Summary

for people ages 18-65 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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

Official Title

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

Keywords

Systemic Lupus Erythematosus Lupus Erythematosus, Systemic XmAb5871

Eligibility

You can join if…

Open to people ages 18-65

  • 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 CAN'T join 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

Locations

  • UC San Diego
    La Jolla California 92037 United States
  • Loma Linda University
    Loma Linda California 92354 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Xencor, Inc.
ID
NCT02725515
Phase
Phase 2
Study Type
Interventional
Last Updated
March 6, 2018