<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01729754</url>
  </required_header>
  <id_info>
    <org_study_id>3222-011</org_study_id>
    <secondary_id>2012-001377-88</secondary_id>
    <secondary_id>P07771</secondary_id>
    <nct_id>NCT01729754</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)</brief_title>
  <acronym>reSURFACE 2</acronym>
  <official_title>A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharmaceutical Industries Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Pharmaceutical Industries Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to evaluate the efficacy and safety/tolerability of&#xD;
      tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe&#xD;
      plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to&#xD;
      placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the&#xD;
      proportion of participants achieving &gt;= Psoriasis Area Sensitivity Index of 75% (PASI-75)&#xD;
      response and the proportion of participants with a Physician's Global Assessment (PGA) score&#xD;
      of &quot;clear&quot; or &quot;minimal&quot; with at least a 2 grade reduction from baseline at Week 12.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The base study consists of a screening phase of up to 4 weeks followed by a treatment period&#xD;
      of 52 weeks, and a 20-week follow-up period. The base study treatment period is divided into&#xD;
      3 sequential parts.&#xD;
&#xD;
      In Part 1 of the base study (Week 0 to Week 12), participants will be randomized to one of 4&#xD;
      study arms (Arm A: tildrakizumab 200 mg + matching placebo to etanercept; Arm B:&#xD;
      tildrakizumab 100 mg + matching placebo to etanercept; Arm C: matching placebo to&#xD;
      tildrakizumab + matching placebo to etanercept; Arm D: matching placebo to tildrakizumab +&#xD;
      etanercept 50 mg).&#xD;
&#xD;
      In Part 2 of the base study (Week 12 to Week 28), participants in Arm A and Arm B will&#xD;
      receive matching placebo to tildrakizumab to maintain blinding at Week 12 and will receive&#xD;
      either tildrakizumab 200 mg (Arm A) or tildrakizumab 100 mg (Arm B) at Weeks 12 and 16.&#xD;
      Participants in Arm A and Arm B will also receive matching placebo to etanercept once weekly&#xD;
      through study Week 28. At study Week 12, Arm C participants will be re-randomized to receive&#xD;
      their first dose of tildrakizumab 200 mg or tildrakizumab 100 mg, and will receive additional&#xD;
      doses of study medication according to their re-randomized treatment assignment at Week 16.&#xD;
      Participants in Arm C will also receive matching placebo to etanercept through treatment Week&#xD;
      28. Participants in Arm D will continue with once weekly doses of etanercept through study&#xD;
      Week 28 in combination with matching placebo to tildrakizumab.&#xD;
&#xD;
      In Part 3 of the base study (Week 28 to Week 52), participants in Arm A with &gt;= PASI-75&#xD;
      response at Week 28 will be re-randomized to either continue tildrakizumab 200 mg or receive&#xD;
      tildrakizumab 100 mg at study Weeks 28, 40, and 52. Participants with &gt;= PASI-50 response but&#xD;
      &lt; PASI-75 response will continue to receive tildrakizumab 200 mg every 12 weeks and those&#xD;
      participants with &lt; PASI-50 response will be discontinued from the study. Participants in Arm&#xD;
      B with &gt;= PASI-75 response at Week 28 will continue to receive tildrakizumab 100 mg every 12&#xD;
      weeks. Those with &gt;= PASI-50 response but &lt; PASI-75 response will be re-randomized to receive&#xD;
      continued tildrakizumab 100 mg or tildrakizumab 200 mg every 12 weeks. Participants in Arm B&#xD;
      with &lt; PASI-50 response will be discontinued from the study. Participants in Arm C will&#xD;
      continue to receive treatment every 12 weeks according to their re-randomized treatment&#xD;
      assignment. Participants in Arm D that achieve &gt;= PASI-75 response at Week 28 will be&#xD;
      discontinued from the study. Those participants with &lt; PASI-75 response at Week 28 will be&#xD;
      crossed over to tildrakizumab 200 mg to receive doses at Weeks 32, 36 and 48.&#xD;
&#xD;
      Eligible participants that choose to enroll in the extension study will have an additional&#xD;
      treatment period of up to 192 weeks and will be monitored for an additional 20 weeks in the&#xD;
      follow-up period. Each participant will receive tildrakizumab 200 mg or tildrakizumab 100 mg&#xD;
      every 12 weeks up to study Week 244 according to their treatment assignment at the conclusion&#xD;
      of Part 3 of the base study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2013</start_date>
  <completion_date type="Actual">October 26, 2021</completion_date>
  <primary_completion_date type="Actual">September 28, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)</measure>
    <time_frame>Week 12</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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)</measure>
    <time_frame>Week 12</time_frame>
    <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)</measure>
    <time_frame>Week 28</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)</measure>
    <time_frame>Week 40</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)</measure>
    <time_frame>Week 52</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Week 28</time_frame>
    <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Week 40</time_frame>
    <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Week 52</time_frame>
    <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)</measure>
    <time_frame>Week 12</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)</measure>
    <time_frame>Week 28</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)</measure>
    <time_frame>Week 40</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)</measure>
    <time_frame>Week 52</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)</measure>
    <time_frame>Week 12</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)</measure>
    <time_frame>Week 28</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)</measure>
    <time_frame>Week 40</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)</measure>
    <time_frame>Week 52</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>Baseline</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the DLQI at Week 12 (Part 1)</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the DLQI at Week 28 (Part 2)</measure>
    <time_frame>Baseline and Week 28</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the DLQI at Week 40 (Part 3)</measure>
    <time_frame>Baseline and Week 40</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the DLQI at Week 52 (Part 3)</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)</measure>
    <time_frame>Week 12</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)</measure>
    <time_frame>Week 28</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)</measure>
    <time_frame>Week 40</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)</measure>
    <time_frame>Week 52</time_frame>
    <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in PASI Score Over Time (Part 1)</measure>
    <time_frame>Baseline and Week 4, Week 8 or Week 12</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in PASI Score Over Time (Part 2)</measure>
    <time_frame>Baseline and Week 16, Week 22 or Week 28</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in PASI Score Over Time (Part 3)</measure>
    <time_frame>Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change From Baseline in PASI Score Over Time (Part 1)</measure>
    <time_frame>Baseline and Week 4, Week 8 or Week 12</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change From Baseline in PASI Score Over Time (Part 2)</measure>
    <time_frame>Baseline and Week 16, Week 22 or Week 28</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change From Baseline in PASI Score Over Time (Part 3)</measure>
    <time_frame>Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52</time_frame>
    <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1090</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Tildrakizumab 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tildrakizumab 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etanercept 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tildrakizumab 200 mg</intervention_name>
    <description>Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.</description>
    <arm_group_label>Tildrakizumab 200 mg</arm_group_label>
    <other_name>SCH 900222, MK-3222</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tildrakizumab 100 mg</intervention_name>
    <description>Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.</description>
    <arm_group_label>Tildrakizumab 100 mg</arm_group_label>
    <other_name>SCH 900222, MK-3222</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tildrakizumab Placebo</intervention_name>
    <description>Matching placebo to tildrakizumab administered SC</description>
    <arm_group_label>Etanercept 50 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etanercept Placebo</intervention_name>
    <description>Matching placebo to etanercept administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tildrakizumab 100 mg</arm_group_label>
    <arm_group_label>Tildrakizumab 200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etanercept 50 mg</intervention_name>
    <description>Etanercept 50 mg administered SC</description>
    <arm_group_label>Etanercept 50 mg</arm_group_label>
    <other_name>Embrel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior&#xD;
             to enrollment;&#xD;
&#xD;
          -  Candidate for phototherapy or systemic therapy;&#xD;
&#xD;
          -  Premenopausal female participants must agree to abstain from heterosexual activity or&#xD;
             use a medically approved method of contraception or use appropriate effective&#xD;
             contraception as per local regulations or guidelines&#xD;
&#xD;
          -  For the extension study: must have completed Part 3 of the base study&#xD;
&#xD;
          -  For the extension study: must have achieved at least a PASI-50 response by the end of&#xD;
             Part 3 of the base study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-plaque forms of psoriasis&#xD;
&#xD;
          -  Presence or history of severe psoriatic arthritis and is well-controlled on current&#xD;
             treatment regimen&#xD;
&#xD;
          -  Women of childbearing potential who are pregnant, intend to become pregnant, or are&#xD;
             lactating&#xD;
&#xD;
          -  Participant is expected to require topical therapy, phototherapy, or systemic therapy&#xD;
             during the trial&#xD;
&#xD;
          -  Presence of any infection or history of recurrent infection requiring treatment with&#xD;
             systemic antibiotics&#xD;
&#xD;
          -  Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23&#xD;
             (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17&#xD;
             antagonists&#xD;
&#xD;
          -  Latex allergy or sensitivity&#xD;
&#xD;
          -  Active or untreated latent tuberculosis (TB)&#xD;
&#xD;
          -  For the extension study: women of child-bearing potential who are pregnant, intend to&#xD;
             become pregnant within 6 months of completing the trial, or are breast feeding&#xD;
&#xD;
          -  For the extension study: active or uncontrolled significant organ dysfunction or&#xD;
             clinically significant laboratory abnormalities&#xD;
&#xD;
          -  For the extension study: expected to require topical treatment, phototherapy, or&#xD;
             systemic treatment during the extension study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>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. Erratum In: Lancet. 2017 Jul 15;390(10091):230.</citation>
    <PMID>28596043</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>April 10, 2018</results_first_submitted>
  <results_first_submitted_qc>May 25, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 27, 2018</results_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The tables below present the Participant Flow for the Base Study only (Weeks 0 to 52: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 24 weeks).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)</title>
          <description>Participants received tildrakizumab 200 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
        </group>
        <group group_id="P2">
          <title>Tildrakizumab 200 mg (Parts 1, 2, &amp; 3)</title>
          <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
        </group>
        <group group_id="P3">
          <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3)</title>
          <description>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.</description>
        </group>
        <group group_id="P4">
          <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)</title>
          <description>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.</description>
        </group>
        <group group_id="P5">
          <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3)</title>
          <description>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.</description>
        </group>
        <group group_id="P6">
          <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3)</title>
          <description>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.</description>
        </group>
        <group group_id="P7">
          <title>Placebo (Part 1)</title>
          <description>Participants received PBO to tildrakizumab SC on Weeks 0 and 4 plus etanercept PBO twice weekly until Week 12 (Part 1).</description>
        </group>
        <group group_id="P8">
          <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
          <description>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.</description>
        </group>
        <group group_id="P9">
          <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
          <description>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</description>
        </group>
        <group group_id="P10">
          <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
          <description>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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="184"/>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="268"/>
                <participants group_id="P7" count="14"/>
                <participants group_id="P8" count="72"/>
                <participants group_id="P9" count="70"/>
                <participants group_id="P10" count="313"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="184"/>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="268"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="72"/>
                <participants group_id="P9" count="70"/>
                <participants group_id="P10" count="289"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="14"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Protocol Specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="184"/>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="5">1 participant completed Part 1 but did not enter Part 2</participants>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="268"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="72"/>
                <participants group_id="P9" count="70"/>
                <participants group_id="P10" count="289"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="184"/>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="268"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="69"/>
                <participants group_id="P9" count="66"/>
                <participants group_id="P10" count="277"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Protocol Specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="170">14 participants completed Part 2 but did not enter Part 3</participants>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="237">31 participants completed Part 2 but did not enter Part 3</participants>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="69"/>
                <participants group_id="P9" count="66"/>
                <participants group_id="P10" count="121">156 participants completed Part 2 but did not enter Part 3</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="165"/>
                <participants group_id="P3" count="105"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="224"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="66"/>
                <participants group_id="P9" count="65"/>
                <participants group_id="P10" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="13"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Protocol Specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>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).</population>
      <group_list>
        <group group_id="B1">
          <title>Tildrakizumab 200 mg (Part 1)</title>
          <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1).</description>
        </group>
        <group group_id="B2">
          <title>Tildrakizumab 100 mg (Part 1)</title>
          <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1).</description>
        </group>
        <group group_id="B3">
          <title>Placebo (Part 1)</title>
          <description>Participants received tildrakizumab placebo SC at Weeks 0 and 4 and etanercept placebo SC twice weekly until Week 12 (Part 1).</description>
        </group>
        <group group_id="B4">
          <title>Etanercept 50 mg (Part 1)</title>
          <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="314"/>
            <count group_id="B2" value="307"/>
            <count group_id="B3" value="156"/>
            <count group_id="B4" value="313"/>
            <count group_id="B5" value="1090"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.6" spread="13.62"/>
                    <measurement group_id="B2" value="44.6" spread="13.59"/>
                    <measurement group_id="B3" value="46.4" spread="12.20"/>
                    <measurement group_id="B4" value="45.8" spread="13.97"/>
                    <measurement group_id="B5" value="45.2" spread="13.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="91"/>
                    <measurement group_id="B5" value="311"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="225"/>
                    <measurement group_id="B2" value="220"/>
                    <measurement group_id="B3" value="112"/>
                    <measurement group_id="B4" value="222"/>
                    <measurement group_id="B5" value="779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="284"/>
                    <measurement group_id="B2" value="279"/>
                    <measurement group_id="B3" value="144"/>
                    <measurement group_id="B4" value="289"/>
                    <measurement group_id="B5" value="996"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body weight</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;=90 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="176"/>
                    <measurement group_id="B3" value="90"/>
                    <measurement group_id="B4" value="180"/>
                    <measurement group_id="B5" value="626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;90 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="133"/>
                    <measurement group_id="B5" value="464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior exposure to biologic therapy for psoriasis</title>
          <description>The following therapies constitute biologics therapy for psoriasis: efalizumab (RAPTIVA®), alefacept (AMEVIVE®), infliximab (REMICADE®), adalimumab (HUMIRA®), ustekinumab (STELARA®), and etanercept (Enbrel®)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="156"/>
                    <count group_id="B4" value="313"/>
                    <count group_id="B5" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="276"/>
                    <measurement group_id="B2" value="268"/>
                    <measurement group_id="B3" value="136"/>
                    <measurement group_id="B4" value="276"/>
                    <measurement group_id="B5" value="956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psoriasis Area Sensitivity Index (PASI)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
          <population>Analysis populations includes randomized participants with PASI value at baseline.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="307"/>
                    <count group_id="B3" value="155"/>
                    <count group_id="B4" value="312"/>
                    <count group_id="B5" value="1088"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.8" spread="7.52"/>
                    <measurement group_id="B2" value="20.5" spread="7.63"/>
                    <measurement group_id="B3" value="20.0" spread="7.57"/>
                    <measurement group_id="B4" value="20.2" spread="7.36"/>
                    <measurement group_id="B5" value="20.1" spread="7.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.</description>
        <time_frame>Week 12</time_frame>
        <population>Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.</description>
          <population>Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6"/>
                    <measurement group_id="O2" value="61.2"/>
                    <measurement group_id="O3" value="5.8"/>
                    <measurement group_id="O4" value="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>59.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>52.9</ci_lower_limit>
            <ci_upper_limit>65.9</ci_upper_limit>
            <estimate_desc>Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>55.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>48.3</ci_lower_limit>
            <ci_upper_limit>61.8</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)</title>
        <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.</description>
        <time_frame>Week 12</time_frame>
        <population>Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)</title>
          <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.</description>
          <population>Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2"/>
                    <measurement group_id="O2" value="54.7"/>
                    <measurement group_id="O3" value="4.5"/>
                    <measurement group_id="O4" value="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>54.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>47.9</ci_lower_limit>
            <ci_upper_limit>60.8</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in percentages</param_type>
            <param_value>50.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>43.2</ci_lower_limit>
            <ci_upper_limit>56.5</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to Week 12</time_frame>
        <population>Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.4"/>
                    <measurement group_id="O2" value="44.3"/>
                    <measurement group_id="O3" value="55.1"/>
                    <measurement group_id="O4" value="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to Week 12</time_frame>
        <population>Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="1.0"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.</description>
        <time_frame>Week 28</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.</description>
          <population>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.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="294"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.6"/>
                    <measurement group_id="O2" value="73.5"/>
                    <measurement group_id="O3" value="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in percentages</param_type>
            <param_value>19.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.5</ci_lower_limit>
            <ci_upper_limit>26.7</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in percentages</param_type>
            <param_value>20.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.4</ci_lower_limit>
            <ci_upper_limit>27.6</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 40</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="67"/>
                <count group_id="O8" value="64"/>
                <count group_id="O9" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.3"/>
                    <measurement group_id="O2" value="92.6"/>
                    <measurement group_id="O3" value="97.6"/>
                    <measurement group_id="O4" value="63.3"/>
                    <measurement group_id="O5" value="66.7"/>
                    <measurement group_id="O6" value="61.9"/>
                    <measurement group_id="O7" value="82.1"/>
                    <measurement group_id="O8" value="68.8"/>
                    <measurement group_id="O9" value="57.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 52</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="204"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="66"/>
                <count group_id="O8" value="63"/>
                <count group_id="O9" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1"/>
                    <measurement group_id="O2" value="94.2"/>
                    <measurement group_id="O3" value="93.6"/>
                    <measurement group_id="O4" value="66.7"/>
                    <measurement group_id="O5" value="78.9"/>
                    <measurement group_id="O6" value="68.4"/>
                    <measurement group_id="O7" value="92.4"/>
                    <measurement group_id="O8" value="85.7"/>
                    <measurement group_id="O9" value="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)</title>
        <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.</description>
        <time_frame>Week 28</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16 and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)</title>
          <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.</description>
          <population>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.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="294"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2"/>
                    <measurement group_id="O2" value="64.6"/>
                    <measurement group_id="O3" value="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>24.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.2</ci_lower_limit>
            <ci_upper_limit>31.7</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>19.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.7</ci_lower_limit>
            <ci_upper_limit>27.3</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)</title>
        <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 40</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)</title>
          <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="66"/>
                <count group_id="O8" value="64"/>
                <count group_id="O9" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2"/>
                    <measurement group_id="O2" value="79.2"/>
                    <measurement group_id="O3" value="84.9"/>
                    <measurement group_id="O4" value="57.6"/>
                    <measurement group_id="O5" value="38.1"/>
                    <measurement group_id="O6" value="57.1"/>
                    <measurement group_id="O7" value="75.8"/>
                    <measurement group_id="O8" value="62.5"/>
                    <measurement group_id="O9" value="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)</title>
        <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 52</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)</title>
          <description>The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="204"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="66"/>
                <count group_id="O8" value="63"/>
                <count group_id="O9" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8"/>
                    <measurement group_id="O2" value="77.7"/>
                    <measurement group_id="O3" value="79.4"/>
                    <measurement group_id="O4" value="50.8"/>
                    <measurement group_id="O5" value="42.1"/>
                    <measurement group_id="O6" value="57.9"/>
                    <measurement group_id="O7" value="77.3"/>
                    <measurement group_id="O8" value="55.6"/>
                    <measurement group_id="O9" value="68.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.</description>
        <time_frame>Week 12</time_frame>
        <population>Analysis population includes randomized participants who received at least one dose of study medication in study Part 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.</description>
          <population>Analysis population includes randomized participants who received at least one dose of study medication in study Part 1.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6"/>
                    <measurement group_id="O2" value="38.8"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>35.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.2</ci_lower_limit>
            <ci_upper_limit>41.1</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>37.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.1</ci_lower_limit>
            <ci_upper_limit>43.4</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>15.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.3</ci_lower_limit>
            <ci_upper_limit>22.1</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>17.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.3</ci_lower_limit>
            <ci_upper_limit>24.4</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.</description>
        <time_frame>Week 28</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and 16 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.</description>
          <population>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.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="293"/>
                <count group_id="O2" value="290"/>
                <count group_id="O3" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.7"/>
                    <measurement group_id="O2" value="55.5"/>
                    <measurement group_id="O3" value="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in percentages</param_type>
            <param_value>27.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.1</ci_lower_limit>
            <ci_upper_limit>34.7</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>24.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.0</ci_lower_limit>
            <ci_upper_limit>32.6</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 40</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="67"/>
                <count group_id="O8" value="64"/>
                <count group_id="O9" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6"/>
                    <measurement group_id="O2" value="73.1"/>
                    <measurement group_id="O3" value="78.8"/>
                    <measurement group_id="O4" value="28.3"/>
                    <measurement group_id="O5" value="23.8"/>
                    <measurement group_id="O6" value="42.9"/>
                    <measurement group_id="O7" value="64.2"/>
                    <measurement group_id="O8" value="48.4"/>
                    <measurement group_id="O9" value="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 52</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="204"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="66"/>
                <count group_id="O8" value="63"/>
                <count group_id="O9" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.9"/>
                    <measurement group_id="O2" value="68.3"/>
                    <measurement group_id="O3" value="78.4"/>
                    <measurement group_id="O4" value="31.7"/>
                    <measurement group_id="O5" value="26.3"/>
                    <measurement group_id="O6" value="42.1"/>
                    <measurement group_id="O7" value="63.6"/>
                    <measurement group_id="O8" value="47.6"/>
                    <measurement group_id="O9" value="41.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.</description>
        <time_frame>Week 12</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.</description>
          <population>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.</population>
          <units>Perentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="12.4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>11.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.8</ci_lower_limit>
            <ci_upper_limit>16.0</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>12.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.5</ci_lower_limit>
            <ci_upper_limit>16.6</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>7.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.8</ci_lower_limit>
            <ci_upper_limit>11.6</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>7.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.3</ci_lower_limit>
            <ci_upper_limit>12.3</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.</description>
        <time_frame>Week 28</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and 16 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.</description>
          <population>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.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="293"/>
                <count group_id="O2" value="290"/>
                <count group_id="O3" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0"/>
                    <measurement group_id="O2" value="22.8"/>
                    <measurement group_id="O3" value="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>15.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.4</ci_lower_limit>
            <ci_upper_limit>22.1</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>11.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.6</ci_lower_limit>
            <ci_upper_limit>17.9</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 40</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="67"/>
                <count group_id="O8" value="64"/>
                <count group_id="O9" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3"/>
                    <measurement group_id="O2" value="38.9"/>
                    <measurement group_id="O3" value="33.5"/>
                    <measurement group_id="O4" value="11.7"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="14.3"/>
                    <measurement group_id="O7" value="29.9"/>
                    <measurement group_id="O8" value="28.1"/>
                    <measurement group_id="O9" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 52</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="204"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="66"/>
                <count group_id="O8" value="63"/>
                <count group_id="O9" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="37.5"/>
                    <measurement group_id="O3" value="35.3"/>
                    <measurement group_id="O4" value="10.0"/>
                    <measurement group_id="O5" value="5.3"/>
                    <measurement group_id="O6" value="31.6"/>
                    <measurement group_id="O7" value="39.4"/>
                    <measurement group_id="O8" value="23.8"/>
                    <measurement group_id="O9" value="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Dermatology Life Quality Index (DLQI)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
        <time_frame>Baseline</time_frame>
        <population>Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Dermatology Life Quality Index (DLQI)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
          <population>Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="7.03"/>
                    <measurement group_id="O2" value="14.8" spread="7.24"/>
                    <measurement group_id="O3" value="13.7" spread="6.98"/>
                    <measurement group_id="O4" value="14.5" spread="7.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the DLQI at Week 12 (Part 1)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the DLQI at Week 12 (Part 1)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
          <population>Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.3" lower_limit="-11.0" upper_limit="-9.7"/>
                    <measurement group_id="O2" value="-10.2" lower_limit="-10.9" upper_limit="-9.6"/>
                    <measurement group_id="O3" value="-2.0" lower_limit="-2.9" upper_limit="-1.1"/>
                    <measurement group_id="O4" value="-8.9" lower_limit="-9.6" upper_limit="-8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>cLDA</method>
            <method_desc>Terms for time, the interaction of time by treatment, body weight (&lt;=90 kg, &gt;90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-8.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.3</ci_lower_limit>
            <ci_upper_limit>-7.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>cLDA</method>
            <method_desc>Terms for time, the interaction of time by treatment, body weight (&lt;=90 kg, &gt;90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-8.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.3</ci_lower_limit>
            <ci_upper_limit>-7.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>cLDA</method>
            <method_desc>Terms for time, the interaction of time by treatment, body weight (&lt;=90 kg, &gt;90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>cLDA</method>
            <method_desc>Terms for time, the interaction of time by treatment, body weight (&lt;=90 kg, &gt;90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the DLQI at Week 28 (Part 2)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
        <time_frame>Baseline and Week 28</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the DLQI at Week 28 (Part 2)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
          <population>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.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="294"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" lower_limit="-12.3" upper_limit="-11.1"/>
                    <measurement group_id="O2" value="-11.2" lower_limit="-11.8" upper_limit="-10.5"/>
                    <measurement group_id="O3" value="-9.5" lower_limit="-10.1" upper_limit="-8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>cLDA</method>
            <method_desc>Terms for time, the interaction of time by treatment, body weight (&lt;=90 kg, &gt;90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.4</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>cLDA</method>
            <method_desc>Terms for time, the interaction of time by treatment, body weight (&lt;=90 kg, &gt;90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>-1.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the DLQI at Week 40 (Part 3)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Baseline and Week 40</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the DLQI at Week 40 (Part 3)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="69"/>
                <count group_id="O8" value="65"/>
                <count group_id="O9" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.6" spread="6.61"/>
                    <measurement group_id="O2" value="-12.0" spread="7.11"/>
                    <measurement group_id="O3" value="-13.2" spread="6.92"/>
                    <measurement group_id="O4" value="-9.7" spread="5.62"/>
                    <measurement group_id="O5" value="-9.0" spread="7.76"/>
                    <measurement group_id="O6" value="-9.8" spread="7.25"/>
                    <measurement group_id="O7" value="-10.4" spread="6.66"/>
                    <measurement group_id="O8" value="-10.1" spread="6.08"/>
                    <measurement group_id="O9" value="-10.8" spread="6.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the DLQI at Week 52 (Part 3)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the DLQI at Week 52 (Part 3)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="65"/>
                <count group_id="O8" value="63"/>
                <count group_id="O9" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.3" spread="6.16"/>
                    <measurement group_id="O2" value="-11.5" spread="7.26"/>
                    <measurement group_id="O3" value="-13.1" spread="6.80"/>
                    <measurement group_id="O4" value="-9.2" spread="6.18"/>
                    <measurement group_id="O5" value="-9.4" spread="8.47"/>
                    <measurement group_id="O6" value="-9.3" spread="7.22"/>
                    <measurement group_id="O7" value="-11.1" spread="6.45"/>
                    <measurement group_id="O8" value="-10.4" spread="6.38"/>
                    <measurement group_id="O9" value="-11.5" spread="6.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
        <time_frame>Week 12</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
          <population>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.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="306"/>
                <count group_id="O2" value="296"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4"/>
                    <measurement group_id="O2" value="40.2"/>
                    <measurement group_id="O3" value="8.0"/>
                    <measurement group_id="O4" value="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>39.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.8</ci_lower_limit>
            <ci_upper_limit>46.1</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>32.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.5</ci_lower_limit>
            <ci_upper_limit>39.1</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>11.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.1</ci_lower_limit>
            <ci_upper_limit>19.5</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.221</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>12.5</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
        <time_frame>Week 28</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.</description>
          <population>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.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="290"/>
                <count group_id="O3" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0"/>
                    <measurement group_id="O2" value="54.1"/>
                    <measurement group_id="O3" value="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>25.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.7</ci_lower_limit>
            <ci_upper_limit>33.4</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>15.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.9</ci_lower_limit>
            <ci_upper_limit>22.9</ci_upper_limit>
            <estimate_desc>Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (&lt;=90kg, &gt;90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 40</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="69"/>
                <count group_id="O8" value="66"/>
                <count group_id="O9" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2"/>
                    <measurement group_id="O2" value="68.5"/>
                    <measurement group_id="O3" value="71.2"/>
                    <measurement group_id="O4" value="41.7"/>
                    <measurement group_id="O5" value="9.5"/>
                    <measurement group_id="O6" value="19.0"/>
                    <measurement group_id="O7" value="50.7"/>
                    <measurement group_id="O8" value="51.5"/>
                    <measurement group_id="O9" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)</title>
        <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Week 52</time_frame>
        <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)</title>
          <description>The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="105"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="65"/>
                <count group_id="O8" value="64"/>
                <count group_id="O9" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.4"/>
                    <measurement group_id="O2" value="71.4"/>
                    <measurement group_id="O3" value="68.8"/>
                    <measurement group_id="O4" value="40.0"/>
                    <measurement group_id="O5" value="10.5"/>
                    <measurement group_id="O6" value="42.1"/>
                    <measurement group_id="O7" value="60.0"/>
                    <measurement group_id="O8" value="57.8"/>
                    <measurement group_id="O9" value="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in PASI Score Over Time (Part 1)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
        <time_frame>Baseline and Week 4, Week 8 or Week 12</time_frame>
        <population>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).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in PASI Score Over Time (Part 1)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
          <population>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).</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="155"/>
                <count group_id="O4" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="303"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.1" spread="6.54"/>
                    <measurement group_id="O2" value="-7.9" spread="6.83"/>
                    <measurement group_id="O3" value="-2.3" spread="6.18"/>
                    <measurement group_id="O4" value="-7.0" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="299"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.1" spread="7.71"/>
                    <measurement group_id="O2" value="-12.8" spread="7.57"/>
                    <measurement group_id="O3" value="-3.1" spread="7.18"/>
                    <measurement group_id="O4" value="-11.4" spread="8.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="297"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.4" spread="7.77"/>
                    <measurement group_id="O2" value="-15.1" spread="7.94"/>
                    <measurement group_id="O3" value="-3.4" spread="6.77"/>
                    <measurement group_id="O4" value="-13.5" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in PASI Score Over Time (Part 2)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
        <time_frame>Baseline and Week 16, Week 22 or Week 28</time_frame>
        <population>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).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2)</title>
            <description>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.</description>
          </group>
          <group group_id="O5">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in PASI Score Over Time (Part 2)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
          <population>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).</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="312"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="298"/>
                    <count group_id="O2" value="291"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="72"/>
                    <count group_id="O5" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.2" spread="7.70"/>
                    <measurement group_id="O2" value="-15.9" spread="7.87"/>
                    <measurement group_id="O3" value="-14.2" spread="8.20"/>
                    <measurement group_id="O4" value="-11.6" spread="6.97"/>
                    <measurement group_id="O5" value="-9.6" spread="6.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="290"/>
                    <count group_id="O3" value="281"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.1" spread="7.66"/>
                    <measurement group_id="O2" value="-16.7" spread="7.88"/>
                    <measurement group_id="O3" value="-14.5" spread="8.32"/>
                    <measurement group_id="O4" value="-15.1" spread="6.55"/>
                    <measurement group_id="O5" value="-13.7" spread="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="290"/>
                    <count group_id="O3" value="277"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" spread="7.81"/>
                    <measurement group_id="O2" value="-16.5" spread="7.71"/>
                    <measurement group_id="O3" value="-14.8" spread="7.85"/>
                    <measurement group_id="O4" value="-17.3" spread="7.62"/>
                    <measurement group_id="O5" value="-14.5" spread="8.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in PASI Score Over Time (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52</time_frame>
        <population>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).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in PASI Score Over Time (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>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).</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="65"/>
                <count group_id="O9" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="207"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="20"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="65"/>
                    <count group_id="O9" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" spread="7.13"/>
                    <measurement group_id="O2" value="-19.0" spread="8.03"/>
                    <measurement group_id="O3" value="-18.7" spread="6.83"/>
                    <measurement group_id="O4" value="-14.0" spread="5.72"/>
                    <measurement group_id="O5" value="-15.0" spread="6.69"/>
                    <measurement group_id="O6" value="-15.5" spread="7.08"/>
                    <measurement group_id="O7" value="-16.9" spread="7.68"/>
                    <measurement group_id="O8" value="-16.4" spread="8.02"/>
                    <measurement group_id="O9" value="-10.5" spread="6.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="107"/>
                    <count group_id="O3" value="210"/>
                    <count group_id="O4" value="59"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="65"/>
                    <count group_id="O9" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.9" spread="7.11"/>
                    <measurement group_id="O2" value="-19.0" spread="8.17"/>
                    <measurement group_id="O3" value="-18.9" spread="7.18"/>
                    <measurement group_id="O4" value="-14.5" spread="5.92"/>
                    <measurement group_id="O5" value="-15.7" spread="8.09"/>
                    <measurement group_id="O6" value="-16.0" spread="8.13"/>
                    <measurement group_id="O7" value="-17.6" spread="6.80"/>
                    <measurement group_id="O8" value="-16.7" spread="8.19"/>
                    <measurement group_id="O9" value="-12.9" spread="6.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="212"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="67"/>
                    <count group_id="O8" value="64"/>
                    <count group_id="O9" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.8" spread="7.04"/>
                    <measurement group_id="O2" value="-18.5" spread="7.56"/>
                    <measurement group_id="O3" value="-18.7" spread="6.95"/>
                    <measurement group_id="O4" value="-14.4" spread="6.00"/>
                    <measurement group_id="O5" value="-16.0" spread="8.73"/>
                    <measurement group_id="O6" value="-16.5" spread="8.59"/>
                    <measurement group_id="O7" value="-17.9" spread="7.03"/>
                    <measurement group_id="O8" value="-16.9" spread="7.99"/>
                    <measurement group_id="O9" value="-14.6" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="105"/>
                    <count group_id="O3" value="205"/>
                    <count group_id="O4" value="59"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                    <count group_id="O7" value="65"/>
                    <count group_id="O8" value="64"/>
                    <count group_id="O9" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" spread="7.13"/>
                    <measurement group_id="O2" value="-18.1" spread="7.45"/>
                    <measurement group_id="O3" value="-18.7" spread="6.76"/>
                    <measurement group_id="O4" value="-14.5" spread="5.99"/>
                    <measurement group_id="O5" value="-16.2" spread="8.76"/>
                    <measurement group_id="O6" value="-15.8" spread="9.72"/>
                    <measurement group_id="O7" value="-17.9" spread="6.24"/>
                    <measurement group_id="O8" value="-17.1" spread="7.30"/>
                    <measurement group_id="O9" value="-15.6" spread="7.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="204"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="19"/>
                    <count group_id="O7" value="66"/>
                    <count group_id="O8" value="63"/>
                    <count group_id="O9" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.9" spread="7.13"/>
                    <measurement group_id="O2" value="-18.4" spread="7.66"/>
                    <measurement group_id="O3" value="-18.4" spread="6.65"/>
                    <measurement group_id="O4" value="-14.6" spread="5.72"/>
                    <measurement group_id="O5" value="-15.5" spread="9.00"/>
                    <measurement group_id="O6" value="-16.3" spread="9.55"/>
                    <measurement group_id="O7" value="-18.1" spread="7.00"/>
                    <measurement group_id="O8" value="-17.0" spread="7.30"/>
                    <measurement group_id="O9" value="-16.2" spread="6.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change From Baseline in PASI Score Over Time (Part 1)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
        <time_frame>Baseline and Week 4, Week 8 or Week 12</time_frame>
        <population>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).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept 50 mg</title>
            <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change From Baseline in PASI Score Over Time (Part 1)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
          <population>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).</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="155"/>
                <count group_id="O4" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="303"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.2" spread="27.86"/>
                    <measurement group_id="O2" value="-39.3" spread="30.02"/>
                    <measurement group_id="O3" value="-11.7" spread="30.37"/>
                    <measurement group_id="O4" value="-33.9" spread="33.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="299"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-65.7" spread="26.58"/>
                    <measurement group_id="O2" value="-63.8" spread="29.65"/>
                    <measurement group_id="O3" value="-15.3" spread="35.95"/>
                    <measurement group_id="O4" value="-55.7" spread="35.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="297"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-78.0" spread="22.31"/>
                    <measurement group_id="O2" value="-74.8" spread="28.11"/>
                    <measurement group_id="O3" value="-17.4" spread="32.95"/>
                    <measurement group_id="O4" value="-66.7" spread="30.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change From Baseline in PASI Score Over Time (Part 2)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
        <time_frame>Baseline and Week 16, Week 22 or Week 28</time_frame>
        <population>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).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg</title>
            <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50 mg</title>
            <description>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.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2)</title>
            <description>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.</description>
          </group>
          <group group_id="O5">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change From Baseline in PASI Score Over Time (Part 2)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.</description>
          <population>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).</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="307"/>
                <count group_id="O3" value="312"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="298"/>
                    <count group_id="O2" value="291"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="72"/>
                    <count group_id="O5" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.0" spread="21.26"/>
                    <measurement group_id="O2" value="-79.3" spread="25.27"/>
                    <measurement group_id="O3" value="-70.3" spread="27.55"/>
                    <measurement group_id="O4" value="-59.2" spread="28.34"/>
                    <measurement group_id="O5" value="-49.4" spread="28.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="290"/>
                    <count group_id="O3" value="281"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-86.6" spread="17.58"/>
                    <measurement group_id="O2" value="-82.9" spread="23.16"/>
                    <measurement group_id="O3" value="-71.9" spread="29.40"/>
                    <measurement group_id="O4" value="-77.9" spread="20.25"/>
                    <measurement group_id="O5" value="-70.1" spread="25.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="290"/>
                    <count group_id="O3" value="277"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-85.7" spread="17.44"/>
                    <measurement group_id="O2" value="-82.5" spread="22.33"/>
                    <measurement group_id="O3" value="-73.5" spread="24.40"/>
                    <measurement group_id="O4" value="-84.0" spread="16.89"/>
                    <measurement group_id="O5" value="-72.9" spread="30.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change From Baseline in PASI Score Over Time (Part 3)</title>
        <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
        <time_frame>Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52</time_frame>
        <population>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).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 200 mg (Parts 1 &amp; 2)/ 100 mg (Part 3) Wk-28 R</title>
            <description>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.</description>
          </group>
          <group group_id="O3">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 R</title>
            <description>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</description>
          </group>
          <group group_id="O4">
            <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 PR</title>
            <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.</description>
          </group>
          <group group_id="O5">
            <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O6">
            <title>Tildrakizumab 100 mg (Parts 1, 2, &amp; 3) Wk-28 PR</title>
            <description>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.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O8">
            <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
            <description>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.</description>
          </group>
          <group group_id="O9">
            <title>Etanercept 50 mg (Parts 1 &amp; 2)/ Tildrakizumab 200 mg (Part 3)</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change From Baseline in PASI Score Over Time (Part 3)</title>
          <description>The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and &lt;75% improvement in PASI response from baseline at Week 28.</description>
          <population>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).</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="212"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="65"/>
                <count group_id="O9" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="207"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="20"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="65"/>
                    <count group_id="O9" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-94.9" spread="6.19"/>
                    <measurement group_id="O2" value="-94.0" spread="7.02"/>
                    <measurement group_id="O3" value="-94.3" spread="7.33"/>
                    <measurement group_id="O4" value="-77.1" spread="16.73"/>
                    <measurement group_id="O5" value="-71.1" spread="13.21"/>
                    <measurement group_id="O6" value="-75.3" spread="16.90"/>
                    <measurement group_id="O7" value="-84.4" spread="24.18"/>
                    <measurement group_id="O8" value="-81.6" spread="21.69"/>
                    <measurement group_id="O9" value="-54.7" spread="24.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="107"/>
                    <count group_id="O3" value="210"/>
                    <count group_id="O4" value="59"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="65"/>
                    <count group_id="O9" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-94.5" spread="7.47"/>
                    <measurement group_id="O2" value="-94.0" spread="6.93"/>
                    <measurement group_id="O3" value="-94.4" spread="7.06"/>
                    <measurement group_id="O4" value="-79.9" spread="15.94"/>
                    <measurement group_id="O5" value="-74.4" spread="15.69"/>
                    <measurement group_id="O6" value="-77.9" spread="15.47"/>
                    <measurement group_id="O7" value="-87.7" spread="15.20"/>
                    <measurement group_id="O8" value="-83.1" spread="19.83"/>
                    <measurement group_id="O9" value="-65.9" spread="21.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="212"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="67"/>
                    <count group_id="O8" value="64"/>
                    <count group_id="O9" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-94.2" spread="7.69"/>
                    <measurement group_id="O2" value="-92.6" spread="10.25"/>
                    <measurement group_id="O3" value="-94.3" spread="7.40"/>
                    <measurement group_id="O4" value="-79.1" spread="17.10"/>
                    <measurement group_id="O5" value="-75.7" spread="19.24"/>
                    <measurement group_id="O6" value="-80.6" spread="17.57"/>
                    <measurement group_id="O7" value="-88.2" spread="14.55"/>
                    <measurement group_id="O8" value="-84.1" spread="17.08"/>
                    <measurement group_id="O9" value="-76.5" spread="17.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="105"/>
                    <count group_id="O3" value="205"/>
                    <count group_id="O4" value="59"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                    <count group_id="O7" value="65"/>
                    <count group_id="O8" value="64"/>
                    <count group_id="O9" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-94.8" spread="7.77"/>
                    <measurement group_id="O2" value="-91.4" spread="12.09"/>
                    <measurement group_id="O3" value="-94.3" spread="7.64"/>
                    <measurement group_id="O4" value="-79.3" spread="17.77"/>
                    <measurement group_id="O5" value="-77.1" spread="19.67"/>
                    <measurement group_id="O6" value="-75.3" spread="23.35"/>
                    <measurement group_id="O7" value="-90.3" spread="12.32"/>
                    <measurement group_id="O8" value="-86.9" spread="13.08"/>
                    <measurement group_id="O9" value="-80.3" spread="17.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="204"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="19"/>
                    <count group_id="O7" value="66"/>
                    <count group_id="O8" value="63"/>
                    <count group_id="O9" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-94.7" spread="8.06"/>
                    <measurement group_id="O2" value="-92.2" spread="10.57"/>
                    <measurement group_id="O3" value="-93.4" spread="9.81"/>
                    <measurement group_id="O4" value="-80.4" spread="15.68"/>
                    <measurement group_id="O5" value="-75.7" spread="36.00"/>
                    <measurement group_id="O6" value="-79.6" spread="21.46"/>
                    <measurement group_id="O7" value="-91.0" spread="12.16"/>
                    <measurement group_id="O8" value="-87.1" spread="12.90"/>
                    <measurement group_id="O9" value="-84.2" spread="16.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52)</time_frame>
      <desc>Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3) Wk-28 R</title>
          <description>Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.</description>
        </group>
        <group group_id="E2">
          <title>Tildrakizumab 100 mg (Parts 1, 2 &amp; 3)</title>
          <description>Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and then every 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Part 1)</title>
          <description>Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4.</description>
        </group>
        <group group_id="E4">
          <title>Etanercept 50 mg (Parts 1 &amp; 2)</title>
          <description>Participants received etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="487"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="527"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="487"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="527"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy alcoholic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Haemorrhoids thrombosed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Oesophageal polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Steatohepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="527"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Breact cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Renal oncocytoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Borderline personality disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Obstructive uropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="527"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="167" subjects_at_risk="527"/>
                <counts group_id="E2" subjects_affected="151" subjects_at_risk="487"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="118" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="527"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="487"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="98" subjects_affected="28" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="527"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="54" subjects_affected="17" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="173" subjects_affected="119" subjects_at_risk="527"/>
                <counts group_id="E2" events="152" subjects_affected="112" subjects_at_risk="487"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="156"/>
                <counts group_id="E4" events="79" subjects_affected="63" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="30" subjects_affected="27" subjects_at_risk="527"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" events="14" subjects_affected="11" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="527"/>
                <counts group_id="E2" events="30" subjects_affected="26" subjects_at_risk="487"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E4" events="13" subjects_affected="10" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="40" subjects_affected="30" subjects_at_risk="527"/>
                <counts group_id="E2" events="46" subjects_affected="29" subjects_at_risk="487"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="156"/>
                <counts group_id="E4" events="31" subjects_affected="18" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head-Clinical Development</name_or_title>
      <organization>Sun Pharma Advanced Research Company Limited</organization>
      <phone>912266455645</phone>
      <email>clinical.trials@sparcmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01729754
org study id: 3222-011
secondary id: 2012-001377-88
secondary id: P07771
nct id: NCT01729754
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)
time frame: Week 12
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
measure: 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)
time frame: Week 12
description: The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
measure: Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)
time frame: Up to Week 12
description: An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)
time frame: Up to Week 12
description: An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)
time frame: Week 28
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.
measure: Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)
time frame: Week 40
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)
time frame: Week 52
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: 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)
time frame: Week 28
description: The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
measure: 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)
time frame: Week 40
description: The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: 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)
time frame: Week 52
description: The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)
time frame: Week 12
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
measure: Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)
time frame: Week 28
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
measure: Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)
time frame: Week 40
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)
time frame: Week 52
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)
time frame: Week 12
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
measure: Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)
time frame: Week 28
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
measure: Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)
time frame: Week 40
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)
time frame: Week 52
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Baseline Dermatology Life Quality Index (DLQI)
time frame: Baseline
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
measure: Change From Baseline in the DLQI at Week 12 (Part 1)
time frame: Baseline and Week 12
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
measure: Change From Baseline in the DLQI at Week 28 (Part 2)
time frame: Baseline and Week 28
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
measure: Change From Baseline in the DLQI at Week 40 (Part 3)
time frame: Baseline and Week 40
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Change From Baseline in the DLQI at Week 52 (Part 3)
time frame: Baseline and Week 52
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)
time frame: Week 12
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)
time frame: Week 28
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)
time frame: Week 40
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)
time frame: Week 52
description: The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Mean Change From Baseline in PASI Score Over Time (Part 1)
time frame: Baseline and Week 4, Week 8 or Week 12
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
measure: Mean Change From Baseline in PASI Score Over Time (Part 2)
time frame: Baseline and Week 16, Week 22 or Week 28
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
measure: Mean Change From Baseline in PASI Score Over Time (Part 3)
time frame: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
measure: Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
time frame: Baseline and Week 4, Week 8 or Week 12
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
measure: Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
time frame: Baseline and Week 16, Week 22 or Week 28
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
measure: Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
time frame: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52
description: The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
arm group label: Tildrakizumab 200 mg
arm group type: Experimental
description: 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.
arm group label: Tildrakizumab 100 mg
arm group type: Experimental
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
arm group label: Etanercept 50 mg
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: Tildrakizumab 200 mg
description: Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.
arm group label: Tildrakizumab 200 mg
other name: SCH 900222, MK-3222
intervention type: Drug
intervention name: Tildrakizumab 100 mg
description: Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.
arm group label: Tildrakizumab 100 mg
other name: SCH 900222, MK-3222
intervention type: Drug
intervention name: Tildrakizumab Placebo
description: Matching placebo to tildrakizumab administered SC
arm group label: Etanercept 50 mg
arm group label: Placebo
intervention type: Drug
intervention name: Etanercept Placebo
description: Matching placebo to etanercept administered SC
arm group label: Placebo
arm group label: Tildrakizumab 100 mg
arm group label: Tildrakizumab 200 mg
intervention type: Drug
intervention name: Etanercept 50 mg
description: Etanercept 50 mg administered SC
arm group label: Etanercept 50 mg
other name: Embrel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
country: Austria
country: Belgium
country: Canada
country: Czech Republic
country: Denmark
country: France
country: Germany
country: Hungary
country: Italy
country: Netherlands
country: Poland
country: United States
citation: 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. Erratum In: Lancet. 2017 Jul 15;390(10091):230.
PMID: 28596043
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Etanercept
mesh term: Antibodies, Monoclonal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 