Overview

This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatments belimumab, placebo
Phase phase 3
Sponsor GlaxoSmithKline
Collaborator Human Genome Sciences Inc.
Start date May 2011
End date September 2015
Trial size 709 participants
Trial identifier NCT01345253, 113750

Summary

The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
10mg/kg
belimumab
10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
(Placebo Comparator)
placebo
placebo
Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Primary Outcomes

Measure
SLE Responder Index (SRI) Response Rate
time frame: 52 weeks

Secondary Outcomes

Measure
Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52.
time frame: 52 weeks
SLE Responder Index (SRI) 7 Response Rate
time frame: 52 weeks
Number of days of daily prednisone dose ≤ 7.5 mg/day and/or reduced by 50% from baseline over 52 weeks.
time frame: 52 weeks
Time to severe SFI flare over 52 weeks.
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 years and older. - Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria. - Have active SLE disease. - Have positive anti-nuclear antibody (ANA) test results. - Are on a stable SLE treatment regimen. - Females of childbearing age are willing to use appropriate contraception Exclusion Criteria: - Have received treatment with any B cell targeted therapy at any time. - Have received a biologic investigational agent in the past year. - Have received 3 or more courses of systemic corticosteroids in the past year. - Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0. - Have severe lupus kidney disease. - Have active central nervous system (CNS) lupus. - Have had a major organ transplant. - Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE. - Have a planned surgical procedure. - Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix. - Have required management of acute or chronic infections in the past 60 days. - Have current drug or alcohol abuse or dependence. - Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C. - Have an IgA deficiency. - Have severe laboratory Abnormalities. - Have had anaphylactic reaction to X-ray contrast agents or biologic agents. - Suicidal behavior or ideation.

Additional Information

Official title GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
Description The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.