Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Inclusion Criteria:

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
• Active SLE disease
• On stable SLE treatment regimen

Exclusion Criteria:

• Pregnant or nursing
• Have received treatment with an B cell targeted therapy
• Have received treatment with a biologic investigational agent in the past year
• Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
• Have severe lupus kidney disease
• Have active central nervous system (CNS) lupus
• Have required management of acute or chronic infections with the past 60 days
• Have current drug or alcohol abuse or dependence or within the past year
• Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention