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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)
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)

NCT03347396

CompletedPhase 3

Sponsor: Bioverativ, a Sanofi company

Conditions: Agglutinin Disease, Cold

Interventions: BIVV009

Countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Israel

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to \>= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had 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 CAD.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (49)
  • Tucson, Arizona, United States
  • Los Angeles, California, United States
  • Whittier, California, United States
  • Georgetown, District of Columbia, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Valhalla, New York, United States
  • Greenville, North Carolina, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Madison, Wisconsin, United States
  • Buderim, Queensland, Australia
  • Ballarat, Victoria, Australia
  • Clayton, Victoria, Australia
  • Vienna, Austria
  • Antwerp, Belgium
  • La Louvière, Belgium
  • Leuven, Belgium
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Edmonton, Canada
  • Caen, France
  • Créteil, France
  • Lyon, France
  • Dresden, Germany
  • Essen, Germany
  • Ulm, Germany
  • Jerusalem, Israel
  • + 19 more on CT.gov