A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis
The purpose of the study is to evaluate the safety and effectiveness of the study medicine in adults with ulcerative colitis.
Key Inclusion Criteria*:
Women or men may be able to take part in the study if you;
- Are between 18 and 65 years of age (inclusive).
- Have been diagnosed with UC for at least three months.
- Have moderately to severely active UC.
- Have not improved on, or have not been able to tolerate, at least 1 prior UC medication. Eligible medications include 5-ASAs (such as sulfasalazine or mesalamine), corticosteroids, immunomodulators and biologic drugs (such as infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab).
Key Exclusion Criteria*:
You may not be able to take part in this study if any of the following apply to you:
- Diagnosis of another disease that can cause inflammation of the colon or intestine, such as Crohn's disease, indeterminate colitis, or ischemic colitis.
- Currently have fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation.
- History of colonic resection.
*Other inclusion and exclusion criteria apply
- 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 4 out of 5 chance of receiving the active investigational 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.