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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bioverativ, a Sanofi company
The planned total study duration per participant was approximately 1.5 to 2.5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
