<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/NCT02203032</url>
  </required_header>
  <id_info>
    <org_study_id>CR104918</org_study_id>
    <secondary_id>CNTO1959PSO3003</secondary_id>
    <secondary_id>2014-000721-20</secondary_id>
    <nct_id>NCT02203032</nct_id>
  </id_info>
  <brief_title>A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab</brief_title>
  <acronym>NAVIGATE</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in&#xD;
      the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash)&#xD;
      who had inadequate response to ustekinumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (assignment of study drug by chance), double-blind (participants nor&#xD;
      study staff will know the identity of study drugs), multicenter study to evaluate efficacy&#xD;
      and safety of guselkumab for the treatment of participants with moderate to severe&#xD;
      plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist&#xD;
      of a screening period, open-label and double-blind treatment periods, and a follow-up period.&#xD;
      The treatment period will have 2 phases: an open-label treatment phase during which all&#xD;
      participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during&#xD;
      which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to&#xD;
      ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through&#xD;
      Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16&#xD;
      will continue to receive open-label treatment with ustekinumab every 12 weeks through Week&#xD;
      40. All participants will complete a follow-up phase through Week 52 for efficacy and through&#xD;
      Week 60 for safety evaluations. The total duration of the study will be approximately 64&#xD;
      weeks (includes a 4-week screening period). Participants' safety will be monitored throughout&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2014</start_date>
  <completion_date type="Actual">May 24, 2016</completion_date>
  <primary_completion_date type="Actual">December 25, 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>Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40</measure>
    <time_frame>Week 28 through Week 40</time_frame>
    <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40</measure>
    <time_frame>Week 28 through Week 40</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40</measure>
    <time_frame>Week 28 through Week 40</time_frame>
    <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28</measure>
    <time_frame>Week 28</time_frame>
    <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">872</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Open-label ustekinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Double-blind guselkumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Double-blind ustekinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab</intervention_name>
    <description>45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.</description>
    <arm_group_label>Double-blind ustekinumab</arm_group_label>
    <arm_group_label>Open-label ustekinumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guselkumab</intervention_name>
    <description>100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.</description>
    <arm_group_label>Double-blind guselkumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for ustekinumab</intervention_name>
    <description>Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.</description>
    <arm_group_label>Double-blind guselkumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for guselkumab</intervention_name>
    <description>Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.</description>
    <arm_group_label>Double-blind ustekinumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at&#xD;
             least 6 months before the first administration of study drug&#xD;
&#xD;
          -  Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (&gt;=) 12 at&#xD;
             Screening and at Baseline&#xD;
&#xD;
          -  Have an Investigator's Global Assessment (IGA) &gt;=3 at Screening and at Baseline&#xD;
&#xD;
          -  Have an involved body surface area (BSA) &gt;= 10 percent (%) at Screening and at&#xD;
             Baseline&#xD;
&#xD;
          -  Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or&#xD;
             history of previous treatment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history or current signs or symptoms of severe, progressive, or uncontrolled&#xD;
             renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,&#xD;
             hematologic, rheumatologic, psychiatric, or metabolic disturbances&#xD;
&#xD;
          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration&#xD;
             (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a&#xD;
             cardiac hospitalization within the last 3 months&#xD;
&#xD;
          -  Currently has a malignancy or has a history of malignancy within 5 years before&#xD;
             Screening (with the exception of a nonmelanoma skin cancer that has been adequately&#xD;
             treated with no evidence of recurrence for at least 3 months before the first study&#xD;
             drug administration, or cervical carcinoma in situ that has been treated with no&#xD;
             evidence of recurrence for at least 3 months before the first study drug&#xD;
             administration)&#xD;
&#xD;
          -  Has previously received guselkumab or ustekinumab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fremantle</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Victoria Park</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woden</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quebec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gera</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mahlow</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Witten</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torun</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chelyabinsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krasnodar</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lipetsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stavropol</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alcorcon</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dudley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>June 14, 2017</results_first_submitted>
  <results_first_submitted_qc>June 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2017</results_first_posted>
  <disposition_first_submitted>July 12, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 12, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 14, 2016</disposition_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Plaque-type psoriasis</keyword>
  <keyword>Guselkumab</keyword>
  <keyword>Ustekinumab</keyword>
  <keyword>CNTO 1959</keyword>
  <keyword>Monoclonal antibody</keyword>
  <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>Ustekinumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Study consists of 2 periods: Open label run-in (Period 1) and blinded phase (Period 2). Participants were enrolled in open label run-in period only. Participants completed the open label run-in period entered into blinded phase period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ustekinumab (Open Label Run-in)</title>
          <description>All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [&lt;=]100 kilogram [kg]) or 90 mg (participants weighing &gt;100 kg) at Weeks 0 and 4. At Week 16, participants with IGA &gt;=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.</description>
        </group>
        <group group_id="P2">
          <title>100 mg Guselkumab (Randomized)</title>
          <description>Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (&gt;=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.</description>
        </group>
        <group group_id="P3">
          <title>Ustekinumab (Randomized)</title>
          <description>Participants from open label run-in phase with an IGA &gt;=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.</description>
        </group>
        <group group_id="P4">
          <title>Ustekinumab (Nonrandomized Open Label Continuation)</title>
          <description>Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open Label Run-in (Week 0 to Week 16)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="872"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="871"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="853"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </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="0"/>
                <participants group_id="P4" 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="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" 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_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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled but not treated</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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Blinded Phase (Week 16 to Week 44)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="135"/>
                <participants group_id="P3" count="133"/>
                <participants group_id="P4" count="585"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="120"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="539"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="46"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Completed Safety follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.</population>
      <group_list>
        <group group_id="B1">
          <title>Ustekinumab (Open Label Run-in)</title>
          <description>All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [&lt;=]100 kilogram [kg]) or 90 mg (participants weighing &gt;100 kg) at Weeks 0 and 4. At Week 16, participants with IGA &gt;=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="871"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="814"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.1" 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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="305"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic Of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan, Province Of China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40</title>
        <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 28 through Week 40</time_frame>
        <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab (Randomized)</title>
            <description>Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (&gt;=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.</description>
          </group>
          <group group_id="O2">
            <title>Ustekinumab (Randomized)</title>
            <description>Participants from open label run-in phase with an IGA &gt;=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40</title>
          <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.57"/>
                    <measurement group_id="O2" value="0.7" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Row mean score test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 28 through Week 40</time_frame>
        <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab (Randomized)</title>
            <description>Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (&gt;=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.</description>
          </group>
          <group group_id="O2">
            <title>Ustekinumab (Randomized)</title>
            <description>Participants from open label run-in phase with an IGA &gt;=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.69"/>
                    <measurement group_id="O2" value="1.1" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Row mean score test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40</title>
        <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 28 through Week 40</time_frame>
        <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab (Randomized)</title>
            <description>Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (&gt;=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.</description>
          </group>
          <group group_id="O2">
            <title>Ustekinumab (Randomized)</title>
            <description>Participants from open label run-in phase with an IGA &gt;=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40</title>
          <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.34"/>
                    <measurement group_id="O2" value="0.4" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Row mean score test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28</title>
        <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 28</time_frame>
        <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab (Randomized)</title>
            <description>Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (&gt;=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.</description>
          </group>
          <group group_id="O2">
            <title>Ustekinumab (Randomized)</title>
            <description>Participants from open label run-in phase with an IGA &gt;=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28</title>
          <description>The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized population included all enrolled participants with IGA &gt;=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.</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="135"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1"/>
                    <measurement group_id="O2" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>= 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 60</time_frame>
      <desc>Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ustekinumab (Open Label Run-in)</title>
          <description>All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [&lt;=]100 kilogram [kg]) or 90 mg (participants weighing &gt;100 kg) at Weeks 0 and 4. At Week 16, participants with IGA &gt;=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.</description>
        </group>
        <group group_id="E2">
          <title>100 mg Guselkumab (Randomized)</title>
          <description>Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (&gt;=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.</description>
        </group>
        <group group_id="E3">
          <title>Ustekinumab (Randomized)</title>
          <description>Participants from open label run-in phase with an IGA &gt;=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.</description>
        </group>
        <group group_id="E4">
          <title>Ustekinumab (Nonrandomized Open Label Continuation)</title>
          <description>Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Sinus Node Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Retinal Artery Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Retinal Detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Large Intestinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Paraspinal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Arthritis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol Poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Scapula Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Toxicity to Various Agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Foot Deformity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma Metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ectopic Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Abortion Spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 18.1</default_vocab>
        <default_assessment>Non-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="80" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="60" subjects_at_risk="585"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="585"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="871"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="135"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="133"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="585"/>
              </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>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT02203032
org study id: CR104918
secondary id: CNTO1959PSO3003
secondary id: 2014-000721-20
nct id: NCT02203032
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in
      the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash)
      who had inadequate response to ustekinumab.
This is a randomized (assignment of study drug by chance), double-blind (participants nor
      study staff will know the identity of study drugs), multicenter study to evaluate efficacy
      and safety of guselkumab for the treatment of participants with moderate to severe
      plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist
      of a screening period, open-label and double-blind treatment periods, and a follow-up period.
      The treatment period will have 2 phases: an open-label treatment phase during which all
      participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during
      which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to
      ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through
      Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16
      will continue to receive open-label treatment with ustekinumab every 12 weeks through Week
      40. All participants will complete a follow-up phase through Week 52 for efficacy and through
      Week 60 for safety evaluations. The total duration of the study will be approximately 64
      weeks (includes a 4-week screening period). Participants' safety will be monitored throughout
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
time frame: Week 28 through Week 40
description: The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
time frame: Week 28 through Week 40
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
time frame: Week 28 through Week 40
description: The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28
time frame: Week 28
description: The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
arm group label: Open-label ustekinumab
arm group type: Experimental
arm group label: Double-blind guselkumab
arm group type: Experimental
arm group label: Double-blind ustekinumab
arm group type: Experimental
intervention type: Drug
intervention name: Ustekinumab
description: 45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.
arm group label: Double-blind ustekinumab
arm group label: Open-label ustekinumab
intervention type: Drug
intervention name: Guselkumab
description: 100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.
arm group label: Double-blind guselkumab
intervention type: Drug
intervention name: Placebo for ustekinumab
description: Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.
arm group label: Double-blind guselkumab
intervention type: Drug
intervention name: Placebo for guselkumab
description: Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
arm group label: Double-blind ustekinumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Australia
country: Canada
country: Germany
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Ustekinumab
mesh term: Antibodies, Monoclonal
participant flow: 
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reported events: 
certain agreements: 
point of contact: 