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

• Status: Recruiting
• Trial end date: 2024-07-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Apremilast; BMS-986165

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

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