NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 1

Sponsor: Bioverativ, a Sanofi company

Conditions: Autoimmune Haemolytic Anaemia

Interventions: BIVV020

Countries: United States, Germany, Italy, Netherlands, Norway, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria :

* Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by:

1. Chronic hemolysis per Investigator's judgement,
2. Polyspecific direct antiglobulin test (DAT) positive,
3. Monospecific DAT strongly positive for C3d,
4. Cold agglutinin (CAg) titer ≥ 64 at 4 C; and,
5. 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.

Exclusion criteria:

* 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.

Locations (10)

Fayetteville, Georgia, United States
St Louis, Missouri, United States
The Bronx, New York, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Essen, Germany
Milan, Milano, Italy
Amsterdam, Netherlands
Bergen, Norway
London, London, City of, United Kingdom