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Recruiting

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 - IM011-054

Actualizada: 29 septiembre, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 55

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Deucravacitinib
Drug: Deucravacitinib
Placebo Comparator: Placebo
Other: Placebo

Criterios clave de elegibilidad

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

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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