Active, Not Recruiting
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease - IM011-023
Updated:
8 September, 2023
|
ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
Inclusion Criteria: - Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution - Must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments - Must have active moderate to severe CD - Men and women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Severe or fulminant colitis that is likely to require surgery or hospitalization - Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease - Previous exposure to BMS-986165 in any study - Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant 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