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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725515
Recruitment Status : Completed
First Posted : April 1, 2016
Results First Posted : August 9, 2019
Last Update Posted : August 20, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
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
Actual Study Start Date : February 16, 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 ]
    Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225


Secondary Outcome Measures :
  1. Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 [ Time Frame: Day 169 ]
    Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169

  2. Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients [ Time Frame: 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. ]

    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:

    1. SELENA- SLEDAI increase of >=4 points from maximal improvement OR
    2. Worsening of at least 1 BILAG A or B score OR
    3. New BILAG A or B score.



Information from the National Library of Medicine

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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
Show Show 23 study locations
Sponsors and Collaborators
Xencor, Inc.
PPD
ICON plc
  Study Documents (Full-Text)

Documents provided by Xencor, Inc.:
Study Protocol  [PDF] July 29, 2016
Statistical Analysis Plan  [PDF] May 2, 2018

Publications:
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02725515    
Other Study ID Numbers: XmAb5871-04
First Posted: April 1, 2016    Key Record Dates
Results First Posted: August 9, 2019
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases