<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/NCT04478825</url>
  </required_header>
  <id_info>
    <org_study_id>BBT401-UC-004</org_study_id>
    <nct_id>NCT04478825</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis</brief_title>
  <official_title>An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bridge Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, single-arm, proof of mechanism study to explore the efficacy and&#xD;
      safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Internal Company Decision&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Actual">August 24, 2021</completion_date>
  <primary_completion_date type="Actual">August 4, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endoscopic remission rate</measure>
    <time_frame>Day 57</time_frame>
    <description>measured by a Mayo endoscopic subscore of 0 or 1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endoscopic response rate</measure>
    <time_frame>Day 57</time_frame>
    <description>defined by a ≥2-point reduction from baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical remission rate</measure>
    <time_frame>Day 57</time_frame>
    <description>measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical response rate</measure>
    <time_frame>Day 57</time_frame>
    <description>measured by a reduction of ≥3 points and ≥30% improvement from baseline of total Mayo score, which includes a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore ≤1</description>
  </other_outcome>
  <other_outcome>
    <measure>Inflammatory Bowel Disease Questionnaire total score</measure>
    <time_frame>Day 57</time_frame>
    <description>measured by change from baseline. Scores for each question range between 1 and 7, reflecting poor to good health-related quality-of-life, for a range of possible total scores from 32 to 224.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</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, rectal administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBT-401-1S</intervention_name>
    <description>BBT-401-1S, 8 weeks, once a day</description>
    <arm_group_label>BBT-401-1S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, of any race, ≥18 and ≤60 years of age on Day 1.&#xD;
&#xD;
          -  Have been diagnosed with active distal UC for ≥3 months prior to Day 1, as determined&#xD;
             by clinical and endoscopic evidence and documented in a histopathology evaluation.&#xD;
&#xD;
          -  Have UC that is restricted to between the descending colon and the rectum (ie, left&#xD;
             sided distal colitis), with demarcation of the lesion confirmed by endoscopy.&#xD;
&#xD;
          -  Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1,&#xD;
             and a stool frequency subscore ≥1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have used any biologics or Janus kinase (JAK) inhibitors including, but not limited&#xD;
             to, anti TNF α biologics or tofacitinib for the treatment of UC.&#xD;
&#xD;
          -  Have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or&#xD;
             immunosuppressants (methotrexate or cyclosporine) for the treatment of UC within 12&#xD;
             weeks or have any history of nonresponse to these medications.&#xD;
&#xD;
          -  Have used any rectal therapy for the treatment of UC with exception of rectal&#xD;
             suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2&#xD;
             weeks prior to Day 1.&#xD;
&#xD;
          -  Have received oral and/or rectal suppository 5-aminosalicylic acid, oral&#xD;
             sulphasalazine, or low-dose oral corticosteroids that have been stable for &lt;4 weeks.&#xD;
             Doses of the drugs must remain stable until the last dose of study drug.&#xD;
&#xD;
          -  Have received any other concomitant medications for UC that have been stable (ie, have&#xD;
             not started dosing with a new drug or had a change to their dosing regimen) for &lt;7&#xD;
             days or 5 half lives, whichever is longer, prior to Day 1.&#xD;
&#xD;
          -  Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis,&#xD;
             toxic megacolon, chronic pancolitis, or symptomatic intestinal stenosis.&#xD;
&#xD;
          -  Have a history of extensive colonic resection (subtotal or total colectomy) or are&#xD;
             anticipated to require surgical intervention for UC.&#xD;
&#xD;
          -  Have an ileostomy or colostomy.&#xD;
&#xD;
          -  Have evidence of treatment for Clostridium difficile infection or other pathogenic&#xD;
             bowel infection within 60 days or for another intestinal pathogen within 30 days prior&#xD;
             to Day 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>P3 Research</name>
      <address>
        <city>Tauranga</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P3 Research</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</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>
  <!-- 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/NCT04478825
org study id: BBT401-UC-004
nct id: NCT04478825
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is an open label, single-arm, proof of mechanism study to explore the efficacy and
      safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endoscopic remission rate
time frame: Day 57
description: measured by a Mayo endoscopic subscore of 0 or 1
measure: Endoscopic response rate
time frame: Day 57
description: defined by a ≥2-point reduction from baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
measure: Clinical remission rate
time frame: Day 57
description: measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point
measure: Clinical response rate
time frame: Day 57
description: measured by a reduction of ≥3 points and ≥30% improvement from baseline of total Mayo score, which includes a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore ≤1
measure: Inflammatory Bowel Disease Questionnaire total score
time frame: Day 57
description: measured by change from baseline. Scores for each question range between 1 and 7, reflecting poor to good health-related quality-of-life, for a range of possible total scores from 32 to 224.
arm group label: BBT-401-1S
arm group type: Experimental
description: BBT-401-1S, rectal administration
intervention type: Drug
intervention name: BBT-401-1S
description: BBT-401-1S, 8 weeks, once a day
arm group label: BBT-401-1S
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer