NCT01438489

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

Detailed description

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment regimens in adult participants with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE. The investigational product (anifrolumab or placebo) will be administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Anifrolumab 300 mg	Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
BIOLOGICAL	Anifrolumab 1000 mg	Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
OTHER	Placebo	Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-09-22
• Last updated: 2016-10-07
• Results posted: 2016-08-15

Locations

79 sites across 14 countries: United States, Brazil, Bulgaria, Colombia, Czechia, Hungary, India, Mexico, Peru, Poland, Romania, South Korea, Taiwan, Ukraine