A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:8/29/2018
Start Date:February 2016
End Date:July 17, 2018

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A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity

The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus
Erythematosus (SLE) disease activity improvement achieved by a brief course of
disease-suppressing steroid therapy


Inclusion Criteria:

- Patients with a diagnosis of SLE as defined by the ACR criteria

- Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented
within one year prior to randomization

- Investigator has assessed the patient and in their judgment, the SLE disease activity
is not organ threatening

- Both investigator and patient agree that it is acceptable to discontinue their current
immunosuppressant SLE medications and receive a brief course of IM steroid therapy

- If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of
prednisone to enter screening, and must be able to taper to ≤10 mg/day by
randomization

Exclusion Criteria:

- History or evidence of a clinically unstable/uncontrolled disorder, condition or
disease, other than SLE that, in the opinion of the investigator would pose a risk to
patient safety or interfere with the study evaluation, procedures or completion

- Patients who have organ threatening manifestations of SLE including active Class 3 or
4 lupus nephritis requiring induction or maintenance therapy or any other disorder for
which stopping SLE therapy is contraindicated

- Active CNS lupus such as seizures or psychosis that in the opinion of the investigator
would preclude participation

- Unstable hemolytic anemia or thrombocytopenia

- Patient is pregnant or breast feeding, or planning to become pregnant while
participating in the study

- Use of any biologic therapy (including belimumab) within 6 months of randomization, or
prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12
months of randomization
We found this trial at
23
sites
450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Atlanta, GA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Atlanta, Georgia 30309
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Bronx, New York 10461
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28210
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303 East Superior Street
Chicago, Illinois 60611
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Cleveland, OH
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Duncansville, Pennsylvania 16635
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Fort Lauderdale, Florida 33309
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La Jolla, California 92093
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Lansing, Michigan 48910
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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Manhasset, NY
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10016
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Oklahoma City, Oklahoma 73103
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Saint Louis, Missouri 63110
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San Leandro, California 94578
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Washington, District of Columbia
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