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A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.
Official title: A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-12-30
Completion Date
2028-12-19
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Ianalumab
i.v. infusion, prepared from concentrate solution
Placebo
i.v. infusion, prepared from matching placebo
Locations (53)
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
University of Minnesota Med Center
Minneapolis, Minnesota, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Argentina
Novartis Investigative Site
Caba, Argentina
Novartis Investigative Site
Garran, Australian Capital Territory, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Dalian, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Créteil, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Giessen, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Madurai, Tamil Nadu, India
Novartis Investigative Site
Hyderabad, Telangana, India
Novartis Investigative Site
Lucknow, Uttar Pradesh, India
Novartis Investigative Site
Kfar Saba, Israel
Novartis Investigative Site
Petah Tikva, Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Bassano del Grappa, VI, Italy
Novartis Investigative Site
Novara, Italy
Novartis Investigative Site
Narita, Chiba, Japan
Novartis Investigative Site
Matsuyama, Ehime, Japan
Novartis Investigative Site
Gifu, Gifu, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Isehara, Kanagawa, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Johor Bahru, Malaysia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Murcia, Spain
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Chiang Mai, Thailand
Novartis Investigative Site
Birmingham, West Midlands, United Kingdom
Novartis Investigative Site
Leeds, United Kingdom
Novartis Investigative Site
London, United Kingdom