<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/NCT01722331</url>
  </required_header>
  <id_info>
    <org_study_id>3222-010</org_study_id>
    <secondary_id>2012-002255-42</secondary_id>
    <secondary_id>P07770</secondary_id>
    <secondary_id>132284</secondary_id>
    <nct_id>NCT01722331</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)</brief_title>
  <acronym>reSURFACE 1</acronym>
  <official_title>A 64-Week, Phase 3, Randomized, 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-3222-010)</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;
      subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension&#xD;
      study, in participants with moderate-to-severe chronic plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are initially randomized to receive tildrakizumab 200 or 100 mg once weekly at&#xD;
      Weeks 0, 4, and every 12 weeks thereafter; or placebo at Weeks 0 and 4.&#xD;
&#xD;
      At Week 12, participants initially randomized to placebo will be re-randomized to receive&#xD;
      either tildrakizumab 200 or 100 mg at Weeks 12 and 16.&#xD;
&#xD;
      At Week 28, all participants enrolled will be assessed for their improvement in PASI score&#xD;
      from baseline.&#xD;
&#xD;
      RESPONDERS: Participants initially randomized to tildrakizumab who achieve at least a 75%&#xD;
      improvement from baseline PASI will be re-randomized to either continue on their initial&#xD;
      treatment or to receive placebo at Week 28.&#xD;
&#xD;
        -  Participants who are re-randomized to continue on their initial treatment will continue&#xD;
           tildrakizumab 200 or 100 mg every 12 weeks through Week 64.&#xD;
&#xD;
        -  Participants who are re-randomized to placebo will receive placebo every 4 weeks until&#xD;
           relapse (reduction in maximum PASI response by 50%). If relapse occurs, the&#xD;
           tildrakizumab dose that the participants was originally randomized to at baseline will&#xD;
           be re-initiated (tildrakizumab 200 or 100 mg). Participants will be dosed tildrakizumab&#xD;
           at the visit when the relapse occurs, and subsequent dosing of tildrakizumab will be&#xD;
           given 4 weeks after treatment re-initiation, and every 12 weeks thereafter through Week&#xD;
           64.&#xD;
&#xD;
      PARTIAL RESPONDERS: Participants initially randomized to tildrakizumab who achieved a PASI&#xD;
      response of ≥50% but &lt;75% improvement from baseline will be assigned a treatment regimen as&#xD;
      described below, with their first dose started at Week 28.&#xD;
&#xD;
        -  Participants initially randomized to tildrakizumab 200 mg will remain on tildrakizumab&#xD;
           200 mg every 12 weeks.&#xD;
&#xD;
        -  Participants initially randomized to tildrakizumab 100 mg will be re-randomized to&#xD;
           either remain on tildrakizumab 100 mg every 12 weeks or to receive tildrakizumab 200 mg&#xD;
           every 12 weeks.&#xD;
&#xD;
        -  Participants initially randomized to placebo who achieved ≥50% improvement from baseline&#xD;
           in PASI will receive tildrakizumab (200 or 100 mg) according to their re-randomized&#xD;
           treatment assignment at Week 12 and continue on this treatment every 12 weeks through&#xD;
           Week 64.&#xD;
&#xD;
      NON-RESPONDERS: Participants who did not achieve at least 50% improvement from baseline PASI&#xD;
      at Week 28 will be discontinued from the study.&#xD;
&#xD;
      EXTENSION: Participants will receive tildrakizumab 200 mg or 100 mg every 12 weeks through&#xD;
      Extension Week 192, depending on the treatment received at the time of completion of the base&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2012</start_date>
  <completion_date type="Actual">November 10, 2021</completion_date>
  <primary_completion_date type="Actual">October 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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)</measure>
    <time_frame>Week 12 (or end of trial if prior to 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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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.</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 (Base Study)</measure>
    <time_frame>Baseline and Week 12 (or end of trial if prior to 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)</measure>
    <time_frame>Up to 12 weeks</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>Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)</measure>
    <time_frame>Up to 12 weeks</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>Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With PASI-90 Response At Week 12</measure>
    <time_frame>Week 12 (or end of trial if prior to 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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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 With PASI-100 Response at Week 12</measure>
    <time_frame>Week 12 (or end of trial if prior to 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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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>Baseline Dermatology Life Quality Index (DLQI) Score</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 Participant DLQI Score at Week 12</measure>
    <time_frame>Baseline and Week 12 (or end of trial if prior to 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. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With DLQI Score of 0 or 1 at Week 12</measure>
    <time_frame>Week 12 (or end of trial if prior to 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>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">772</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Tildrakizumab 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tildrakizumab 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tildrakizumab 200 mg</intervention_name>
    <description>Two tildrakizumab 100 mg/mL pre-filled syringes (PFS)</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tildrakizumab 200 mg</arm_group_label>
    <other_name>MK-3222, SCH 900222</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tildrakizumab 100 mg</intervention_name>
    <description>Tildrakizumab 100 mg/mL PFS</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tildrakizumab 100 mg</arm_group_label>
    <other_name>MK-3222, SCH 900222</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>Matching placebo to tildrakizumab PFS</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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior&#xD;
             to study enrollment&#xD;
&#xD;
          -  A candidate for phototherapy or systemic therapy&#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;
          -  For the extension study: must have received active tildrakizumab (MK-3222) treatment&#xD;
             within 12 weeks prior to the end of Part 3 of the base study&#xD;
&#xD;
          -  Premenopausal female participants must agree to abstain from heterosexual activity or&#xD;
             use a medically accepted method of contraception or use appropriate effective&#xD;
             contraception as per local regulations or guidelines&#xD;
&#xD;
          -  If enrolled at a Japanese site, participants with psoriatic arthritis using&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4&#xD;
             weeks prior to the first dose of study drug and must not be expected to require an&#xD;
             increase in dose over the course of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or&#xD;
             medication-exacerbated psoriasis, or new onset guttate psoriasis&#xD;
&#xD;
          -  Current or history of severe psoriatic arthritis and is well-controlled on current&#xD;
             treatment&#xD;
&#xD;
          -  Women of child-bearing potential who are pregnant, intend to become pregnant within 6&#xD;
             months of completing the trial, or who are breast feeding&#xD;
&#xD;
          -  Expected to require topical treatment, phototherapy, or systemic treatment during the&#xD;
             trial&#xD;
&#xD;
          -  Presence of any infection&#xD;
&#xD;
          -  History of recurrent infection requiring treatment with systemic antibiotics within 2&#xD;
             weeks of screening&#xD;
&#xD;
          -  Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors&#xD;
             including P40, p19, and IL-17 antagonists&#xD;
&#xD;
          -  Evidence of active or untreated latent tuberculosis (TB)&#xD;
&#xD;
          -  Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
             (HBsAg) or hepatitis C virus (HCV)&#xD;
&#xD;
          -  At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV)&#xD;
             deoxyribonucleic acid (DNA)&#xD;
&#xD;
          -  At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA&#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 who 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;
&#xD;
          -  At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the&#xD;
             screening visit.&#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>Australia</country>
    <country>Canada</country>
    <country>Japan</country>
    <country>United Kingdom</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 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>March 28, 2018</results_first_submitted>
  <results_first_submitted_qc>May 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 13, 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 23, 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>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The tables below present the Participant Flow for the Base Study only (Weeks 0 to 64: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 36 weeks).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tildrakizumab 200 mg (Parts 1, 2 &amp; 3)</title>
          <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).</description>
        </group>
        <group group_id="P2">
          <title>Tildrakizumab 100 mg (Parts 1, 2 &amp; 3)</title>
          <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).</description>
        </group>
        <group group_id="P3">
          <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)</title>
          <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2).</description>
        </group>
        <group group_id="P4">
          <title>Tildrakizumab 100 mg (Parts 1 &amp; 2)/ 200 mg (Part 3)</title>
          <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 200 mg administered SC once a week at Weeks 28, 40, 52, and 64 (Part 3).</description>
        </group>
        <group group_id="P5">
          <title>Placebo (Part 1)</title>
          <description>Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1).</description>
        </group>
        <group group_id="P6">
          <title>Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 &amp; 3)</title>
          <description>Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).</description>
        </group>
        <group group_id="P7">
          <title>Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 &amp; 3)</title>
          <description>Matching placebo administered SC once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="308"/>
                <participants group_id="P2" count="249"/>
                <participants group_id="P3" count="41"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="72"/>
                <participants group_id="P7" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="298"/>
                <participants group_id="P2" count="249"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="72"/>
                <participants group_id="P7" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" 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="1"/>
                <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_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="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" 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="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</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_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="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</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="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </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="298"/>
                <participants group_id="P2" count="249"/>
                <participants group_id="P3" count="31">1 participant who completed Part 1 did not enter Part 2</participants>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="72"/>
                <participants group_id="P7" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="279"/>
                <participants group_id="P2" count="249"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="62"/>
                <participants group_id="P7" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" 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="3"/>
                <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="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="3"/>
              </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="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
              </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="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_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="2"/>
                <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_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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </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="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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</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_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="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Protocol Specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
              </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="279"/>
                <participants group_id="P2" count="249"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="62"/>
                <participants group_id="P7" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="264"/>
                <participants group_id="P2" count="232"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="59"/>
                <participants group_id="P7" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
              </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="2"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</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_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="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </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="1"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
                <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="1"/>
              </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="1"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Overall Number of Baseline Participants includes randomized participants according to assigned treatment for Part 1 of the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Tildrakizumab 200 mg (Part 1)</title>
          <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Tildrakizumab 100 mg (Part 1)</title>
          <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo (Part 1)</title>
          <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
        </group>
        <group group_id="B4">
          <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="308"/>
            <count group_id="B2" value="309"/>
            <count group_id="B3" value="155"/>
            <count group_id="B4" value="772"/>
          </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="308"/>
                    <count group_id="B2" value="309"/>
                    <count group_id="B3" value="155"/>
                    <count group_id="B4" value="772"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.9" spread="13.16"/>
                    <measurement group_id="B2" value="46.4" spread="13.09"/>
                    <measurement group_id="B3" value="47.9" spread="13.55"/>
                    <measurement group_id="B4" value="46.9" spread="13.21"/>
                  </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="308"/>
                    <count group_id="B2" value="309"/>
                    <count group_id="B3" value="155"/>
                    <count group_id="B4" value="772"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="226"/>
                    <measurement group_id="B2" value="207"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (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="308"/>
                    <count group_id="B2" value="309"/>
                    <count group_id="B3" value="155"/>
                    <count group_id="B4" value="772"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="271"/>
                    <measurement group_id="B2" value="275"/>
                    <measurement group_id="B3" value="135"/>
                    <measurement group_id="B4" value="681"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physician's Global Assessment (PGA) score</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; 2 =Mild; 3= Moderate; 4= Marked; 5= Severe. Round average to the nearest whole number.</description>
          <population>Analysis population includes participants with baseline PGA data.</population>
          <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="308"/>
                    <count group_id="B2" value="309"/>
                    <count group_id="B3" value="154"/>
                    <count group_id="B4" value="771"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;3</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_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="519"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="231"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="20"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="308"/>
                    <count group_id="B2" value="309"/>
                    <count group_id="B3" value="155"/>
                    <count group_id="B4" value="772"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=90 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="458"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;90 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior exposure to biologics therapy for psoriasis</title>
          <description>The following therapies constitute biologics therapy for psoriasis: efalizumab, alefacept, infliximab, adalimumab, ustekinumab, and etanercept.</description>
          <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="308"/>
                    <count group_id="B2" value="309"/>
                    <count group_id="B3" value="155"/>
                    <count group_id="B4" value="772"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="120"/>
                    <measurement group_id="B4" value="595"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)</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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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.</description>
        <time_frame>Week 12 (or end of trial if prior to Week 12)</time_frame>
        <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)</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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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.</description>
          <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 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="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.3"/>
                    <measurement group_id="O2" value="63.8"/>
                    <measurement group_id="O3" value="5.8"/>
                  </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>56.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>49.6</ci_lower_limit>
            <ci_upper_limit>62.8</ci_upper_limit>
          </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>58.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>51.0</ci_lower_limit>
            <ci_upper_limit>64.1</ci_upper_limit>
          </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 (Base Study)</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>Baseline and Week 12 (or end of trial if prior to Week 12)</time_frame>
        <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</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 (Base Study)</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 consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 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="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.1"/>
                    <measurement group_id="O2" value="57.9"/>
                    <measurement group_id="O3" value="7.1"/>
                  </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>52.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>44.8</ci_lower_limit>
            <ci_upper_limit>58.5</ci_upper_limit>
          </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>50.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>43.6</ci_lower_limit>
            <ci_upper_limit>57.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)</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 12 weeks</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)</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 included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="146"/>
                    <measurement group_id="O3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)</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 12 weeks</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)</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 included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)</title>
        <description>A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)</title>
          <description>A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With PASI-90 Response At Week 12</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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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 (or end of trial if prior to Week 12)</time_frame>
        <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With PASI-90 Response At Week 12</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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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 consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 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="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4"/>
                    <measurement group_id="O2" value="34.6"/>
                    <measurement group_id="O3" value="2.6"/>
                  </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>32.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.8</ci_lower_limit>
            <ci_upper_limit>38.8</ci_upper_limit>
          </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>32.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.9</ci_lower_limit>
            <ci_upper_limit>38.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With PASI-100 Response at Week 12</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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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 (or end of trial if prior to Week 12)</time_frame>
        <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With PASI-100 Response at Week 12</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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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 consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 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="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0"/>
                    <measurement group_id="O2" value="13.9"/>
                    <measurement group_id="O3" value="1.3"/>
                  </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>12.7</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>17.2</ci_upper_limit>
          </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>12.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.0</ci_lower_limit>
            <ci_upper_limit>17.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Dermatology Life Quality Index (DLQI) Score</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 consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Dermatology Life Quality Index (DLQI) Score</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 consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement</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="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="6.87"/>
                    <measurement group_id="O2" value="13.9" spread="6.68"/>
                    <measurement group_id="O3" value="13.2" spread="7.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Participant DLQI Score at Week 12</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. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.</description>
        <time_frame>Baseline and Week 12 (or end of trial if prior to Week 12)</time_frame>
        <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Participant DLQI Score at Week 12</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. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.</description>
          <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).</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="308"/>
                <count group_id="O2" value="309"/>
                <count group_id="O3" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" lower_limit="-10.7" upper_limit="-9.4"/>
                    <measurement group_id="O2" value="-9.8" lower_limit="-10.4" upper_limit="-9.1"/>
                    <measurement group_id="O3" value="-2.3" lower_limit="-3.1" upper_limit="-1.5"/>
                  </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>Constrained Longitudinal Data Analysis</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>-7.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.6</ci_lower_limit>
            <ci_upper_limit>-6.8</ci_upper_limit>
          </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>Constrained Longitudinal Data Analysis</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>-7.4</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>-6.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With DLQI Score of 0 or 1 at Week 12</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 (or end of trial if prior to Week 12)</time_frame>
        <population>Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to Week 12).</population>
        <group_list>
          <group group_id="O1">
            <title>Tildrakizumab 200 mg (Part 1)</title>
            <description>Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Tildrakizumab 100 mg (Part 1)</title>
            <description>Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Part 1)</title>
            <description>Matching placebo administered SC once a week at Weeks 0 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With DLQI Score of 0 or 1 at Week 12</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 consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to 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="299"/>
                <count group_id="O2" value="304"/>
                <count group_id="O3" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.2"/>
                    <measurement group_id="O2" value="41.5"/>
                    <measurement group_id="O3" value="5.3"/>
                  </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>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>38.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.9</ci_lower_limit>
            <ci_upper_limit>45.4</ci_upper_limit>
          </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>36.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.3</ci_lower_limit>
            <ci_upper_limit>42.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)</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, including those re-randomized to placebo during Part 3.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tildrakizumab 200 mg (Part 1)</title>
          <description>Tildrakizumab 200 mg administered once a week at Weeks 0 and 4.</description>
        </group>
        <group group_id="E2">
          <title>Tildrakizumab 100 mg (Part 1)</title>
          <description>Tildrakizumab 100 mg administered once a week at Weeks 0 and 4.</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Part 1)</title>
          <description>Placebo administered once a week at Weeks 0 and 4.</description>
        </group>
        <group group_id="E4">
          <title>Tildrakizumab 200 mg (Part 2)</title>
          <description>Tildrakizumab 200 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 200 mg).</description>
        </group>
        <group group_id="E5">
          <title>Tildrakizumab 100 mg (Part 2)</title>
          <description>Tildrakizumab 100 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 100 mg). Includes 1 participant who did not enter Part 2, but received an unscheduled dose at Week 12.</description>
        </group>
        <group group_id="E6">
          <title>Tildrakizumab 200 mg (Part 3)</title>
          <description>Participants received tildrakizumab 200 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).</description>
        </group>
        <group group_id="E7">
          <title>Tildrakizumab 100 mg (Part 3)</title>
          <description>Participants received tildrakizumab 100 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 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="308"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="155"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="308"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="309"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="370"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="374"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="360"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Macular fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Salivary gland enlargement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Epiglottitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Bone tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="374"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="360"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Benign biliary neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Carcinoma in situ of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </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="308"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="316"/>
              </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="308"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="308"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="374"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="360"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 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="35" subjects_at_risk="308"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="309"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="38" subjects_at_risk="370"/>
                <counts group_id="E5" subjects_affected="42" subjects_at_risk="374"/>
                <counts group_id="E6" subjects_affected="86" subjects_at_risk="360"/>
                <counts group_id="E7" subjects_affected="78" subjects_at_risk="316"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="308"/>
                <counts group_id="E2" events="26" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="154"/>
                <counts group_id="E4" events="18" subjects_affected="17" subjects_at_risk="370"/>
                <counts group_id="E5" events="24" subjects_affected="24" subjects_at_risk="374"/>
                <counts group_id="E6" events="55" subjects_affected="44" subjects_at_risk="360"/>
                <counts group_id="E7" events="66" subjects_affected="48" subjects_at_risk="316"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="308"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="309"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="154"/>
                <counts group_id="E4" events="21" subjects_affected="20" subjects_at_risk="370"/>
                <counts group_id="E5" events="17" subjects_affected="16" subjects_at_risk="374"/>
                <counts group_id="E6" events="43" subjects_affected="37" subjects_at_risk="360"/>
                <counts group_id="E7" events="32" subjects_affected="26" subjects_at_risk="316"/>
              </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="308"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="154"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="370"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="374"/>
                <counts group_id="E6" events="9" subjects_affected="9" subjects_at_risk="360"/>
                <counts group_id="E7" events="9" subjects_affected="9" subjects_at_risk="316"/>
              </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/NCT01722331
org study id: 3222-010
secondary id: 2012-002255-42
secondary id: P07770
secondary id: 132284
nct id: NCT01722331
lead sponsor: 
has dmc: Yes
This study is being conducted to evaluate the efficacy and safety/tolerability of
      subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension
      study, in participants with moderate-to-severe chronic plaque psoriasis.
Participants are initially randomized to receive tildrakizumab 200 or 100 mg once weekly at
      Weeks 0, 4, and every 12 weeks thereafter; or placebo at Weeks 0 and 4.

      At Week 12, participants initially randomized to placebo will be re-randomized to receive
      either tildrakizumab 200 or 100 mg at Weeks 12 and 16.

      At Week 28, all participants enrolled will be assessed for their improvement in PASI score
      from baseline.

      RESPONDERS: Participants initially randomized to tildrakizumab who achieve at least a 75%
      improvement from baseline PASI will be re-randomized to either continue on their initial
      treatment or to receive placebo at Week 28.

        -  Participants who are re-randomized to continue on their initial treatment will continue
           tildrakizumab 200 or 100 mg every 12 weeks through Week 64.

        -  Participants who are re-randomized to placebo will receive placebo every 4 weeks until
           relapse (reduction in maximum PASI response by 50%). If relapse occurs, the
           tildrakizumab dose that the participants was originally randomized to at baseline will
           be re-initiated (tildrakizumab 200 or 100 mg). Participants will be dosed tildrakizumab
           at the visit when the relapse occurs, and subsequent dosing of tildrakizumab will be
           given 4 weeks after treatment re-initiation, and every 12 weeks thereafter through Week
           64.

      PARTIAL RESPONDERS: Participants initially randomized to tildrakizumab who achieved a PASI
      response of ≥50% but <75% improvement from baseline will be assigned a treatment regimen as
      described below, with their first dose started at Week 28.

        -  Participants initially randomized to tildrakizumab 200 mg will remain on tildrakizumab
           200 mg every 12 weeks.

        -  Participants initially randomized to tildrakizumab 100 mg will be re-randomized to
           either remain on tildrakizumab 100 mg every 12 weeks or to receive tildrakizumab 200 mg
           every 12 weeks.

        -  Participants initially randomized to placebo who achieved ≥50% improvement from baseline
           in PASI will receive tildrakizumab (200 or 100 mg) according to their re-randomized
           treatment assignment at Week 12 and continue on this treatment every 12 weeks through
           Week 64.

      NON-RESPONDERS: Participants who did not achieve at least 50% improvement from baseline PASI
      at Week 28 will be discontinued from the study.

      EXTENSION: Participants will receive tildrakizumab 200 mg or 100 mg every 12 weeks through
      Extension Week 192, depending on the treatment received at the time of completion of the base
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)
time frame: Week 12 (or end of trial if prior to 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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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.
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 (Base Study)
time frame: Baseline and Week 12 (or end of trial if prior to 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.
measure: Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)
time frame: Up to 12 weeks
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: Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)
time frame: Up to 12 weeks
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: Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)
time frame: Up to 12 weeks
description: A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.
measure: Percentage of Participants With PASI-90 Response At Week 12
time frame: Week 12 (or end of trial if prior to 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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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 With PASI-100 Response at Week 12
time frame: Week 12 (or end of trial if prior to 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 amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% 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: Baseline Dermatology Life Quality Index (DLQI) Score
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 Participant DLQI Score at Week 12
time frame: Baseline and Week 12 (or end of trial if prior to 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. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.
measure: Percentage of Participants With DLQI Score of 0 or 1 at Week 12
time frame: Week 12 (or end of trial if prior to 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.
arm group label: Tildrakizumab 200 mg
arm group type: Experimental
description: Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
arm group label: Tildrakizumab 100 mg
arm group type: Experimental
description: Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo administered SC once a week at Weeks 0 and 4.
intervention type: Drug
intervention name: Tildrakizumab 200 mg
description: Two tildrakizumab 100 mg/mL pre-filled syringes (PFS)
arm group label: Placebo
arm group label: Tildrakizumab 200 mg
other name: MK-3222, SCH 900222
intervention type: Drug
intervention name: Tildrakizumab 100 mg
description: Tildrakizumab 100 mg/mL PFS
arm group label: Placebo
arm group label: Tildrakizumab 100 mg
other name: MK-3222, SCH 900222
intervention type: Drug
intervention name: Matching Placebo
description: Matching placebo to tildrakizumab PFS
arm group label: Placebo
arm group label: Tildrakizumab 100 mg
arm group label: Tildrakizumab 200 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
country: Australia
country: Canada
country: Japan
country: United Kingdom
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: Antibodies, Monoclonal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 