A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT04613518

Run by

Bristol-Myers Squibb

People needed

38

Starts

2021-03-15

Expected to finish

2023-11-29

Last updated by the study team

2024-07-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0014 — San Diego, California, United States
• Local Institution - 0036 — Arlington Heights, Illinois, United States
• Local Institution - 0016 — Shreveport, Louisiana, United States
• Local Institution - 0015 — New York, New York, United States
• Local Institution - 0026 — Chapel Hill, North Carolina, United States
• Local Institution - 0013 — Cleveland, Ohio, United States
• Local Institution - 0020 — Oklahoma City, Oklahoma, United States
• Local Institution - 0032 — Garland, Texas, United States
• Local Institution - 0039 — Lubbock, Texas, United States
• Local Institution - 0033 — Southlake, Texas, United States
• Local Institution - 0005 — Sydney, New South Wales, Australia
• Local Institution - 0002 — Camberwell, Victoria, Australia
• Local Institution - 0007 — Edmonton, Alberta, Canada
• Local Institution - 0025 — London, Ontario, Canada
• Local Institution - 0008 — Vaughan, Ontario, Canada
• Local Institution - 0003 — Berlin, Germany
• Local Institution - 0019 — Dresden, Germany
• Local Institution - 0006 — Kiel, Germany
• Local Institution - 0009 — Amsterdam, North Holland, Netherlands
• Local Institution - 0031 — Warsaw, Masovian Voivodeship, Poland
• Local Institution - 0030 — Warsaw, Masovian Voivodeship, Poland
• Local Institution - 0029 — Bydgoszcz, Poland
• Local Institution - 0028 — Bydgoszcz, Poland
• Local Institution - 0011 — San Juan, Puerto Rico
• Local Institution - 0023 — London, England, United Kingdom

Full record on ClinicalTrials.gov

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