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

Phase 2

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Biological: Placebo to match XmAb5871
Biological: XmAb5871

Registration Number: NCT02725515

Lead Sponsor: Xencor, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to match XmAb5871	Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
XmAb5871	XmAb5871	XmAb5871 administered by IV infusion for up to a total of 16 infusions

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225	Day 225	Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169	Day 169	Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on 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.	Loss of improvement was defined as worsening of disease activity that in the opinion of the principal investigator requires a change in treatment (exclusive of a decrease in oral steroids) AND one of: 1. SELENA- SLEDAI increase of \>=4 points from maximal improvement OR 2. Worsening of at least 1 BILAG A or B score OR 3. New BILAG A or B score.

Trial Locations

Locations (23): Emory University School of Medicine
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Atlanta, Georgia, United States
UC San Diego
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La Jolla, California, United States
Loma Linda University
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Loma Linda, California, United States
Center For Rheumatology
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Fort Lauderdale, Florida, United States
Piedmont Atlanta Rheumatology
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Atlanta, Georgia, United States
Washington University
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Saint Louis, Missouri, United States
Joshua P June, DO
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Lansing, Michigan, United States
Suny Downstate Medical Center
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Brooklyn, New York, United States
Hospital for Special Surgery
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New York, New York, United States
Feinstein Institute for Medical Research
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Manhasset, New York, United States
DJL Clinical Research
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Charlotte, North Carolina, United States
Oklahoma Center for Arthritis Therapy & Research
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Tulsa, Oklahoma, United States
Altoona Center for Clinical Research
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Duncansville, Pennsylvania, United States
Northwestern University
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Chicago, Illinois, United States
University of Chicago
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Chicago, Illinois, United States
Paramount Medical Research and Consulting LLC
🇺🇸
Cleveland, Ohio, United States
NYU Langone Medical Center
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New York, New York, United States
MedStar Washington Hospital Center
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Washington, District of Columbia, United States
East Bay Rheumatology Medical Group
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San Leandro, California, United States
Yale University School of Medicine
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New Haven, Connecticut, United States
Arthritis & Rheumatology Center of Oklahoma, PLLC
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Oklahoma City, Oklahoma, United States
Columbia University Medical Center
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Bronx, New York, United States
CTRC University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, United States