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
Condition: Cold Agglutinin Disease
MeSH terms: Anemia, Hemolytic, Autoimmune
Intervention: sutimlimab (BIVV009); placebo
Intervention description: Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.); Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of Part A was to determine whether sutimlimab administration resulted in a
      greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb)
      level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD)
      without a recent history of blood transfusion. The purpose of Part B was to evaluate the
      long-term safety and tolerability of sutimlimab in participants with primary CAD.
    

Eligibility criteria:

        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 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.