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
Published: 12/10/2020
General Information:
The purpose of the study is to evaluate the safety and effectiveness of the study medicine in adults with ulcerative colitis.
Eligibility:
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
Study Details:
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)