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
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Psoriatic Arthritis
Age (in years)
18+
Phase
Phase 3
Participants needed
650
Est. Completion Date
May 12, 2027
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04908202
Study number
IM011054
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