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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 - IM011-055

Updated: 30 October, 2024   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Other: Apremilast
Drug: Apremilast
Experimental: Deucravacitinib
Drug: Deucravacitinib
Placebo Comparator: Placebo
Drug: Deucravacitinib Other: Placebo

Key Eligibility Criteria

Inclusion Criteria: - 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 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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