NCT04269551

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Autoimmune Haemolytic Anaemia

Interventions

Type	Name	Description
DRUG	BIVV020	Pharmaceutical form:solution for injection Route of administration: intravenous

Timeline

• Start date: 2020-06-15
• Primary completion: 2022-01-06
• Completion: 2022-01-06
• First posted: 2020-02-17
• Last updated: 2025-09-22

Locations

10 sites across 6 countries: United States, Germany, Italy, Netherlands, Norway, United Kingdom

Regulatory

• FDA-regulated drug study