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

NCT04908189 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2021-07-15

Last updated

2026-09-11

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

DeucravacitinibPlaceboApremilast

Deucravacitinib: Specified dose on specified days

Placebo: Specified dose on specified days

Apremilast: Specified dose on specified days

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 — Week 16
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Trial sites (138)

Facility	City	Region
Local Institution - 0149	Mountain Brook	Alabama
Local Institution - 0212	Sacramento	California
Local Institution - 0188	Whittier	California
Local Institution - 0192	Skokie	Illinois
Local Institution - 0203	Hopkinsville	Kentucky
Local Institution - 0195	Baton Rouge	Louisiana
Local Institution - 0169	Cumberland	Maryland
Local Institution - 0034	Okemos	Michigan
Local Institution - 0133	Eagan	Minnesota
Local Institution - 0109	Hattiesburg	Mississippi
Local Institution - 0108	New York	New York
Local Institution - 0186	Rochester	New York
Local Institution - 0196	Charlotte	North Carolina
Local Institution - 0180	Cleveland	Ohio
Local Institution - 0189	Oklahoma City	Oklahoma
Local Institution - 0147	Portland	Oregon
Local Institution - 0016	Duncansville	Pennsylvania
Local Institution - 0182	Summerville	South Carolina
Local Institution - 0167	Lubbock	Texas
Local Institution - 0070	Mesquite	Texas
Local Institution - 0184	Plano	Texas
Local Institution - 0187	Seattle	Washington
Local Institution - 0190	Franklin	Wisconsin
Local Institution - 0175	Milwaukee	Wisconsin
Local Institution - 0048	La Plata	Buenos Aires
Local Institution - 0038	San Isidro	Buenos Aires
Local Institution - 0039	CABA	Distrito Federal
Local Institution - 0171	San Miguel de Tucumán	Tucumán Province
Local Institution - 0200	Buenos Aires	Argentina
Local Institution - 0003	Botany	New South Wales
Local Institution - 0018	Parramatta	New South Wales
Local Institution - 0004	Maroochydore	Queensland
Local Institution - 0099	Woodville	South Australia
Local Institution - 0002	Camberwell	Victoria
Local Institution - 0017	Geelong	Victoria
Local Institution - 0078	Brussels	Belgium
Local Institution - 0058	Ghent	Belgium
Local Institution - 0061	Liège	Belgium
Local Institution - 0111	Vancouver	British Columbia
Local Institution - 0006	Hamilton	Ontario

+ 98 more sites — see the full list on the official registry below.

On this site

📄 Otezla (apremilast) drug profile →

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Other trials for the same condition

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy 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 Active, not recruiting

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04908189 on ClinicalTrials.gov ↗ ← All trials in the UK