Status:
COMPLETED
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 sever...
Eligibility Criteria
Inclusion
- • Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
Exclusion
- 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
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04877990
Start Date
May 7 2021
End Date
August 29 2023
Last Update
September 24 2024
Active Locations (43)
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1
Local Institution - 0036
Shreveport, Louisiana, United States, 71105
2
Local Institution - 0002
Wyoming, Michigan, United States, 49519
3
Local Institution - 0037
Jackson, Mississippi, United States, 39216
4
Local Institution - 0041
Cleveland, Ohio, United States, 44195