<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/NCT03018054</url>
  </required_header>
  <id_info>
    <org_study_id>E6007-J081-201</org_study_id>
    <nct_id>NCT03018054</nct_id>
  </id_info>
  <brief_title>Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis</brief_title>
  <official_title>A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EA Pharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the&#xD;
      efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate&#xD;
      active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and&#xD;
      Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg),&#xD;
      E6007 60 mg or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Actual">August 16, 2019</completion_date>
  <primary_completion_date type="Actual">April 17, 2019</primary_completion_date>
  <phase>Phase 2</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>Change from Baseline in Mayo score at 8 weeks</measure>
    <time_frame>Baseline; 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal, clinically significant laboratory values</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in body temperature at 8 weeks</measure>
    <time_frame>Baseline; 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks</measure>
    <time_frame>Baseline; 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in heart rate at 8 weeks</measure>
    <time_frame>Baseline; 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in respiratory rate at 8 weeks</measure>
    <time_frame>Baseline; 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in standard 12-lead electrocardiogram (ECG) values</measure>
    <time_frame>Baseline; 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal, clinically significant chest X-ray findings</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any serious adverse event and number of participants with any non-serious adverse event</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Moderate Active Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>E6007 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive E6007 30 milligrams (mg) once daily after breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E6007 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive E6007 60 mg once daily after breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive matching placebo once daily after breakfast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E6007</intervention_name>
    <description>once daily administration</description>
    <arm_group_label>E6007 30 mg</arm_group_label>
    <arm_group_label>E6007 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>once daily administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese participants aged from 20 to 74 years at the time of informed consent&#xD;
&#xD;
          -  Participants with a diagnosis based on the Revised Diagnostic Criteria for Ulcerative&#xD;
             Colitis (UC) issued by the Research Group for Intractable Inflammatory Bowel Disease&#xD;
             Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan&#xD;
             (2013) at least 4 weeks before the start of administration of study drug&#xD;
&#xD;
          -  Active UC participants as determined by Baseline complete Mayo score of 6 to 10 points&#xD;
             with an endoscopic subscore of ≥2 and a rectal bleeding subscore of ≥1&#xD;
&#xD;
          -  Participants who are currently being treated with oral 5-ASA or immunomodulator or&#xD;
             corticosteroid with inadequate response or intolerance, or are corticosteroid&#xD;
             dependent&#xD;
&#xD;
          -  Participants being seen on an outpatient basis&#xD;
&#xD;
          -  Has voluntarily consented, in writing, to participate in this study and is able and&#xD;
             willing to comply with the requirements of this study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reduction in partial Mayo score of ≥3 points at Baseline from Screening&#xD;
&#xD;
          -  Diagnosed with right-sided or segmental colitis, and proctitis from a Baseline&#xD;
             endoscopy&#xD;
&#xD;
          -  Received any anti-tumor necrosis factor (TNF) agent for over 2 years, or within 12&#xD;
             weeks prior to Baseline&#xD;
&#xD;
          -  History of colectomy, or planning to have surgery for treatment of UC at Screening or&#xD;
             Baseline&#xD;
&#xD;
          -  White blood cell count below 3000/microliters (µL) at Screening&#xD;
&#xD;
          -  History or suspected history of central nervous system disorder found at Screening or&#xD;
             Baseline&#xD;
&#xD;
          -  Current complication or suspected malignancy or toxic megacolon at Screening or&#xD;
             Baseline&#xD;
&#xD;
          -  Prior history or current complication of colonic dysplasia at Screening or Baseline&#xD;
&#xD;
          -  History of any severe drug allergy at Screening or Baseline&#xD;
&#xD;
          -  Received a live vaccine within 4 weeks prior to Baseline&#xD;
&#xD;
          -  QTc repeatedly above 450 milliseconds (ms) on the electrocardiogram (ECG) test at&#xD;
             Screening&#xD;
&#xD;
          -  In the case of women: nursing mothers or pregnant women at Screening or Baseline&#xD;
&#xD;
          -  Refusal to use medically suitable contraception (both the participant and the&#xD;
             participant's partner) throughout the entire study period, if the participant is a man&#xD;
             capable of reproduction or a woman of childbearing potential&#xD;
&#xD;
          -  Female participants who want to become pregnant or male participants whose partners&#xD;
             want to become pregnant throughout the entire study period&#xD;
&#xD;
          -  Evidence of clinically significant disease that in the opinion of the investigator(s)&#xD;
             could affect the participant's safety or interfere with the study assessments at&#xD;
             Screening or Baseline&#xD;
&#xD;
          -  History of any medical conditions or concomitant medical conditions that in the&#xD;
             opinion of the investigator(s) would compromise the participant's ability to safely&#xD;
             complete the study at Screening or Baseline&#xD;
&#xD;
          -  A positive finding on the human immunodeficiency virus antigen and antibody test at&#xD;
             Screening&#xD;
&#xD;
          -  In tests conducted at Screening, a positive finding for any of the following:&#xD;
             hepatitis B virus surface antigen, hepatitis B virus surface antibody, hepatitis B&#xD;
             virus core antibody, or hepatitis C virus antibody&#xD;
&#xD;
          -  Any result other than negative on the tuberculosis test at Screening&#xD;
&#xD;
          -  Findings indicating a history of tuberculosis on chest X-ray during Screening&#xD;
&#xD;
          -  History of drug or alcohol dependency or abuse within approximately the last 2 years&#xD;
             prior to Screening or Baseline&#xD;
&#xD;
          -  Use of illegal recreational drugs at Screening or Baseline&#xD;
&#xD;
          -  Currently enrolled in another clinical trial or used any investigational drug or&#xD;
             device within 16 weeks preceding informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Nagakute</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #3</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Toyoake</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Toyota</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Sakura</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Urayasu</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Ogaki</city>
        <state>Gifu</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Takasaki</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Obihiro</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Takamatsu</city>
        <state>Kagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Takamatsu</city>
        <state>Kagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kamakura</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Tsu</city>
        <state>Mie</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Nagaoka</city>
        <state>Niigata</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kurashiki</city>
        <state>Okayama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kawagoe</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Izumo</city>
        <state>Shimane</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Shimotsuga</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Bunkyo</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Chuo</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Minato</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Minato</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Shinagawa</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Shinjuku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kofu</city>
        <state>Yamanashi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #2</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EA Pharma Trial Site #1</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>moderate active ulcerative colitis</keyword>
  <keyword>Japanese</keyword>
  <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>
  <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/NCT03018054
org study id: E6007-J081-201
nct id: NCT03018054
lead sponsor: 
has dmc: Yes
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the
      efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate
      active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and
      Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg),
      E6007 60 mg or placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline in Mayo score at 8 weeks
time frame: Baseline; 8 weeks
measure: Number of participants with abnormal, clinically significant laboratory values
time frame: up to 8 weeks
measure: Change from Baseline in body temperature at 8 weeks
time frame: Baseline; 8 weeks
measure: Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks
time frame: Baseline; 8 weeks
measure: Change from Baseline in heart rate at 8 weeks
time frame: Baseline; 8 weeks
measure: Change from Baseline in respiratory rate at 8 weeks
time frame: Baseline; 8 weeks
measure: Change from Baseline in standard 12-lead electrocardiogram (ECG) values
time frame: Baseline; 8 weeks
measure: Number of participants with abnormal, clinically significant chest X-ray findings
time frame: up to 8 weeks
measure: Number of participants with any serious adverse event and number of participants with any non-serious adverse event
time frame: up to 8 weeks
arm group label: E6007 30 mg
arm group type: Experimental
description: Participants will receive E6007 30 milligrams (mg) once daily after breakfast.
arm group label: E6007 60 mg
arm group type: Experimental
description: Participants will receive E6007 60 mg once daily after breakfast.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive matching placebo once daily after breakfast.
intervention type: Drug
intervention name: E6007
description: once daily administration
arm group label: E6007 30 mg
arm group label: E6007 60 mg
intervention type: Drug
intervention name: Placebo
description: once daily administration
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 74 Years
healthy volunteers: No
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country: Japan
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No