NCT02446912

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

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (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 moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Detailed description

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. The study will be performed in adult subjects aged 18 to 70 years of age.

Conditions

• Active Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Anifrolumab	Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
DRUG	Placebo	Placebo IV administration every 4 weeks from Week 0 to Week 48

Timeline

• Start date: 2015-06-09
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2015-05-18
• Last updated: 2023-01-12
• Results posted: 2019-12-05

Locations

145 sites across 18 countries: United States, Argentina, Australia, Brazil, Chile, Colombia, Germany, Hungary, Israel, Italy, New Zealand, Peru, Poland, Romania, South Korea, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study