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

Recruiting Phase 2 Interventional Study
Primary Immune Thrombocytopenia Warm Autoimmune Hemolytic Anemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Signed informed consent obtained prior to participation in the study. * Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP patients: * Previously enrolled and treated either with ianalumab/placebo in addition to first-line …
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Novartis Pharmaceuticals

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