Percent change
Standard Deviation 30.05
|
—
|
—
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
Week 16
|
-82.0 Percent change
Standard Deviation 21.26
|
-79.3 Percent change
Standard Deviation 25.27
|
-70.3 Percent change
Standard Deviation 27.55
|
-59.2 Percent change
Standard Deviation 28.34
|
-49.4 Percent change
Standard Deviation 28.95
|
—
|
—
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
Week 22
|
-86.6 Percent change
Standard Deviation 17.58
|
-82.9 Percent change
Standard Deviation 23.16
|
-71.9 Percent change
Standard Deviation 29.40
|
-77.9 Percent change
Standard Deviation 20.25
|
-70.1 Percent change
Standard Deviation 25.24
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52Population: Analysis population includes randomized participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 32, 36, 40, 46 and 52).
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28.
Outcome measures
| Measure |
Tildrakizumab 200 mg
n=108 Participants
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Tildrakizumab 100 mg
n=110 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Placebo
n=212 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
|
Etanercept 50 mg
n=60 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
|
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR
n=21 Participants
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
|
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
n=68 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
|
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
n=65 Participants
Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
|
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
n=121 Participants
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Week 32
|
-94.9 Percent change
Standard Deviation 6.19
|
-94.0 Percent change
Standard Deviation 7.02
|
-94.3 Percent change
Standard Deviation 7.33
|
-77.1 Percent change
Standard Deviation 16.73
|
-71.1 Percent change
Standard Deviation 13.21
|
-75.3 Percent change
Standard Deviation 16.90
|
-84.4 Percent change
Standard Deviation 24.18
|
-81.6 Percent change
Standard Deviation 21.69
|
-54.7 Percent change
Standard Deviation 24.05
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Week 36
|
-94.5 Percent change
Standard Deviation 7.47
|
-94.0 Percent change
Standard Deviation 6.93
|
-94.4 Percent change
Standard Deviation 7.06
|
-79.9 Percent change
Standard Deviation 15.94
|
-74.4 Percent change
Standard Deviation 15.69
|
-77.9 Percent change
Standard Deviation 15.47
|
-87.7 Percent change
Standard Deviation 15.20
|
-83.1 Percent change
Standard Deviation 19.83
|
-65.9 Percent change
Standard Deviation 21.35
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Week 40
|
-94.2 Percent change
Standard Deviation 7.69
|
-92.6 Percent change
Standard Deviation 10.25
|
-94.3 Percent change
Standard Deviation 7.40
|
-79.1 Percent change
Standard Deviation 17.10
|
-75.7 Percent change
Standard Deviation 19.24
|
-80.6 Percent change
Standard Deviation 17.57
|
-88.2 Percent change
Standard Deviation 14.55
|
-84.1 Percent change
Standard Deviation 17.08
|
-76.5 Percent change
Standard Deviation 17.98
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Week 46
|
-94.8 Percent change
Standard Deviation 7.77
|
-91.4 Percent change
Standard Deviation 12.09
|
-94.3 Percent change
Standard Deviation 7.64
|
-79.3 Percent change
Standard Deviation 17.77
|
-77.1 Percent change
Standard Deviation 19.67
|
-75.3 Percent change
Standard Deviation 23.35
|
-90.3 Percent change
Standard Deviation 12.32
|
-86.9 Percent change
Standard Deviation 13.08
|
-80.3 Percent change
Standard Deviation 17.92
|
|
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Week 52
|
-94.7 Percent change
Standard Deviation 8.06
|
-92.2 Percent change
Standard Deviation 10.57
|
-93.4 Percent change
Standard Deviation 9.81
|
-80.4 Percent change
Standard Deviation 15.68
|
-75.7 Percent change
Standard Deviation 36.00
|
-79.6 Percent change
Standard Deviation 21.46
|
-91.0 Percent change
Standard Deviation 12.16
|
-87.1 Percent change
Standard Deviation 12.90
|
-84.2 Percent change
Standard Deviation 16.07
|
Adverse Events
Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R
Serious events: 26 serious events
Other events: 167 other events
Deaths: 0 deaths
Tildrakizumab 100 mg (Parts 1, 2 & 3)
Serious events: 30 serious events
Other events: 151 other events
Deaths: 3 deaths
Placebo (Part 1)
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Etanercept 50 mg (Parts 1 & 2)
Serious events: 20 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R
n=527 participants at risk
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2 & 3)
n=487 participants at risk
Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and then every 12 weeks.
|
Placebo (Part 1)
n=156 participants at risk
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4.
|
Etanercept 50 mg (Parts 1 & 2)
n=313 participants at risk
Participants received etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
2/527 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.41%
2/487 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Atrial flutter
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.38%
2/527 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Pyelonephritis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Sepsis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Wound infection
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.38%
2/527 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Investigations
Blood glucose increased
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.57%
3/527 • Number of events 3 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.62%
3/487 • Number of events 3 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
2/313 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breact cancer
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Nervous system disorders
Radiculopathy
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.41%
2/487 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.32%
1/313 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/527 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.21%
1/487 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.19%
1/527 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/487 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/156 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.00%
0/313 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
Other adverse events
| Measure |
Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R
n=527 participants at risk
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
|
Tildrakizumab 100 mg (Parts 1, 2 & 3)
n=487 participants at risk
Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and then every 12 weeks.
|
Placebo (Part 1)
n=156 participants at risk
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4.
|
Etanercept 50 mg (Parts 1 & 2)
n=313 participants at risk
Participants received etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28.
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.95%
5/527 • Number of events 7 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
1.0%
5/487 • Number of events 5 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
8.9%
28/313 • Number of events 98 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
General disorders
Injection site reaction
|
0.76%
4/527 • Number of events 8 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.41%
2/487 • Number of events 2 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
5.4%
17/313 • Number of events 54 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
22.6%
119/527 • Number of events 173 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
23.0%
112/487 • Number of events 152 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
7.7%
12/156 • Number of events 14 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
20.1%
63/313 • Number of events 79 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
27/527 • Number of events 30 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
3.1%
15/487 • Number of events 18 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
0.64%
1/156 • Number of events 1 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
3.5%
11/313 • Number of events 14 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
14/527 • Number of events 17 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
5.3%
26/487 • Number of events 30 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
1.9%
3/156 • Number of events 3 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
3.2%
10/313 • Number of events 13 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
|
Nervous system disorders
Headache
|
5.7%
30/527 • Number of events 40 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
6.0%
29/487 • Number of events 46 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
3.8%
6/156 • Number of events 6 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
5.8%
18/313 • Number of events 31 • Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
|
Additional Information
Head-Clinical Development
Sun Pharma Advanced Research Company Limited
Phone: 912266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER