NCT07421167

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)

A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include an exploratory cohort of participants with primary Evans syndrome (ES) for whom IC TPO-RA therapy is appropriate per investigator's assessment. The study will consist of a 28-day screening period; a 16-week treatment period; an IC TPO-RA tapering period during which all participants will be monitored for 16 weeks. All participants will then continue to be followed for another 60-weeks (15 months) of long-term safety follow-up period.

Conditions

• Primary Immune Thrombocytopenia (ITP)
• Primary Evans Syndrome (ES)

Interventions

Type	Name	Description
BIOLOGICAL	ianalumab	9 mg per kilogram infusion every 4 weeks (Q4W) for 16 weeks
DRUG	thrombopoietin receptor agonist (TPO-RA)	IC TPO-RAs will be administered according to the respective United States Prescribing Information (USPIs)

Timeline

• Start date: 2026-06-30
• Primary completion: 2028-06-09
• Completion: 2030-03-13
• First posted: 2026-02-19
• Last updated: 2026-04-02

Regulatory

• FDA-regulated drug study