Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: BBT-401-1S or Placebo

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan Gwang'yeogsi
    • Haeundae, Busan Gwang'yeogsi, Korea, Republic of, 48108
      • Inje University Haeundae Paik Hospital
  • Daegu
    • Bugok, Daegu, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital
  • Gang'weondo
    • Wŏnju, Gang'weondo, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital
  • Gwang'yeogsi
    • Daegu, Gwang'yeogsi, Korea, Republic of, 42415
      • Yeungnam University Hospital
  • Gyeonggido
    • Ansan, Gyeonggido, Korea, Republic of, 15355
      • Korea University Ansan Hospital
  • Seoul
    • Junggu, Seoul, Korea, Republic of, 04551
      • Inje University, Seoul Paik Hospital
  • Seoul Teugbyeolsi
    • Seocho, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St Mary's Hospital
• Poland
  • Kujawsko-pomorskie,
    • Bydgoszcz, Kujawsko-pomorskie,, Poland, 85-796
      • Centrum medyczne Pratia Bydgoszcz
  • Wroclaw
    • Wrocław, Wroclaw, Poland, 50-449
      • Centrum Medyczne Melita Medical
  • Łódzkie
    • Łódź, Łódzkie, Poland, 90-153
      • Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego
  • Śląskie
    • Katowice, Śląskie, Poland, 40-748
      • Vita Longa Sp. z o.o.
• Ukraine
  • Kyiv, Ukraine, 04078
    • Municipal Non-Profit Enterprise of the Kyiv Regional Council Kyiv Regional Hospital, Therapeutics De
  • Kharkivs'ka Oblast
    • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61037
      • Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the
  • Khersons'ka Oblast
    • Kherson, Khersons'ka Oblast, Ukraine, 73003
      • Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso
  • Kyïv
    • Kyiv, Kyïv, Ukraine, 01023
      • Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di
    • Kyiv, Kyïv, Ukraine, 01030
      • Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv
    • Obukhiv, Kyïv, Ukraine, 08711
      • Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom
  • Vinnyts'ka Oblast
    • Luts'k, Vinnyts'ka Oblast, Ukraine, 43005
      • Municipal Enterprise Volyn Regional Clinical Hospital of the Volyn Regional Council, Department of S
    • Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21018
      • Medical Center of LLC Oxford Medical-Vinnytsia
    • Vinnytsya, Vinnyts'ka Oblast, Ukraine, 21018
      • Communal Non-profit enterprise Vinnytsya city clinical hospital 1 gastroenterology department
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Premier Gastroenterology
    • Little Rock, Arkansas, United States, 72211
      • Premier Gastroenterology
  • California
    • Fountain Valley, California, United States, 92708
      • Saini Surinder S MD
    • Lancaster, California, United States, 93534
      • Gastro Care Institute
  • New York
    • Fresh Meadows, New York, United States, 11366
      • Intercity Gastroentertology
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Javara Research
  • Texas
    • McAllen, Texas, United States, 78503
      • Inves Clinic
    • Pflugerville, Texas, United States, 78660
      • Discovery Clinical Trials - AACT
  • Utah
    • Riverton, Utah, United States, 84065
      • Velocity Clinical Research
    • West Jordan, Utah, United States, 84088
      • West Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, of any race, ≥18 and ≤60 years of age.
• Have been diagnosed with active UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
• Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history.
• Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

• Have received:

  1. intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
  2. Janus kinase (JAK) inhibitors within 2 weeks, or
  3. cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
  4. anti-TNF-α biologics within 9 weeks, or
  5. any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.
• Have received orally administered azathioprine or 6-mercaptopurine that has been stable for <8 weeks.
• Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or equivalent) that have been stable for <5 weeks.
• Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for <7 days or 5 half-lives, whichever is longer.
• Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, ≤15 cm), or symptomatic intestinal stenosis.
• Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
• Have an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
• Have a positive test for Clostridium difficile, or have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBT-401-1S (800mg); Induction Phase: BBT-401 800mg for 8 weeks; Extension Phase: After 8 weeks,Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeksParticipants who did not achieve clinical remission in the induction phase will receive BBT-401 1600mg for 8 weeks	Drug: BBT-401-1S or Placebo; Administered by 200mg capsules of BBT-401-1S or placebo
Experimental: BBT-401-1S (1,600mg); Induction Phase: BBT-401 1600mg for 8 weeks; Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks	Drug: BBT-401-1S or Placebo; Administered by 200mg capsules of BBT-401-1S or placebo
Placebo Comparator: Placebo; Induction Phase: Placebo for 8 weeks; Extension Phase: After 8 weeks,Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeksParticipants who did not achieve clinical remission in the induction phase will receive BBT-401 800mg for 8 weeks	Drug: BBT-401-1S or Placebo; Administered by 200mg capsules of BBT-401-1S or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57	Clinical Response was defined as a Total Mayo Score, as measured by a reduction of ≥ 3 points and ≥ 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore ≤ 1	Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57	Clinical Remission was defined as a Total Mayo score, as measured by a total Mayo score of ≤ 2 points, with no individual subscore exceeding 1 point. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score is consisted of 4 subscores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment), each graded from 0 to 3 with higher scores indicating more severe disease	Day 57
Percentage of Participants Who Achieved an Endoscopic Remission at Day 57	Endoscopic Remission was defined as a Mayo endoscopic subscore of 0 or 1. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score is consisted of 4 subscores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment), each graded from 0 to 3 with higher scores indicating more severe disease	Day 57
Change From Baseline to Day 57 in Total Mayo Score	Change from Baseline to Day 57 in Total Mayo Score. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score, ranged from 0 to 12, are sum of 4 subscores. Subscores are stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment, each graded from 0 to 3 with higher scores indicating more severe disease.	Baseline, Day 57

Collaborators and Investigators

• Sponsor: Bridge Biotherapeutics, Inc.
• Collaborators: Covance

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: BBT401-UC-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No