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Klinische Studien von BMS suchen
BMS-Symbol für "Aktive Studie, für die noch nicht rekrutiert wird"

Active, Not Recruiting

Studien-Nr. IM011-054  |   NCT04908202

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

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Zusammenfassung

  • Phase 3
  • Symbol für männliches und weibliches Geschlecht
  • 18+
    Altersgruppe
  • BMS-Symbol für "Aktive Studie, für die noch nicht rekrutiert wird"
    Active, Not Recruiting

Überblick

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.

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Wichtigste Einschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 - ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading 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

Behandlungsmöglichkeiten

Studienarme

ZUGEWIESENE BEHANDLUNG

Studienarme

Experimental: Deucravacitinib

ZUGEWIESENE BEHANDLUNG
  • Drug: Deucravacitinib

Studienarme

Placebo Comparator: Placebo

ZUGEWIESENE BEHANDLUNG
  • Other: Placebo

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