Clinical Trial

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)

Study acronym: VAY2EXPLORE
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.
Protocol Amendment History 11 changes
notable Primary completion moved earlier: 2029-01-10 -> 2028-04-01 2026-07-03
minor Completion moved earlier: 2030-09-18 -> 2030-08-08 2026-07-03
notable Primary completion pushed: 2027-03-03 -> 2029-01-10 2026-06-12
minor Completion pushed: 2027-03-31 -> 2030-09-18 2026-06-12
notable Primary completion moved earlier: 2028-12-26 -> 2027-03-03 2026-05-09
minor Completion moved earlier: 2030-09-05 -> 2027-03-31 2026-05-09
critical Recruitment opened 2026-05-06
notable Primary completion pushed: 2028-06-09 -> 2028-12-26 2026-05-06
minor Completion pushed: 2030-03-13 -> 2030-09-05 2026-05-06
notable Primary completion moved earlier: 2028-12-26 -> 2028-06-09 2026-04-03
minor Completion moved earlier: 2030-08-08 -> 2030-03-13 2026-04-03
Trial Details
NCT Number NCT07421167
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrollment 164 participants
Start Date 2026-06-29
Primary Completion 2028-04-01 (estimated)
Study Completion 2030-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-14