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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis; Crohn Disease

Treatments: Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04877990

U1111-1258-3838 (Registry Identifier)

IM011-077

2020-004461-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

67 participants in 1 patient group

Long-Term Extension Rollover Study: Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib