eligibility_summary
Consent required. Adults (≥18) with confirmed primary ITP, prior corticosteroid (±IVIG) and TPO‑RA, prior transient response to IVIG/anti‑D or steroids, last/current treatment failure or intolerance, platelets <30 G/L needing treatment (if on ITP meds, stable ≥14 days). Exclude secondary thrombocytopenia, recent transfusion/plasmapheresis/rescue (<14 d), neutrophils <1000/mm3, IgG <5 g/L, B‑cell depleters/anti‑BAFF within 12 w, other immunosuppressants within 5 half‑lives or 14 d, prior splenectomy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ianalumab (VAY736) — a biological, fully human IgG1 monoclonal antibody given IV. Mechanism of action: binds and blocks BAFF receptor (BAFF‑R/TNFRSF13C) on B cells, inhibiting BAFF-mediated survival signaling and inducing B‑cell depletion via ADCC (and potentially complement), thereby reducing pathogenic autoantibody production. Cells/pathways targeted: BAFF/BAFF‑R pathway on transitional and mature B lymphocytes, downstream effect is reduction of autoreactive B cells and autoantibodies implicated in platelet destruction in primary ITP.