Crohn’s Disease Study

The purpose of the IM011-023 study is to evaluate how well an oral investigational drug (called BMS-986165) works and how safe it is for patients with moderately to severely active Crohn’s disease.

About the study:

The IM011-023 study is designed to evaluate the safety and effectiveness of BMS-986165, an oral investigational study drug, compared with placebo (an inactive substance) to see if it may reduce symptoms of moderate to severe CD. Participants will have a 3 out of 4 chance of receiving the active investigational drug at the start of the study.

Study treatment assignment is blinded, so that neither you nor your study doctor will know if you are receiving active study drug or placebo. Participants who do not have an adequate response at Week 12 may be eligible to receive open-label BMS-986165, where you will know that you are receiving the active investigational drug.

Participation in the blinded period of this study is expected to last up to 52 weeks (1 year). Depending on your response and the study doctor’s recommendation, you may be eligible to receive active study drug for an additional 52 weeks (1 year) within this study.

Eligibility Criteria

To be eligible, subjects must:

  • Be between 18 and 75 years of age
  • Have moderate to severe Crohn’s disease
  • Have tried 1 or more standard of care treatments that did not work, stopped working, or were not tolerated

If eligible to enroll in this study, you may receive the study drug or placebo (a pill that looks like the study drug but does not contain an active medicine). All study-related medical procedures and tests will be provided at no cost to you.

How do I get involved?

If you feel you are interested in participating in the IM011-023 study, please call (318) 525-3233. A study coordinator will determine if the trial is right for you.