A Study to Evaluate the Safety and Effectiveness of BMS-986165 in Subjects with Moderate-to-Severe Ulcerative Colitis (UC)

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of BMS-986165 in ulcerative colitis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Documented diagnosis of UC at least 12 weeks prior to screening.
Active UC with an an adapted Mayo score of 5 to 9 points, endoscopic subscore of ≥ 2.
Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, 5-aminosalicylic acids (ASAs), corticosteroids, immunosuppressants, anti-tumor necrosis factor (TNF)-α agents, integrin inhibitor.

Exclusion Criteria:

Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, pseudomembranous colitis.
Current 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Edward Loftus, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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