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RECRUITING
NCT07039422
PHASE2

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

View on ClinicalTrials.gov

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

BIOLOGICAL

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