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
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Tucuman,San Miguel De Tucuman,4000,Argentina
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Buenos aires,C1039AAC,Argentina
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Caba,Buenos Aires,C1280AEB,Argentina
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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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Clayton,Victoria,3168,Australia
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Wooloongabba,Queensland,4102,Australia
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Canberra,Australian Capital Territory,2605,Australia
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Prahran,Victoria,3181,Australia
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Innsbruck,Tyrol,6020,Austria
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Wien,1140,Austria
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Salzburg,5020,Austria
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Roeselare,8800,Belgium
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Brugge,8000,Belgium
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Leuven,3000,Belgium
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Sofia,1413,Bulgaria
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Varna,9010,Bulgaria
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Sofia,1431,Bulgaria
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Plovdiv,4002,Bulgaria
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Xian,Shaanxi,710004,China
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Zhengzhou,Henan,450052,China
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Kunming,Yunnan,650101,China
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Nanchang,Jiangxi,330006,China
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Changsha,Hunan,410008,China
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Dalian,116000,China
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Guangzhou,Guangdong,510515,China
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Jinan,250012,China
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Chengdu,Sichuan,610041,China
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Shenzhen,Guangdong,518037,China
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Hangzhou,Zhejiang,310003,China
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Taiyuan,Shanxi,030001,China
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Hangzhou,Zhejiang,310006,China
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Tianjin,300020,China
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Wuhan,Hubei,430022,China
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Beijing,100044,China
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Ostrava,Poruba,708 52,Czech Republic
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Brno Bohunice,Czech Republic,625 00,Czech Republic
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Praha 10,100 34,Czech Republic
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Praha,12808,Czech Republic
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Chambéry cedex,73011,France
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Rennes,35043,France
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Paris,75014,France
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Le Mans,Cedex 09,72037,France
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Caen,Cedex,14033,France
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Lille,59037,France
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Essen,45147,Germany
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Greifswald,17475,Germany
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Jena,07740,Germany
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Frankfurt,60590,Germany
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Giessen,35392,Germany
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Dresden,01307,Germany
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Hannover,30161,Germany
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New Territories,Hong Kong
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Budapest,1085,Hungary
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Debrecen,4032,Hungary
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Kolkata,West Bengal,700094,India
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Firenze,FI,50134,Italy
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Bologna,BO,40138,Italy
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Roma,RM,00168,Italy
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Vicenza,VI,36100,Italy
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Trieste,TS,34129,Italy
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Sapporo,Hokkaido,060-8604,Japan
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Fukuoka,815-8555,Japan
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Iruma-gun,Saitama,350-0495,Japan
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Matsumoto-city,Nagano,399-8701,Japan
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Shibukawa-city,Gunma,377-0280,Japan
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Okayama city,Okayama,701-1192,Japan
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Chiba,260-0852,Japan
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Gifu shi,Gifu,500 8513,Japan
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Osaka-city,Osaka,543-8555,Japan
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Kuching,Sarawak,93586,Malaysia
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Selangor,68000,Malaysia
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Penang,10050,Malaysia
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Johor Bahru,80100,Malaysia
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Kuala Lumpur,MYS,56000,Malaysia
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Ciudad de Mexico,Mexico CP,14080,Mexico
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Monterrey,Nuevo Leon,64460,Mexico
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Morelia,Michoacan,58260,Mexico
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Gralum,1714,Norway
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Bucuresti,013975,Romania
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Bucharest,District 2,022328,Romania
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Bucharest,030171,Romania
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Singapore,169608,Singapore
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Singapore,S308433,Singapore
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Singapore,119228,Singapore
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Murcia,30008,Spain
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Madrid,28009,Spain
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Sevilla,Andalucia,41013,Spain
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Madrid,28046,Spain
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Salamanca,Castilla Y Leon,37007,Spain
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Barcelona,Catalunya,08035,Spain
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Bangkok,10330,Thailand
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Chiang Mai,50200,Thailand
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Bangkok,10700,Thailand
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Izmir,35040,Turkey
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Aydin,09100,Turkey
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Istanbul,34214,Turkey
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Edirne,22030,Turkey
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Samsun,55139,Turkey
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Istanbul,TUR,34098,Turkey
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London,SW17 0QT,United Kingdom
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Truro,Cornwall,TR1 3LJ,United Kingdom
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Birmingham,B15 2TH,United Kingdom
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London,W12 0HS,United Kingdom
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Leeds,LS1 3EX,United Kingdom
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Nottingham,NG5 1PB,United Kingdom
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Glasgow,G31 2ER,United Kingdom
Metro Minnesota CCOP Main Site Address Oncology
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Saint Louis Park,Yan Ji,55416 - Minnesota,United States
Community Cancer Institute
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Clovis,Kelly Meehan (559-387-1850) email: [email protected] -- Mohammed Bukari,93611 - California,United States
Uni of Chi Medi Ctr Hema and Onco Main Centre
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Chicago,Sara Moellering (773-834-0783) email: [email protected] -- Michael Drazer,60637 - Illinois,United States
Napa Research
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Margate,Emilio Araujo-Mino,33063 - Florida,United States
Community Cancer Trials of Utah
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Ogden,Sibian Torres (801-689-3909) email: [email protected] -- Carl Gray,84405 - Utah,United States
Yuma Regional Medical Center
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Yuma,Amy Olmeda email: [email protected] -- Abhinav Chandra,85349 - Arizona,United States
Oncology Care Associates
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Bethesda,Natalie Bongiorno (301-897-1503) email: [email protected] -- Ralph V Boccia,20817 - Maryland,United States
Compassionate Care Res Group Inc
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Fountain Valley,(714-210-2300) -- Eric Lee,92708 - California,United States
St Vincent Frontier Cancer Center .
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Billings,Amanda Klein (406-238-6290) email: [email protected] -- Patrick Cobb,59102 - Montana,United States
Hematology Oncology Association of Rockland
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Nyack,Marion VanWoudenberg (845-362-1750) email: [email protected] -- Sung Ho Lee,10960 - New York,United States
STAT Research Inc Premier Clin Res LLC STAT Res
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Dayton,Aby Madrigal email: [email protected] -- Charles Bane,45402 - Ohio,United States
Inspira Medical Cent Mullica Hill
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Mullica Hill,Catherine Vasquez (856-641-7526) email: [email protected] -- Erev Tubb,08062 - New Jersey,United States
Cleveland Clinic Foundation .
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Cleveland,Antonio Wilson (216-445-2572) email: [email protected] -- Alan Lichtin,44195 - Ohio,United States
Texas Oncology
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McAllen,Nereida Salinas email: [email protected] -- Nurul Wahid,78503 - Texas,United States
INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center
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Oklahoma City,Kellie Larsen-Dyer email: [email protected] -- Basgar Alasad,73142 - Oklahoma,United States
Clinical Research Alliance Research
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Lake Success,William Krenn (+1 516 488 2918#183) email: [email protected] -- James D Olimpio,11042 - New York,United States
Texas Oncology-Baylor Res Ins
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Dallas,(+1 214 820 2687) -- Moshe Yair Levy,75204 - Texas,United States
Novartis Investigative Site
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Hanoi,100000,Vietnam
Worldwide Contacts
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