A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
1 other identifier
interventional
105
1 country
23
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2016
CompletedStudy Start
First participant enrolled
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2018
CompletedResults Posted
Study results publicly available
August 9, 2019
CompletedAugust 20, 2019
August 1, 2019
2.4 years
January 8, 2016
June 6, 2019
August 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225
Day 225
Secondary Outcomes (2)
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169
Day 169
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients
From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.
Study Arms (2)
XmAb5871
EXPERIMENTALXmAb5871 administered by IV infusion for up to a total of 16 infusions
Placebo
PLACEBO COMPARATORPlacebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
- PPD Development, LPcollaborator
- ICON plccollaborator
Study Sites (23)
UC San Diego
La Jolla, California, 92037, United States
Loma Linda University
Loma Linda, California, 92354, United States
East Bay Rheumatology Medical Group
San Leandro, California, 94578, United States
Yale University School of Medicine
New Haven, Connecticut, 06250, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Center For Rheumatology
Fort Lauderdale, Florida, 33309, United States
Piedmont Atlanta Rheumatology
Atlanta, Georgia, 30309, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Joshua P June, DO
Lansing, Michigan, 48910, United States
Washington University
St Louis, Missouri, 63110, United States
Suny Downstate Medical Center
Brooklyn, New York, 11203, United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University Medical Center
The Bronx, New York, 10461, United States
CTRC University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517, United States
DJL Clinical Research
Charlotte, North Carolina, 28210, United States
Paramount Medical Research and Consulting LLC
Cleveland, Ohio, 44130, United States
Arthritis & Rheumatology Center of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, 74104, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Related Publications (3)
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.
PMID: 1599520BACKGROUNDGladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PMID: 11838846BACKGROUNDMerrill 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.
PMID: 37459248DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Prior to database lock, an evaluation of early discontinuation rates indicated that the efficacy-evaluable population might be insufficient to power the primary analysis. An additional 15 patients were enrolled beyond the originally planned 90.
Results Point of Contact
- Title
- Vice President, Biometrics
- Organization
- Xencor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2016
First Posted
April 1, 2016
Study Start
February 16, 2016
Primary Completion
July 17, 2018
Study Completion
July 17, 2018
Last Updated
August 20, 2019
Results First Posted
August 9, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share