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

ID#: NCT04908189

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: July 15, 2021

End Date: July 09, 2026

Contact Information:
BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
First line of email MUST contain NCT # and site #.
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:

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