drugset / Trial / 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)

NCT07421167

Phase 2 Recruiting 164 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-06-29
Primary completion
2028-04-01
Completion
2030-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody 9 mg/kg
Background Avatrombopag Small molecule
Background Eltrombopag Small molecule
Background Romiplostim Peptide

Indications