Last updated 9 days ago

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

150 patients around the world

Available in Spain, Argentina, United States

This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count <30 G/L) who failed previous first-line treatment with corticosteroids. After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.

Novartis Pharmaceuticals

150Patients around the world

This study is for people with

Thrombocytopenia

Primary immune thrombocytopenia

Requirements for the patient

To 100 Years

All Gender

Medical requirements

: 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.
Patient with platelet count <30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag

: 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 low grade anemia related to bleeding or iron deficiency are eligible).
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. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
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 with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
Female patients who are pregnant or nursing

StudyVAYHIT2

SponsorNovartis Pharmaceuticals

Conditions

Primary immune thrombocytopenia

Requirements

To 100 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05653219