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Clinical Trials in Taiwan / NCT04908202
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

NCT04908202 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2021-07-13
Last updated
2026-10-16

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

Deucravacitinib →Placebo

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
No
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)

FacilityCityRegionStatus
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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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
An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis Recruiting
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis Active, not recruiting
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis 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 or Had Previously Received TNFα Inhibitor Treatment 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 NCT04908202 on ClinicalTrials.gov ↗ ← All trials in Taiwan