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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
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

NCT03347422

CompletedPhase 3

Sponsor: Bioverativ, a Sanofi company

Conditions: Cold Agglutinin Disease

Interventions: sutimlimab (BIVV009), placebo

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 (\>=)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 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, 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.
Locations (53)
  • Tucson, Arizona, United States
  • Los Angeles, California, United States
  • Georgetown, District of Columbia, United States
  • Weston, Florida, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, 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
  • West Perth, Western Australia, Australia
  • Vienna, Austria
  • Antwerp, Belgium
  • Leuven, Belgium
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Angers, France
  • Caen, France
  • Créteil, France
  • Pierre-Bénite, France
  • Dresden, Germany
  • Essen, Germany
  • Ulm, Germany
  • + 23 more on CT.gov