Health Condition 1: D694- Other primary thrombocytopenia
Conditions
Interventions
Intervention1: ianalumab: 3 mg/kg and 9 mg/kg intravenously given every 4 weeks for 16 weeks
Intervention2: placebo: intravenously given every 4 weeks for 16 weeks
Control Intervention1: Eltrombopag:
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1a. Male or female patients aged 18 years and older on the day of signing the informed consent. 2a. A signed informed consent must be obtained prior to participation in the study. 3a. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG. 4. Platelet count
Exclusion criteria
Exclusion criteria: 1. ITP patients who received second-line ITP treatments (other than corticosteroid 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 anti-platelet or anticoagulant medication 9. Female patients who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure (TTF)Timepoint: Time to Treatment Failure (TTF) | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of participants who successfully taper and discontinue eltrombopag in each treatment armTimepoint: at the end of the planned treatment period (end of Week 24);safety profile of ianalumabTimepoint: Frequency of adverse events and other safety parameters;time to and duration of response in each treatment armTimepoint: proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment.;To assess B-cell levels and immunoglobulin (Ig)Timepoint: Time to first occurrence of B-cell recovery, defined as =80% of baseline or =50 cells/µL;To assess ianalumab pharmacokinetics (PK)Timepoint: Ianalumab concentration in serum and PK parameters after the first and last dose in a subset of participants;To assess the immunogenicity of ianalumabTimepoint: Incidence and titer of anti-ianalumab antibodies in serum (anti-drug- antibodies (ADA) assay) over time;To assess the need for rescue treatments in each treatment groupTimepoint: Number and proportion of participants receiving rescue treatment;To evaluate treatment effects on ITP-related symptoms, functioning, and health-related quality of life (HRQoL)Timepoint: Change from baseline on total score of the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 Fatigue 13a. Change from baseline in ITP Patient Assessment Questionnaire (PAQ) domain scores of Symptoms, Fatigue, Bother, Activity ;assess the incidence and severity of bleeding in each treatment armTimepoint: Proportion of participants with bleeding events according to World Health Organization (WHO) Bleeding Scale | — |
Countries
Australia, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Singapore, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed