At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 559 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 Extension Study to Characterise the Long-term Safety and Tolerability 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 559 participants across 175 sites in 24 countries.
Detailed Summary
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActive Systemic Lupus Erythematosus
CountriesArgentina, Australia, Bulgaria, Canada, Chile, Colombia, France, Germany, Hungary, Israel, Japan, Lithuania, Mexico, Peru, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsPRA Health Sciences
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJun 2016
Primary CompletionDec 2021
TodayJul 2026
First PostedJun 9, 2016
Enrollment StartJun 30, 2016
Primary CompletionDec 21, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.1 years ago
Interventions
Anifrolumabbiological
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Placebodrug
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses