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

Launched by NOVARTIS PHARMACEUTICALS · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called ianalumab, used alongside another drug called eltrombopag, for adults with a condition known as primary immune thrombocytopenia (ITP). This study is specifically for people who have not responded well to steroid treatments in the past. Researchers are looking to see if ianalumab can help increase the time before treatment needs to change, which is important for managing this condition.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of primary ITP, with a platelet count below a certain level. Participants should not have received other treatments for ITP, such as splenectomy (surgery to remove the spleen), and must not have any serious infections or liver issues. Those who join the study will receive either ianalumab or a placebo (a non-active substance) in addition to eltrombopag, and the trial is currently recruiting participants. It’s important for potential participants to discuss with their doctors to see if they qualify and to understand what being part of the trial would involve.

Gender

ALL

Eligibility 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. Patient with platelet count \<30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag
• • 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, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
• • 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. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
• • 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 with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
• • 9. Nursing (breast feeding) or pregnant women
• • Other protocol-defined inclusion/exclusion criteria may apply.