Phase 3 Trial: Anifrolumab Shows Promise in SLE with BICLA Response as Primary Outcome

Status: ACTIVE_NOT_RECRUITING | Phase: PHASE3 Condition(s): Systemic Lupus Erythematosus Intervention(s): Medi-546 (DRUG), Placebo (DRUG) The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy Detailed: This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age. Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the Primary Outcome(s): British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response Enrollment: 367 (ACTUAL) Lead Sponsor: AstraZeneca Start: 2021-06-08 | Primary Completion: 2025-08-22