eligibility_summary
Inclusion: SLE per 2019 EULAR/ACR ≥6 mo, age ≥12 (≥18 if required), ≥35 kg, ANA ≥1:80, on CS/antimalarial/DMARD, SLEDAI‑2K ≥6 (excl. fever/headache/alopecia/OBS), BILAG A≥1 or B≥2. Exclusion: prior ianalumab, recent prohibited IS/biologics/B‑cell depleters/cyclophosphamide/TCM, active infection incl. HBV/HCV/TB/HIV, severe organ dysfunction or lupus nephritis, Plt<25k, Hgb<8/7, ANC<0.8k, recent live vaccine, uncontrolled disease, non‑lupus CS, malignancy (except BCC/in situ cervix), pregnancy/breastfeeding, inadequate contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 3, randomized, double-blind, placebo-controlled study in active SLE. Intervention: Ianalumab (VAY736), a biologic monoclonal antibody (IgG1) given monthly subcutaneously on top of standard-of-care (e.g., corticosteroids, antimalarials, DMARDs) vs placebo. Mechanism of action: Ianalumab binds the BAFF receptor (BAFF‑R/TNFRSF13C) on B cells, blocking BAFF (BLyS) survival/activation signaling and inducing B‑cell depletion via immune effector functions (e.g., ADCC). Cells/pathways targeted: B cells (naive and memory, impacts plasmablast/plasma cell generation), the BAFF/BLyS–BAFF‑R axis, leading to reduced B‑cell activation, survival, differentiation, and autoantibody (e.g., ANA) production implicated in SLE pathogenesis.