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A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02725515•Xencor, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (23)

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

Key Dates

Start Date

February 16, 2016

Primary Completion Date

July 17, 2018

Completion Date

July 17, 2018

Last Updated

August 20, 2019

Enrollment

105

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

XmAb5871

BIOLOGICAL

Placebo to match XmAb5871

BIOLOGICAL

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

NCT07371468

Systemic Lupus Erythematosus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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