Status:
ACTIVE_NOT_RECRUITING
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirhe...
Eligibility Criteria
Inclusion
- Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
- Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
- Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening
- Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and Day 1
- Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
- Must have completed the week 52 treatment for the optional open-label long-term extension period
Exclusion
- Nonplaque psoriasis at Screening or Day 1
- Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
- History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
- Active fibromyalgia
- Received an approved or investigational biologic therapy for the treatment of PsA or PsO
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2026
Estimated Enrollment :
729 Patients enrolled
Trial Details
Trial ID
NCT04908189
Start Date
July 15 2021
End Date
November 12 2026
Last Update
June 13 2025
Active Locations (138)
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1
Local Institution - 0149
Mountain Brook, Alabama, United States, 35223
2
Local Institution - 0212
Sacramento, California, United States, 95815
3
Local Institution - 0188
Whittier, California, United States, 90602
4
Local Institution - 0192
Skokie, Illinois, United States, 60076