BMS-986165 in Moderate to Severe Ulcerative Colitis
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis
IRAS ID
263312
Contact name
Tim Raine
Contact email
Sponsor organisation
Bristol-Meyers Squibb International Corporation
Eudract number
2018-004694-27
Clinicaltrials.gov Identifier
141055, IND
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Bristol-Myers Squibb Company (the Sponsor) is running this study to see if an experimental medication named BMS-986165 will help in the treatment of ulcerative colitis, and how safe it is to use in patients. The study is planned to involve 120 people who have ulcerative colitis.
Current treatments for ulcerative colitis often fail, only partially work, or are poorly tolerated. There is still a need for new, safe, well-tolerated, and orally administered therapies.
Ulcerative colitis (UC) is a long-term condition where the colon and rectum become inflamed. The severity of the inflammation varies; for some people, the condition has a significant impact on their everyday lives. Ulcerative colitis is thought to be an autoimmune condition. This means the immune system (the body's defence against infection) goes wrong and attacks healthy tissue.
BMS-986165 is a tyrosine kinase inhibitor, which has potential to treat a variety of immune system conditions.
The study will have 2 groups of participants who will receive either BMS-986165 or placebo. Participants may receive a placebo during the study, which looks like BMS-986165, but contains no active medication.
Participation in the study will last up to 60 weeks. This will involve some screening visits (to check participant eligibility) and then 13 visits to the study doctor’s office which will last for a couple of hours. One visit will last 7-8 hours. Participants will receive study medication for 52 weeks, and then there will be a 4-week follow-up period.
Participants will also be asked to complete questionnaires and will receive an electronic device (tablet) to complete a study diary each day at home. Blood, urine, colon biopsy and stool samples will be collected. Endoscopies will be performed, and a chest x-ray is required during the screening period.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0328
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion