Active, Not Recruiting

Trial ID IM011-055 | NCT04908189

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

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About This Trial
Key Eligibility Criteria

Summary

Phase 3
18+

Age Range
Active, Not Recruiting

Overview

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.

Key Eligibility Criteria

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

Additional Information *

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Other: Apremilast

ASSIGNED INTERVENTION

Drug: Apremilast

Study Arms

Experimental: Deucravacitinib

ASSIGNED INTERVENTION

Drug: Deucravacitinib

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION

Drug: Deucravacitinib
Other: Placebo

Trial ID IM011-055 | NCT04908189

Summary

Overview

Key Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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