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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:8/29/2018
Start Date:February 2016
End Date:July 17, 2018

Use our guide to learn which trials are right for you!

A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity

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


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
We found this trial at
23
sites
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Bronx, New York 10461
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33309
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lansing, Michigan 48910
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
?
mi
from
New York, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Leandro, California 94578
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials