CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,164 enrolled
Drug / intervention
LY2127399 +3 moredrug
Likely dose
LY2127399 120 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.

Search/NCT01196091
NCT01196091Phase 3Completed
CompareCT.gov

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)

Eli Lilly and Company·interventional·Posted Sep 8, 2010·Updated Jun 12, 2018

In Brief

A Phase 3 clinical trial evaluating LY2127399, Placebo every 2 weeks, and 2 other interventions for Systemic Lupus Erythematosus and 2 related conditions. Completed, enrolled 1,164 participants across 192 sites in 23 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 participants with active SLE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
CountriesArgentina, Austria, Belarus, Bulgaria, Canada, Chile, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, North Macedonia, Peru, Philippines, Poland, Puerto Rico, Singapore, South Korea, Thailand, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.8 years ago

Interventions

LY2127399drug

120 mg administered via subcutaneous (SC) 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 of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose

Placebo every 4 weeksdrug

Administered via subcutaneous injection for 52 weeks.

Standard of Caredrug