At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, and 1 other intervention for Lupus Nephritis. Completed, enrolled 448 participants across 118 sites in 21 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Study Details
Timeline
Interventions
Placebo plus standard therapy
Belimumab 10 mg/kg plus 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