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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
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
Recruitment Status
Coming Soon