A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Completed · Phase 2

Conditions studied: Crohn Disease, Ulcerative Colitis

In brief

The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.

Key facts

Study ID

NCT04877990

Run by

Bristol-Myers Squibb

People needed

67

Starts

2021-05-07

Expected to finish

2023-08-29

Last updated by the study team

2024-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies

You may not qualify if…

• Women who are pregnant or breastfeeding
• Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0036 — Shreveport, Louisiana, United States
• Local Institution - 0002 — Wyoming, Michigan, United States
• Local Institution - 0037 — Jackson, Mississippi, United States
• Local Institution - 0041 — Cleveland, Ohio, United States
• Local Institution - 0038 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0066 — Charleston, South Carolina, United States
• Local Institution - 0053 — Garland, Texas, United States
• Local Institution - 0056 — San Antonio, Texas, United States
• Local Institution - 0049 — Tyler, Texas, United States
• Local Institution - 0055 — Richmond, Virginia, United States
• Local Institution - 0013 — Ballarat, Victoria, Australia
• Local Institution - 0050 — Vaughan, Ontario, Canada
• Local Institution - 0030 — Guangzhou, Guangdong, China
• Local Institution - 0029 — Guangzhou, Guangdong, China
• Local Institution - 0012 — Kiel, Germany
• Local Institution - 0062 — Budapest, Hungary
• Local Institution - 0023 — Budapest, Hungary
• Humanitas — Rozzano, Lombardy, Italy
• Fondazione Irccs - Policlinico San Matteo — Pavia, Italy
• Local Institution - 0063 — Hirosaki, Aomori, Japan
• Local Institution - 0047 — Sagamihara, Kanagawa, Japan
• Local Institution - 0027 — Saga, Saga-ken, Japan
• Local Institution - 0026 — Bunkyo-ku, Tokyo, Japan
• Local Institution - 0044 — Minato-ku, Tokyo, Japan
• Local Institution - 0060 — Amsterdam, North Holland, Netherlands

Full record on ClinicalTrials.gov

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