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
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 efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheu...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
- Meets the Classification Criteria for Psoriatic Arthritis 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.
- ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
- Must have completed the week 52 treatment for the optional open-label long-term extension period.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2027
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT04908202
Start Date
July 13 2021
End Date
June 10 2027
Last Update
October 24 2025
Active Locations (183)
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1
Local Institution - 0197
Gilbert, Arizona, United States, 85297
2
Local Institution - 0188
Jonesboro, Arkansas, United States, 72401
3
Local Institution - 0168
Fontana, California, United States, 92335
4
Local Institution - 0199
Fullerton, California, United States, 92835