NCT01488708

On Open-Label Study in Participants With Systemic Lupus Erythematosus

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,518 (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 long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).

Conditions

• Systemic Lupus Erythematosus
• Connective Tissue Disease
• Autoimmune Disease

Interventions

Type	Name	Description
DRUG	LY2127399	120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
DRUG	Placebo	Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-12-08
• Last updated: 2018-05-17
• Results posted: 2018-05-17

Locations

1 site across 1 country: United States