Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: VAY736 (ianalumab)
Arm1- 3 mg/kg
Arm2- 9 mg/kg
: 150 mg/1 mL, Intravenous administration, will be administered every 4 weeks as 2-hour (+/- 15 minutes) intravenous (i.v.) infusion (4 doses in total) in addition to fi
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Signed informed consent prior to participation in the study. Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG) Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG) Response (platelet count less than or equal to 50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization.
Exclusion criteria
Exclusion criteria: Evans syndrome or any other cytopenia, Current life-threatening bleeding, Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG for up to 28 days before randomization, Prior use of B-cell depleting therapy (e.g., rituximab). Absolute neutrophil count below 1.0 G/L at randomization, Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that the addition of ianalumab (either dose) to standard first-line corticosteroids prolongs Time to Treatment Failure (TTF) compared to corticosteroids alone in participants with primary ITP who responded to corticosteroids (+/-IVIG) prior to randomization. Timepoint: Time from randomization to Treatment Failure (TTF) defined as platelet count below 30 G/L later than 8 weeks from randomization, need for a rescue treatment later than 8 weeks from randomization, start of a second-line therapy or death, (whatever the cause) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR)Timepoint: day 1 of EVery week;Response (R) rateTimepoint: day 1 of EVery week;safety profile of ianalumabTimepoint: day 1 of EVery week;To assess the incidence & severity of bleeding in each treatment armTimepoint: day 1 of EVery week;To assess the need of rescue treatment in each treatment groupTimepoint: day 1 of EVery week;To evaluate treatment effects on ITP related symptoms, functioning, & health-related quality of life (HRQoL)Timepoint: Screening, W1D1, W5D1, W9D1, W13D1, W17D1, eoT;B-cell & immunoglobulin levelsTimepoint: Screening, W1D1, W5D1, W9D1, W13D1, W17D1, eoT;To assess ianalumab pharmacokinetics (PK)Timepoint: W1D1 W2D1 W3D1 W4D1 W5D1 W9D1 W13D1 W15D1 W17D1 End of Treatment;To assess the immunogenicity of ianalumabTimepoint: W1D1, W5D1, W9D1, W13D1, EOt | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Mexico, Norway, Romania, Singapore, Spain, Thailand, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed