Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088

Summary

Primary Objective: To assess the long-term safety and tolerability in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088 Secondary Objective: To assess, in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088: * The long-term effect of SAR445088 on complement mediated hemolysis * The long-term pharmacodynamics (PD) effect of SAR445088 relating to complement inhibition * The long-term pharmacokinetic (PK) profile of SAR445088 * The long-term immunogenicity of SAR445088

Timeline

Start

2021-03-22

Primary completion

2025-03-04

Completion

2025-03-04

Drugs

Indications