Clinical Trial

Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

Study acronym: VAY RE-HIT
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).
Protocol Amendment History 4 changes
notable Trial sites expanded: 22 -> 25 locations 2026-07-19
notable Trial sites expanded: 18 -> 22 locations 2026-06-09
notable Trial sites expanded: 14 -> 18 locations 2026-05-27
notable Trial sites expanded: 10 -> 14 locations 2026-04-14
Trial Details
NCT Number NCT07039422
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Enrollment 60 participants
Start Date 2026-06-26
Primary Completion 2030-08-30 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17