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
NCT ID: NCT03347422
Last Updated: 2022-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2018-03-17
2021-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BIVV009/BIVV009
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an intravenous (IV) infusion of BIVV009 6.5 g (for participants less than \[\<\]75 kilograms \[kg\]) or 7.5 g dose (for participants greater than or equal to \[\>=\]75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
sutimlimab (BIVV009)
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
Placebo/BIVV009
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if \<75 kg) or 7.5 g (if \>=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
sutimlimab (BIVV009)
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
placebo
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
Interventions
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sutimlimab (BIVV009)
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
placebo
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bioverativ, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Arizona Oncology Associates PC
Tucson, Arizona, United States
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
Centre Hospitalier Henri Mondor
Créteil, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, , Germany
Universitätsklinikum Essen
Essen, , Germany
Univ Ulm, Inst Klin. Transfusions. Immungen
Ulm, , Germany
Hadassah Medical Center
Jerusalem, , Israel
Laniado Hospital
Netanya, , Israel
A. O. Spedali Civili di Brescia
Brescia, , Italy
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
U.O.C. Ematologia- Policlinico "A. Gemelli"
Rome, , Italy
U.O.C. Ematologia Ospedale San Bortolo
Vicenza, , Italy
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Osaka University Hospital
Suita, Osaka, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
Aichi Medical University Hospital
Nagakute, , Japan
Academisch Medisch Centrum
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Haukeland University Hospital
Bergen, , Norway
St Olavs Hospital, Avdeling for blodsykdommer
Trondheim, , Norway
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Clinci i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
St James Hospital, Leeds
Leeds, , United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, , United Kingdom
University College London
London, , United Kingdom
Countries
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References
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Roth A, Broome CM, Barcellini W, Jilma B, Hill QA, Cella D, Tvedt THA, Yamaguchi M, Lee M, Shafer F, Wardecki M, Jiang X, Patel P, Joly F, Weitz IC. Sutimlimab provides clinically meaningful improvements in patient-reported outcomes in patients with cold agglutinin disease: Results from the randomised, placebo-controlled, Phase 3 CADENZA study. Eur J Haematol. 2023 Mar;110(3):280-288. doi: 10.1111/ejh.13903. Epub 2022 Dec 9.
Roth A, Berentsen S, Barcellini W, D'Sa S, Jilma B, Michel M, Weitz IC, Yamaguchi M, Nishimura JI, Vos JMI, Storek M, Wong N, Patel P, Jiang X, Vagge DS, Wardecki M, Shafer F, Lee M, Broome CM. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022 Sep 1;140(9):980-991. doi: 10.1182/blood.2021014955.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003539-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIVV009-04
Identifier Type: OTHER
Identifier Source: secondary_id
EFC16216
Identifier Type: -
Identifier Source: org_study_id