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

Part of paid clinical trials in Shreveport, Louisiana.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04877990
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
May 7, 2021
Status verified
Aug 2024
Primary completion
Aug 29, 2023
Completion
Aug 29, 2023

Study Design

Enrollment
67 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Long-Term Extension Rollover Study: Deucravacitinib

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: From first dose to 30 days post last dose (Up to 110 weeks) ]

Locations (10)

FacilityCityStateZIPSite coordinators
Local Institution - 0036ShreveportLouisiana71105-
Local Institution - 0002WyomingMichigan49519-
Local Institution - 0037JacksonMississippi39216-
Local Institution - 0041ClevelandOhio44195-
Local Institution - 0038PittsburghPennsylvania15213-
Local Institution - 0066CharlestonSouth Carolina29425-
Local Institution - 0053GarlandTexas75044-
Local Institution - 0056San AntonioTexas78229-
Local Institution - 0049TylerTexas75701-
Local Institution - 0055RichmondVirginia23249-

Find similar trials in Shreveport, LA

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Local Institution - 0036· Shreveport, LALocal Institution - 0002· Wyoming, MILocal Institution - 0037· Jackson, MSLocal Institution - 0041· Cleveland, OHLocal Institution - 0038· Pittsburgh, PALocal Institution - 0066· Charleston, SC

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