<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/NCT01708629</url>
  </required_header>
  <id_info>
    <org_study_id>20120104</org_study_id>
    <nct_id>NCT01708629</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects</brief_title>
  <acronym>AMAGINE-3</acronym>
  <official_title>A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of brodalumab at two different&#xD;
      doses compared with placebo in participants with moderate to severe plaque psoriasis.&#xD;
&#xD;
      A second purpose of this study is to assess the safety and efficacy brodalumab at two&#xD;
      different doses compared with ustekinumab in participants with moderate to severe plaque&#xD;
      psoriasis.&#xD;
&#xD;
      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens&#xD;
      of brodalumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study assess the safety and efficacy of brodalumab at two different doses compared with&#xD;
      placebo in participants with moderate to severe plaque psoriasis.&#xD;
&#xD;
      A second purpose of this study is to assess the safety and efficacy brodalumab at two&#xD;
      different doses compared with ustekinumab in participants with moderate to severe plaque&#xD;
      psoriasis.&#xD;
&#xD;
      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens&#xD;
      of brodalumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1881</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>210 mg brodalumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>140 mg brodalumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ustekinumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>210 mg brodalumab</intervention_name>
    <description>210 mg brodalumab administered SC</description>
    <arm_group_label>210 mg brodalumab</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Siliq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>140 mg brodalumab</intervention_name>
    <description>140 mg brodalumab administered SC</description>
    <arm_group_label>140 mg brodalumab</arm_group_label>
    <other_name>Siliq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ustekinumab</intervention_name>
    <description>45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
    <arm_group_label>ustekinumab</arm_group_label>
    <other_name>Stelara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months&#xD;
&#xD;
          -  Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at&#xD;
             screening and at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,&#xD;
             medication-induced psoriasis, or other skin conditions at (eg, eczema) that would&#xD;
             interfere with study evaluations&#xD;
&#xD;
          -  Subject has known history of Crohn's disease&#xD;
&#xD;
          -  Subject has any other significant concurrent medical condition or laboratory&#xD;
             abnormalities, as defined in the study protocol&#xD;
&#xD;
          -  Subject has not stopped using certain psoriasis therapies as defined in the study&#xD;
             protocol&#xD;
&#xD;
          -  Subject has previously used ustekinumab or any anti-IL-17 biologic therapy&#xD;
&#xD;
          -  Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in&#xD;
             the study&#xD;
&#xD;
          -  Female subject is unwilling to use highly effective methods of birth control unless 2&#xD;
             years post-menopausal or surgically sterile&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
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  <location>
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      <name>Research Site</name>
      <address>
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        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <zip>30327</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>31217</zip>
        <country>United States</country>
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        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
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        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
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    <facility>
      <name>Research Site</name>
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        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
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        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wheaton</city>
        <state>Illinois</state>
        <zip>60189</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <state>Kansas</state>
        <zip>66202</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42303</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48103</zip>
        <country>United States</country>
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      <name>Research Site</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <zip>08520</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hoboken</city>
        <state>New Jersey</state>
        <zip>07030</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <zip>07044</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>High Point</city>
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        <zip>27262</zip>
        <country>United States</country>
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  <location>
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      <name>Research Site</name>
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        <zip>45249</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>97035</zip>
        <country>United States</country>
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        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
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      <name>Research Site</name>
      <address>
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        <state>Pennsylvania</state>
        <zip>19341</zip>
        <country>United States</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <city>Moscow</city>
        <zip>107076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>121614</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saratov</city>
        <zip>410026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>191015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>November 8, 2016</results_first_submitted>
  <results_first_submitted_qc>December 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 3, 2020</results_first_posted>
  <disposition_first_submitted>April 14, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>April 14, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 5, 2015</disposition_first_posted>
  <last_update_submitted>December 17, 2019</last_update_submitted>
  <last_update_submitted_qc>December 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psoriasis, brodalumab, AMG 827</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>Brodalumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
        </group>
        <group group_id="P2">
          <title>140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
        </group>
        <group group_id="P3">
          <title>Ustekinumab</title>
          <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.&#xD;
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: placebo administered SC</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="624"/>
                <participants group_id="P2" count="629"/>
                <participants group_id="P3" count="313"/>
                <participants group_id="P4" count="315"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="608"/>
                <participants group_id="P2" count="604"/>
                <participants group_id="P3" count="303"/>
                <participants group_id="P4" count="301"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
        </group>
        <group group_id="B2">
          <title>140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
        </group>
        <group group_id="B3">
          <title>Ustekinumab</title>
          <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.&#xD;
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: placebo administered SC</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="624"/>
            <count group_id="B2" value="629"/>
            <count group_id="B3" value="313"/>
            <count group_id="B4" value="315"/>
            <count group_id="B5" value="1881"/>
          </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="578"/>
                    <measurement group_id="B2" value="589"/>
                    <measurement group_id="B3" value="292"/>
                    <measurement group_id="B4" value="300"/>
                    <measurement group_id="B5" value="1759"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="122"/>
                  </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="45.2" spread="13.3"/>
                    <measurement group_id="B2" value="44.6" spread="13.0"/>
                    <measurement group_id="B3" value="44.8" spread="13.1"/>
                    <measurement group_id="B4" value="44.2" spread="12.5"/>
                    <measurement group_id="B5" value="44.8" spread="13.0"/>
                  </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="193"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="107"/>
                    <measurement group_id="B5" value="593"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="431"/>
                    <measurement group_id="B2" value="437"/>
                    <measurement group_id="B3" value="212"/>
                    <measurement group_id="B4" value="208"/>
                    <measurement group_id="B5" value="1288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="565"/>
                    <measurement group_id="B2" value="569"/>
                    <measurement group_id="B3" value="280"/>
                    <measurement group_id="B4" value="294"/>
                    <measurement group_id="B5" value="1708"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="29"/>
                  </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>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="276"/>
                    <measurement group_id="B2" value="278"/>
                    <measurement group_id="B3" value="140"/>
                    <measurement group_id="B4" value="141"/>
                    <measurement group_id="B5" value="835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="63"/>
                    <measurement group_id="B5" value="381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12</title>
        <description>The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>210 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
          </group>
          <group group_id="O2">
            <title>140 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: placebo administered SC</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12</title>
          <description>The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="624"/>
                <count group_id="O2" value="629"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="531"/>
                    <measurement group_id="O2" value="435"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo</title>
        <description>Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).</description>
        <time_frame>12 weeks</time_frame>
        <population>sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>210 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
          </group>
          <group group_id="O2">
            <title>140 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: placebo administered SC</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo</title>
          <description>Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).</description>
          <population>sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="624"/>
                <count group_id="O2" value="629"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497"/>
                    <measurement group_id="O2" value="377"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
        </group>
        <group group_id="E2">
          <title>140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: placebo administered SC</description>
        </group>
        <group group_id="E4">
          <title>Ustekinumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.</description>
        </group>
      </group_list>
      <serious_events>
        <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="9" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Altered State of Consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Appendicitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Meningitis Cryptoccocal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Peritonsillar Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Erythrodermic Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Rash Papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="353" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="329" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="152" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="168" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Injection Site erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury and Complications</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and Nutritional Disorders</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Psoriatic Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="629"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Bausch Health</organization>
      <phone>510-259-5284</phone>
    </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/NCT01708629
org study id: 20120104
nct id: NCT01708629
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the safety and efficacy of brodalumab at two different
      doses compared with placebo in participants with moderate to severe plaque psoriasis.

      A second purpose of this study is to assess the safety and efficacy brodalumab at two
      different doses compared with ustekinumab in participants with moderate to severe plaque
      psoriasis.

      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens
      of brodalumab.
This study assess the safety and efficacy of brodalumab at two different doses compared with
      placebo in participants with moderate to severe plaque psoriasis.

      A second purpose of this study is to assess the safety and efficacy brodalumab at two
      different doses compared with ustekinumab in participants with moderate to severe plaque
      psoriasis.

      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens
      of brodalumab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
time frame: 12 weeks
description: The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
measure: Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
time frame: 12 weeks
description: Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).
arm group label: 210 mg brodalumab
arm group type: Experimental
description: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
arm group label: 140 mg brodalumab
arm group type: Experimental
description: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
arm group label: ustekinumab
arm group type: Active Comparator
description: Administered by subcutaneous (SC) injection per the labeled dosing regimen.
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
intervention type: Drug
intervention name: 210 mg brodalumab
description: 210 mg brodalumab administered SC
arm group label: 210 mg brodalumab
arm group label: Placebo
other name: Siliq
intervention type: Drug
intervention name: 140 mg brodalumab
description: 140 mg brodalumab administered SC
arm group label: 140 mg brodalumab
other name: Siliq
intervention type: Drug
intervention name: ustekinumab
description: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
arm group label: ustekinumab
other name: Stelara
intervention type: Drug
intervention name: placebo
description: placebo administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Belgium
country: Canada
country: France
country: Greece
country: Hungary
country: Italy
country: Latvia
country: Poland
country: Russian Federation
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Ustekinumab
mesh term: Brodalumab
mesh term: Antibodies, Monoclonal
sharing ipd: Yes
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point of contact: 