Last Update: Feb 13, 2024
A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736I12301
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Primary Immune Thrombocytopenia (ITP)
Phase 3
Recruiting
225
Mar 06, 2023
Feb 04, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Corticosteroids

Oral or parental (if clinically justified)
Biological

Ianalumab

Intravenous infusion, prepared from concentrate solution
Drug

Placebo

Intravenous infusion, prepared from matching 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

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Caba,Buenos Aires,C1414DRK,Argentina

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Wooloongabba,Queensland,4102,Australia

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Prahran,Victoria,3181,Australia

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Clayton,Victoria,3168,Australia

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Canberra,Australian Capital Territory,2605,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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Leuven,3000,Belgium

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Brugge,8000,Belgium

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Roeselare,8800,Belgium

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Sofia,1431,Bulgaria

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Varna,9010,Bulgaria

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Sofia,1413,Bulgaria

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Nanchang,Jiangxi,330006,China

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Dalian,116000,China

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Guangzhou,Guangdong,510515,China

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Shenzhen,Guangdong,518037,China

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Taiyuan,Shanxi,030001,China

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Hangzhou,Zhejiang,310003,China

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Beijing,100044,China

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Changsha,Hunan,410008,China

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Jinan,250012,China

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Tianjin,300020,China

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Hangzhou,Zhejiang,310006,China

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Chengdu,Sichuan,610041,China

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Wuhan,Hubei,430022,China

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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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Praha 10,100 34,Czech Republic

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Praha,12808,Czech Republic

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Brno Bohunice,Czech Republic,625 00,Czech Republic

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Ostrava,Poruba,708 52,Czech Republic

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Chambéry cedex,73011,France

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Le Mans,Cedex 09,72037,France

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Lille Cedex,59037,France

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Rennes,35043,France

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Caen,Cedex,14033,France

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Paris,75014,France

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Jena,07740,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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Essen,45147,Germany

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Greifswald,17475,Germany

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Frankfurt,60590,Germany

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Hong Kong,Hong Kong

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Debrecen,4032,Hungary

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Budapest,1085,Hungary

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Vicenza,VI,36100,Italy

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Roma,RM,00168,Italy

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Bologna,BO,40138,Italy

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Trieste,TS,34129,Italy

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Firenze,FI,50134,Italy

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Fukuoka,815-8555,Japan

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Iruma-gun,Saitama,350-0495,Japan

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Shibukawa-city,Gunma,377-0280,Japan

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Matsumoto-city,Nagano,399-8701,Japan

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Gifu shi,Gifu,500 8513,Japan

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Okayama city,Okayama,701-1192,Japan

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Osaka-city,Osaka,543-8555,Japan

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Sapporo,Hokkaido,060-8604,Japan

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Chiba,260-0852,Japan

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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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Selangor,68000,Malaysia

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Kuching,Sarawak,93586,Malaysia

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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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Bucharest,District 2,022328,Romania

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Bucharest,030171,Romania

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Bucuresti,013975,Romania

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Singapore,119228,Singapore

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Singapore,169608,Singapore

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Singapore,S308433,Singapore

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Madrid,28009,Spain

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Barcelona,Catalunya,08035,Spain

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Salamanca,Castilla Y Leon,37007,Spain

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Madrid,28046,Spain

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Murcia,30008,Spain

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Sevilla,Andalucia,41013,Spain

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Chiang Mai,50200,Thailand

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Bangkok,10330,Thailand

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Bangkok,10700,Thailand

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Istanbul,34214,Turkey

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Istanbul,TUR,34098,Turkey

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Samsun,55139,Turkey

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Edirne,22030,Turkey

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Aydin,09100,Turkey

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Izmir,35040,Turkey

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Leeds,LS1 3EX,United Kingdom

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Nottingham,NG5 1PB,United Kingdom

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Birmingham,B15 2TH,United Kingdom

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Glasgow,G31 2ER,United Kingdom

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Truro,Cornwall,TR1 3LJ,United Kingdom

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London,SW17 0QT,United Kingdom

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London,W12 0HS,United Kingdom

Cleveland Clinic Foundation .

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Cleveland,Antonio Wilson (216-445-2572) email: [email protected] -- Alan Lichtin,44195 - Ohio,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,(+1 516 488 2918#183) -- James D Olimpio,11042 - New York,United States

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

St Vincent Frontier Cancer Center .

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Billings,Amanda Klein (406-238-6290) email: [email protected] -- Patrick Cobb,59102 - Montana,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

Texas Oncology

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McAllen,Nereida Salinas email: [email protected] -- Nurul Wahid,78503 - Texas,United States

Compassionate Care Research Group Inc

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Fountain Valley,(714-210-2300) -- Eric Lee,92708 - California,United States

University of Chicago Medical Center Hematology and Oncology Main Centre

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Chicago,Sara Moellering (773-834-0783) email: [email protected] -- Michael Drazer,60637 - Illinois,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

Yuma Regional Medical Center

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Yuma,Amy Olmeda email: [email protected] -- Abhinav Chandra,85349 - Arizona,United States

Baylor Research Institute

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Dallas,(+1 214 820 2687) -- Moshe Yair Levy,75204 - Texas,United States

Oncology Care Associates

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Bethesda,(301-897-1503) -- Ralph V Boccia,20817 - Maryland,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

Novartis Investigative Site

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Hanoi,100000,Vietnam

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