Active, Not Recruiting
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis - IM011-127
Updated:
26 September, 2023
|
ClinicalTrials.gov
Print Friendly Summary
Trial Details
Phase
Gender(s)
Age Range
Active, Not Recruiting
Treatment Options
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.
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information