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

• Status: Recruiting
• Trial end date: 2024-07-11
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: 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

• ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading

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