Study of Ianalumab With Thrombopoietin Receptor Agonist in Adults With Primary Immune Thrombocytopenia or Evans Syndrome

What this Trial Is About

Researchers are studying the tolerability of ianalumab combined with an investigators choice thrombopoietin receptor agonist IC TPO-RA in adults diagnosed with primary immune thrombocytopenia ITP who have been treated with one to four prior therapies. The study also includes an exploratory group with primary Evans syndrome ES who are appropriate candidates for IC TPO-RA therapy. This phase 2 trial aims to evaluate treatment tolerability and safety in these patient populations. Participants will receive ianalumab at a dose of 9 mg per kilogram via infusion every four weeks for 16 weeks alongside their IC TPO-RA treatment, which is administered according to usual prescribing guidelines. The study consists of a 28-day screening period followed by a 16-week treatment phase. After treatment, there is an IC TPO-RA tapering period with monitoring for 16 weeks, and all participants will then enter a 60-week long-term safety follow-up. During the study, participants will undergo regular assessments including platelet counts and monitoring for adverse events. Researchers will measure the percentage of participants who tolerate the treatment up to week 16 and evaluate platelet responses and adverse event rates over the course of the study. Participants are followed for an average of four years to assess safety and treatment effects, with ongoing monitoring during tapering and long-term follow-up periods.

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)