Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Women's Cancer Health Study Area: Breast Cancer For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Please Log In/Join Now first, and then use this function!


Safety and Efficacy of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis - IM011-024

Updated: 1 February, 2021   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 18-80

    Age Range

  • 80


  • Recruiting

Treatment Options

Study Arms
Experimental: BMS-986165
Drug: BMS-986165
Placebo Comparator: Placebo
Other: Placebo

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit - Documented diagnosis of UC of at least 3 months' duration prior to screening - Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2 - Documentation of an inadequate response, loss of response, or intolerance to at least one of the medications including Oral 5-aminosalicylic acids (5-ASAs) (eg, mesalamine, sulfasalazine, olsalazine, or balsalazide), CS such as Corticosteroids (eg, prednisone ([or equivalent)] or budesonide ([or equivalent)]), Immunosuppressants such as Immunomodulators (eg, azathioprine ([AZA),], 6-mercaptopurine ([6-MP),], or methotrexate ([MTX)]), Anti-tumor necrosis factor-alpha (TNF)--α) agents (eg, infliximab, adalimumab, or golimumab), Integrin inhibitor (eg, vedolizumab), Anti-interleukin (IL)-12/IL-23p40 antibodies (eg, ustekinumab) - Males and females must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation - History or evidence of any extensive colonic resection, subtotal or total colectomy, with or without presence of a stoma or ileoanal pouch - Current or recent (within 3 months before the first dose) gastrointestinal disease, including gastrointestinal surgery, which could impact the absorption of study treatment, or current or recent (within 6 months before the first dose) gastrointestinal resections - Women who are pregnant or breastfeeding Other protocol-defined inclusion/exclusion criteria apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Email Us

Have questions?
Email Us