NCT01753193

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

Detailed description

This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
BIOLOGICAL	Anifrolumab	Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Timeline

• Start date: 2013-03-28
• Primary completion: 2018-07-18
• Completion: 2018-07-18
• First posted: 2012-12-20
• Last updated: 2019-07-31
• Results posted: 2019-07-31

Locations

57 sites across 13 countries: United States, Brazil, Bulgaria, Colombia, Czechia, Hungary, Mexico, Peru, Poland, Romania, South Korea, Taiwan, Ukraine