Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus

The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.

Key Inclusion Criteria:

• Clinical diagnosis of SLE by ACR criteria
• Stable SLE disease activity
• On stable SLE treatment regimen
• History of measurable autoantibodies

Key Exclusion Criteria:

• 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