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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 (VAYHIA)

Primary objective(s) To demonstrate that either dose of ianalumab induces durable hemoglobin (Hb) response compared to placebo, in patients with wAIHA who failed at least one previous line of treatment Secondary objective(s) Key secondary objective: to demonstrate that either dose of ianalumab maintains durable hemoglobin response, that is sustained beyond the end of the treatment period, compared to placebo To assess the time to durable response/response/complete response in each treatment group To assess quality of response in each treatment group To assess the need for rescue treatments in each treatment group To assess the safety profile of ianalumab To characterize the pharmacokinetics (PK) of ianalumab To assess B-cell levels and immunoglobulin levels in each treatment group To assess the immunogenicity of ianalumab To assess quality of life in each treatment group Exploratory objective(s) To identify biomarkers predictive of response, to assess the immunomodulatory effects in each treatment group and correlate biomarker measurements with key outcomes of efficacy (Hb level) To explore patient reported outcomes in each treatment group To explore exposure-response relations To explore medical resource utilization To assess efficacy, safety, PK/PD/immunogenicity of ianalumab in the open label extension part

Phase

III

Recruitment Status

Current Studies