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Recruiting

A Study to Evaluate Efficacy and Safety of BMS-986165 in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) - IM011-132

Actualizada: 29 septiembre, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 2

    Fase

  • Géneros

  • 18-75

    Rango de edad

  • 30

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Active Treatment: BMS-986165 Dose 1
Drug: BMS-986165
Experimental: Active Treatment: BMS-986165 Dose 2
Drug: BMS-986165
Placebo Comparator: Placebo
Drug: Placebo

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit - Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol - Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant Exclusion Criteria: - Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period - Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains - Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE) - Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit - History of 3 or more unexplained consecutive pregnancy losses - Active severe or unstable neuropsychiatric SLE - Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity 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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