NCT02446899

Efficacy and Safety 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 Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 373 (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 anifrolumab versus placebo in adult participants 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 anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral corticosteroids (OCS), antimalarial, and/or immunosuppressants. The study will be performed in adult participants aged 18 to 70 years of age. Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed intravenous dose of anifrolumab 300 mg or placebo every 4 weeks for a total of 13 doses (Week 0 to Week 48), with the primary endpoint evaluated at the Week 52 visit. Investigational product will be administered as an intravenous infusion (IV) via an infusion pump over a minimum of 30 minutes, every 4 weeks.

Conditions

• Active Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Anifrolumab	Intravenous infusion (IV)
DRUG	Placebo	Intravenous infusion (IV)

Timeline

• Start date: 2015-07-09
• Primary completion: 2018-09-27
• Completion: 2018-09-27
• First posted: 2015-05-18
• Last updated: 2023-01-10
• Results posted: 2020-03-18

Locations

113 sites across 15 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, France, Germany, Japan, Lithuania, Mexico, Russia, South Africa, South Korea, Spain

Regulatory

• FDA-regulated drug study