At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 218 enrolled
Drug / intervention
Anifrolumabbiological
Likely dose
Anifrolumab 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating Anifrolumab for Lupus Erythematosus, Systemic. Completed, enrolled 218 participants across 57 sites in 13 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Erythematosus, Systemic
CountriesBrazil, Bulgaria, Colombia, Czechia, Hungary, Mexico, Peru, Poland, Romania, South Korea, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartMar 2013
Primary CompletionJul 2018
TodayJul 2026
First PostedDec 20, 2012
Enrollment StartMar 28, 2013
Primary CompletionJul 18, 2018
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.5 years ago
Interventions
Anifrolumabbiological
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.