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

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 rituximab combination therapies (example, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.
• •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.