Psoriatic Arthritis
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Psoriatic Arthritis
IM011-054 Enrolling

Research Trial for Psoriatic Arthritis (60 Weeks)


Treatment: Oral Age: 18 Years

Adults aged 18 and over diagnosed to have Psoriatic Arthritis (PsA) for at least 3 months in duration, may be eligible for this study. Individuals must have active plaque psoriatic skin lesion(s) or a documented medical history of plaque psoriasis at screening, along with active arthritis as shown by 3 or more swollen joints and 3 or more tender joints.

Participants will receive investigational oral medication (active study drug) or placebo, during the placebo-controlled period. All participants will then receive active study drug during the active study treatment period. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 60 weeks and involve about 15 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov ID

NCT04908202

Sponsor

Bristol-Myers Squibb

Study Description

  • Brief 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.

  • Condition or Disease:

    Psoriatic Arthritis

  • Intervention/Treatment:

    Drug: Deucravacitinib
    Other: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Lynda Spelman

Dermatologist

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Learn More About

Psoriatic Arthritis

Psoriatic arthritis is a type of arthritis associated with the skin condition psoriasis. Psoriasis lesions usually appear as dry, red, scaly patches and may occur anywhere on the body. Arthritis causes swelling, pain, stiffness, and tenderness of the joints. Psoriatic arthritis is a persistent condition characterized by inflammation of the skin (psoriasis) and joints (arthritis). Learn More
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