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

• Status: Not yet recruiting
• Trial end date: 2028-02-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion criteria

1. Male or female patients aged 18 years and older on the day of signing the informed consent.

2. A signed informed consent must be obtained prior to participation in the study.

3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.

4. Platelet count <30 G/L and assessed need for treatment (per physician's discretion).

Key Exclusion criteria

1. 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.

2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia

3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters

4. Patients with current or history of life-threatening bleeding

5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive

6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period

7. Patients with hepatic impairment

8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication

9. Female patients who are pregnant or nursing

Other protocol-defined inclusion/exclusion criteria may apply.