NCT04613518
Recruiting
November 3, 2020
April 22, 2022
Brief summary:
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: BMS-986165 |
Drug: BMS-986165 Specified Dose on Specified Days |
Experimental: Open label Extension, BMS-986165 |
Drug: BMS-986165 Specified Dose on Specified Days |
Placebo Comparator: Placebo |
Other: Placebo Comparator Specified Dose on Specified Days |
Inclusion Criteria: Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening Moderately to severely active UC as assessed by the modified Mayo score Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors[SA1] Documentation of prior treatment with corticosteroids for ≥ 4 weeks Males and females must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation History or evidence of any extensive colonic resection, or subtotal or total colectomy Women who are pregnant or breastfeeding Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor Other protocol-defined inclusion/exclusion criteria apply.
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, California
Medical Associates Research Group
San Diego
United States, Louisiana
Louisiana Research Center-Research
Shreveport
United States, New York
Local Institution
New York
United States, North Carolina
Local Institution
Chapel Hill
United States, Ohio
Cleveland Clinic-Gastroenterology
Cleveland
United States, Oklahoma
Digestive Disease Specialists
Oklahoma City
United States, Texas
Local Institution
Garland
United States, Texas
Local Institution
Southlake
Australia, New South Wales
St Vincent's Hospital-Gastroenterology
Darlinghurst
Australia, Victoria
Local Institution - 0002
Camberwell
Canada, Alberta
Local Institution
Edmonton
Canada, Ontario
Local Institution
London
Canada, Ontario
Local Institution - 0008
Vaughan
Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroentero
Berlin
Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medizinische Klinik I, Hepatology
Dresden
Germany
Local Institution - 0006
Kiel
Netherlands
Local Institution - 0009
Amsterdam
Poland
Local Institution - 0029
Bydgoszcz
Poland
Local Institution - 0028
Bydgoszcz
Poland
Local Institution - 0030
Warsaw
Poland
Local Institution
Warszawa
Puerto Rico
UPR Medical Sciences Campus-UPR GI Research Unit
San Juan
United Kingdom
Local Institution
Cambridge
United Kingdom
Local Institution
London
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb