NCT01484496

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 839 (actual)
• Sponsor: Human Genome Sciences Inc., a GSK Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Detailed description

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Placebo
BIOLOGICAL	Belimumab 200 mg SC	Belimumab 200 mg SC
DRUG	Standard therapy	Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

Timeline

• Start date: 2011-11-16
• Primary completion: 2015-02-13
• Completion: 2015-10-01
• First posted: 2011-12-02
• Last updated: 2018-06-06
• Results posted: 2017-07-25

Locations

207 sites across 31 countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom