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.

Study Description

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.

Condition

Primary Immune Thrombocytopenia

Phase

Phase 3

Overall status

Recruiting

Start date

Feb 02, 2023

Completion date

Mar 15, 2028

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Biological

Ianalumab

Concentrate for solution for infusion for intravenous use

Drug

Eltrombopag

Film-coated tablet for oral use

Drug

Placebo

Concentrate for solution for infusion for intravenous use.

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.