At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 373 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 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
In Brief
A Phase 3 clinical trial evaluating Anifrolumab and Placebo for Active Systemic Lupus Erythematosus. Completed, enrolled 373 participants across 113 sites in 15 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActive Systemic Lupus Erythematosus
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, France, Germany, Japan, Lithuania, Mexico, Russia, South Africa, South Korea, Spain, United States
CollaboratorsPRA Health Sciences
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJul 2015
Primary CompletionSep 2018
TodayJul 2026
First PostedMay 18, 2015
Enrollment StartJul 9, 2015
Primary CompletionSep 27, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.1 years ago
Interventions
Anifrolumabbiological
Intravenous infusion (IV)
Placebodrug
Intravenous infusion (IV)