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

NCT04596293 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BBT401-UC-005
• Study Type: interventional
• Target: 38
• Locations: 4 countries
• Sites: 30

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57

  Day 57

• Percentage of Participants Who Achieved an Endoscopic Remission at Day 57

  Day 57

• Change From Baseline to Day 57 in Total Mayo Score

  Baseline, Day 57

Study Arms (3)

BBT-401-1S (800mg)

EXPERIMENTAL

* 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

Drug: BBT-401-1S or Placebo

BBT-401-1S (1,600mg)

EXPERIMENTAL

* 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

Placebo

PLACEBO COMPARATOR

* 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

Drug: BBT-401-1S or Placebo

Interventions

BBT-401-1S or Placebo DRUG

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

BBT-401-1S (1,600mg); BBT-401-1S (800mg); Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Have received:
• intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
• Janus kinase (JAK) inhibitors within 2 weeks, or
• cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
• anti-TNF-α biologics within 9 weeks, or
• 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.

Sponsors & Collaborators

• Bridge Biotherapeutics, Inc.: lead
• Covance: collaborator

Study Sites (30)

Premier Gastroenterology

Little Rock, Arkansas, 72211, United States

Location

Premier Gastroenterology

Little Rock, Arkansas, 72212, United States

Location

Saini Surinder S MD

Fountain Valley, California, 92708, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

Intercity Gastroentertology

Fresh Meadows, New York, 11366, United States

Location

Javara Research

Charlotte, North Carolina, 28210, United States

Location

Inves Clinic

McAllen, Texas, 78503, United States

Location

Discovery Clinical Trials - AACT

Pflugerville, Texas, 78660, United States

Location

Velocity Clinical Research

Riverton, Utah, 84065, United States

Location

West Jordan

West Jordan, Utah, 84088, United States

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

VITA LONGA Sp. z o.o.

Katowice, Silesian Voivodeship, 40-748, Poland

Location

Centrum Medyczne Melita Medical

Wroclaw, Wroclaw, 50-449, Poland

Location

Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego

Lodz, Łódź Voivodeship, 90-153, Poland

Location

Inje University Haeundae Paik Hospital

Haeundae, Busan Gwang'yeogsi, 48108, South Korea

Location

Kyungpook National University Chilgok Hospital

Bugok, Daegu, 41404, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Gang'weondo, 26426, South Korea

Location

Yeungnam University Hospital

Daegu, Gwang'yeogsi, 42415, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggido, 15355, South Korea

Location

Inje University, Seoul Paik Hospital

Junggu, Seoul, 04551, South Korea

Location

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

Seocho, Seoul Teugbyeolsi, 06591, South Korea

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine

Location

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

Kherson, Kherson Oblast, 73003, Ukraine

Location

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

Kyiv, Kyïv, 01023, Ukraine

Location

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

Kyiv, Kyïv, 01030, Ukraine

Location

Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom

Obukhiv, Kyïv, 08711, Ukraine

Location

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

Luts'k, Vinnytsia Oblast, 43005, Ukraine

Location

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

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

Medical Center of LLC Oxford Medical-Vinnytsia

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

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

Kyiv, 04078, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Clinical Trial Lead
• Organization: Bridge Biotherapeutics, Inc.

clinicaltrials.gov_inquiries@bridgebiorx.com

031-8092-3280

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: June 11, 2021
• Primary Completion: May 17, 2022
• Study Completion: July 12, 2022
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2023-08

Locations

US (10); UA (9); PL (4); KR (7)