A multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema

简要总结

主要结局

次要结局

• Reduction in the HAE attack rate(up to 6 months)
• Time-normalized number of attacks requiring on-demand treatment(6 months, and first 3 months and second 3 months)
• Time-normalized number of moderate and/or severe HAE attacks(6 months, and first 3 months and second 3 months)
• Time-normalized number of HAE attacks at various timepoints(first 3 months and second 3 months and 6 months)
• Subject's Global Assessment of Response to Therapy (SGART)(up to 6 months)
• Percent reduction in the time-normalized number of HAE attacks between CSL312 and Placebo(6 months, and first 3 months and second 3 months)
• Number and percent of subjects with adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments(up to 8 months)