A Phase 3 interventional study of Tildrakizumab 200 mg and Tildrakizumab 100 mg in Plaque Psoriasis, sponsored by Sun Pharmaceutical Industries Limited. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Sun Pharmaceutical Industries Limited · Phase 3, Interventional, and Treatment
This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of participants achieving >= Psoriasis Area Sensitivity Index of 75% (PASI-75) response and the proportion 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.
The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 52 weeks, and a 20-week follow-up period. The base study treatment period is divided into 3 sequential parts.
In Part 1 of the base study (Week 0 to Week 12), participants will be randomized to one of 4 study arms (Arm A: tildrakizumab 200 mg + matching placebo to etanercept; Arm B: tildrakizumab 100 mg + matching placebo to etanercept; Arm C: matching placebo to tildrakizumab + matching placebo to etanercept; Arm D: matching placebo to tildrakizumab + etanercept 50 mg).
In Part 2 of the base study (Week 12 to Week 28), participants in Arm A and Arm B will receive matching placebo to tildrakizumab to maintain blinding at Week 12 and will receive either tildrakizumab 200 mg (Arm A) or tildrakizumab 100 mg (Arm B) at Weeks 12 and 16. Participants in Arm A and Arm B will also receive matching placebo to etanercept once weekly through study Week 28. At study Week 12, Arm C participants will be re-randomized to receive their first dose of tildrakizumab 200 mg or tildrakizumab 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16. Participants in Arm C will also receive matching placebo to etanercept through treatment Week 28. Participants in Arm D will continue with once weekly doses of etanercept through study Week 28 in combination with matching placebo to tildrakizumab.
In Part 3 of the base study (Week 28 to Week 52), participants in Arm A with >= PASI-75 response at Week 28 will be re-randomized to either continue tildrakizumab 200 mg or receive tildrakizumab 100 mg at study Weeks 28, 40, and 52. Participants with >= PASI-50 response but \< PASI-75 response will continue to receive tildrakizumab 200 mg every 12 weeks and those participants with \< PASI-50 response will be discontinued from the study. Participants in Arm B with >= PASI-75 response at Week 28 will continue to receive tildrakizumab 100 mg every 12 weeks. Those with >= PASI-50 response but \< PASI-75 response will be re-randomized to receive continued tildrakizumab 100 mg or tildrakizumab 200 mg every 12 weeks. Participants in Arm B with \< PASI-50 response will be discontinued from the study. Participants in Arm C will continue to receive treatment every 12 weeks according to their re-randomized treatment assignment. Participants in Arm D that achieve >= PASI-75 response at Week 28 will be discontinued from the study. Those participants with \< PASI-75 response at Week 28 will be crossed over to tildrakizumab 200 mg to receive doses at Weeks 32, 36 and 48.
Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be monitored for an additional 20 weeks in the follow-up period. Each participant will receive tildrakizumab 200 mg or tildrakizumab 100 mg every 12 weeks up to study Week 244 according to their treatment assignment at the conclusion of Part 3 of the base study.
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Participants receive tildrakizumab 200 mg subcutaneously (SC) on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Drug: Tildrakizumab 200 mg · Drug: Etanercept Placebo
Participants receive tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Drug: Tildrakizumab 100 mg · Drug: Etanercept Placebo
Participants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive tildrakizumab 200 mg or tildrakizumab 100 mg on Weeks 12, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244.
Drug: Tildrakizumab Placebo · Drug: Etanercept Placebo
Participants receive 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 don't achieve PASI-75, receive tildrakizumab 200 mg after Week 28 (Weeks 32, 36 and 48) and, optionally, every 12 weeks thereafter until Week 244.
Drug: Tildrakizumab Placebo · Drug: Etanercept 50 mg
Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.
Also known as: SCH 900222, MK-3222
Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.
Also known as: SCH 900222, MK-3222
Matching placebo to tildrakizumab administered SC
Matching placebo to etanercept administered SC
Etanercept 50 mg administered SC
Also known as: Embrel
Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-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
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)
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
Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)
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
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)
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
Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.
Time frame: Week 28
Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)
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
Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)
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
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)
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
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)
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
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)
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
Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Time frame: Week 12
Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Time frame: Week 28
Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)
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
Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)
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
Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Time frame: Week 12
Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Time frame: Week 28
Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)
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
Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)
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
Baseline Dermatology Life Quality Index (DLQI)
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
Change From Baseline in the DLQI at Week 12 (Part 1)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Time frame: Baseline and Week 12
Change From Baseline in the DLQI at Week 28 (Part 2)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Time frame: Baseline and Week 28
Change From Baseline in the DLQI at Week 40 (Part 3)
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
Change From Baseline in the DLQI at Week 52 (Part 3)
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
Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Time frame: Week 12
Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Time frame: Week 28
Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)
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
Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)
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
Mean Change From Baseline in PASI Score Over Time (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Time frame: Baseline and Week 4, Week 8 or Week 12
Mean Change From Baseline in PASI Score Over Time (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Time frame: Baseline and Week 16, Week 22 or Week 28
Mean Change From Baseline in PASI Score Over Time (Part 3)
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
Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Time frame: Baseline and Week 4, Week 8 or Week 12
Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Time frame: Baseline and Week 16, Week 22 or Week 28
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
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
| Milestone | 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) |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Withdrew: Adverse event | 2 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 5 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 0 | 0 | 3 |
| Withdrew: Non-compliance with study drug | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 5 | 0 | 0 | 7 | 0 | 0 | 5 | 0 | 0 | 6 |
| Withdrew: Other protocol specified criteria | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 |
| Milestone | 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) |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 6 | 184 | 110 | 5 | 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 |
| Withdrew: Adverse event | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 2 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 4 |
| Withdrew: Other protocol specified criteria | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Milestone | 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) |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 170 | 110 | 0 | 21 | 237 | 0 | 69 | 66 | 121 |
| Completed | 0 | 165 | 105 | 0 | 17 | 224 | 0 | 66 | 65 | 114 |
| Not completed | 0 | 5 | 5 | 0 | 4 | 13 | 0 | 3 | 1 | 7 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 5 | 0 | 0 | 0 | 3 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 | 2 | 0 | 0 | 3 | 0 | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 4 | 1 | 0 | 2 | 1 | 0 | 2 | 0 | 0 |
| Withdrew: Other protocol specified criteria | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | 65.6 | 61.2 | 5.8 | 48.2 |
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1) | 59.2 | 54.7 | 4.5 | 47.6 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) | 49.4 | 44.3 | 55.1 | 54.0 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) | 1.0 | 1.0 | 1.3 | 1.9 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Etanercept 50 mg |
|---|---|---|---|
| Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2) | 72.6 | 73.5 | 53.6 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3) | 96.3 | 92.6 | 97.6 | 63.3 | 66.7 | 61.9 | 82.1 | 68.8 | 57.0 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3) | 97.1 | 94.2 | 93.6 | 66.7 | 78.9 | 68.4 | 92.4 | 85.7 | 81.4 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Etanercept 50 mg |
|---|---|---|---|
| Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2) | 69.2 | 64.6 | 45.3 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3) | 83.2 | 79.2 | 84.9 | 57.6 | 38.1 | 57.1 | 75.8 | 62.5 | 50.9 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3) | 84.8 | 77.7 | 79.4 | 50.8 | 42.1 | 57.9 | 77.3 | 55.6 | 68.5 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1) | 36.6 | 38.8 | 1.3 | 21.4 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Etanercept 50 mg |
|---|---|---|---|
| Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2) | 57.7 | 55.5 | 30.7 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3) | 76.6 | 73.1 | 78.8 | 28.3 | 23.8 | 42.9 | 64.2 | 48.4 | 24.6 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3) | 81.9 | 68.3 | 78.4 | 31.7 | 26.3 | 42.1 | 63.6 | 47.6 | 41.6 |
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.
| Perentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1) | 11.8 | 12.4 | 0 | 4.8 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Etanercept 50 mg |
|---|---|---|---|
| Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2) | 27.0 | 22.8 | 11.2 |
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. 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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3) | 39.3 | 38.9 | 33.5 | 11.7 | 0 | 14.3 | 29.9 | 28.1 | 5.3 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3) | 46.7 | 37.5 | 35.3 | 10.0 | 5.3 | 31.6 | 39.4 | 23.8 | 15.9 |
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.
| Score on a scale | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Baseline Dermatology Life Quality Index (DLQI) | 13.2 ± 7.03 | 14.8 ± 7.24 | 13.7 ± 6.98 | 14.5 ± 7.20 |
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.
| Score on a scale | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Change From Baseline in the DLQI at Week 12 (Part 1) | -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) |
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.
| Score on a scale | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Etanercept 50 mg |
|---|---|---|---|
| Change From Baseline in the DLQI at Week 28 (Part 2) | -11.7 (-12.3 to -11.1) | -11.2 (-11.8 to -10.5) | -9.5 (-10.1 to -8.9) |
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.
| Score on a scale | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline in the DLQI at Week 40 (Part 3) | -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 |
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.
| Score on a scale | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline in the DLQI at Week 52 (Part 3) | -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 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1) | 47.4 | 40.2 | 8.0 | 35.5 |
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.
| Percentage of participants | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Etanercept 50 mg |
|---|---|---|---|
| Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2) | 65.0 | 54.1 | 39.4 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3) | 72.2 | 68.5 | 71.2 | 41.7 | 9.5 | 19.0 | 50.7 | 51.5 | 38.8 |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3) | 72.4 | 71.4 | 68.8 | 40.0 | 10.5 | 42.1 | 60.0 | 57.8 | 48.3 |
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.
| Scores on a scale | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Week 4 | -8.1 ± 6.54 | -7.9 ± 6.83 | -2.3 ± 6.18 | -7.0 ± 7.15 |
| Week 8 | -13.1 ± 7.71 | -12.8 ± 7.57 | -3.1 ± 7.18 | -11.4 ± 8.77 |
| Week 12 | -15.4 ± 7.77 | -15.1 ± 7.94 | -3.4 ± 6.77 | -13.5 ± 8.29 |
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.
| Scores on a scale | 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) |
|---|---|---|---|---|---|
| Week 16 | -16.2 ± 7.70 | -15.9 ± 7.87 | -14.2 ± 8.20 | -11.6 ± 6.97 | -9.6 ± 6.71 |
| Week 22 | -17.1 ± 7.66 | -16.7 ± 7.88 | -14.5 ± 8.32 | -15.1 ± 6.55 | -13.7 ± 7.18 |
| Week 28 | -17.0 ± 7.81 | -16.5 ± 7.71 | -14.8 ± 7.85 | -17.3 ± 7.62 | -14.5 ± 8.46 |
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.
| Scores on a scale | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Week 32 | -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 | -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 | -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 | -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 | -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 |
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.
| Percent change | Tildrakizumab 200 mg | Tildrakizumab 100 mg | Placebo | Etanercept 50 mg |
|---|---|---|---|---|
| Week 4 | -40.2 ± 27.86 | -39.3 ± 30.02 | -11.7 ± 30.37 | -33.9 ± 33.55 |
| Week 8 | -65.7 ± 26.58 | -63.8 ± 29.65 | -15.3 ± 35.95 | -55.7 ± 35.10 |
| Week 12 | -78.0 ± 22.31 | -74.8 ± 28.11 | -17.4 ± 32.95 | -66.7 ± 30.78 |
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.
| Percent change | 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) |
|---|---|---|---|---|---|
| Week 16 | -82.0 ± 21.26 | -79.3 ± 25.27 | -70.3 ± 27.55 | -59.2 ± 28.34 | -49.4 ± 28.95 |
| Week 22 | -86.6 ± 17.58 | -82.9 ± 23.16 | -71.9 ± 29.40 | -77.9 ± 20.25 | -70.1 ± 25.24 |
| Week 28 | -85.7 ± 17.44 | -82.5 ± 22.33 | -73.5 ± 24.40 | -84.0 ± 16.89 | -72.9 ± 30.05 |
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.
| Percent change | 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) |
|---|---|---|---|---|---|---|---|---|---|
| Week 32 | -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 | -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 | -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 | -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 | -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 |
Collected over Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 0/527 (0%) | 26/527 (4.9%) | 167/527 (31.7%) |
| Tildrakizumab 100 mg (Parts 1, 2 & 3) | 3/487 (0.6%) | 30/487 (6.2%) | 151/487 (31%) |
| Placebo (Part 1) | 0/156 (0%) | 4/156 (2.6%) | 23/156 (14.7%) |
| Etanercept 50 mg (Parts 1 & 2) | 0/313 (0%) | 20/313 (6.4%) | 118/313 (37.7%) |
| Event | 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) |
|---|---|---|---|---|
| PericarditisCardiac disorders | 0/527 | 0/487 | 1/156 | 0/313 |
| CellulitisInfections and infestations | 1/527 | 0/487 | 1/156 | 0/313 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/527 | 0/487 | 1/156 | 0/313 |
| UreterolithiasisRenal and urinary disorders | 0/527 | 0/487 | 1/156 | 0/313 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/527 | 3/487 | 0/156 | 2/313 |
| Atrial fibrillationCardiac disorders | 2/527 | 2/487 | 0/156 | 0/313 |
| DepressionPsychiatric disorders | 0/527 | 2/487 | 0/156 | 0/313 |
| DiverticulitisInfections and infestations | 2/527 | 0/487 | 0/156 | 0/313 |
| Tendon ruptureInjury, poisoning and procedural complications | 2/527 | 1/487 | 0/156 | 0/313 |
| Cardiac failure congestiveCardiac disorders | 0/527 | 0/487 | 0/156 | 1/313 |
| Event | 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) |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 119/527 | 112/487 | 12/156 | 63/313 |
| Injection site erythemaGeneral disorders | 5/527 | 5/487 | 1/156 | 28/313 |
| HeadacheNervous system disorders | 30/527 | 29/487 | 6/156 | 18/313 |
| Injection site reactionGeneral disorders | 4/527 | 2/487 | 1/156 | 17/313 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 14/527 | 26/487 | 3/156 | 10/313 |
| Upper respiratory tract infectionInfections and infestations | 27/527 | 15/487 | 1/156 | 11/313 |
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(Years) | Tildrakizumab 200 mg (Part 1) | Tildrakizumab 100 mg (Part 1) | Placebo (Part 1) | Etanercept 50 mg (Part 1) | Total |
|---|---|---|---|---|---|
| Mean | 44.6 ± 13.62 | 44.6 ± 13.59 | 46.4 ± 12.20 | 45.8 ± 13.97 | 45.2 ± 13.52 |
| Sex: Female, Male(Participants) | Tildrakizumab 200 mg (Part 1) | Tildrakizumab 100 mg (Part 1) | Placebo (Part 1) | Etanercept 50 mg (Part 1) | Total |
|---|---|---|---|---|---|
| Female | 89 | 87 | 44 | 91 | 311 |
| Male | 225 | 220 | 112 | 222 | 779 |
| Race (NIH/OMB)(Participants) | Tildrakizumab 200 mg (Part 1) | Tildrakizumab 100 mg (Part 1) | Placebo (Part 1) | Etanercept 50 mg (Part 1) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 | 2 |
| Asian | 14 | 9 | 3 | 10 | 36 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 8 | 7 | 1 | 8 | 24 |
| White | 284 | 279 | 144 | 289 | 996 |
| More than one race | 2 | 7 | 3 | 3 | 15 |
| Unknown or Not Reported | 6 | 4 | 4 | 2 | 16 |
| Body weight(Participants) | Tildrakizumab 200 mg (Part 1) | Tildrakizumab 100 mg (Part 1) | Placebo (Part 1) | Etanercept 50 mg (Part 1) | Total |
|---|---|---|---|---|---|
| <=90 kg | 180 | 176 | 90 | 180 | 626 |
| >90 kg | 134 | 131 | 66 | 133 | 464 |
| Prior exposure to biologic therapy for psoriasis(Participants) | Tildrakizumab 200 mg (Part 1) | Tildrakizumab 100 mg (Part 1) | Placebo (Part 1) | Etanercept 50 mg (Part 1) | Total |
|---|---|---|---|---|---|
| Yes | 38 | 39 | 20 | 37 | 134 |
| No | 276 | 268 | 136 | 276 | 956 |
| Psoriasis Area Sensitivity Index (PASI)(Score on a scale) | Tildrakizumab 200 mg (Part 1) | Tildrakizumab 100 mg (Part 1) | Placebo (Part 1) | Etanercept 50 mg (Part 1) | Total |
|---|---|---|---|---|---|
| Mean | 19.8 ± 7.52 | 20.5 ± 7.63 | 20.0 ± 7.57 | 20.2 ± 7.36 | 20.1 ± 7.51 |
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Studies of the drug tested here: Tildrakizumab
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