<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/NCT02985983</url>
  </required_header>
  <id_info>
    <org_study_id>4827-006</org_study_id>
    <nct_id>NCT02985983</nct_id>
  </id_info>
  <brief_title>A Study of KHK4827 in Subjects With Axial Spondyloarthritis (axSpA)</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 Axial Spondyloarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyowa Kirin Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of KHK4827 in axSpA (ankylosing spondylitis [AS] and&#xD;
      non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as&#xD;
      measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis&#xD;
      international Society (ASAS) 40 response at week 16.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Actual">September 23, 2019</completion_date>
  <primary_completion_date type="Actual">September 23, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of ASAS 40 in axSpA subjects</measure>
    <time_frame>Week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of ASAS 40 in AS subjects</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of ASAS 40 in nr-axSpA subjects</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Up to week 68</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients exposed to anti-KHK4827 antibodies</measure>
    <time_frame>Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum KHK4827 concentration</measure>
    <time_frame>pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Axial Spondyloarthritis</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 66.</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 16. Administered KHK4827 by SC injection from week 17 until week 66.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with age at onset &lt;45 years and continuous chronic back pain for ≥ 3 months&#xD;
             fulfills the ASAS classification criteria of axial spondyloarthritis (with the&#xD;
             exception of the Crohn's disease)&#xD;
&#xD;
          -  Subject has Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at&#xD;
             screening and enrollment&#xD;
&#xD;
          -  Subject has spinal pain score (BASDAI question #2) ≥ 4 at screening and enrollment&#xD;
&#xD;
          -  Subject has had adequate therapy with non-steroidal anti-inflammatory drugs (oral&#xD;
             NSAIDs) for back pain for at least 3 months with inadequate treatment response before&#xD;
             enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complete ankylosis (fusion) of the spine&#xD;
&#xD;
          -  Subject with active ongoing inflammatory diseases other than axSpA that might confound&#xD;
             the evaluation of KHK4827 therapy, including reactive arthritis, spondyloarthritis&#xD;
             associated with inflammatory bowel disease, SAPHO syndrome (pustulotic&#xD;
             arthro-osteitis), fibromyalgia, ankylosing spinal hyperostosis, osteitis condensans&#xD;
             ilii, spondylosis deformans, or osteoarthritis sacroiliac joint disease&#xD;
&#xD;
          -  Subject has a prior history of &gt;1 anti-TNF therapy&#xD;
&#xD;
          -  Subject has a 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 enrollment&#xD;
&#xD;
          -  Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance&#xD;
             abuse&#xD;
&#xD;
          -  Subject has severe depression based on a total score of ≥ 15 on the Patient Health&#xD;
             Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14&#xD;
             on the PHQ-8 should be referred to a mental health care professional)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fujita Health University Hpspital</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Yachiyo Medical Center</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chihaya Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyusyu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katayama Seikeigeka Rheumatism Clinic</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital</name>
      <address>
        <city>Kagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi Medical School Hospital</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sasebo Chuo Hospital</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenri Hospital</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama Saiseikai Outpatient Centerl Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okinawa Prefectural Chubu Hospital</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomishiro Central Hospital</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hosptal Organization Osaka Minami Medical Center</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yukioka Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Luke's International Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Ohashi Medical Center</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Omori Medical Center</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Seoul Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungHee University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The catholic university of korea Seoul St.mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung Shan Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cathay General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brodalumab</keyword>
  <keyword>KHK4827</keyword>
  <keyword>Axial Spondyloarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Axial Spondyloarthritis</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>
  <pending_results>
    <submitted>November 17, 2021</submitted>
    <returned>January 26, 2022</returned>
    <submitted>March 9, 2022</submitted>
    <returned>June 8, 2022</returned>
  </pending_results>
  <!-- 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/NCT02985983
org study id: 4827-006
nct id: NCT02985983
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy of KHK4827 in axSpA (ankylosing spondylitis [AS] and
      non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as
      measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis
      international Society (ASAS) 40 response at week 16.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of ASAS 40 in axSpA subjects
time frame: Week 16
measure: Percentage of ASAS 40 in AS subjects
time frame: Week 16
measure: Percentage of ASAS 40 in nr-axSpA subjects
time frame: Week 16
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects
time frame: Week 16
measure: Number of adverse events
time frame: Up to week 68
measure: Number of patients exposed to anti-KHK4827 antibodies
time frame: Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
measure: Serum KHK4827 concentration
time frame: pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32
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 66.
arm group label: KHK4827
other name: Brodalumab
intervention type: Drug
intervention name: Placebo
description: Administered Placebo by subcutaneous (SC) injection until week 16. Administered KHK4827 by SC injection from week 17 until week 66.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Japan
country: Korea, Republic of
country: Taiwan
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
mesh term: Brodalumab
sharing ipd: No
submitted: November 17, 2021
returned: January 26, 2022
submitted: March 9, 2022
returned: June 8, 2022