Active, Not Recruiting
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus - IM026-027
Actualizada:
7 febrero, 2023
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ClinicalTrials.gov
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Detalles del estudio
Fase
Géneros
Rango de edad
Active, Not Recruiting
Opciones de tratamiento
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) ii) Biopsy-proven cutaneous lupus erythematosus (CLE) - Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 - Active cutaneous lupus skin lesion(s) amenable to biopsy - Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Diagnosis of discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) without SLE. - Active severe or unstable neuropsychiatric SLE - Active, severe Lupus Nephritis (LN) - Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains 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