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ACTIVE NOT RECRUITING
NCT05653349
PHASE3

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2023-02-03

Completion Date

2028-09-07

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Ianalumab

Intravenous infusion, prepared from concentrate solution

DRUG

Placebo

Intravenous infusion, prepared from matching placebo

DRUG

Corticosteroids

Oral or parental (if clinically justified)

Locations (117)

Yuma Regional Medical Center

Yuma, Arizona, United States

Community Cancer Institute

Clovis, California, United States

Compassionate Care Res Group Inc

Fountain Valley, California, United States

University of Colorado Anschutz

Aurora, Colorado, United States

DH Cancer Research Center LLC

Margate, Florida, United States

Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

Oncology Care Associates

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Med Center

Boston, Massachusetts, United States

Michigan Center of Medical Research

Farmington Hills, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Metro Minnesota CCOP

Saint Louis Park, Minnesota, United States

St Vincent Frontier Cancer Center

Billings, Montana, United States

Clinical Research Alliance

Lake Success, New York, United States

Hematology Oncology Association of Rockland

Nyack, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

STAT Research Inc

Dayton, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Mays Cancer Ctr Uthsa Mdacc

San Antonio, Texas, United States

Community Cancer Trials of Utah

Ogden, Utah, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Garran, Australian Capital Territory, Australia

Novartis Investigative Site

Wooloongabba, Queensland, Australia

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Novartis Investigative Site

Salzburg, Austria

Novartis Investigative Site

Roeselare, West-Vlaanderen, Belgium

Novartis Investigative Site

Brasschaat, Belgium

Novartis Investigative Site

Bruges, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Plovdiv, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Guangzhou, Guangdong, China

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Shenzhen, Guangdong, China

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Shijiazhuang, Hebei, China

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Luoyang, Henan, China

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Zhengzhou, Henan, China

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Wuhan, Hubei, China

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Changzhou, Jiangsu, China

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Nanchang, Jiangxi, China

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Chengdu, Sichuan, China

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Kunming, Yunnan, China

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Hangzhou, Zhejiang, China

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Bengbu, China

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Dalian, China

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Tianjin, China

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Ostrava, Poruba, Czechia

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Brno, Czechia

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Prague, Czechia

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Prague, Czechia

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Caen, France

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Chambéry, France

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Le Mans, France

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Lille, France

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Rennes, France

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Frankfurt am Main, Hesse, Germany

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Dresden, Saxony, Germany

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Jena, Thuringia, Germany

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Dresden, Germany

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Essen, Germany

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Giessen, Germany

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New Territories, Hong Kong, Hong Kong

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Hong Kong, Hong Kong

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Ahmedabad, Gujarat, India

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Rishikesh, Uttarakhand, India

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Kolkata, West Bengal, India

Novartis Investigative Site

Bologna, BO, Italy

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Florence, FI, Italy

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Roma, RM, Italy

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Trieste, TS, Italy

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Vicenza, VI, Italy

Novartis Investigative Site

Nagakute, Aichi-ken, Japan

Novartis Investigative Site

Shibukawa, Gunma, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Novartis Investigative Site

Iruma-gun, Saitama, Japan

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Chiba, Japan

Novartis Investigative Site

Fukuoka, Japan

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Gifu, Japan

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Osaka, Japan

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Kuching, Sarawak, Malaysia

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George Town, Malaysia

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Johor Bahru, Malaysia

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Kuala Selangor, Malaysia

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Grålum, Norway

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Bucharest, Romania

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Singapore, Singapore

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Singapore, Singapore

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Murcia, Spain

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Salamanca, Spain

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Seville, Spain

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

Novartis Investigative Site

Samsun, Atakum, Turkey (Türkiye)

Novartis Investigative Site

Aydin, Efeler, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Birmingham, West Midlands, United Kingdom

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London, United Kingdom

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Nottingham, United Kingdom

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Hanoi, Vietnam

Novartis Investigative Site

Ho Chi Minh City, Vietnam