Lupus Eritematoso CutáneoEstado: No Reclutando Aún
A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
Principales Criterios de Inclusión:
- This is a 2-part seamless, randomized, double-blind, placebo-controlled, multicenter, Phase 2/3 study designed to evaluate the efficacy and safety of BIIB059 for the treatment of participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.
- The study includes a Part A (Phase 2) and a Part B (Phase 3 registrational).
- Part A (Phase 2) is intended to confirm the adequacy of the performance of the CLA-IGA-R instrument to be implemented as a primary endpoint in the Phase 3 portion of the study in the US.
- Part B (Phase 3) is a registrational study intended to show efficacy and safety of BIIB059 compared to placebo in CLE participants
- Both Part A and Part B consist of a 24-week DBPC (Double Blind Placebo Controlled) followed by a 28-week ETP (Extended Treatment Period) during which all participants will receive BIIB059
- The total treatment duration of 52 weeks
- Both Part A and Part B will be followed by a long-term extension (LTE) study under a separate protocol.
- The LTE study will evaluate the long-term safety profile of BIIB059 in the treatment of CLE.
- Participants who discontinue the study or study medication, or choose to not participate in the LTE, will enter a 24-week SFU period
- Área Terapéutica:Reumatología
- Fase del estudio:II/III
- Código de Estudio:230LE301
- Biomedica Research Group
- Centro Internacional de Estudios Clínicos
- Clínica Dermacross
- Oncocentro APYS
- Clinical Research Chile SpA
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