<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/NCT02985593</url>
  </required_header>
  <id_info>
    <org_study_id>4083-003</org_study_id>
    <nct_id>NCT02985593</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis</brief_title>
  <official_title>A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to evaluate the safety and tolerability of a single&#xD;
      intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a&#xD;
      placebo-controlled, single-blind comparative study, and to evaluate the safety and&#xD;
      tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an&#xD;
      open-label study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 26, 2017</completion_date>
  <primary_completion_date type="Actual">December 26, 2017</primary_completion_date>
  <phase>Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature</measure>
    <time_frame>Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum KHK4083 concentration</measure>
    <time_frame>Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax) of KHK4083</measure>
    <time_frame>Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach Cmax (tmax) of KHK4083</measure>
    <time_frame>Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) of KHK4083</measure>
    <time_frame>Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-KHK4083 antibody production</measure>
    <time_frame>art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Healthy Men and Subjects With Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>KHK4083</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV/SC administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IV/SC administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KHK4083</intervention_name>
    <arm_group_label>KHK4083</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        &quot;Part1:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary written informed consent to participate in the study;&#xD;
&#xD;
          2. Japanese or White men ≥20 and &lt;45 years at the time of informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current illness requiring treatment;&#xD;
&#xD;
          2. Current respiratory, gastric, renal, or liver disease;&#xD;
&#xD;
        Part2:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary written informed consent to participate in the study;&#xD;
&#xD;
          2. Men or women ≥20 years of age at the time of informed consent;&#xD;
&#xD;
          3. Ulcerative colitis diagnosed ≥6 months prior to informed consent;&#xD;
&#xD;
          4. Moderate or more severe ulcerative colitis;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Definitive diagnosis of bacillary dysentery, amebic colitis, Salmonella enteritis,&#xD;
             Campylobacter enteritis, colonic tuberculosis, Chlamydia enteritis, Crohn's disease,&#xD;
             radiation colitis, drug-induced colitis, angiolymphoid hyperplasia, ischemic colitis,&#xD;
             or intestinal Behcet's disease;&#xD;
&#xD;
          2. Any of the following clinically significant concurrent illnesses:&#xD;
&#xD;
               -  Type 1 diabetes&#xD;
&#xD;
               -  Poorly controlled type 2 diabetes (HbA1c &gt;8.5%)&#xD;
&#xD;
               -  Congestive heart failure (class II to IV of the New York Heart Association&#xD;
                  classification)&#xD;
&#xD;
               -  Myocardial infarction within 1 year&#xD;
&#xD;
               -  Unstable angina pectoris within 1 year&#xD;
&#xD;
               -  Poorly controlled hypertension (systolic pressure &gt;150 mmHg or diastolic pressure&#xD;
                  &gt;90 mmHg at screening)&#xD;
&#xD;
               -  Severe chronic lung diseases requiring oxygen therapy&#xD;
&#xD;
               -  Multiple sclerosis or other demyelinating diseases&#xD;
&#xD;
               -  Active malignancies, or onset or a history of treatment of malignancies within 5&#xD;
                  years prior to informed consent (except for resected or surgically cured&#xD;
                  epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma,&#xD;
                  cutaneous squamous cell carcinoma, or ductal carcinoma);&#xD;
&#xD;
          3. Current or past history of clinically significant cardiovascular, liver, renal,&#xD;
             respiratory, hematologic, central nervous system, psychiatric, or autoimmune&#xD;
             diseases/disorders other than those in 2);&#xD;
&#xD;
          4. Suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or&#xD;
             ischemic colitis based on clinical or radiographic data within 1 year prior to&#xD;
             enrollment; suspected or confirmed toxic megacolon or history of toxic megacolon;&#xD;
             history of any colonic resection, subtotal or total colectomy, ileostomy, or&#xD;
             colostomy; or any previous surgery for ulcerative colitis or an anticipated&#xD;
             requirement for surgery for ulcerative colitis;&#xD;
&#xD;
          5. Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis);&#xD;
&#xD;
          6. Any planned surgical treatment during the study;&#xD;
&#xD;
          7. Clostridium difficile infection within 8 weeks prior to enrollment;&#xD;
&#xD;
          8. Any active infection, including Grade ≥2 localized diseases per Common Terminology&#xD;
             Criteria for Adverse Events, version 4.0, Japan Clinical Oncology Group edition (CTCAE&#xD;
             v4.0-JCOG), within 4 weeks prior to enrollment;&#xD;
&#xD;
          9. Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema,&#xD;
             or steroid suppository within 2 weeks prior to enrollment;&#xD;
&#xD;
         10. Treatment with adalimumab within 2 weeks prior to enrollment or treatment with&#xD;
             infliximab within 8 weeks prior to enrollment;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>KHK4083</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02985593
org study id: 4083-003
nct id: NCT02985593
lead sponsor: 
has dmc: Yes
The objectives of this study are to evaluate the safety and tolerability of a single
      intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a
      placebo-controlled, single-blind comparative study, and to evaluate the safety and
      tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an
      open-label study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
time frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
measure: Serum KHK4083 concentration
time frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
measure: Maximum concentration (Cmax) of KHK4083
time frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
measure: Time to reach Cmax (tmax) of KHK4083
time frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
measure: Area under the curve (AUC) of KHK4083
time frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
measure: Anti-KHK4083 antibody production
time frame: art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
arm group label: KHK4083
arm group type: Experimental
description: IV/SC administration
arm group label: Placebo
arm group type: Placebo Comparator
description: IV/SC administration
intervention type: Drug
intervention name: KHK4083
arm group label: KHK4083
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: KHK4083
sharing ipd: Undecided