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.
Study Location
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina
Novartis Investigative Site
Recruiting
Buenos aires,C1039aac,Argentina
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1280aeb,Argentina
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1414drk,Argentina
Novartis Investigative Site
Recruiting
Tucuman,San Miguel De Tucuman,4000,Argentina
Novartis Investigative Site
Recruiting
Wooloongabba,Queensland,4102,Australia
Novartis Investigative Site
Recruiting
Clayton,Victoria,3168,Australia
Novartis Investigative Site
Recruiting
Canberra,Australian Capital Territory,2605,Australia
Novartis Investigative Site
Recruiting
Prahran,Victoria,3181,Australia
Novartis Investigative Site
Recruiting
Salzburg,5020,Austria
Novartis Investigative Site
Recruiting
Wien,1140,Austria
Novartis Investigative Site
Recruiting
Innsbruck,Tyrol,6020,Austria
Novartis Investigative Site
Recruiting
Brugge,8000,Belgium
Novartis Investigative Site
Recruiting
Leuven,3000,Belgium
Novartis Investigative Site
Recruiting
Roeselare,8800,Belgium
Novartis Investigative Site
Recruiting
Varna,9010,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1413,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1431,Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv,4002,Bulgaria
Novartis Investigative Site
Recruiting
Chengdu,Sichuan,610041,China
Novartis Investigative Site
Recruiting
Kunming,Yunnan,650101,China
Novartis Investigative Site
Recruiting
Shenzhen,Guangdong,518037,China
Novartis Investigative Site
Recruiting
Nanchang,Jiangxi,330006,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430022,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510515,China
Novartis Investigative Site
Recruiting
Xian,Shaanxi,710004,China
Novartis Investigative Site
Recruiting
Hangzhou,Zhejiang,310003,China
Novartis Investigative Site
Recruiting
Taiyuan,Shanxi,030001,China
Novartis Investigative Site
Recruiting
Zhengzhou,Henan,450052,China
Novartis Investigative Site
Recruiting
Hangzhou,Zhejiang,310006,China
Novartis Investigative Site
Recruiting
Changsha,Hunan,410008,China
Novartis Investigative Site
Recruiting
Beijing,100044,China
Inspira Medical Cent Mullica Hill
Recruiting
Mullica Hill,New Jersey,08062,United States
Erev Tubb
Uni of Chi Medi Ctr Hema and Onco Main Centre
Recruiting
Chicago,Illinois,60637,United States
Michael Drazer
Community Cancer Trials of Utah
Recruiting
Ogden,Utah,84405,United States
Carl Gray
Oncology Care Associates
Recruiting
Bethesda,Maryland,20817,United States
Ralph V Boccia
Cleveland Clinic Foundation .
Recruiting
Cleveland,Ohio,44195,United States
Alan Lichtin
St Vincent Frontier Cancer Center .
Recruiting
Billings,Montana,59102,United States
Patrick Cobb
INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center
Recruiting
Oklahoma City,Oklahoma,73142,United States
Basgar Alasad
Kellie Larsen-Dyer
Yuma Regional Medical Center
Recruiting
Yuma,Arizona,85349,United States
Abhinav Chandra
Amy Olmeda
Compassionate Care Res Group Inc
Recruiting
Fountain Valley,California,92708,United States
Eric Lee
Clinical Research Alliance Research
Recruiting
Lake Success,New York,11042,United States
James D Olimpio
STAT Research Inc Premier Clin Res LLC STAT Res
Recruiting
Dayton,Ohio,45402,United States
Aby Madrigal
Charles Bane
Texas Oncology
Recruiting
McAllen,Texas,78503,United States
Nurul Wahid
Nereida Salinas
Metro Minnesota CCOP Main Site Address Oncology
Recruiting
Saint Louis Park,Minnesota,55416,United States
Yan Ji
Hematology Oncology Association of Rockland
Recruiting
Nyack,New York,10960,United States
Sung Ho Lee
Texas Oncology-Baylor Res Ins
Recruiting
Dallas,Texas,75204,United States
Moshe Yair Levy
Community Cancer Institute
Recruiting
Clovis,California,93611,United States
Mohammed Bukari
Napa Research
Recruiting
Margate,Florida,33063,United States
Emilio Araujo-Mino
Worldwide Contacts
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