eligibility_summary
Adults (≥18 in some regions) and adolescents ≥12, ≥35 kg, SLE ≥6 mo (2019 EULAR/ACR), ANA ≥1:80, on CS/antimalarial/DMARDs, SLEDAI-2K ≥6 (excl fever/headache/alopecia/OBS), and BILAG A≥1 organ or B≥2. Exclude prior ianalumab, recent prohibited immunosuppressants/biologics/TCM, active/chronic infections (HBV/HCV/TB/HIV), cytopenias, severe organ/renal disease, recent live vaccine, cancer (except BCC/cervical in situ), pregnancy, inadequate contraception, unsafe comorbidities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, double-blind, placebo-controlled SIRIUS-SLE 1 tests ianalumab (VAY736), a subcutaneous fully human monoclonal antibody against the BAFF receptor (BAFF‑R, TNFRSF13C), given monthly or quarterly on top of standard-of-care in active SLE. Mechanism: antagonizes BAFF/BAFF‑R survival signaling and depletes B cells via ADCC, aiming to curb autoreactive B cells and autoantibody production. Comparator: placebo s.c. monthly plus standard therapy. Target cells/pathways: naïve and mature peripheral B cells expressing BAFF‑R, BAFF-driven B‑cell maturation and survival with downstream NF‑κB signaling central to humoral autoimmunity in SLE.