Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Participants in this trial will receive intravenous sutimlimab in Part A. Participants who complete Part A through to Day 182 (end of treatment) according to the protocol will participate in Part B. Participants in Part B will continue to receive sutimlimab up to one year after last patient out (LPO) in Part A.
Conditions
This trial is treating people with primary cold agglutinin disease
Eligibility
Inclusion
- 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
- 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.
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bioverativ Therapeutics Inc.
Scientific Title
A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion
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