NCT01261793

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 791 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Placebo	Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
DRUG	Epratuzumab	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
DRUG	Epratuzumab	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2010-12-16
• Last updated: 2020-12-04
• Results posted: 2018-06-29

Locations

133 sites across 16 countries: United States, Brazil, Canada, France, Germany, Hungary, India, Italy, Mexico, Poland, Romania, Russia, South Africa, Spain, Ukraine, United Kingdom