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 - IM011-054
Updated: 26 September, 2024 | ClinicalTrials.gov
Phase
Gender(s)
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Active, Not Recruiting
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.
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