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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Caba,Buenos Aires,C1414drk,Argentina
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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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Wooloongabba,Queensland,4102,Australia
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Salzburg,5020,Austria
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Wien,1140,Austria
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Brugge,8000,Belgium
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Leuven,3000,Belgium
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Roeselare,8800,Belgium
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Brasschaat,2930,Belgium
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Varna,9010,Bulgaria
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Sofia,1413,Bulgaria
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Sofia,1431,Bulgaria
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Zhengzhou,Henan,450052,China
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Tianjin,300020,China
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Hangzhou,Zhejiang,310003,China
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Wuhan,Hubei,430022,China
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Beijing,Beijing,100044,China
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Hangzhou,Zhejiang,310006,China
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Dalian,116000,China
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Ostrava,Poruba,708 52,Czechia
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Brno Bohunice,625 00,Czechia
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Praha 10,100 34,Czechia
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Praha,12808,Czechia
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Chambery cedex,73011,France
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Le Mans,72000,France
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Lille,59037,France
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Paris,75014,France
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Rennes,35043,France
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Caen,14033,France
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Frankfurt,60590,Germany
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Giessen,35392,Germany
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Hannover,30161,Germany
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Jena,07740,Germany
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Dresden,01307,Germany
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Essen,45147,Germany
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New Territories,Hong Kong
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Clovis,California,93611,United States
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Hematology Oncology Association of Rockland
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Nyack,New York,10960,United States
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Lake Success,New York,11042,United States
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Bethesda,Maryland,20817,United States
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Mayo Clinic Rochester
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Cleveland Clinic Foundation
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Cleveland,Ohio,44195,United States
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Michigan Center of Medical Research
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Texas Oncology
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McAllen,Texas,78503,United States
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University of Pennsylvania
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STAT Research Inc
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St Vincent Frontier Cancer Center
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Billings,Montana,59102,United States
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Community Cancer Trials of Utah
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Ogden,Utah,84405,United States
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Uni of Chi Medi Ctr Hema and Onco
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Chicago,Illinois,60637,United States
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Rhode Island Hospital
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Providence,Rhode Island,02903,United States
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Inspira Medical Cent Mullica Hill
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