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A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) - IM026-024

Actualizada: 19 mayo, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 2

    Fase

  • Géneros

  • 18-70

    Rango de edad

  • 18

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: BMS-986256: Dose 1
Drug: BMS-986256 (Oral)
Experimental: BMS-986256: Dose 2
Drug: BMS-986256 (Oral)
Experimental: BMS-986256: Dose 3
Drug: BMS-986256 (Oral)
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: - Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria ≥ 12 weeks before the screening visit - Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody. - Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash Exclusion Criteria: - Active severe lupus nephritis (LN) as assessed by the investigator - Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI - Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE - Antiphospholipid Syndrome 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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Llame 855-907-3286 o Envíenos un correo electrónico