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ACTIVE NOT RECRUITING
NCT05653219
PHASE3

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

Official title: A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2023-02-02

Completion Date

2028-04-08

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

BIOLOGICAL

Ianalumab

Concentrate for solution for infusion for intravenous use

DRUG

Eltrombopag

Film-coated tablet for oral use

DRUG

Placebo

Concentrate for solution for infusion for intravenous use.

Locations (74)

Yuma Regional Medical Center

Yuma, Arizona, United States

University of Colorado Anschutz

Aurora, Colorado, United States

NorthShore University Health System

Evanston, Illinois, United States

Boston Medical Center

Boston, Massachusetts, United States

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

Michigan Center of Medical Research

Farmington Hills, Michigan, United States

St Vincent Frontier Cancer Center

Billings, Montana, United States

Hematology Oncology Association of Rockland

Nyack, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Yvoir, Namur, Belgium

Novartis Investigative Site

Roeselare, West-Vlaanderen, Belgium

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Binzhou, Shandong, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Jinan, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Blois, France

Novartis Investigative Site

Le Mans, France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Jena, Thuringia, Germany

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Rishikesh, Uttarakhand, India

Novartis Investigative Site

Kolkata, West Bengal, India

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Trieste, TS, Italy

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Kofu, Yamanashi, Japan

Novartis Investigative Site

Kumamoto, Japan

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Novartis Investigative Site

Kota Kinabalu, Sabah, Malaysia

Novartis Investigative Site

Subang Jaya, Selangor, Malaysia

Novartis Investigative Site

George Town, Malaysia

Novartis Investigative Site

Johor Bahru, Malaysia

Novartis Investigative Site

Kuala Selangor, Malaysia

Novartis Investigative Site

Saltillo, Coahuila, Mexico

Novartis Investigative Site

Morelia, Michoacán, Mexico

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Novartis Investigative Site

Leiden, South Holland, Netherlands

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Makati City, Philippines

Novartis Investigative Site

Quezon, Philippines

Novartis Investigative Site

Craiova, Dolj, Romania

Novartis Investigative Site

Timișoara, Romania

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Jeollanam, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

Salamanca, Spain

Novartis Investigative Site

Taoyuan District, Taiwan

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Chiang Mai, Thailand

Novartis Investigative Site

Samsun, Atakum, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Bilkent Cankaya, Turkey (Türkiye)

Novartis Investigative Site

Aydin, Efeler, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Oxford, United Kingdom