At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 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 Two Doses 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 460 participants across 145 sites in 18 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 moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActive Systemic Lupus Erythematosus
CountriesArgentina, Australia, Brazil, Chile, Colombia, Germany, Hungary, Israel, Italy, New Zealand, Peru, Poland, Romania, South Korea, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsPRA Health Sciences
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionJul 2018
TodayJul 2026
First PostedMay 18, 2015
Enrollment StartJun 9, 2015
Primary CompletionJul 17, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.1 years ago
Interventions
Anifrolumabbiological
Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
Placebodrug
Placebo IV administration every 4 weeks from Week 0 to Week 48