NCT01196091

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 Participants With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,164 (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 participants with active SLE.

Conditions

• Systemic Lupus Erythematosus
• Connective Tissue Disease
• Autoimmune Disease

Interventions

Type	Name	Description
DRUG	LY2127399	120 mg administered via subcutaneous (SC) 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 of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose
DRUG	Placebo every 4 weeks	Administered via subcutaneous injection for 52 weeks.
DRUG	Standard of Care

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-07-01
• Completion: 2015-06-01
• First posted: 2010-09-08
• Last updated: 2018-06-12
• Results posted: 2018-06-12

Locations

192 sites across 23 countries: United States, Argentina, Austria, Belarus, Bulgaria, Canada, Chile, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, North Macedonia, Peru, Philippines, Poland, Puerto Rico, Singapore, South Korea, Thailand, Ukraine