Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: BMS-986165

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03934216

2018-004694-27 (EudraCT Number)

IM011-024

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Enrollment

131 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
Must have 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

Exclusion Criteria:

Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
Stool positive for C. difficile toxin at screening visit
Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

Other protocol-defined inclusion/exclusion criteria apply