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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

NCT03347422•Bioverativ, a Sanofi company

View on ClinicalTrials.gov

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 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.

Detailed Description

The planned total study duration per participant was approximately 1.5 to 2.5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (53)

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

Key Dates

Start Date

March 17, 2018

Primary Completion Date

December 3, 2021

Completion Date

December 3, 2021

Last Updated

December 23, 2022

Enrollment

ACTUAL participants

Conditions

Cold Agglutinin Disease

Interventions

sutimlimab (BIVV009)

DRUG

placebo

DRUG

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

NCT05096403

Cold Agglutinin Disease

View study

COMPLETEDPHASE2

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

NCT02689986

Cold Agglutinin DiseaseAutoimmune Hemolytic Anemia

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders