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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001377-88 | EudraCT Number | ||
| P07771 | Other Identifier | Merck Protocol Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tildrakizumab 200 mg | Experimental | 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. |
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| Tildrakizumab 100 mg | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Etanercept 50 mg | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tildrakizumab 200 mg | Drug | Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to Week 12 |
| Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28596043 | Result | Reich K, Papp KA, Blauvelt A, Tyring SK, Sinclair R, Thaci D, Nograles K, Mehta A, Cichanowitz N, Li Q, Liu K, La Rosa C, Green S, Kimball AB. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5. Epub 2017 Jun 6. | |
| 41838287 |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tildrakizumab 200 mg (Parts 1 & 2) | Participants received tildrakizumab 200 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28. |
| FG001 | Tildrakizumab 200 mg (Parts 1, 2, & 3) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
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| Tildrakizumab 100 mg | Drug | Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL. |
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| Tildrakizumab Placebo | Drug | Matching placebo to tildrakizumab administered SC |
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| Etanercept Placebo | Drug | Matching placebo to etanercept administered SC |
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| Etanercept 50 mg | Drug | Etanercept 50 mg administered SC |
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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.
| Up to Week 12 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52 |
| Derived |
| Bagel J, Gogineni R, Shaikh A, Lebwohl MG. Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2. Dermatol Ther (Heidelb). 2026 Apr;16(4):2153-2167. doi: 10.1007/s13555-026-01708-y. Epub 2026 Mar 16. |
| 40365708 | Derived | Armstrong AW, Blauvelt A, Lebwohl M, Asahina A, Gogineni R, Griffiths CEM. Efficacy and safety of tildrakizumab in patients with early- vs. late-onset psoriasis. Br J Dermatol. 2025 Aug 18;193(3):442-450. doi: 10.1093/bjd/ljaf171. |
| 36098877 | Derived | Thaci D, Gerdes S, Du Jardin KG, Perrot JL, Puig L. Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies. Dermatol Ther (Heidelb). 2022 Oct;12(10):2325-2341. doi: 10.1007/s13555-022-00793-z. Epub 2022 Sep 13. |
| 33544883 | Derived | Thaci D, Piaserico S, Warren RB, Gupta AK, Cantrell W, Draelos Z, Foley P, Igarashi A, Langley RG, Asahina A, Young M, Falques M, Pau-Charles I, Mendelsohn AM, Rozzo SJ, Reich K. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4. |
| 32162721 | Derived | Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25. |
| 31268369 | Derived | Elewski B, Menter A, Crowley J, Tyring S, Zhao Y, Lowry S, Rozzo S, Mendelsohn AM, Parno J, Gordon K. Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2020 Dec;31(8):763-768. doi: 10.1080/09546634.2019.1640348. Epub 2019 Jul 22. |
| 31218661 | Derived | Reich K, Warren RB, Iversen L, Puig L, Pau-Charles I, Igarashi A, Ohtsuki M, Falques M, Harmut M, Rozzo S, Lebwohl MG, Cantrell W, Blauvelt A, Thaci D. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18. |
| 30915660 | Derived | Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7. |
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. |
| FG002 | Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) | Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 100 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. |
| FG003 | Tildrakizumab 100 mg (Parts 1 & 2) | Participants received tildrakizumab 100 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28. |
| FG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. |
| FG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. |
| FG006 | Placebo (Part 1) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 plus etanercept PBO twice weekly until Week 12 (Part 1). |
| FG007 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. |
| FG008 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28 |
| FG009 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| Part 2 |
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| Part 3 |
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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).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tildrakizumab 200 mg (Part 1) | Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1). |
| BG001 | Tildrakizumab 100 mg (Part 1) | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1). |
| BG002 | Placebo (Part 1) | Participants received tildrakizumab placebo SC at Weeks 0 and 4 and etanercept placebo SC twice weekly until Week 12 (Part 1). |
| BG003 | Etanercept 50 mg (Part 1) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body weight | Count of Participants | Participants |
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| Prior exposure to biologic therapy for psoriasis | The following therapies constitute biologics therapy for psoriasis: efalizumab (RAPTIVA®), alefacept (AMEVIVE®), infliximab (REMICADE®), adalimumab (HUMIRA®), ustekinumab (STELARA®), and etanercept (Enbrel®) | Count of Participants | Participants |
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| Psoriasis Area Sensitivity Index (PASI) | 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. | Analysis populations includes randomized participants with PASI value at baseline. | Mean | Standard Deviation | Score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned. | Posted | Number | Percentage of participants | Week 12 |
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| Primary | 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. | Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned. | Posted | Number | Percentage of participants | Week 12 |
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| Primary | 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. | Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received. | Posted | Number | Percentage of participants | Up to Week 12 |
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| Primary | 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. | Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received. | Posted | Number | Percentage of participants | Up to Week 12 |
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| Secondary | 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. | 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. | Posted | Number | Percentage of participants | Week 28 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40. | Posted | Number | Percentage of participants | Week 40 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | 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. | 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. | Posted | Number | Percentage of participants | Week 28 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40. | Posted | Number | Percentage of participants | Week 40 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | 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. | Analysis population includes randomized participants who received at least one dose of study medication in study Part 1. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | 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. | 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. | Posted | Number | Percentage of participants | Week 28 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40. | Posted | Number | Percentage of participants | Week 40 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | 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. | 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. | Posted | Number | Perentage of participants | Week 12 |
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| Secondary | 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. | 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. | Posted | Number | Percentage of participants | Week 28 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40. | Posted | Number | Percentage of participants | Week 40 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | 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. | Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Secondary | 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. | Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 28 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 40 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 52 |
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| Secondary | 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. | 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. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | 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. | 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. | Posted | Number | Percentage of participants | Week 28 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40. | Posted | Number | Percentage of participants | Week 40 |
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| Secondary | 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. | Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 4, Week 8 or Week 12 |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 16, Week 22 or Week 28 |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52 |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 4, Week 8 or Week 12 |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 16, Week 22 or Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52 |
|
Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 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. | 0 | 527 | 26 | 527 | 167 | 527 |
| EG001 | Tildrakizumab 100 mg (Parts 1, 2 & 3) | Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and then every 12 weeks. | 3 | 487 | 30 | 487 | 151 | 487 |
| EG002 | Placebo (Part 1) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4. | 0 | 156 | 4 | 156 | 23 | 156 |
| EG003 | Etanercept 50 mg (Parts 1 & 2) | Participants received etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. | 0 | 313 | 20 | 313 | 118 | 313 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Cardiomyopathy alcoholic | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | 19.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 19.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 19.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Oesophageal polyp | Gastrointestinal disorders | 19.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 19.1 | Systematic Assessment |
| |
| Steatohepatitis | Hepatobiliary disorders | 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | 19.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Breact cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Renal oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 19.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | 19.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 19.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 19.1 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | 19.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | 19.1 | Systematic Assessment |
| |
| Borderline personality disorder | Psychiatric disorders | 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 19.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 19.1 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | 19.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | 19.1 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | 19.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | 19.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | 19.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | 19.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | 19.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | 19.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 19.1 | Systematic Assessment |
|
The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head-Clinical Development | Sun Pharma Advanced Research Company Limited | 912266455645 | clinical.trials@sparcmail.com |
| ID | Term |
|---|---|
| C000598434 | tildrakizumab |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Non-Compliance with Study Drug |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Other Protocol Specified Criteria |
|
| Death |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other Protocol Specified Criteria |
|
|
|
|
|
| >90 kg |
|
|
|
| No |
|
|
|
| Cochran-Mantel-Haenszel | Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity. | <0.001 | Difference in percentages | 55.5 | 2-Sided | 95 | 48.3 | 61.8 | 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. | Superiority |
| OG002 | Placebo | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12. |
| OG003 | Etanercept 50 mg | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg 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.
|
|
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
|
|
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.
|
|
|
| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
|
|
| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg. |
|
|
| OG002 | Etanercept 50 mg | 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. |
|
|
|
| OG001 |
| Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R |
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. |
| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
|
|
| OG001 |
| Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R |
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. |
| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
|
|
| Etanercept 50 mg |
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
|
|
|
|
|
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg. |
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| OG003 |
| Etanercept 50 mg |
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg. |
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Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
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Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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. |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| Etanercept 50 mg |
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
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| OG003 | Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2) | 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. |
| OG004 | Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2) | 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. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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 |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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| Etanercept 50 mg |
Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12. |
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| OG003 | Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2) | 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. |
| OG004 | Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2) | 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. |
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| OG002 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R | 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 |
| OG003 | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR | 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. |
| OG004 | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28. |
| OG005 | Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR | Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28. |
| OG006 | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2. |
| OG007 | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2. |
| OG008 | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. |
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