Loading clinical trials...

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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib 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•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (138)

Local Institution - 0149

Mountain Brook, Alabama, United States

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

Key Dates

Start Date

July 15, 2021

Primary Completion Date

February 6, 2024

Completion Date

November 12, 2026

Last Updated

June 13, 2025

Enrollment

729

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

Deucravacitinib

DRUG

Placebo

OTHER

Apremilast

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

View study

RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

View study

RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis