NCT00732940

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Human Genome Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Belimumab 100 mg SC	Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
DRUG	Belimumab 100 mg SC	Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-10-01
• Completion: 2012-03-01
• First posted: 2008-08-12
• Last updated: 2013-08-07
• Results posted: 2011-05-05

Locations

11 sites across 2 countries: United States, Mexico