A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
NCT ID: NCT02725515
Last Updated: 2019-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2016-02-16
2018-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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XmAb5871
XmAb5871 administered by IV infusion for up to a total of 16 infusions
XmAb5871
Placebo
Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Placebo to match XmAb5871
Interventions
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XmAb5871
Placebo to match XmAb5871
Eligibility Criteria
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Inclusion 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
ICON plc
INDUSTRY
Xencor, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
Merrill JT, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh SZ, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James JA, Zack DJ. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co-Expression Patterns: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Arthritis Rheumatol. 2023 Dec;75(12):2185-2194. doi: 10.1002/art.42652.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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XmAb5871-04
Identifier Type: -
Identifier Source: org_study_id
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