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
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
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Phase 1 | |
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