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

  • STATUS
    Recruiting
  • End date
    May 12, 2027
  • participants needed
    650
  • sponsor
    Bristol-Myers Squibb
Updated on 7 April 2023
skin lesion
psoriasis
x-rays
arthritis
anti-rheumatic drugs
high sensitivity
plaque psoriasis
biological drug

Summary

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.

Details
Condition Psoriatic Arthritis
Treatment Placebo, Deucravacitinib
Clinical Study IdentifierNCT04908202
SponsorBristol-Myers Squibb
Last Modified on7 April 2023

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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