CompletedPhase 1

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

United States12 participantsStarted 2020-06-15

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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+.

What they're measuring

Assessment of adverse events (AEs)

Timeframe: Screening to Day 106

Trial details

NCT IDNCT04269551

SponsorBioverativ, a Sanofi company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-06

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