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

NCT04269551 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-22

No results posted yet for this study

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

Conditions

  • Autoimmune Haemolytic Anaemia

Interventions

DRUG

BIVV020

Pharmaceutical form:solution for injection Route of administration: intravenous

Sponsors & Collaborators

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-01-06
Completion
2022-01-06
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269551 on ClinicalTrials.gov