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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
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-rheumatic drugs. The long term extension period will provide
additional long-term efficacy and safety information.
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.
Additional Information *
Other protocol-defined Inclusion/Exclusion criteria apply.
Treatment Options
Study Arms
ASSIGNED INTERVENTION
Study Arms
Experimental: Deucravacitinib
ASSIGNED INTERVENTION
Drug: Deucravacitinib
Study Arms
Placebo Comparator: Placebo
ASSIGNED INTERVENTION
Other: Placebo
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