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

• Status: Recruiting
• Trial end date: 2023-04-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Confirmed diagnosis of 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

• 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, 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 TYK2 inhibitor

Other protocol-defined inclusion/exclusion criteria apply