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Trial ID IM011-054  |   NCT04908202

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
    1. Meets the Classification Criteria for Psoriatic Arthritis at Screening.
      1. Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
        1. Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1.
          1. Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
            1. ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
              1. Must have completed the week 52 treatment for the optional open-label long-term extension period.

                Exclusion Criteria

                Exclusion Criteria Icon
                • Nonplaque psoriasis at screening or day 1.
                  1. Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
                    1. History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
                      1. Active fibromyalgia.
                        1. 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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