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

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.

Timeline

Start

2017-05-09

Primary completion

2020-05-26

Completion

2021-05-27

Outcome

Met primary endpoint

registry analysis (superiority test); Combined IXE vs Placebo; p <0.001; Odds Ratio (OR) 4.35 (95% CI 2.03 to 9.35); Regression, Logistic NCT03129100 ↗

Publications

• Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
• Braun J, Kiltz U, Deodhar A, Tomita T, Dougados M, Bolce R, Sandoval D, Lin CY, Walsh J. Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. RMD Open. 2022 Jul;8(2):e002165. doi: 10.1136/rmdopen-2021-002165.

Drugs

Indications