eligibility_summary
Eligibility: Consent (guardian/assent if <18, re-consent at adulthood), completed SIRIUS-SLE core study CVAY736F12301/12302 through Week 60 without discontinuation, investigator expects benefit. Exclude: prohibited therapies, significant active infections needing IV/IM treatment, planned live vaccines, pregnant/nursing, WOCBP without highly effective contraception to 6 months post, sexually active males unwilling to use barrier protection. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 3, double-blind, placebo-controlled extension in ANA-positive moderate–severe SLE, assessing long-term safety/tolerability of ianalumab (VAY736) given subcutaneously monthly or quarterly vs monthly placebo. Drug/intervention: Ianalumab—fully human (afucosylated) IgG1 monoclonal antibody targeting the BAFF receptor (BAFF‑R/BR3/TNFRSF13C), type: biologic mAb. Mechanism of action: Dual—(1) blocks BAFF (BLyS) binding to BAFF‑R, inhibiting B‑cell survival/differentiation signals, (2) depletes BAFF‑R–expressing B cells via enhanced antibody‑dependent cellular cytotoxicity (and phagocytosis). Cells/pathways targeted: BAFF/BLyS–BAFF‑R pathway on B cells, affects naïve and memory B cells and plasmablasts, reducing autoreactive B‑cell activity and autoantibody production relevant to SLE pathogenesis. Comparator: Placebo (s.c. monthly).