At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of SLE
- ✓Active SLE disease
- ✓On a stable SLE treatment regimen
- ✓History of measurable autoantibodies
- ✕Received non-FDA approved investigational agent within 28 days
- ✕Cyclosporin, IVIG, or plasmapheresis within 90 days
- ✕Active lupus nephritis requiring hemodialysis, cyclophosphamide, or high-dose prednisone (>100 mg/day) within 90 days
- ✕Active CNS lupus requiring therapeutic intervention within 60 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
In Brief
A Phase 2 clinical trial evaluating Placebo, Belimumab 1 mg/kg, and 2 other interventions for Lupus Erythematosus, Systemic. Completed, enrolled 449 participants across 62 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.