NCT01205438

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,124 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

Conditions

• Systemic Lupus Erythematosus
• Connective Tissue Disease
• Autoimmune Disease

Interventions

Type	Name	Description
DRUG	LY2127399	120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
DRUG	Placebo every 2 weeks	Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
DRUG	Placebo every 4 weeks	Administered via subcutaneous injection for 52 weeks.

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-08-01
• Completion: 2015-03-01
• First posted: 2010-09-20
• Last updated: 2018-07-17
• Results posted: 2018-06-19

Locations

185 sites across 21 countries: United States, Australia, Brazil, Canada, Ecuador, France, Hungary, India, Israel, Latvia, Malaysia, Mexico, New Zealand, Romania, Russia, Serbia, South Africa, Spain, Taiwan, Tunisia, United Kingdom