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

Completed · Phase 1

Conditions studied: Autoimmune Haemolytic Anaemia

In brief

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

Key facts

Study ID

NCT04269551

Run by

Bioverativ, a Sanofi company

People needed

12

Starts

2020-06-15

Expected to finish

2022-01-06

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by:
• Chronic hemolysis per Investigator's judgement,
• Polyspecific direct antiglobulin test (DAT) positive,
• Monospecific DAT strongly positive for C3d,
• Cold agglutinin (CAg) titer ≥ 64 at 4 C; and,
• IgG DAT ≤1+.
• A hemoglobin level ≤11 mg/dL.
• A total bilirubin level above the normal reference range that is thought to be due to hemolysis.
• Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis, including serogroup B meningococcus and Streptococcus pneumoniae) within five years of screening or willing to complete protocol specified vaccinations.
• Having given written informed consent prior to undertaking any study-related procedure.

You may not qualify if…

• Cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high grade hematologic malignancy, or known solid organ tumor.
• Clinically relevant infection of any kind within one month preceding screening.
• Treatment with anti-CD20 monotherapy within three months or anti CD20 combination therapies within six months prior to screening.
• Concurrent treatment with systemic immunosuppressive agents targeting B- or T-cell function and/or cytotoxic agents within 3 months prior to screening. Concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening.
• Any specific complement system inhibitor within three months prior to screening.
• Concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within three months prior to screening.
• If female, pregnant or lactating.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number :8400002 — Fayetteville, Georgia, United States
• Investigational Site Number :8400009 — St Louis, Missouri, United States
• Investigational Site Number :8400006 — The Bronx, New York, United States
• Investigational Site Number :8400008 — Pittsburgh, Pennsylvania, United States
• Investigational Site Number :8400004 — Seattle, Washington, United States
• Investigational Site Number :2760001 — Essen, Germany
• Investigational Site Number :3800001 — Milan, Milano, Italy
• Investigational Site Number :5280001 — Amsterdam, Netherlands
• Investigational Site Number :5780001 — Bergen, Norway
• Investigational Site Number :8260001 — London, London, City of, United Kingdom

Full record on ClinicalTrials.gov

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