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

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

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: XmAb5871; Biological: Placebo to match XmAb5871

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical Group
  • Connecticut
    • New Haven, Connecticut, United States, 06250
      • Yale University School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • Center for Rheumatology
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Rheumatology
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Joshua P June, DO
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Bronx, New York, United States, 10461
      • Columbia University Medical Center
    • Brooklyn, New York, United States, 11203
      • SUNY downstate Medical Center
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • CTRC University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44130
      • Paramount Medical Research and Consulting LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Arthritis & Rheumatology Center of Oklahoma, PLLC
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Center For Arthritis Therapy & Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XmAb5871; XmAb5871 administered by IV infusion for up to a total of 16 infusions	Biological: XmAb5871
Placebo Comparator: Placebo; Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions	Biological: Placebo to match XmAb5871

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169	Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169	Day 169
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients	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: SELENA- SLEDAI increase of >=4 points from maximal improvement OR; Worsening of at least 1 BILAG A or B score OR; New BILAG A or B score.	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.

Collaborators and Investigators

• Sponsor: Xencor, Inc.
• Collaborators: PPD; ICON plc

Publications and helpful links

General Publications

• Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
• Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): July 17, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: XmAb5871-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No