BMS-986165 in Moderate-to-Severe Crohn's Disease
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 Crohn’s Disease
IRAS ID
245410
Contact name
Jonathan MacDonald
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-001976-48
Clinicaltrials.gov Identifier
134444, IND Number
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Crohn’s disease (CD) is a chronic inflammatory disease of the gastrointestinal tract that causes significant morbidity, impact on quality of life, and health care expenditures. Outcomes for patients with CD have improved significantly over the last several years due to better treatment strategies and the emergence of highly targeted biological therapies, yet significant therapeutic challenges still remain. The current treatment regimens often fail, induce only a partial response, or are poorly tolerated. Therefore, there is still a critical unmet need for novel, safe, well tolerated, and orally administered therapies with a different mechanism of action that can effectively modify the disease course.
Tyrosine kinase 2 (TYK2) is an enzyme implicated in the pathophysiology of multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, spondyloarthritides and CD. BMS-986165 is a potent, highly selective small molecule inhibitor of TYK2 that is being developed for the treatment of CD and psoriasis.
The primary objective of this study is to assess the safety and efficacy of 3 dosing regimens of BMS-986165 in participants with moderate to severe CD. Participants will be randomised in a 1:1:1:1 ratio to receive BMS-986165 oral capsules 12mg once daily (with placebo as the second daily dose), 6mg twice daily, 3mg twice daily or placebo twice daily for an induction period of 12 weeks.
Participants who achieve a clinical response will continue with the same blinded treatment for an additional 40 weeks (Maintenance period). If a clinical response is not achieved, participants can continue with their blinded treatment, switch to open-label supply of BMS-986165 12mg once daily or end their study participation. Approximately 240 participants (men and women ages 18 to 75 years) will participate in this research study. Participation in this study will last approximately 60 weeks.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0511
Date of REC Opinion
23 Aug 2018
REC opinion
Further Information Favourable Opinion