Status:
COMPLETED
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
Lead Sponsor:
Bioverativ, a Sanofi company
Conditions:
Cold Agglutinin Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The planned total study duration per participant was approximately 1.5 to 2.5 years.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03347422
Start Date
March 17 2018
End Date
December 3 2021
Last Update
December 23 2022
Active Locations (53)
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1
Arizona Oncology Associates PC
Tucson, Arizona, United States, 85711
2
USC/Keck School of Medicine
Los Angeles, California, United States, 90033
3
Georgetown University Medical Center
Georgetown, District of Columbia, United States, 20007
4
Cleveland Clinic Florida
Weston, Florida, United States, 33331