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 (Cadenza Study)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:November 20, 2017
End Date:August 2020
Contact:Bioverativ Therapeutics Inc, Waltham, MA, USA
Email:clinicaltrials@bioverativ.com
Phone:1-844-308-0808(US only)

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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

The purpose of Part A is to determine whether sutimlimab administration results in a greater
than or equal to (>=)1.5 gram 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 is to evaluate the long-term
safety and tolerability of sutimlimab in participants with primary CAD.


Inclusion Criteria:

- Body weight of greater than or equal to (>=) 39 kilogram (kg) at Screening

- Confirmed diagnosis of primary cold agglutinin disease (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 (IgG) DAT less than or equal to (<=)
1+, and, f) No overt malignant disease

- Hemoglobin level <= 10.0 gram per deciliter (g/dL)

- Bilirubin level above the normal reference range, including patients with Gilbert's
Syndrome

Exclusion Criteria:

- Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active
hematologic malignancy

- Clinically relevant infection of any kind within the month preceding enrollment
(example, active hepatitis C, pneumonia)

- Clinical diagnosis of systemic lupus erythematosus (SLE); or other autoimmune
disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of
long-standing duration without associated clinical symptoms will be 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 (example, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs)
within 6 months prior to enrollment
We found this trial at
16
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Dr. Joseph E. Kiss
Phone: 412-623-1668
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Kuter dkuter@partners.org, 617-726-8033
Phone: 617-726-8033
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-525-9337
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Bernard Silver, MD
Phone: 216-444-2774
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Dr. J. Eric Russell
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Dr. Chakra Chaulagain
Phone: 954-487-2255
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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9 Ochre Way
Buderim, Queensland 4556
Phone: +61 7 54563797
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3800 Reservoir Road Northwest
Georgetown, District of Columbia 20007
Principal Investigator: Catherine Broome
Phone: 713-559-7633
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Georgetown,
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Dr. Darla Liles
Phone: 252-744-1720
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Los Angeles, California 90033
Principal Investigator: Dr. Ilene Weitz
Phone: 323-865-0371
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Madison, Wisconsin 53792
Principal Investigator: Dr. Eliot Williams
Phone: 608-262-5223
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New York, New York 10467
Principal Investigator: Dr. Irina Murakhovskaya
Phone: 718-430-2748
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Tucson, Arizona 85745
Principal Investigator: Dr. Michael Boxer
Phone: 520-668-5678
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Valhalla, New York 10595
Principal Investigator: Seah Lim, MD
Phone: 914-533-4115
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Whittier, California 90606
Principal Investigator: Dr. Richy Agajanian
Phone: 1 562-693-4477
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