NCT01639339

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (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 in adult patients with active lupus nephritis.

Detailed description

Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo plus standard therapy	Placebo plus standard therapy
BIOLOGICAL	Belimumab 10 mg/kg plus standard therapy	Belimumab 10 mg/kg plus standard therapy
DRUG	Standard therapy	The standard therapies allowed in this study are: \- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR \- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy

Timeline

• Start date: 2012-07-12
• Primary completion: 2019-07-25
• Completion: 2020-03-12
• First posted: 2012-07-12
• Last updated: 2021-03-19
• Results posted: 2020-07-07

Locations

118 sites across 21 countries: United States, Argentina, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Mexico, Netherlands, Philippines, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom