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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    Page 1 of 46 (183 locations)

    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