A Phase 2 Randomized Double-Blind Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease
Brief description of study
The purpose of this research study is to measure how effective and how safe BMS-986165 is in treating study participants with moderate to severe Crohn's Disease (CD). The assessment will be done by measurements on how you are feeling, any side effects or changes to your laboratory tests. BMS-986165 is an investigational drug. This means that it has not been approved for use in your disease by the U.S. Food and Drug Administration (FDA). Further, biological samples will be collected to assess biomarkers (substances in your body) related to autoimmunity, inflammation, Crohn's disease and associated medical conditions, the effects of BMS-986165 or other medicines you may be taking for Crohn's disease, how your body handles BMS-986165 or other medicines you may be taking and to identify markers that may predict response to treatment. As part of this study, you may be given a placebo. A placebo is a medication which looks exactly like the investigational drug but has no active ingredient. Animal and human studies have shown that BMS-986165 may help control the immune system that is responsible for the signs and symptoms of CD.
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