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

Autoimmune Haemolytic Anaemia Clinical Trial

Official title: A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease

Status Completed

Clinical Trial 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

Clinical Trial Description

Up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks) ;

Related Conditions & MeSH terms

• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Haemolytic Anaemia

• NCT number: NCT04269551
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2020
• Completion date: January 6, 2022