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Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
Sponsor: Novartis Pharmaceuticals
Summary
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).
Official title: A Phase 2 Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-27
Completion Date
2030-08-30
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Ianalumab
Concentrate for solution for infusion for intravenous use
Locations (10)
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Ostrava, Poruba, Czechia
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Vicenza, VI, Italy
Novartis Investigative Site
George Town, Malaysia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Samsun, Atakum, Turkey (Türkiye)
Novartis Investigative Site
London, United Kingdom