A study of BT051 in Subjects with Ulcerative Colitis
Research type
Research Study
Full title
A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects with Moderately to Severely Active Ulcerative Colitis (UC)
IRAS ID
300608
Contact name
Paul Westhead
Contact email
Sponsor organisation
Bacainn Therapeutics, Inc.
Eudract number
2021-000035-31
Duration of Study in the UK
1 years, 6 months, 21 days
Research summary
BT051 is being developed to learn how safe and tolerable this medication is in participants with Ulcerative Colitis (UC).
This study will enroll approximately 44 participants at approximately 11 sites in the United States, United Kingdom and Europe. Participants will be in this study for approximately 8 weeks.
Participants will be randomly assigned to receive either BT051 or placebo and will have a 75% chance of receiving BT051.
Participants may be involved in the study’s 3 periods:
Screening period (up to 4 weeks)
Treatment period (4 weeks; 5 visits)
Post Dosing Follow-up period (30 days; 1 visit, 1 phone call)Participants assigned to either cohort 1, 2, or 3 will receive the following treatment:
Cohort 1: BT051 200 mg or placebo daily
Cohort 2: BT051 800 mg or placebo daily
Cohort 3: BT051 3200 mg or placebo daily
Based on data generated from the first 3 cohorts, the Sponsor may decide to add an additional cohort to the study. Participants assigned to this Cohort 4 will receive the following treatment:
Additional Cohort 4: BT051 ≤3200 mg or placebo daily
Once assigned to a cohort, participants will continue in that cohort for the 28-day Treatment Period.Neither study participants nor the Study Doctor will know if they are receiving BT051 or placebo. The study starts with the lowest dose (200 mg), Cohort 1. The medication dose is planned to increase in Cohort 2 and 3. Before increasing the dose, a Safety Review Committee (SRC) will review the data generated from the prior cohort. The medication dose for the additional Cohort 4 will be decided by the SRC based on the data obtained from Cohorts 1, 2, and 3, but will not exceed 3200 mg BT051 daily.
The study is paid for by Bacainn Therapeutics, Inc., the sponsor of this study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0120
Date of REC Opinion
12 Jul 2021
REC opinion
Further Information Favourable Opinion