A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
Status: Active_not_recruiting
Location: See all (118) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Yuma Regional Medical Center
Yuma
California
Community Cancer Institute
Clovis
Compassionate Care Res Group Inc
Fountain Valley
Colorado
University of Colorado Anschutz
Aurora
Florida
DH Cancer Research Center LLC
Margate
Illinois
Uni of Chi Medi Ctr Hema and Onco
Chicago
Indiana
Parkview Research Center
Fort Wayne
Massachusetts
Beth Israel Deaconess Med Center
Boston
Massachusetts General Hospital
Boston
Maryland
Oncology Care Associates
Bethesda
Michigan
Michigan Center of Medical Research
Farmington Hills
Minnesota
Mayo Clinic Rochester
Rochester
Metro Minnesota CCOP
Saint Louis Park
Montana
St Vincent Frontier Cancer Center
Billings
New York
Clinical Research Alliance
Lake Success
Hematology Oncology Association of Rockland
Nyack
Ohio
Cleveland Clinic Foundation
Cleveland
STAT Research Inc
Dayton
Rhode Island
Rhode Island Hospital
Providence
Texas
Mays Cancer Ctr Uthsa Mdacc
San Antonio
Utah
Community Cancer Trials of Utah
Ogden
Other Locations
Argentina
Novartis Investigative Site
Caba
Novartis Investigative Site
Caba
Novartis Investigative Site
Caba
Novartis Investigative Site
Ciudad De Buenos Aires
Novartis Investigative Site
Córdoba
Novartis Investigative Site
San Miguel De Tucumán
Australia
Novartis Investigative Site
Clayton
Novartis Investigative Site
Garran
Novartis Investigative Site
Melbourne
Novartis Investigative Site
Wooloongabba
Austria
Novartis Investigative Site
Innsbruck
Novartis Investigative Site
Salzburg
Novartis Investigative Site
Vienna
Belgium
Novartis Investigative Site
Brasschaat
Novartis Investigative Site
Bruges
Novartis Investigative Site
Leuven
Novartis Investigative Site
Roeselare
Bulgaria
Novartis Investigative Site
Plovdiv
Novartis Investigative Site
Sofia
China
Novartis Investigative Site
Beijing
Novartis Investigative Site
Bengbu
Novartis Investigative Site
Changzhou
Novartis Investigative Site
Chengdu
Novartis Investigative Site
Dalian
Novartis Investigative Site
Guangzhou
Novartis Investigative Site
Hangzhou
Novartis Investigative Site
Kunming
Novartis Investigative Site
Luoyang
Novartis Investigative Site
Nanchang
Novartis Investigative Site
Shenzhen
Novartis Investigative Site
Shijiazhuang
Novartis Investigative Site
Tianjin
Novartis Investigative Site
Wuhan
Novartis Investigative Site
Xi'an
Novartis Investigative Site
Zhengzhou
France
Novartis Investigative Site
Caen
Novartis Investigative Site
Chambéry
Novartis Investigative Site
Lille
Novartis Investigative Site
Rennes
Germany
Novartis Investigative Site
Dresden
Novartis Investigative Site
Dresden
Novartis Investigative Site
Essen
Novartis Investigative Site
Frankfurt Am Main
Novartis Investigative Site
Giessen
Novartis Investigative Site
Jena
Hong Kong Special Administrative Region
Novartis Investigative Site
Hong Kong
Novartis Investigative Site
New Territories
Hungary
Novartis Investigative Site
Budapest
Novartis Investigative Site
Debrecen
India
Novartis Investigative Site
Ahmedabad
Novartis Investigative Site
Kolkata
Novartis Investigative Site
Mumbai
Novartis Investigative Site
Rishikesh
Italy
Novartis Investigative Site
Bologna
Novartis Investigative Site
Florence
Novartis Investigative Site
Roma
Novartis Investigative Site
Trieste
Novartis Investigative Site
Vicenza
Japan
Novartis Investigative Site
Chiba
Novartis Investigative Site
Fukuoka
Novartis Investigative Site
Gifu
Novartis Investigative Site
Iruma-gun
Novartis Investigative Site
Nagakute
Novartis Investigative Site
Okayama
Novartis Investigative Site
Osaka
Novartis Investigative Site
Sapporo
Novartis Investigative Site
Shibukawa
Malaysia
Novartis Investigative Site
George Town
Novartis Investigative Site
Johor Bahru
Novartis Investigative Site
Kuala Selangor
Novartis Investigative Site
Kuching
Mexico
Novartis Investigative Site
Mexico City
Novartis Investigative Site
Mexico City
Novartis Investigative Site
Monterrey
Novartis Investigative Site
Morelia
Norway
Novartis Investigative Site
Grålum
Romania
Novartis Investigative Site
Bucharest
Novartis Investigative Site
Bucharest
Singapore
Novartis Investigative Site
Singapore
Novartis Investigative Site
Singapore
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Madrid
Novartis Investigative Site
Murcia
Novartis Investigative Site
Salamanca
Novartis Investigative Site
Seville
Thailand
Novartis Investigative Site
Bangkok
Novartis Investigative Site
Bangkok
Novartis Investigative Site
Chiang Mai
Turkey
Novartis Investigative Site
Aydin
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Samsun
United Kingdom
Novartis Investigative Site
Birmingham
Novartis Investigative Site
London
Novartis Investigative Site
Nottingham
Viet Nam
Novartis Investigative Site
Hanoi
Novartis Investigative Site
Ho Chi Minh City
Time Frame
Start Date: 2023-03-06
Completion Date: 2028-09-29
Participants
Target number of participants: 226
Treatments
Experimental: Ianalumab Lower dose
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Experimental: Ianalumab Higher dose
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Placebo_comparator: Placebo
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals