A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
ClinicalTrials.gov Identifier: NCT05653219
Novartis Reference Number: CVAY736Q12301
Last Update: Mar 23, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
Key Inclusion criteria
Male or female patients aged 18 years and older on the day of signing the informed consent.
A signed informed consent must be obtained prior to participation in the study.
A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
Platelet count <30 G/L and assessed need for treatment (per physician's discretion).
Key Exclusion criteria
ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia
Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
Patients with current or history of life-threatening bleeding
Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive
Patients with known active or uncontrolled infection requiring systemic treatment during screening period
Patients with hepatic impairment
Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication
Female patients who are pregnant or nursing
Other protocol-defined inclusion/exclusion criteria may apply.