Study Description
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP. This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary ITP (platelets count \<30 G/L) who require first-line standard-of-care corticosteroids.
After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids).
After the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.
Interventions
Corticosteroids
Ianalumab
Placebo
Eligibility 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 \>=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.
Key Exclusion Criteria:
* Evans syndrome or any other cytopenia (patients with anemia related to bleeding or iron deficiency are eligible)
* Current life-threatening bleeding
* Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .
* 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
Other protocol-defined Inclusion/Exclusion may apply.
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Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina
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Tucuman,San Miguel De Tucuman,4000,Argentina
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Buenos aires,C1039aac,Argentina
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Cordoba,5000,Argentina
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Caba,Buenos Aires,C1280aeb,Argentina
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Caba,Buenos Aires,C1414drk,Argentina
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Wien,1140,Austria
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Leuven,3000,Belgium
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Roeselare,8800,Belgium
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Shijiazhuang,050000,China
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University of Pennsylvania
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Mayo Clinic Rochester
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