Phase 2
N=38
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
Colitis, Ulcerative
Bottom Line
View on ClinicalTrials.gov: NCT04613518 ↗Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Jul 2024
Primary outcome: Primary: Percentage of Participants in Clinical Response at Week 12 — 53.8; 50.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986165 (Drug); Placebo Comparator (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Clinical Response at Week 12 |
53.8; 50.0 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) |
21; 6; 15; 6 | — |
| PRIMARY Number of Participants Experiencing Serious Adverse Events (SAEs) |
4; 1; 1; 1 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
2; 0; 1; 3 | — |
| PRIMARY Number of Participants Experiencing Adverse Events of Special Interest (AEIs) |
15; 5; 1; 2; 0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04613518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.