Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Biological: PlaceboBiological: belimumab
- Registration Number
- NCT00657007
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Clinical diagnosis of SLE by ACR criteria
- Stable SLE disease activity
- On stable SLE treatment regimen
- History of measurable autoantibodies
Key
- Pregnant or nursing
- Received a non-FDA approved investigational agent within last 28 days
- Received cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 6 months
- Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 6 months
- Active central nervous system (CNS) lupus requiring medical intervention within last 6 months
- History of renal transplant
- History of clinical evidence of an active significant acute or chronic diseases
- Have required management or hospitalization of any infection within last 4 weeks.
- History of hypogammaglobulinemia or IgA deficiency
- Have current drug or alcohol addiction
- History of or test positive at screening for HIV, Hepatitis B or Hepatitis C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo IV infusion over 2 hours Belimumab 1 mg/kg belimumab 1 mg/kg IV infused over 2 hours Belimumab 4 mg/kg belimumab 4 mg/kg IV infused over 2 hours Beimumab 10 mg/kg belimumab 10 mg/kg IV infused over 2 hours Belimumab 20 mg/kg belimumab 20 mg/kg IV infused over 2 hours
- Primary Outcome Measures
Name Time Method To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. Days 0-105
- Secondary Outcome Measures
Name Time Method To evaluate the effect of belimumab on clinical disease activity, total serum IgG (and IgM, IgA, IgE) and concentrations of peripheral mature B lymphocytes and plasmacytoid cells, and markers of SLE disease activity, including autoantibodies. Days 0-105
Trial Locations
- Locations (18)
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Pittsburgh School of Medicine
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Hospital for Joint Diseases
🇺🇸New York, New York, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Rush-Presbyterian-St Luke's Medical Center
🇺🇸Chicago, Illinois, United States
The University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
University of California-Los Angeles
🇺🇸Los Angeles, California, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States