At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 147 enrolled
Drug / intervention
Anifrolumab +1 morebiological
Likely dose
Not stated in 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 Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis
In Brief
A Phase 2 clinical trial evaluating Anifrolumab and Placebo for Lupus Nephritis. Completed, enrolled 147 participants across 80 sites in 17 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesArgentina, Australia, Belgium, France, Germany, Hungary, Italy, Mexico, Peru, Poland, Russia, Serbia, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsParexel
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartNov 2015
Primary CompletionNov 2019
Study CompletionJan 2021
TodayJul 2026
First PostedSep 14, 2015
Enrollment StartNov 4, 2015
Primary CompletionNov 26, 2019
Study CompletionJan 18, 2021
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.8 years ago
Interventions
Anifrolumabbiological
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Placebodrug
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112