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

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

Conditions studied: Psoriatic Arthritis

In brief

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Key facts

Study ID

NCT04908189

Run by

Bristol-Myers Squibb

People needed

729

Starts

2021-07-15

Expected to finish

2026-11-12

Last updated by the study team

2025-06-13

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 (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

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 - 0212 — Sacramento, California, United States
• Local Institution - 0188 — Whittier, California, United States
• Local Institution - 0192 — Skokie, Illinois, United States
• Local Institution - 0203 — Hopkinsville, Kentucky, United States
• Local Institution - 0195 — Baton Rouge, Louisiana, United States
• Local Institution - 0169 — Cumberland, Maryland, United States
• Local Institution - 0034 — Okemos, Michigan, United States
• Local Institution - 0133 — Eagan, Minnesota, United States
• Local Institution - 0109 — Hattiesburg, Mississippi, United States
• Local Institution - 0108 — New York, New York, United States
• Local Institution - 0186 — Rochester, New York, United States
• Local Institution - 0196 — Charlotte, North Carolina, United States
• Local Institution - 0180 — Cleveland, Ohio, United States
• Local Institution - 0189 — Oklahoma City, Oklahoma, United States
• Local Institution - 0147 — Portland, Oregon, United States
• Local Institution - 0016 — Duncansville, Pennsylvania, United States
• Local Institution - 0182 — Summerville, South Carolina, United States
• Local Institution - 0167 — Lubbock, Texas, United States
• Local Institution - 0070 — Mesquite, Texas, United States
• Local Institution - 0184 — Plano, Texas, United States
• Local Institution - 0187 — Seattle, Washington, United States
• Local Institution - 0190 — Franklin, Wisconsin, United States
• Local Institution - 0175 — Milwaukee, Wisconsin, United States
• Local Institution - 0048 — La Plata, Buenos Aires, Argentina
• Local Institution - 0149 — Mountain Brook, Alabama, United States

Full record on ClinicalTrials.gov

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