Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Xencor, Inc.
With
PPD Development, LP
ICON plc
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
