NCT02547922

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

Detailed description

This is a Phase 2, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two intravenous (IV) treatment regimens of anifrolumab versus placebo while taking standard of care (SOC) treatment with mycophenolate mofetil (MMF) and corticosteroids in adult subjects with active proliferative lupus nephritis (LN).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	Anifrolumab	Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
DRUG	Placebo	Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112

Timeline

• Start date: 2015-11-04
• Primary completion: 2019-11-26
• Completion: 2021-01-18
• First posted: 2015-09-14
• Last updated: 2021-11-24
• Results posted: 2021-11-24

Locations

80 sites across 17 countries: United States, Argentina, Australia, Belgium, France, Germany, Hungary, Italy, Mexico, Peru, Poland, Russia, Serbia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study