Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc.
• Treatments: Belimumab

Criteria

Primary Inclusion Criteria

• Clinical diagnosis of SLE

• "Active" SLE disease

• On a stable SLE treatment regimen

• History of measurable autoantibodies

Primary Exclusion Criteria

• Received a non-FDA approved investigational agent within last 28 days

• Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days

• Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days

• Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days

• History of renal transplant

• History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days

• History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency

• Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C