Clinical trial NCT02725515: A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
name: ICON plc
First posted: 2016-04-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
timeFrame: Day 225
Secondary outcomes:
measure: Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169
timeFrame: Day 169
measure: Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients
timeFrame: 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.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Center For Rheumatology
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Rheumatology
state: Georgia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lansing
country: United States
facility: Joshua P June, DO
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Bronx
country: United States
facility: Columbia University Medical Center
state: New York
city: Brooklyn
country: United States
facility: Suny Downstate Medical Center
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Chapel Hill
country: United States
facility: CTRC University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Paramount Medical Research and Consulting LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma, PLLC
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Center for Arthritis Therapy & Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.