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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT04908202

Run by

Bristol-Myers Squibb

People needed

670

Starts

2021-07-13

Expected to finish

2027-06-10

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0188 — Jonesboro, Arkansas, United States
• Local Institution - 0168 — Fontana, California, United States
• Local Institution - 0199 — Fullerton, California, United States
• Local Institution - 0038 — Sacramento, California, United States
• Cohen Medical Centers — Thousand Oaks, California, United States
• Local Institution - 0170 — Denver, Colorado, United States
• Local Institution - 0195 — Clearwater, Florida, United States
• Local Institution - 0272 — Margate, Florida, United States
• Local Institution - 0082 — Miami Lakes, Florida, United States
• Local Institution - 0171 — Gainesville, Georgia, United States
• Local Institution - 0087 — Boise, Idaho, United States
• Local Institution - 0080 — Chicago, Illinois, United States
• Local Institution - 0177 — Orland Park, Illinois, United States
• Local Institution - 0178 — Schaumburg, Illinois, United States
• Local Institution - 0083 — Lexington, Kentucky, United States
• Local Institution - 0042 — Hagerstown, Maryland, United States
• Local Institution - 0198 — Detroit, Michigan, United States
• Local Institution - 0201 — Springfield, Missouri, United States
• Local Institution - 0268 — Kalispell, Montana, United States
• Local Institution - 0186 — Voorhees Township, New Jersey, United States
• University Hospitals Cleveland Medical Center-Dermatology — Cleveland, Ohio, United States
• Local Institution - 0028 — Middleburg Heights, Ohio, United States
• Local Institution - 0179 — Perrysburg, Ohio, United States
• Local Institution - 0182 — Oklahoma City, Oklahoma, United States
• Local Institution - 0197 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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