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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Deucravacitinib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04908202

2020-005097-10 (EudraCT Number)

U1111-1259-9443 (Registry Identifier)

IM011-054

Details and patient eligibility

About

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. The long term extension period will provide additional long-term efficacy and safety information.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
• Meets the Classification Criteria for Psoriatic Arthritis 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.
• 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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650 participants in 2 patient groups, including a placebo group

Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo

Placebo Comparator group

Treatment:

Other: Placebo