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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cold Agglutinin Disease

In brief

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.

Key facts

Study ID

NCT03347422

Run by

Bioverativ, a Sanofi company

People needed

42

Starts

2018-03-17

Expected to finish

2021-12-03

Last updated by the study team

2022-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• USC/Keck School of Medicine — Los Angeles, California, United States
• Georgetown University Medical Center — Georgetown, District of Columbia, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Montefiore Medical Center — New York, New York, United States
• New York Medical College at Westchester Medical Center — Valhalla, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• UW Hospitals and Clinics — Madison, Wisconsin, United States
• USC Health Clinics — Buderim, Queensland, Australia
• Ballarat Oncology & Haematology — Ballarat, Victoria, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Perth Blood Institute — West Perth, Western Australia, Australia
• Medical University of Vienna — Vienna, Austria
• ZNA Stuivenberg — Antwerp, Belgium
• University Hospitals Leuven — Leuven, Belgium
• St. Michael's Hospital — Toronto, Ontario, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• CHU d'Angers — Angers, France
• Hôpital de Caen — Caen, France
• Arizona Oncology Associates PC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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