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

NCT ID: NCT04596293

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2022-07-12

Brief Summary

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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 weeks
• Participants who did not achieve clinical remission in the induction phase will receive BBT-401 1600mg for 8 weeks

Group Type: EXPERIMENTAL

BBT-401-1S or Placebo

Intervention Type: DRUG

Administered by 200mg capsules of BBT-401-1S or placebo

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

Group Type: EXPERIMENTAL

BBT-401-1S or Placebo

Intervention Type: DRUG

Administered by 200mg capsules of BBT-401-1S or placebo

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 weeks
• Participants who did not achieve clinical remission in the induction phase will receive BBT-401 800mg for 8 weeks

Group Type: PLACEBO_COMPARATOR

BBT-401-1S or Placebo

Intervention Type: DRUG

Administered by 200mg capsules of BBT-401-1S or placebo

Interventions

BBT-401-1S or Placebo

Administered by 200mg capsules of BBT-401-1S or placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Bridge Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Premier Gastroenterology

Little Rock, Arkansas, United States

Premier Gastroenterology

Little Rock, Arkansas, United States

Saini Surinder S MD

Fountain Valley, California, United States

Gastro Care Institute

Lancaster, California, United States

Intercity Gastroentertology

Fresh Meadows, New York, United States

Javara Research

Charlotte, North Carolina, United States

Inves Clinic

McAllen, Texas, United States

Discovery Clinical Trials - AACT

Pflugerville, Texas, United States

Velocity Clinical Research

Riverton, Utah, United States

West Jordan

West Jordan, Utah, United States

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

VITA LONGA Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Centrum Medyczne Melita Medical

Wroclaw, Wroclaw, Poland

Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego

Lodz, Łódź Voivodeship, Poland

Inje University Haeundae Paik Hospital

Haeundae, Busan Gwang'yeogsi, South Korea

Kyungpook National University Chilgok Hospital

Bugok, Daegu, South Korea

Wonju Severance Christian Hospital

Wŏnju, Gang'weondo, South Korea

Yeungnam University Hospital

Daegu, Gwang'yeogsi, South Korea

Korea University Ansan Hospital

Ansan, Gyeonggido, South Korea

Inje University, Seoul Paik Hospital

Junggu, Seoul, South Korea

The Catholic university of Korea, Seoul St Mary's Hospital

Seocho, Seoul Teugbyeolsi, South Korea

Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso

Kherson, Kherson Oblast, Ukraine

Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di

Kyiv, Kyïv, Ukraine

Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv

Kyiv, Kyïv, Ukraine

Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom

Obukhiv, Kyïv, Ukraine

Municipal Enterprise Volyn Regional Clinical Hospital of the Volyn Regional Council, Department of S

Luts'k, Vinnytsia Oblast, Ukraine

Communal Non-profit enterprise Vinnytsya city clinical hospital 1 gastroenterology department

Vinnytsia, Vinnytsia Oblast, Ukraine

Medical Center of LLC Oxford Medical-Vinnytsia

Vinnytsia, Vinnytsia Oblast, Ukraine

Municipal Non-Profit Enterprise of the Kyiv Regional Council Kyiv Regional Hospital, Therapeutics De

Kyiv, , Ukraine

Countries

United States; Poland; South Korea; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BBT401-UC-005

Identifier Type: -

Identifier Source: org_study_id