Site for A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Non-Biologic Lupus Standard of Care

Brief description of study

Site for This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to evaluate the efficacy and safety of BIIB059 in participants = 18 years of age with active SLE, including joint and/or skin manifestations, who are receiving background nonbiologic lupus SOC therapy. The study will be conducted at approximately 135 sites globally. Approximately 540 participants will be randomized 1:1:1 to receive BIIB059 450 mg, BIIB059 225 mg, or placebo SC Q4W, with an additional dose at Week 2, as add-on to background nonbiologic lupus SOC therapy. The study includes a screening period of up to 4 weeks; a double-blind, placebo-controlled treatment period of 52 weeks; and an SFU period (off-treatment) of 24 weeks. Details of these different study periods are given below.


Clinical Study Identifier: s21-00354
ClinicalTrials.gov Identifier: NCT04895241
Principal Investigator: David H. Goddard.


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