A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids (VAYHIT2)
Primary Immune Thrombocytopenia
About this trial
This is an interventional treatment trial for Primary Immune Thrombocytopenia focused on measuring Primary immune thrombocytopenia (ITP),, ianalumab, VAY736, B-cell depletion, B-cell Activating Factor Receptor (BAFF-R) blockade, eltrombopag
Eligibility Criteria
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.
Sites / Locations
- Hematology Oncology Association of RocklandRecruiting
- Community Cancer Trials of UtahRecruiting
- Novartis Investigative SiteRecruiting
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Treatment arm 1
Treatment arm 2
Treatment arm 3
Participants will receive eltrombopag and ianalumab lower dose
Participants will receive eltrombopag and ianalumab higher dose
Participants will receive eltrombopag and placebo