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Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04596293•Bridge Biotherapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (30)

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

Key Dates

Start Date

June 11, 2021

Primary Completion Date

May 17, 2022

Completion Date

July 12, 2022

Last Updated

September 7, 2023

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

BBT-401-1S or Placebo

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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