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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) (reSURFACE 2)

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ClinicalTrials.gov Identifier: NCT01729754
Recruitment Status : Completed
First Posted : November 20, 2012
Results First Posted : June 27, 2018
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Tildrakizumab 200 mg
Drug: Tildrakizumab 100 mg
Drug: Tildrakizumab Placebo
Drug: Etanercept Placebo
Drug: Etanercept 50 mg
Enrollment 1090
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Tildrakizumab 200 mg (Parts 1 & 2) Tildrakizumab 200 mg (Parts 1, 2, & 3) Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Tildrakizumab 100 mg (Parts 1 & 2) Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Tildrakizumab 100 mg (Parts 1, 2, & 3) Placebo (Part 1) Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. Participants received PBO to tildrakizumab SC on Weeks 0 and 4 plus etanercept PBO twice weekly until Week 12 (Part 1). 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. 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 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.
Period Title: Part 1
Started 20 184 110 18 21 268 14 72 70 313
Completed 6 184 110 6 21 268 0 72 70 289
Not Completed 14 0 0 12 0 0 14 0 0 24
Reason Not Completed
Adverse Event             2             0             0             1             0             0             2             0             0             5
Lack of Efficacy             1             0             0             0             0             0             2             0             0             0
Lost to Follow-up             1             0             0             2             0             0             3             0             0             3
Non-compliance with Study Drug             1             0             0             0             0             0             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             4
Pregnancy             0             0             0             1             0             0             0             0             0             1
Progressive Disease             0             0             0             0             0             0             0             0             0             1
Protocol Violation             2             0             0             1             0             0             1             0             0             0
Withdrawal by Subject             5             0             0             7             0             0             5             0             0             6
Other Protocol Specified Criteria             2             0             0             0             0             0             1             0             0             4
Period Title: Part 2
Started 6 184 110 5 [1] 21 268 0 72 70 289
Completed 0 184 110 0 21 268 0 69 66 277
Not Completed 6 0 0 5 0 0 0 3 4 12
Reason Not Completed
Adverse Event             2             0             0             0             0             0             0             0             1             2
Lack of Efficacy             0             0             0             0             0             0             0             0             2             2
Lost to Follow-up             0             0             0             2             0             0             0             1             0             2
Non-Compliance with Study Drug             0             0             0             0             0             0             0             0             0             1
Pregnancy             0             0             0             1             0             0             0             0             0             1
Withdrawal by Subject             3             0             0             2             0             0             0             1             1             4
Other Protocol Specified Criteria             1             0             0             0             0             0             0             1             0             0
[1]
1 participant completed Part 1 but did not enter Part 2
Period Title: Part 3
Started 0 170 [1] 110 0 21 237 [2] 0 69 66 121 [3]
Completed 0 165 105 0 17 224 0 66 65 114
Not Completed 0 5 5 0 4 13 0 3 1 7
Reason Not Completed
Adverse Event             0             0             1             0             0             5             0             0             0             3
Death             0             0             0             0             0             2             0             0             0             0
Lack of Efficacy             0             0             0             0             2             0             0             0             0             4
Lost to Follow-up             0             1             2             0             0             3             0             0             1             0
Physician Decision             0             0             1             0             0             0             0             0             0             0
Withdrawal by Subject             0             4             1             0             2             1             0             2             0             0
Other Protocol Specified Criteria             0             0             0             0             0             2             0             1             0             0
[1]
14 participants completed Part 2 but did not enter Part 3
[2]
31 participants completed Part 2 but did not enter Part 3
[3]
156 participants completed Part 2 but did not enter Part 3
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1) Etanercept 50 mg (Part 1) Total
Hide Arm/Group Description Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1). Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1). Participants received tildrakizumab placebo SC at Weeks 0 and 4 and etanercept placebo SC twice weekly until Week 12 (Part 1). Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. Total of all reporting groups
Overall Number of Baseline Participants 314 307 156 313 1090
Hide Baseline Analysis Population Description
Baseline characteristics are presented for the study arms: Tildrakizumab 200 mg, Tildrakizumab 100 mg, Placebo, Etanercept 50 mg, as per the treatments administered in Part 1 (Baseline Period).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
44.6  (13.62) 44.6  (13.59) 46.4  (12.20) 45.8  (13.97) 45.2  (13.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
Female
89
  28.3%
87
  28.3%
44
  28.2%
91
  29.1%
311
  28.5%
Male
225
  71.7%
220
  71.7%
112
  71.8%
222
  70.9%
779
  71.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.3%
2
   0.2%
Asian
14
   4.5%
9
   2.9%
3
   1.9%
10
   3.2%
36
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.1%
Black or African American
8
   2.5%
7
   2.3%
1
   0.6%
8
   2.6%
24
   2.2%
White
284
  90.4%
279
  90.9%
144
  92.3%
289
  92.3%
996
  91.4%
More than one race
2
   0.6%
7
   2.3%
3
   1.9%
3
   1.0%
15
   1.4%
Unknown or Not Reported
6
   1.9%
4
   1.3%
4
   2.6%
2
   0.6%
16
   1.5%
Body weight  
Measure Type: Count of Participants
Unit of measure:  Participants
<=90 kg Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
180
  57.3%
176
  57.3%
90
  57.7%
180
  57.5%
626
  57.4%
>90 kg Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
134
  42.7%
131
  42.7%
66
  42.3%
133
  42.5%
464
  42.6%
Prior exposure to biologic therapy for psoriasis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
38
  12.1%
39
  12.7%
20
  12.8%
37
  11.8%
134
  12.3%
No Number Analyzed 314 participants 307 participants 156 participants 313 participants 1090 participants
276
  87.9%
268
  87.3%
136
  87.2%
276
  88.2%
956
  87.7%
[1]
Measure Description: The following therapies constitute biologics therapy for psoriasis: efalizumab (RAPTIVA®), alefacept (AMEVIVE®), infliximab (REMICADE®), adalimumab (HUMIRA®), ustekinumab (STELARA®), and etanercept (Enbrel®)
Psoriasis Area Sensitivity Index (PASI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 314 participants 307 participants 155 participants 312 participants 1088 participants
19.8  (7.52) 20.5  (7.63) 20.0  (7.57) 20.2  (7.36) 20.1  (7.51)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Analysis populations includes randomized participants with PASI value at baseline.
1.Primary Outcome
Title Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 156 313
Measure Type: Number
Unit of Measure: Percentage of participants
65.6 61.2 5.8 48.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 59.8
Confidence Interval (2-Sided) 95%
52.9 to 65.9
Estimation Comments Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 55.5
Confidence Interval (2-Sided) 95%
48.3 to 61.8
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
2.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 156 313
Measure Type: Number
Unit of Measure: Percentage of participants
59.2 54.7 4.5 47.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 54.7
Confidence Interval (2-Sided) 95%
47.9 to 60.8
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 50.2
Confidence Interval (2-Sided) 95%
43.2 to 56.5
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
3.Primary Outcome
Title Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 156 313
Measure Type: Number
Unit of Measure: Percentage of participants
49.4 44.3 55.1 54.0
4.Primary Outcome
Title Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 156 313
Measure Type: Number
Unit of Measure: Percentage of participants
1.0 1.0 1.3 1.9
5.Secondary Outcome
Title Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)
Hide Description 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.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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.
Overall Number of Participants Analyzed 299 294 289
Measure Type: Number
Unit of Measure: Percentage of participants
72.6 73.5 53.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 19.2
Confidence Interval (2-Sided) 95%
11.5 to 26.7
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
12.4 to 27.6
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
6.Secondary Outcome
Title Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)
Hide Description 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.
Time Frame Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 107 108 212 60 21 21 67 64 114
Measure Type: Number
Unit of Measure: Percentage of participants
96.3 92.6 97.6 63.3 66.7 61.9 82.1 68.8 57.0
7.Secondary Outcome
Title Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg.
Overall Number of Participants Analyzed 105 104 204 60 19 19 66 63 113
Measure Type: Number
Unit of Measure: Percentage of participants
97.1 94.2 93.6 66.7 78.9 68.4 92.4 85.7 81.4
8.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16 and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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.
Overall Number of Participants Analyzed 299 294 289
Measure Type: Number
Unit of Measure: Percentage of participants
69.2 64.6 45.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 24.1
Confidence Interval (2-Sided) 95%
16.2 to 31.7
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 19.6
Confidence Interval (2-Sided) 95%
11.7 to 27.3
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights
9.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 107 106 212 59 21 21 66 64 112
Measure Type: Number
Unit of Measure: Percentage of participants
83.2 79.2 84.9 57.6 38.1 57.1 75.8 62.5 50.9
10.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 105 103 204 59 19 19 66 63 111
Measure Type: Number
Unit of Measure: Percentage of participants
84.8 77.7 79.4 50.8 42.1 57.9 77.3 55.6 68.5
11.Secondary Outcome
Title Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes randomized participants who received at least one dose of study medication in study Part 1.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 156 313
Measure Type: Number
Unit of Measure: Percentage of participants
36.6 38.8 1.3 21.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 35.3
Confidence Interval (2-Sided) 95%
29.2 to 41.1
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 37.5
Confidence Interval (2-Sided) 95%
31.1 to 43.4
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
8.3 to 22.1
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 17.4
Confidence Interval (2-Sided) 95%
10.3 to 24.4
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
12.Secondary Outcome
Title Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)
Hide Description 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.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and 16 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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.
Overall Number of Participants Analyzed 293 290 277
Measure Type: Number
Unit of Measure: Percentage of participants
57.7 55.5 30.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 27.1
Confidence Interval (2-Sided) 95%
19.1 to 34.7
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 24.9
Confidence Interval (2-Sided) 95%
17.0 to 32.6
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
13.Secondary Outcome
Title Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)
Hide Description 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.
Time Frame Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 107 108 212 60 21 21 67 64 114
Measure Type: Number
Unit of Measure: Percentage of participants
76.6 73.1 78.8 28.3 23.8 42.9 64.2 48.4 24.6
14.Secondary Outcome
Title Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg.
Overall Number of Participants Analyzed 105 104 204 60 19 19 66 63 113
Measure Type: Number
Unit of Measure: Percentage of participants
81.9 68.3 78.4 31.7 26.3 42.1 63.6 47.6 41.6
15.Secondary Outcome
Title Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 156 313
Measure Type: Number
Unit of Measure: Perentage of participants
11.8 12.4 0 4.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
7.8 to 16.0
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
8.5 to 16.6
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
2.8 to 11.6
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
3.3 to 12.3
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
16.Secondary Outcome
Title Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)
Hide Description 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.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and 16 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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.
Overall Number of Participants Analyzed 293 290 277
Measure Type: Number
Unit of Measure: Percentage of participants
27.0 22.8 11.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
9.4 to 22.1
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
5.6 to 17.9
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
17.Secondary Outcome
Title Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)
Hide Description 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.
Time Frame Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 107 108 212 60 21 21 67 64 114
Measure Type: Number
Unit of Measure: Percentage of participants
39.3 38.9 33.5 11.7 0 14.3 29.9 28.1 5.3
18.Secondary Outcome
Title Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg.
Overall Number of Participants Analyzed 105 104 204 60 19 19 66 63 113
Measure Type: Number
Unit of Measure: Percentage of participants
46.7 37.5 35.3 10.0 5.3 31.6 39.4 23.8 15.9
19.Secondary Outcome
Title Baseline Dermatology Life Quality Index (DLQI)
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 312 307 156 312
Mean (Standard Deviation)
Unit of Measure: Score on a scale
13.2  (7.03) 14.8  (7.24) 13.7  (6.98) 14.5  (7.20)
20.Secondary Outcome
Title Change From Baseline in the DLQI at Week 12 (Part 1)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 312 307 156 312
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-10.3
(-11.0 to -9.7)
-10.2
(-10.9 to -9.6)
-2.0
(-2.9 to -1.1)
-8.9
(-9.6 to -8.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -8.2
Confidence Interval (2-Sided) 95%
-9.3 to -7.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -8.3
Confidence Interval (2-Sided) 95%
-9.3 to -7.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method cLDA
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-2.1 to -0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method cLDA
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.2 to -0.6
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in the DLQI at Week 28 (Part 2)
Hide Description 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.
Time Frame Baseline and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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.
Overall Number of Participants Analyzed 299 294 289
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-11.7
(-12.3 to -11.1)
-11.2
(-11.8 to -10.5)
-9.5
(-10.1 to -8.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.4 to -1.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-2.9 to -1.5
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in the DLQI at Week 40 (Part 3)
Hide Description 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.
Time Frame Baseline and Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 108 107 212 58 21 21 69 65 114
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-11.6  (6.61) -12.0  (7.11) -13.2  (6.92) -9.7  (5.62) -9.0  (7.76) -9.8  (7.25) -10.4  (6.66) -10.1  (6.08) -10.8  (6.81)
23.Secondary Outcome
Title Change From Baseline in the DLQI at Week 52 (Part 3)
Hide Description 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.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 105 104 205 58 19 19 65 63 114
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-11.3  (6.16) -11.5  (7.26) -13.1  (6.80) -9.2  (6.18) -9.4  (8.47) -9.3  (7.22) -11.1  (6.45) -10.4  (6.38) -11.5  (6.97)
24.Secondary Outcome
Title Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 306 296 150 304
Measure Type: Number
Unit of Measure: Percentage of participants
47.4 40.2 8.0 35.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 39.3
Confidence Interval (2-Sided) 95%
31.8 to 46.1
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 32.1
Confidence Interval (2-Sided) 95%
24.5 to 39.1
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
4.1 to 19.5
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-2.9 to 12.5
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
25.Secondary Outcome
Title Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)
Hide Description 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.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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.
Overall Number of Participants Analyzed 297 290 282
Measure Type: Number
Unit of Measure: Percentage of participants
65.0 54.1 39.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 25.7
Confidence Interval (2-Sided) 95%
17.7 to 33.4
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg, Etanercept 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 15.0
Confidence Interval (2-Sided) 95%
6.9 to 22.9
Estimation Comments Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.
26.Secondary Outcome
Title Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)
Hide Description 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.
Time Frame Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 108 108 212 60 21 21 69 66 116
Measure Type: Number
Unit of Measure: Percentage of participants
72.2 68.5 71.2 41.7 9.5 19.0 50.7 51.5 38.8
27.Secondary Outcome
Title Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52.
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 105 105 205 60 19 19 65 64 116
Measure Type: Number
Unit of Measure: Percentage of participants
72.4 71.4 68.8 40.0 10.5 42.1 60.0 57.8 48.3
28.Secondary Outcome
Title Mean Change From Baseline in PASI Score Over Time (Part 1)
Hide Description 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.
Time Frame Baseline and Week 4, Week 8 or Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 155 312
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 308 participants 303 participants 150 participants 306 participants
-8.1  (6.54) -7.9  (6.83) -2.3  (6.18) -7.0  (7.15)
Week 8 Number Analyzed 302 participants 299 participants 146 participants 298 participants
-13.1  (7.71) -12.8  (7.57) -3.1  (7.18) -11.4  (8.77)
Week 12 Number Analyzed 302 participants 297 participants 142 participants 288 participants
-15.4  (7.77) -15.1  (7.94) -3.4  (6.77) -13.5  (8.29)
29.Secondary Outcome
Title Mean Change From Baseline in PASI Score Over Time (Part 2)
Hide Description 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.
Time Frame Baseline and Week 16, Week 22 or Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2) Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2)
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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 received placebo to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received placebo to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Overall Number of Participants Analyzed 314 307 312 72 68
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 16 Number Analyzed 298 participants 291 participants 283 participants 72 participants 68 participants
-16.2  (7.70) -15.9  (7.87) -14.2  (8.20) -11.6  (6.97) -9.6  (6.71)
Week 22 Number Analyzed 293 participants 290 participants 281 participants 71 participants 67 participants
-17.1  (7.66) -16.7  (7.88) -14.5  (8.32) -15.1  (6.55) -13.7  (7.18)
Week 28 Number Analyzed 293 participants 290 participants 277 participants 68 participants 66 participants
-17.0  (7.81) -16.5  (7.71) -14.8  (7.85) -17.3  (7.62) -14.5  (8.46)
30.Secondary Outcome
Title Mean Change From Baseline in PASI Score Over Time (Part 3)
Hide Description 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.
Time Frame Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 108 110 212 60 21 21 68 65 121
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 32 Number Analyzed 105 participants 110 participants 207 participants 60 participants 20 participants 20 participants 68 participants 65 participants 116 participants
-19.0  (7.13) -19.0  (8.03) -18.7  (6.83) -14.0  (5.72) -15.0  (6.69) -15.5  (7.08) -16.9  (7.68) -16.4  (8.02) -10.5  (6.25)
Week 36 Number Analyzed 108 participants 107 participants 210 participants 59 participants 21 participants 21 participants 68 participants 65 participants 118 participants
-18.9  (7.11) -19.0  (8.17) -18.9  (7.18) -14.5  (5.92) -15.7  (8.09) -16.0  (8.13) -17.6  (6.80) -16.7  (8.19) -12.9  (6.64)
Week 40 Number Analyzed 107 participants 108 participants 212 participants 60 participants 21 participants 21 participants 67 participants 64 participants 114 participants
-18.8  (7.04) -18.5  (7.56) -18.7  (6.95) -14.4  (6.00) -16.0  (8.73) -16.5  (8.59) -17.9  (7.03) -16.9  (7.99) -14.6  (6.42)
Week 46 Number Analyzed 105 participants 105 participants 205 participants 59 participants 21 participants 20 participants 65 participants 64 participants 115 participants
-19.0  (7.13) -18.1  (7.45) -18.7  (6.76) -14.5  (5.99) -16.2  (8.76) -15.8  (9.72) -17.9  (6.24) -17.1  (7.30) -15.6  (7.16)
Week 52 Number Analyzed 105 participants 104 participants 204 participants 60 participants 19 participants 19 participants 66 participants 63 participants 113 participants
-18.9  (7.13) -18.4  (7.66) -18.4  (6.65) -14.6  (5.72) -15.5  (9.00) -16.3  (9.55) -18.1  (7.00) -17.0  (7.30) -16.2  (6.83)
31.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
Hide Description 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.
Time Frame Baseline and Week 4, Week 8 or Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Placebo Etanercept 50 mg
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
Overall Number of Participants Analyzed 314 307 155 312
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 4 Number Analyzed 308 participants 303 participants 150 participants 306 participants
-40.2  (27.86) -39.3  (30.02) -11.7  (30.37) -33.9  (33.55)
Week 8 Number Analyzed 302 participants 299 participants 146 participants 298 participants
-65.7  (26.58) -63.8  (29.65) -15.3  (35.95) -55.7  (35.10)
Week 12 Number Analyzed 302 participants 297 participants 142 participants 288 participants
-78.0  (22.31) -74.8  (28.11) -17.4  (32.95) -66.7  (30.78)
32.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
Hide Description 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.
Time Frame Baseline and Week 16, Week 22 or Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tildrakizumab 200 mg Tildrakizumab 100 mg Etanercept 50 mg Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2) Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2)
Hide Arm/Group Description:
Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
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 received placebo to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Participants received placebo to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Overall Number of Participants Analyzed 314 307 312 72 68
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 16 Number Analyzed 298 participants 291 participants 283 participants 72 participants 68 participants
-82.0  (21.26) -79.3  (25.27) -70.3  (27.55) -59.2  (28.34) -49.4  (28.95)
Week 22 Number Analyzed 293 participants 290 participants 281 participants 71 participants 67 participants
-86.6  (17.58) -82.9  (23.16) -71.9  (29.40) -77.9  (20.25) -70.1  (25.24)
Week 28 Number Analyzed 293 participants 290 participants 277 participants 68 participants 66 participants
-85.7  (17.44) -82.5  (22.33) -73.5  (24.40) -84.0  (16.89) -72.9  (30.05)
33.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Hide Description 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.
Time Frame Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)
Hide Arm/Group Description:
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
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 responders at Week 28
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. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 108 110 212 60 21 21 68 65 121
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 32 Number Analyzed 105 participants 110 participants 207 participants 60 participants 20 participants 20 participants 68 participants 65 participants 116 participants
-94.9  (6.19) -94.0  (7.02) -94.3  (7.33) -77.1  (16.73) -71.1  (13.21) -75.3  (16.90) -84.4  (24.18) -81.6  (21.69) -54.7  (24.05)
Week 36 Number Analyzed 108 participants 107 participants 210 participants 59 participants 21 participants 21 participants 68 participants 65 participants 118 participants
-94.5  (7.47) -94.0  (6.93) -94.4  (7.06) -79.9  (15.94) -74.4  (15.69) -77.9  (15.47) -87.7  (15.20) -83.1  (19.83) -65.9  (21.35)
Week 40 Number Analyzed 107 participants 108 participants 212 participants 60 participants 21 participants 21 participants 67 participants 64 participants 114 participants
-94.2  (7.69) -92.6  (10.25) -94.3  (7.40) -79.1  (17.10) -75.7  (19.24) -80.6  (17.57) -88.2  (14.55) -84.1  (17.08) -76.5  (17.98)
Week 46 Number Analyzed 105 participants 105 participants 205 participants 59 participants 21 participants 20 participants 65 participants 64 participants 115 participants
-94.8  (7.77) -91.4  (12.09) -94.3  (7.64) -79.3  (17.77) -77.1  (19.67) -75.3  (23.35) -90.3  (12.32) -86.9  (13.08) -80.3  (17.92)
Week 52 Number Analyzed 105 participants 104 participants 204 participants 60 participants 19 participants 19 participants 66 participants 63 participants 113 participants
-94.7  (8.06) -92.2  (10.57) -93.4  (9.81) -80.4  (15.68) -75.7  (36.00) -79.6  (21.46) -91.0  (12.16) -87.1  (12.90) -84.2  (16.07)
Time Frame Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Adverse Event Reporting Description Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
 
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2 & 3) Placebo (Part 1) Etanercept 50 mg (Parts 1 & 2)
Hide Arm/Group Description 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. Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and then every 12 weeks. Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4. Participants received etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28.
All-Cause Mortality
Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2 & 3) Placebo (Part 1) Etanercept 50 mg (Parts 1 & 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/527 (0.00%)      3/487 (0.62%)      0/156 (0.00%)      0/313 (0.00%)    
Hide Serious Adverse Events
Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R Tildrakizumab 100 mg (Parts 1, 2 & 3) Placebo (Part 1) Etanercept 50 mg (Parts 1 & 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/527 (4.93%)      30/487 (6.16%)      4/156 (2.56%)      20/313 (6.39%)    
Cardiac disorders         
Atrial fibrillation † 1  2/527 (0.38%)  2 2/487 (0.41%)  2 0/156 (0.00%)  0 0/313 (0.00%)  0
Atrial flutter † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Cardiac failure † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Cardiac failure congestive † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Cardiomyopathy alcoholic † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Coronary artery disease † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Coronary artery stenosis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 1/313 (0.32%)  1
Mitral valve incompetence † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Myocardial infarction † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Pericarditis † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 1/156 (0.64%)  1 0/313 (0.00%)  0
Ear and labyrinth disorders         
Vertigo † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Endocrine disorders         
Hyperthyroidism † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Gastrointestinal disorders         
Abdominal hernia † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Abdominal pain † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Abdominal pain upper † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Dyspepsia † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Gastritis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Haemorrhoids thrombosed † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Oesophageal polyp † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Hepatobiliary disorders         
Bile duct stone † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Cholelithiasis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Steatohepatitis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Infections and infestations         
Appendicitis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Cellulitis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 1/156 (0.64%)  1 0/313 (0.00%)  0
Diverticulitis † 1  2/527 (0.38%)  2 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Erysipelas † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Herpes zoster † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Pneumonia † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Pyelonephritis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Sepsis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Sinusitis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Urosepsis † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Wound infection † 1  1/527 (0.19%)  1 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Injury, poisoning and procedural complications         
Ankle fracture † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Concussion † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Hand fracture † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Humerus fracture † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Meniscus injury † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Tendon rupture † 1  2/527 (0.38%)  2 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Investigations         
Blood glucose increased † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Metabolism and nutrition disorders         
Obesity † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Musculoskeletal and connective tissue disorders         
Back pain † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Cervical spinal stenosis † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Intervertebral disc disorder † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Intervertebral disc protrusion † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 1/156 (0.64%)  1 0/313 (0.00%)  0
Osteoarthritis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Rotator cuff syndrome † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Spondylolisthesis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Osteonecrosis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Basal cell carcinoma † 1  3/527 (0.57%)  3 3/487 (0.62%)  3 0/156 (0.00%)  0 2/313 (0.64%)  2
Bladder transitional cell carcinoma † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Bowen's disease † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Breact cancer † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Lung adenocarcinoma † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Malignant melanoma in situ † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Renal oncocytoma † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Squamous cell carcinoma of skin † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Thyroid cancer † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Nervous system disorders         
Carotid artery stenosis † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Headache † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Radiculopathy † 1  1/527 (0.19%)  1 0/487 (0.00%)  0 0/156 (0.00%)  0 0/313 (0.00%)  0
Seizure † 1  0/527 (0.00%)  0 0/487 (0.00%)  0 0/156 (0.00%)  0 1/313 (0.32%)  1
Transient ischaemic attack † 1  0/527 (0.00%)  0 1/487 (0.21%)  1 0/156 (0.00%)  0 0/313 (0.00%)  0
Psychiatric disorders         
Alco