Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With BIVV020
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To assess the long-term safety and tolerability in patients with cold agglutinin disease
(CAD), after multiple doses of BIVV020
Secondary Objective:
To assess, in patients with cold agglutinin disease (CAD), after multiple doses of BIVV020:
- The long-term effect of BIVV020 on complement mediated hemolysis
- The long-term pharmacodynamics (PD) effect of BIVV020 relating to complement inhibition
- The pharmacokinetic profile (PK) after repeated administration of BIVV020
- The long-term immunogenicity of BIVV020