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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT02725515

Run by

Xencor, Inc.

People needed

105

Starts

2016-02-16

Expected to finish

2018-07-17

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC San Diego — La Jolla, California, United States
• Loma Linda University — Loma Linda, California, United States
• East Bay Rheumatology Medical Group — San Leandro, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Center For Rheumatology — Fort Lauderdale, Florida, United States
• Piedmont Atlanta Rheumatology — Atlanta, Georgia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Joshua P June, DO — Lansing, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Suny Downstate Medical Center — Brooklyn, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University Medical Center — The Bronx, New York, United States
• CTRC University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• DJL Clinical Research — Charlotte, North Carolina, United States
• Paramount Medical Research and Consulting LLC — Cleveland, Ohio, United States
• Arthritis & Rheumatology Center of Oklahoma, PLLC — Oklahoma City, Oklahoma, United States
• Oklahoma Center for Arthritis Therapy & Research — Tulsa, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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