eligibility_summary
Eligible: adults ≥18 with consent, primary ITP refractory/relapsed after first-line steroids ± IVIG, platelets <30 G/L, eltrombopag indicated/no contraindication. Exclude: prior second-line ITP therapy incl splenectomy (TPO-RA ≤1 wk allowed), lab abnormalities, Evans syndrome/other cytopenias, significant hematologic disease, life-threatening bleeding, HIV/HCV/HBV (HBcAb+ allowed under strict criteria), active infection, hepatic impairment, coagulation disorders/anticoagulants (except ≤150 mg ASA), pregnant/nursing. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, randomized, double-blind trial in adults with primary ITP after steroid failure. Interventions: ianalumab (VAY736), an IV anti-BAFF-R monoclonal antibody (biologic) that blocks BAFF signaling and depletes B cells, added to eltrombopag, versus placebo plus eltrombopag. Mechanisms: ianalumab targets BAFF-R on B cells to curb autoreactive B-cell survival and reduce autoantibody production, eltrombopag is an oral small-molecule thrombopoietin receptor (c-MPL) agonist that drives megakaryocyte proliferation and platelet production. Targeted cells/pathways: B cells/BAFF-BAFF-R pathway and megakaryocyte lineage/TPO-R (c-MPL). Primary goal: prolong time to treatment failure.