NCT02794285

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 559 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

Detailed description

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period.

Conditions

• Active Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Anifrolumab	Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
DRUG	Placebo	Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

Timeline

• Start date: 2016-06-30
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2016-06-09
• Last updated: 2023-01-13
• Results posted: 2023-01-13

Locations

175 sites across 24 countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, France, Germany, Hungary, Israel, Japan, Lithuania, Mexico, Peru, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom