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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725515
• Other study ID #: XmAb5871-04
• Status: Completed
• Phase: Phase 2
• Start date: February 16, 2016
• Est. completion date: July 17, 2018

Study information

• Verified date: August 2019
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• XmAb5871

• Placebo to match XmAb5871

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Piedmont Atlanta Rheumatology	Atlanta	Georgia
United States	Columbia University Medical Center	Bronx	New York
United States	Suny Downstate Medical Center	Brooklyn	New York
United States	CTRC University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Paramount Medical Research and Consulting LLC	Cleveland	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center For Rheumatology	Fort Lauderdale	Florida
United States	UC San Diego	La Jolla	California
United States	Joshua P June, DO	Lansing	Michigan
United States	Loma Linda University	Loma Linda	California
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Hospital for Special Surgery	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Arthritis & Rheumatology Center of Oklahoma, PLLC	Oklahoma City	Oklahoma
United States	Washington University	Saint Louis	Missouri
United States	East Bay Rheumatology Medical Group	San Leandro	California
United States	Oklahoma Center for Arthritis Therapy & Research	Tulsa	Oklahoma
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Xencor, Inc.	ICON plc, PPD

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Gladman DD, Ibañez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.