NCT03129100

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 773 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Ixekizumab	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2017-05-09
• Primary completion: 2020-05-26
• Completion: 2021-05-27
• First posted: 2017-04-26
• Last updated: 2022-06-13
• Results posted: 2021-06-18

Locations

127 sites across 23 countries: United States, Argentina, Austria, Brazil, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study