CVAY736Q12201 VAY736 in 3rd therapy in pts with primary immune thrombocytopenia (ITP)
Research type
Research Study
Full title
A phase 2 study to evaluate the efficacy and safety of ianalumab (VAY736) in patients with primary immune thrombocytopenia (ITP) previously treated with at least a corticosteroid and a thrombopoietin receptor agonist (TPO-RA)
IRAS ID
1006939
Contact name
Severine BERARD
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
This is a study looking to better understand how effective and safe a new treatment called ianalumab is for treating patients with primary ITP, who have been previously treated with at least one corticosteroid and one TPO-RA (standard treatments available in the UK for patients with ITP). We will assess this by measuring how many patients achieve and maintain an increase in platelet count >50g/L (efficacy) and by recording all side effects experienced by patients and if any of these side effects result in discontinuation of ianalumab, either due to the patients decisions or at the discretion of the study doctor (safety).
It is an open label, single arm study, meaning every patient will receive ianalumab at the same dose. We are aiming to enrol 40 patients across the world with ITP onto this study. All patients will receive 4 infusions of ianalumab, once every 4 weeks. After this participants will go into the follow-up phase of the study, where they will not receive any more doses of ianalumab but will be monitored for their treatment response (primarily platelet counts) and any further side effects they might experience. These follow-up will continue until all patients on study have completed 24 months of follow-up visits or until the patient loses response (platelet count <30g/L) or the patient decides to withdraw from the study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0162
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion