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

NCT04908202 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2021-07-13

Last updated

2026-04-23

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

DeucravacitinibPlacebo

Deucravacitinib: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety 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 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.

Primary outcome measure(s)

Percentage of Participants With ACR 20 Response at Week 16 — Week 16
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Trial sites (183)

Facility	City	Region
Local Institution - 0197	Gilbert	Arizona
Local Institution - 0188	Jonesboro	Arkansas
Local Institution - 0168	Fontana	California
Local Institution - 0199	Fullerton	California
Local Institution - 0038	Sacramento	California
Cohen Medical Centers	Thousand Oaks	California
Local Institution - 0170	Denver	Colorado
Local Institution - 0195	Clearwater	Florida
Local Institution - 0272	Margate	Florida
Local Institution - 0082	Miami Lakes	Florida
Local Institution - 0171	Gainesville	Georgia
Local Institution - 0087	Boise	Idaho
Local Institution - 0080	Chicago	Illinois
Local Institution - 0177	Orland Park	Illinois
Local Institution - 0178	Schaumburg	Illinois
Local Institution - 0083	Lexington	Kentucky
Local Institution - 0042	Hagerstown	Maryland
Local Institution - 0198	Detroit	Michigan
Local Institution - 0201	Springfield	Missouri
Local Institution - 0268	Kalispell	Montana
Local Institution - 0186	Voorhees Township	New Jersey
University Hospitals Cleveland Medical Center-Dermatology	Cleveland	Ohio
Local Institution - 0028	Middleburg Heights	Ohio
Local Institution - 0179	Perrysburg	Ohio
Local Institution - 0182	Oklahoma City	Oklahoma
Local Institution - 0185	Corvallis	Oregon
Local Institution - 0175	Greenville	South Carolina
Local Institution - 0036	Jackson	Tennessee
Local Institution - 0172	Allen	Texas
Local Institution - 0189	Amarillo	Texas
Local Institution - 0032	Dallas	Texas
Local Institution - 0273	Bothell	Washington
Local Institution - 0181	Beckley	West Virginia
Local Institution - 0213	Ciudad Autónoma de Buenos Aires	Buenos Aires
Local Institution - 0054	La Plata	Buenos Aires
Local Institution - 0215	Quilmes	Buenos Aires
Local Institution - 0046	Córdoba	Córdoba Province
Local Institution - 0196	Rosario	Santa Fe Province
Local Institution - 0047	San Miguel de Tucumán	Tucumán Province
Local Institution - 0194	Buenos Aires	Argentina

+ 143 more sites — see the full list on the official registry below.

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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 NCT04908202 on ClinicalTrials.gov ↗ ← All trials in the USA