A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

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, and e) Immunoglobulin G DAT less than or equal to (\<=) 1+, and, f) No overt malignant disease. * 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. * History of blood transfusion within 6 months of screening, or history of more than one blood transfusion within 12 months of screening. * Clinically relevant infection of any kind within the month preceding enrollment (example, 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 would be adjudicated on a case-by-case basis during the confirmatory review of participant eligibility. * Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at screening. * Positive human immunodeficiency virus antibody at screening. * Treatment with rituximab monotherapy within 3 months or ri…