A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

Summary

Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: * The effect of BIVV020 on complement mediated hemolysis * The pharmacodynamics (PD) of BIVV020 relating to complement inhibition * The pharmacokinetics (PK) of BIVV020 * The immunogenicity of BIVV020

Timeline

Start

2020-06-15

Primary completion

2022-01-06

Completion

2022-01-06

Publications

• D'Sa S, Vos JMI, Barcellini W, Wardecki M, Perrin L, Barker G, Zilberstein M, Storek M, Chow T, Roth A. Safety, tolerability, and activity of the active C1s antibody riliprubart in cold agglutinin disease: a phase 1b study. Blood. 2024 Feb 22;143(8):713-720. doi: 10.1182/blood.2023022153.

Drugs

Indications