NCT04613518CompletedPhase 2
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 12 Jul 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 28 Oct 2020
- Start date
- 15 Mar 2021
- Primary completion date
- 31 May 2023
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Ulcerative colitis
- NCT number
- NCT04613518
- EudraCT number
- 2019-004878-26
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 38
- From 15 Mar 2021 to the primary completion date, 31 May 2023
- 26 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or evidence of any extensive colonic resection, or subtotal or total colectomy
- Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor
- Other protocol-defined inclusion/exclusion criteria apply.
Other illness
- 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
Other
- Women who are pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.