Clinical Research Studies

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). The study comprises a 24-week DBPC treatment period followed by a 28-week ETP; the total treatment duration of 52 weeks. Participants who successfully complete the 52-week treatment period will be offered the opportunity to participate in an LTE study under a separate protocol. The LTE study will evaluate the long-term safety profile of BIIB059 in the treatment of CLE. Participants will be randomly assigned in a 2:1 ratio to receive either BIIB059 or placebo SC Q4W, respectively, from Week 0 to Week 20, with an additional loading dose at Week 2 during the DBPC period. During the ETP, all participants will receive BIIB059 from Week 24 to Week 48. At Week 26, participants will receive a loading dose where all participants who were randomly assigned to BIIB059 during the DBPC period will receive the placebo and all participants who were randomly assigned to placebo during the DBPC period will receive BIIB059.