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 Nonbiologic Lupus Standard of Care
The primary objective of this study is to demonstrate efficacy of BIIB059 compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.
Why this Research Matters
This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus
Who can Participate
Participant must be 18 years or older. Participant must be diagnosed with SLE at least 24 weeks prior to screening. Participant must be treated with either stand-alone antimalarial treatment, antimalarial treatment in combination with OCS and/or immunos Key Inclusion Criteria: Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by
Study ID
Protocol Number: 22-0670
More information available at ClinicalTrials.gov: NCT05352919
Meet the Team
Christopher Striebich, MD, PhD
Principal Investigator