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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: BMS-986165; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04613518

IM011-127

2019-004878-26 (EudraCT Number)

U1111-1245-2970 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 3 patient groups, including a placebo group

BMS-986165

Experimental group

Treatment:

Drug: BMS-986165

Placebo

Placebo Comparator group

Treatment:

Other: Placebo Comparator

Open label Extension, BMS-986165

Experimental group

Treatment:

Drug: BMS-986165