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
University of Chicago One of the world's premier academic and research institutions, the University of...
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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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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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