A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Patients with Moderate to Severe Ulcerative Colitis

Study Description:

• The study is designed to evaluate the safety, effectiveness and biomarker response of BMS-986165 in people with active UC.
• Study Treatment assignment is blinded, so that neither you nor your doctor will know if you are receiving the active study drug or placebo. Participants will have a 75% chance of receiving the active investigational drug, and a 25% chance of receiving placebo (inactive drug) at the start of the study.
• After the double-blind study treatment period, you may be able to enter an open-label study treatment. In this part of the study, all study participants will receive BMS-986165.
• The total length of this study is approximately 60 weeks.

Patient Participation Requirements

If qualified, patients will be asked to:

• Attend all study visits (15 during the first 12 week study treatment period).
• Take the oral investigational drug or the placebo as directed.
• A variety of assessments such as lab tests, vital signs, physical exams, and endoscopies will be performed.
• For more information on participation, contact a site near you.

Possible risks and side effects:

• BMS-986165 is still being studied, so not all of its potential side-effects are known.
• The most common side-effects seen in a recent Phase 2 clinical trial of BMS-986165 in psoriasis, a skin disease, were irritation of the nose and throat (nasopharyngitis), headache, diarrhea, nausea, and upper respiratory tract infection.

Additional Information:

For patients outside of the US who may be interested in this study, you can search for a site location near you via this link: Site List | Study Connect (bmsstudyconnect.com)