NCT07039422

Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multicenter, Phase 2 exploratory study to assess the efficacy and safety of a second course of ianalumab in adults with ITP and wAIHA who have previously benefited from ianalumab. All participants will receive ianalumab at the dose of study treatment from which they previously derived benefit. After completion of the screening period, participants who do not meet treatment failure criteria during treatment period will enter the safety and efficacy follow-up, whereas participants who reported a treatment failure during the treatment period will enter the safety follow-up only. The study will end once all participants have completed safety and/or efficacy follow-up since their last dose of ianalumab or discontinued the study earlier.

Conditions

• Primary Immune Thrombocytopenia
• Warm Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Ianalumab	Concentrate for solution for infusion for intravenous use

Timeline

• Start date: 2026-04-27
• Primary completion: 2030-08-30
• Completion: 2030-08-30
• First posted: 2025-06-26
• Last updated: 2026-04-13

Locations

14 sites across 11 countries: Belgium, China, Czechia, Germany, Hungary, Italy, Malaysia, Singapore, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study