<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/NCT03800420</url>
  </required_header>
  <id_info>
    <org_study_id>BBT401-UC-US02</org_study_id>
    <nct_id>NCT03800420</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of BBT-401-1S in Ulcerative Colitis</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bridge Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KCRN Research, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bridge Biotherapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to&#xD;
      evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.&#xD;
&#xD;
      This study consists of three cohorts with 16-week treatment period per cohort that will be&#xD;
      conducted sequentially.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    to carry out the rest of the study with new CRO and modified protocol as a multi-regional&#xD;
    study.&#xD;
  </why_stopped>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 18, 2020</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 Total Mayo Score</measure>
    <time_frame>Week 8</time_frame>
    <description>The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Partial Mayo Score</measure>
    <time_frame>Week 8</time_frame>
    <description>The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Histologic Assessment of Endoscopic Biopsy</measure>
    <time_frame>Week 8</time_frame>
    <description>Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)</measure>
    <time_frame>Week 8</time_frame>
    <description>The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Severity of TEAEs</measure>
    <time_frame>up to 8 weeks after the last dose</time_frame>
    <description>Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of BBT- 401-1S</measure>
    <time_frame>Day 1, Week 4, Week 8</time_frame>
    <description>Analysis of Plasma Pharmacokinetics for BBT- 401 -1S</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Concentration of Serum CRP</measure>
    <time_frame>Week 8</time_frame>
    <description>Widely used serum indicator of inflammation in Ulcerative Colitis(UC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Concentration of Fecal Calprotectin</measure>
    <time_frame>Week 8</time_frame>
    <description>Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Concentration of Fecal Lactoferrin</measure>
    <time_frame>Week 8</time_frame>
    <description>A stool (fecal) test that is used to detect inflammation in the intestines.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>BBT-401-1S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BBT-401-1S, Oral capsule, QD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, Oral capsule, QD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBT-401-1S first and then Placebo</intervention_name>
    <description>Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
    <arm_group_label>BBT-401-1S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo first and then BBT-401-1S</intervention_name>
    <description>Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of signed and dated informed consent form (ICF)&#xD;
&#xD;
          -  Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          -  Male or female, aged &gt;=18 years&#xD;
&#xD;
          -  Diagnosed with active UC for at least 3 months prior to screening&#xD;
&#xD;
          -  Total Mayo score &gt;=5 and Endoscopic sub-score &gt;=1&#xD;
&#xD;
          -  Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or&#xD;
             sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine,&#xD;
             mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks,&#xD;
             and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at&#xD;
             least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must&#xD;
             remain stable until the end of study treatment (with possible exception for tapering&#xD;
             steroid dose after 8 weeks)&#xD;
&#xD;
          -  For females of reproductive potential: use of highly effective contraception for at&#xD;
             least 1 month prior to screening and agreement to use such a method during study&#xD;
             participation and for an additional 3 months after the last dose&#xD;
&#xD;
          -  For males of reproductive potential: use of condoms or other methods to ensure&#xD;
             effective contraception with partner during study participation and for an additional&#xD;
             3 months after the last dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant&#xD;
             colitis, ulcerative proctitis, or toxic mega-colon&#xD;
&#xD;
          -  Previous extensive colonic resection (subtotal or total colectomy)&#xD;
&#xD;
          -  Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine&#xD;
&#xD;
          -  Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel&#xD;
             infection within 60 days or for another intestinal pathogen within 30 days prior to&#xD;
             randomization&#xD;
&#xD;
          -  Active infection with the HIV or Hepatitis B or C viruses&#xD;
&#xD;
          -  Clinically significant active extra-intestinal infection (e.g., pneumonia,&#xD;
             pyelonephritis)&#xD;
&#xD;
          -  Clinically significant abnormal vital signs, physical examination or 12-lead&#xD;
             electrocardiogram (ECG) at screening or baseline&#xD;
&#xD;
          -  Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin&#xD;
             and alkaline phosphatase) &gt; 2X the upper limit of normal (ULN) at screening&#xD;
&#xD;
          -  Other clinically significant abnormal laboratory results at screening in the&#xD;
             investigator's opinion&#xD;
&#xD;
          -  History of any clinically significant medical condition that, in the investigator's&#xD;
             opinion, would preclude participation in the study&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Treatment with another investigational drug or other intervention within 30 days prior&#xD;
             to screening&#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>Site 03</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 01</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 11</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 12</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 04</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 10</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 02</name>
      <address>
        <city>Monroe</city>
        <state>North Carolina</state>
        <zip>28112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 08</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 05</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 13</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 09</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>August 4, 2021</results_first_submitted>
  <results_first_submitted_qc>February 23, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 21, 2022</results_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pellino-1</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03800420/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03800420/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BBT-401-1S</title>
          <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>subjects who were randomized</population>
      <group_list>
        <group group_id="B1">
          <title>BBT-401-1S</title>
          <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
        </group>
        <group group_id="B3">
          <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="12"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed (White/Black)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Total Mayo Score</title>
        <description>The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S First and Then Placebo</title>
            <description>Total 16 weeks&#xD;
First 12 weeks, BBT-401-1S, Oral capsule, QD. Followed by 4 weeks Placebo, Oral capsule, QD.</description>
          </group>
          <group group_id="O2">
            <title>Placebo First and Then BBT-401-1S</title>
            <description>Total 16 weeks First Placebo, 8 weeks Oral capsule, QD Followed by 8 weeks BBT-401-1S, Oral capsule, QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Mayo Score</title>
          <description>The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Partial Mayo Score</title>
        <description>The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Partial Mayo Score</title>
          <description>The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Histologic Assessment of Endoscopic Biopsy</title>
        <description>Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Histologic Assessment of Endoscopic Biopsy</title>
          <description>Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)</title>
        <description>The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)</title>
          <description>The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Severity of TEAEs</title>
        <description>Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.</description>
        <time_frame>up to 8 weeks after the last dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Severity of TEAEs</title>
          <description>Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.</description>
          <units>Number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal tract mucosal pigmentation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haemorrhoids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Melaena</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasopharyngitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Onychomycosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Condition aggravated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of BBT- 401-1S</title>
        <description>Analysis of Plasma Pharmacokinetics for BBT- 401 -1S</description>
        <time_frame>Day 1, Week 4, Week 8</time_frame>
        <population>All samples were below LLOQ and therefore plasma concentrations could not be calculated, (Plasma PK samples of one active patient were not collected.)</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of BBT- 401-1S</title>
          <description>Analysis of Plasma Pharmacokinetics for BBT- 401 -1S</description>
          <population>All samples were below LLOQ and therefore plasma concentrations could not be calculated, (Plasma PK samples of one active patient were not collected.)</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Samples were below the LLOQ</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Samples were below the LLOQ</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Concentration of Serum CRP</title>
        <description>Widely used serum indicator of inflammation in Ulcerative Colitis(UC).</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Concentration of Serum CRP</title>
          <description>Widely used serum indicator of inflammation in Ulcerative Colitis(UC).</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Concentration of Fecal Calprotectin</title>
        <description>Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Concentration of Fecal Calprotectin</title>
          <description>Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Concentration of Fecal Lactoferrin</title>
        <description>A stool (fecal) test that is used to detect inflammation in the intestines.</description>
        <time_frame>Week 8</time_frame>
        <population>No data was collected for this outcome measure due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>BBT-401-1S</title>
            <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Concentration of Fecal Lactoferrin</title>
          <description>A stool (fecal) test that is used to detect inflammation in the intestines.</description>
          <population>No data was collected for this outcome measure due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.&#xD;
Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.</desc>
      <group_list>
        <group group_id="E1">
          <title>BBT-401-1S</title>
          <description>BBT-401-1S, Oral capsule, QD&#xD;
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo, Oral capsule, QD&#xD;
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <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="8" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gastrointestinal tract mucosal pigmentation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Faecal calprotectin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Stool analysis abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </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>
      <restrictive_agreement>The Institution and Investigator shall not publish the results of this study without the prior written consent of sponsor. As used herein, the term &quot;publish&quot; shall include oral presentations, written abstracts, written manuscripts, etc.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials_inquiries</name_or_title>
      <organization>Clinical Trials_inquiries</organization>
      <phone>+82-31-8092-3280</phone>
      <email>clinicaltrials.gov_inquiries@bridgebiorx.com</email>
    </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/NCT03800420
org study id: BBT401-UC-US02
nct id: NCT03800420
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to
      evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.

      This study consists of three cohorts with 16-week treatment period per cohort that will be
      conducted sequentially.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Total Mayo Score
time frame: Week 8
description: The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
measure: Change From Baseline in Partial Mayo Score
time frame: Week 8
description: The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
measure: Change From Baseline in Histologic Assessment of Endoscopic Biopsy
time frame: Week 8
description: Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).
measure: Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)
time frame: Week 8
description: The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.
measure: Number and Severity of TEAEs
time frame: up to 8 weeks after the last dose
description: Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.
measure: Plasma Concentration of BBT- 401-1S
time frame: Day 1, Week 4, Week 8
description: Analysis of Plasma Pharmacokinetics for BBT- 401 -1S
measure: Change From Baseline in Concentration of Serum CRP
time frame: Week 8
description: Widely used serum indicator of inflammation in Ulcerative Colitis(UC).
measure: Change From Baseline in Concentration of Fecal Calprotectin
time frame: Week 8
description: Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).
measure: Change From Baseline in Concentration of Fecal Lactoferrin
time frame: Week 8
description: A stool (fecal) test that is used to detect inflammation in the intestines.
arm group label: BBT-401-1S
arm group type: Experimental
description: BBT-401-1S, Oral capsule, QD
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, Oral capsule, QD
intervention type: Drug
intervention name: BBT-401-1S first and then Placebo
description: Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
arm group label: BBT-401-1S
intervention type: Drug
intervention name: Placebo first and then BBT-401-1S
description: Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
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outcome list: 
reported events: 
certain agreements: 
point of contact: 