eligibility_summary
Eligible: adults (≥18) with primary ITP diagnosed ≤3 months before first-line therapy, platelets <30 G/L pre-treatment, and response (≥50 G/L) to corticosteroids ± IVIG (transfusion counts excluded). Exclude: Evans/other cytopenias (except mild anemia), life-threatening bleeding, prior ITP therapy beyond first-line steroids/IVIG (≤28 days), prior B-cell depletion, ANC <1.0 G/L, coagulation disorders or on anticoagulants/antiplatelets (low-dose ASA allowed). Consent required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized, double-blind trial in first-line ITP tests ianalumab (VAY736) vs placebo, each added to corticosteroids. Ianalumab: biological monoclonal antibody (IV) targeting the B-cell activating factor receptor (BAFF-R), it blocks BAFF-R signaling and depletes B cells, aiming to reduce anti-platelet autoantibody production. Corticosteroids: glucocorticoid drugs (oral/IV) that activate the glucocorticoid receptor to broadly suppress immune/inflammatory pathways. Targets: BAFF/BAFF-R pathway on mature B cells leading to B-cell depletion and reduced autoreactive B-cell survival/activation, corticosteroids broadly dampen T cells, B cells, and macrophage/cytokine effector pathways involved in platelet destruction.