<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/NCT01708590</url>
  </required_header>
  <id_info>
    <org_study_id>20120102</org_study_id>
    <secondary_id>2012-000651-13</secondary_id>
    <nct_id>NCT01708590</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects</brief_title>
  <acronym>AMAGINE-1</acronym>
  <official_title>A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1</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 taken every two&#xD;
      weeks at two different doses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of brodalumab taken every two&#xD;
      weeks at two different doses in participants with moderate to severe plaque psoriasis. A&#xD;
      second purpose of this study is to assess the safety and efficacy when brodalumab is replaced&#xD;
      with placebo in some participants compared with the participants who are still receiving the&#xD;
      brodalumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">May 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 and Severity Index (PASI) 75 at Week 12</measure>
    <time_frame>0-12 weeks</time_frame>
    <description>to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12</measure>
    <time_frame>0 - 12 Weeks</time_frame>
    <description>To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52</measure>
    <time_frame>Week 0 - Week 52</time_frame>
    <description>to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">661</enrollment>
  <condition>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 placebo or continued treatment. Participants are retreated at return of disease.</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 placebo or continued treatment. Participants are retreated at return of disease.</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 particpants 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 subcutaneous (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 subcutaneous (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>placebo</intervention_name>
    <description>Placebo administered subcutaneous (SC)</description>
    <arm_group_label>140 mg brodalumab</arm_group_label>
    <arm_group_label>210 mg brodalumab</arm_group_label>
    <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 must be considered, in the opinion of the investigator, to be a suitable&#xD;
             candidate for treatment with a biologic per regional labeling&#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 stopped using certain psoriasis therapies as defined in the study protocol&#xD;
&#xD;
          -  Subject has previously used any anti-IL-17 biologic therapy&#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>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</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>Los Angeles</city>
        <state>California</state>
        <zip>90045</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>San Ramon</city>
        <state>California</state>
        <zip>94583</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Dundee</city>
        <state>Illinois</state>
        <zip>60118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Richmond</city>
        <state>Kentucky</state>
        <zip>40475</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Gratiot</city>
        <state>Michigan</state>
        <zip>48059</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
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        <zip>63117</zip>
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        <zip>63141</zip>
        <country>United States</country>
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        <state>Nebraska</state>
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        <country>United States</country>
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  <location>
    <facility>
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        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Forest Hills</city>
        <state>New York</state>
        <zip>11375</zip>
        <country>United States</country>
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    <facility>
      <name>Research Site</name>
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        <zip>14618</zip>
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        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
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        <zip>75231</zip>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>77030</zip>
        <country>United States</country>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <address>
        <city>Lodz</city>
        <zip>90-265</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-228</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toruń</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-088</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-368</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Geneva 14</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>Switzerland</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 10, 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 2, 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 1, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>April 1, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 21, 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>Brodalumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Total number should be calculated from the induction phase at 661 subjects starting the study. At week 12 if subjects achieved sPGA success (clear[0] or almost clear[1]) they were not continued in the study withdrawal phase to receive drug. Those not achieving success were re-randomized for treatment continuation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Induction Phase: 210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)</description>
        </group>
        <group group_id="P2">
          <title>Induction Phase: 140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)</description>
        </group>
        <group group_id="P3">
          <title>Induction Phase: Placebo</title>
          <description>Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)</description>
        </group>
        <group group_id="P4">
          <title>Withdrawal Phase: Placebo (140mg)</title>
          <description>Administered SC injection Week 12 - Week 52</description>
        </group>
        <group group_id="P5">
          <title>Withdrawal Phase: 140mg Brodalumab Q2W</title>
          <description>Administered SC injection, Week 12 - Week 52</description>
        </group>
        <group group_id="P6">
          <title>Withdrawal Phase: Placebo (210mg)</title>
          <description>Administered SC, Week 12 - Week 52</description>
        </group>
        <group group_id="P7">
          <title>Withdrawl Phase: 210mg Brodalumab Q2W</title>
          <description>Administered SC injection, Week 12- Week 16</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Induction Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="222"/>
                <participants group_id="P2" count="219"/>
                <participants group_id="P3" count="220"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="212"/>
                <participants group_id="P2" count="212"/>
                <participants group_id="P3" count="209"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Withdrawal Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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="59"/>
                <participants group_id="P5" count="57"/>
                <participants group_id="P6" count="84"/>
                <participants group_id="P7" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</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="6"/>
                <participants group_id="P5" count="45"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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="53"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="82"/>
                <participants group_id="P7" count="9"/>
              </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 placebo or continued treatment. Participants are retreated at return of disease.&#xD;
210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (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 placebo or continued treatment. Participants are retreated at return of disease.&#xD;
140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
        </group>
        <group group_id="B3">
          <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 subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="222"/>
            <count group_id="B2" value="219"/>
            <count group_id="B3" value="220"/>
            <count group_id="B4" value="661"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="46.3" spread="12.2"/>
                    <measurement group_id="B2" value="45.8" spread="13.4"/>
                    <measurement group_id="B3" value="46.9" spread="13.2"/>
                    <measurement group_id="B4" value="46.3" spread="12.9"/>
                  </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="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="162"/>
                    <measurement group_id="B3" value="161"/>
                    <measurement group_id="B4" value="484"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="196"/>
                    <measurement group_id="B3" value="202"/>
                    <measurement group_id="B4" value="601"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </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 and Severity Index (PASI) 75 at Week 12</title>
        <description>to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.</description>
        <time_frame>0-12 weeks</time_frame>
        <population>Data collected is based off of the data from the induction phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Induction Phase: 210 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.&#xD;
210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
          </group>
          <group group_id="O2">
            <title>Induction Phase: 140 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.&#xD;
140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
          </group>
          <group group_id="O3">
            <title>Induction Phase: Placebo</title>
            <description>Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12</title>
          <description>to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.</description>
          <population>Data collected is based off of the data from the induction phase.</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="222"/>
                <count group_id="O2" value="219"/>
                <count group_id="O3" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="132"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12</title>
        <description>To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12</description>
        <time_frame>0 - 12 Weeks</time_frame>
        <population>Data reported is based off of the data collected from the induction phase</population>
        <group_list>
          <group group_id="O1">
            <title>Induction Phase: 210 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.&#xD;
210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
          </group>
          <group group_id="O2">
            <title>Induction Phase: 140 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.&#xD;
140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
          </group>
          <group group_id="O3">
            <title>Induction Phase: Placebo</title>
            <description>Administered by SC injection until week 12.&#xD;
placebo: Placebo administered subcutaneous (SC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12</title>
          <description>To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12</description>
          <population>Data reported is based off of the data collected from the induction phase</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="222"/>
                <count group_id="O2" value="219"/>
                <count group_id="O3" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="118"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52</title>
        <description>to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.</description>
        <time_frame>Week 0 - Week 52</time_frame>
        <population>Only subjects with efficacy data available at Week 52 were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Withdrawal Phase: Placebo (140mg)</title>
            <description>Administered SC injection Week 12 - Week 52</description>
          </group>
          <group group_id="O2">
            <title>Withdrawal Phase: 140mg Brodalumab Q2W</title>
            <description>Administered SC injection, Week 12 - Week 52</description>
          </group>
          <group group_id="O3">
            <title>Withdrawal Phase: Placebo (210mg)</title>
            <description>Administered SC, Week 12 - Week 52</description>
          </group>
          <group group_id="O4">
            <title>Withdrawl Phase: 210mg Brodalumab Q2W</title>
            <description>Administered SC injection, Week 12- Week 16</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52</title>
          <description>to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.</description>
          <population>Only subjects with efficacy data available at Week 52 were included in the analysis.</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="6"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="69"/>
                  </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 placebo or continued treatment. Participants are retreated at return of disease.&#xD;
210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (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 placebo or continued treatment. Participants are retreated at return of disease.&#xD;
140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (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 subcutaneous (SC)&#xD;
placebo: Placebo administered subcutaneous (SC)</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="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="219"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Volvulus of Small Bowel</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Invertebral Disk Intusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COPD</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="85" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="91" subjects_at_risk="219"/>
                <counts group_id="E3" subjects_affected="46" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="219"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="222"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="219"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="222"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="219"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="222"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="219"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="219"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="219"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="219"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="222"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>UTI</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="219"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="222"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="219"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="220"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="219"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="222"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="219"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="220"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="222"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="219"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="220"/>
              </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/NCT01708590
org study id: 20120102
secondary id: 2012-000651-13
nct id: NCT01708590
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two
      weeks at two different doses.
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two
      weeks at two different doses in participants with moderate to severe plaque psoriasis. A
      second purpose of this study is to assess the safety and efficacy when brodalumab is replaced
      with placebo in some participants compared with the participants who are still receiving the
      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 and Severity Index (PASI) 75 at Week 12
time frame: 0-12 weeks
description: to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.
measure: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
time frame: 0 - 12 Weeks
description: To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12
measure: Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
time frame: Week 0 - Week 52
description: to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.
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 placebo or continued treatment. Participants are retreated at return of disease.
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 placebo or continued treatment. Participants are retreated at return of disease.
arm group label: placebo
arm group type: Placebo Comparator
description: Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
intervention type: Drug
intervention name: 210 mg brodalumab
description: 210 mg brodalumab administered subcutaneous (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 subcutaneous (SC)
arm group label: 140 mg brodalumab
other name: Siliq
intervention type: Drug
intervention name: placebo
description: Placebo administered subcutaneous (SC)
arm group label: 140 mg brodalumab
arm group label: 210 mg brodalumab
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: Canada
country: France
country: Germany
country: Poland
country: Switzerland
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Brodalumab
mesh term: Antibodies, Monoclonal
sharing ipd: Yes
participant flow: 
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reported events: 
certain agreements: 
point of contact: 