<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/NCT02982005</url>
  </required_header>
  <id_info>
    <org_study_id>4827-KR001</org_study_id>
    <nct_id>NCT02982005</nct_id>
  </id_info>
  <brief_title>A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea</brief_title>
  <official_title>A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin Korea Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyowa Kirin Korea Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in&#xD;
      subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to&#xD;
      receive KHK4827 or placebo for 12 weeks&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">August 14, 2018</completion_date>
  <primary_completion_date type="Actual">August 14, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psoriasis area and severity index (PASI) 75 response</measure>
    <time_frame>at week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Static physician's global assessment (sPGA) of &quot;0 (clear)&quot; or &quot;1 (almost clear)&quot;</measure>
    <time_frame>at week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PASI 50/75/90/100 response by visit</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sPGA of &quot;0 (clear) or 1 (almost clear)&quot; by visit</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body surface area (BSA) involvement of lesion</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology life quality index (DLQI)</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-emergent adverse events (TEAEs) or drug-related TEAEs</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory values</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs</measure>
    <time_frame>Baseline to week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-KHK4827 antibodies</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 48, Week 64</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum KHK4827 concentration</measure>
    <time_frame>Baseline, Week 8, Week 10, Week 12, Week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Moderate to Severe Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>KHK4827</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KHK4827 administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK4827</intervention_name>
    <description>Administered KHK4827 by subcutaneous (SC) injection until week 62.</description>
    <arm_group_label>KHK4827</arm_group_label>
    <other_name>Brodalumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.</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 BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,&#xD;
             or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at&#xD;
             screening that would interfere with study evaluations&#xD;
&#xD;
          -  Subject scheduled to undergo a surgical intervention during the study period&#xD;
&#xD;
          -  Subject has any active infection or history of infections as defined in the study&#xD;
             protocol&#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 any anti-IL-17 biologic therapy&#xD;
&#xD;
          -  Subject is pregnant or breast feeding, or planning to become pregnant while enrolled&#xD;
             in the study&#xD;
&#xD;
          -  Women of child-bearing potential or fertile men who do not agree to use effective&#xD;
             contraception from the day of providing consent through 12 weeks after the last dose&#xD;
             of investigational product.&#xD;
&#xD;
          -  Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any&#xD;
             suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating&#xD;
             Scale (C-SSRS) at screening or at baseline&#xD;
&#xD;
          -  Subject has severe depression based on a total score of ≥ 15 on the Patient Health&#xD;
             Questionnaire-8 (PHQ-8) at screening or at baseline&#xD;
&#xD;
          -  Subject has known history or evidence of a psychiatric disorder that, in the opinion&#xD;
             of the investigator, would pose a risk to subject safety or interfere with the study&#xD;
             evaluation, procedures or completion&#xD;
&#xD;
          -  Subject has known history of alcohol and/or substance abuse within the last 12 months&quot;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea, Republic of</name>
      <address>
        <city>Seoul</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>September 9, 2018</last_update_submitted>
  <last_update_submitted_qc>September 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>KHK4827 (brodalumab)</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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02982005
org study id: 4827-KR001
nct id: NCT02982005
lead sponsor: 
has dmc: No
The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in
      subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to
      receive KHK4827 or placebo for 12 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Psoriasis area and severity index (PASI) 75 response
time frame: at week 12
measure: Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
time frame: at week 12
measure: PASI 50/75/90/100 response by visit
time frame: Baseline to week 64
measure: sPGA of "0 (clear) or 1 (almost clear)" by visit
time frame: Baseline to week 64
measure: Body surface area (BSA) involvement of lesion
time frame: Baseline to week 64
measure: Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)
time frame: Baseline to week 64
measure: Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)
time frame: Baseline to week 64
measure: Dermatology life quality index (DLQI)
time frame: Baseline to week 64
measure: Treatment-emergent adverse events (TEAEs) or drug-related TEAEs
time frame: Baseline to week 64
measure: Laboratory values
time frame: Baseline to week 64
measure: Vital signs
time frame: Baseline to week 64
measure: Anti-KHK4827 antibodies
time frame: Baseline, Week 12, Week 24, Week 48, Week 64
measure: Serum KHK4827 concentration
time frame: Baseline, Week 8, Week 10, Week 12, Week 24
arm group label: KHK4827
arm group type: Experimental
description: KHK4827 administered SC
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered SC
intervention type: Drug
intervention name: KHK4827
description: Administered KHK4827 by subcutaneous (SC) injection until week 62.
arm group label: KHK4827
other name: Brodalumab
intervention type: Drug
intervention name: Placebo
description: Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Brodalumab
sharing ipd: No