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)

Launched by BIOVERATIV, A SANOFI COMPANY · Nov 16, 2017

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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; 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.