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 |
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
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
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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