Colitis, Ulcerative Clinical Trial
Official title:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
| Verified date | April 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 38 |
| Est. completion date | November 29, 2023 |
| Est. primary completion date | May 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0002 | Camberwell | Victoria |
| Australia | Local Institution - 0005 | Sydney | New South Wales |
| Canada | Local Institution - 0007 | Edmonton | Alberta |
| Canada | Local Institution - 0025 | London | Ontario |
| Canada | Local Institution - 0008 | Vaughan | Ontario |
| Germany | Local Institution - 0003 | Berlin | |
| Germany | Local Institution - 0019 | Dresden | |
| Germany | Local Institution - 0006 | Kiel | |
| Netherlands | Local Institution - 0009 | Amsterdam | Noord-Holland |
| Poland | Local Institution - 0028 | Bydgoszcz | |
| Poland | Local Institution - 0029 | Bydgoszcz | |
| Poland | Local Institution - 0030 | Warsaw | |
| Poland | Local Institution - 0031 | Warsaw | Mazowieckie |
| Puerto Rico | Local Institution - 0011 | San Juan | |
| United Kingdom | Local Institution - 0027 | Cambridge | |
| United Kingdom | Local Institution - 0023 | London | England |
| United States | Local Institution - 0036 | Arlington Heights | Illinois |
| United States | Local Institution - 0026 | Chapel Hill | North Carolina |
| United States | Local Institution - 0013 | Cleveland | Ohio |
| United States | Local Institution - 0032 | Garland | Texas |
| United States | Local Institution - 0039 | Lubbock | Texas |
| United States | Local Institution - 0015 | New York | New York |
| United States | Local Institution - 0020 | Oklahoma City | Oklahoma |
| United States | Local Institution - 0014 | San Diego | California |
| United States | Local Institution - 0016 | Shreveport | Louisiana |
| United States | Local Institution - 0033 | Southlake | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Canada, Germany, Netherlands, Poland, Puerto Rico, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants in clinical response | At Week 12 | ||
| Secondary | Number of adverse events (AEs) | Baseline to Week 56 |
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