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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02446899
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date July 9, 2015
Completion date September 27, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04931563 - Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) Phase 3
Terminated NCT04680637 - Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus Phase 2
Completed NCT02446912 - Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus Phase 3
Completed NCT02794285 - Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus Phase 3