CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,124 enrolled
Drug / intervention
LY2127399 +2 moredrug
Likely dose
LY2127399 120mgfrom 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.

Search/NCT01205438
NCT01205438Phase 3Completed
CompareCT.gov

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)

Eli Lilly and Company·interventional·Posted Sep 20, 2010·Updated Jul 17, 2018

In Brief

A Phase 3 clinical trial evaluating LY2127399, Placebo every 2 weeks, and 1 other intervention for Systemic Lupus Erythematosus and 2 related conditions. Completed, enrolled 1,124 participants across 185 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
CountriesAustralia, Brazil, Canada, Ecuador, France, Hungary, India, Israel, Latvia, Malaysia, Mexico, New Zealand, Romania, Russia, Serbia, South Africa, Spain, Taiwan, Tunisia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2010
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.8 years ago

Interventions

LY2127399drug

120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug

Placebo every 2 weeksdrug

Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.

Placebo every 4 weeksdrug

Administered via subcutaneous injection for 52 weeks.