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A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus - IM034-1000
Actualizada: 23 agosto, 2023 | ClinicalTrials.gov
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Detalles del estudio
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Opciones de tratamiento
Inclusion Criteria: - Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE). - Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring). - Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score). Exclusion criteria: - SLE that is considered by the Investigator to be severe. - Drug-induced CLE and drug-induced SLE. - Women who are pregnant or breastfeeding. - Current use of >10 mg prednisone (or equivalent) per day. Note: 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
