A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

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 criteriaMale 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 criteriaITP 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 cytopeniaPatients with history of clinically significant hematological disorders, or with marked altered hematologic parametersPatients with current or history of life-threatening bleedingPatient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positivePatients with known active or uncontrolled infection requiring systemic treatment during screening periodPatients with hepatic impairmentPatients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medicationFemale patients who are pregnant or nursingOther protocol-defined inclusion/exclusion criteria may apply.