A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

Inclusion Criteria:

Body weight of >= 39 kg at screening.
Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for C3d; d) Cold agglutinin titer >= 64 at 4 degree celsius; e) Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and f) No overt malignant disease.
History of at least one documented blood transfusion within 6 months of enrollment.
Hemoglobin level <= 10.0 g/dL.
Bilirubin level above the normal reference range, including participants with Gilbert's Syndrome.

Exclusion Criteria:

Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy.
Clinically relevant infection of any kind within the month preceding enrollment (e.g., active hepatitis C, pneumonia).
Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms adjudicated on a case-by-case basis during the Confirmatory Review of Patient Eligibility.
Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening.
Positive human immunodeficiency virus (HIV) antibody at screening.
Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.