NCT04802057

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

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Autoimmune Haemolytic Anaemia

Interventions

Type	Name	Description
DRUG	SAR445088	Pharmaceutical form: solution for injection Route of administration: IV and SC (Part 1) IV (Part 2)

Timeline

• Start date: 2021-03-22
• Primary completion: 2025-03-04
• Completion: 2025-03-04
• First posted: 2021-03-17
• Last updated: 2025-09-11

Locations

5 sites across 5 countries: Germany, Italy, Netherlands, Norway, United Kingdom

Regulatory

• FDA-regulated drug study