At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 793 enrolled
Drug / intervention
Epratuzumab +2 moredrug
Likely dose
Epratuzumab 600 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 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
In Brief
A Phase 3 clinical trial evaluating Epratuzumab and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 793 participants across 141 sites in 21 countries.
Detailed Summary
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesAustralia, Belgium, Brazil, Bulgaria, Czechia, Estonia, France, Germany, India, Israel, Italy, Lithuania, Mexico, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionMay 2015
TodayJul 2026
First PostedDec 17, 2010
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.5 years ago
Interventions
Epratuzumabdrug
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Epratuzumabdrug
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Placebodrug
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles