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

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ClinicalTrials.gov Identifier: NCT02725515
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
PPD
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: XmAb5871 Biological: Placebo to match XmAb5871 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
Study Start Date : February 2016
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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



Primary Outcome Measures :
  1. Percentage of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225 [ Time Frame: Day 225 ]

Secondary Outcome Measures :
  1. Time to loss of systemic lupus erythematosus disease activity improvement achieved by a short intramuscular injection steroid therapy [ Time Frame: Day 225 ]
  2. Number of participants who experience Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) as assessed by CTCAE v4.3 [ Time Frame: Day 253 ]
  3. Percentage of participants who experience Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) as assessed by CTCAE v4.3 [ Time Frame: Day 253 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725515


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

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02725515     History of Changes
Other Study ID Numbers: XmAb5871-04
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases