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)
Completed · Phase 3
Conditions studied: Agglutinin Disease, Cold
In brief
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.
Key facts
- Study ID
- NCT03347396
- Run by
- Bioverativ, a Sanofi company
- People needed
- 24
- Starts
- 2018-03-05
- Expected to finish
- 2021-10-05
- Last updated by the study team
- 2022-10-31
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; 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.
You may not qualify if…
- 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.
Where it is running
- Arizona Oncology Associates PC — Tucson, Arizona, United States
- USC/Keck School of Medicine — Los Angeles, California, United States
- The Oncology Institute of Hope and Innovation — Whittier, California, United States
- Georgetown University Medical Center — Georgetown, District of Columbia, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, 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
- Medical University of Vienna — Vienna, Austria
- ZNA Stuivenberg — Antwerp, Belgium
- Centre Hospitalier Jolimont — La Louvière, Belgium
- University Hospitals Leuven — Leuven, Belgium
- St. Michael's Hospital — Toronto, Ontario, Canada
- McGill University Health Center — Montreal, Quebec, Canada
- University of Alberta — Edmonton, Canada
- CHU de Caen — Caen, France
- Centre Hospitalier Henri Mondor — Créteil, France
Full record on ClinicalTrials.gov
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