A Phase 3 Randomized Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BIVV009 in Patients with Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion (Cadenza)

Study Overview

This is a randomized, double-blind, placebo-controlled, multicenter study in patients with primary cold agglutinin disease (CAgD) without a recent history of blood transfusion. Eligible patients will receive study drug (BIVV009 or placebo) and undergo safety and efficacy assessments for 6 months (26 weeks) during Part A. Following completion of the initial 6-month treatment period (Part A), patients will roll into the open-label long-term safety and durability of response extension phase (Part B) during which they will receive BIVV009. For the purpose of marketing authorization application, an interim analysis of safety and efficacy data will be performed after all patients have completed the double-blind treatment period (Part A). The Part B open-label extension study will run for 1 year following last patient out (LPO) under Part A.

• Study Identifier: 830017