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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Apremilast; Drug: Deucravacitinib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04908189

IM011-055

U1111-1259-9466 (Registry Identifier)

2020-005099-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 729 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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729 participants in 3 patient groups, including a placebo group

Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Drug: Deucravacitinib

Apremilast

Other group

Treatment:

Drug: Apremilast