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

Autoimmune Haemolytic Anaemia Clinical Trial

Official title: An Open-label, Long-term, Safety and Tolerability Study of SAR445088 in Participants With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

The screening period for this study is up to 6 weeks. The treatment period for this study will continue for 2 years after last participant entered Part 2 (either having switched from Part 1 or as a SAR445088-naïve participant), or until SAR445088 development is discontinued, whichever comes first. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04802057
• Study type: Interventional
• Source: Sanofi
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 22, 2021
• Completion date: January 23, 2026