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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT03934216

Run by

Bristol-Myers Squibb

People needed

131

Starts

2019-07-01

Expected to finish

2023-04-04

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Local Institution - 0048 — New Port Richey, Florida, United States
• Local Institution - 0044 — Sweetwater, Florida, United States
• Local Institution - 0011 — Suwanee, Georgia, United States
• Local Institution - 0121 — Glenview, Illinois, United States
• Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge — Baton Rouge, Louisiana, United States
• Local Institution - 0018 — Shreveport, Louisiana, United States
• Local Institution - 0047 — Chevy Chase, Maryland, United States
• Infusion Associates — Grand Rapids, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Local Institution - 0002 — Las Vegas, Nevada, United States
• Local Institution - 0049 — Lake Success, New York, United States
• New York University Langone Medical Center — New York, New York, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Local Institution - 0074 — Charleston, South Carolina, United States
• Rapid City Medical Center — Rapid City, South Dakota, United States
• Gastro One — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Local Institution - 0097 — Garland, Texas, United States
• Local Institution - 0008 — Houston, Texas, United States
• Gastroenterology Research of San Antonio — San Antonio, Texas, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States

Full record on ClinicalTrials.gov

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