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Clinical Trials in the UK / NCT04908189
Active, not recruiting Phase 3

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)

Deucravacitinib →PlaceboApremilast →

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
No
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)

FacilityCityRegionStatus
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 Active, not 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