A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Summary

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).

Timeline

Start

2020-04-10

Primary completion

2021-03-31

Completion

2022-03-17

Outcome

Met primary endpoint

registry NUMBER Placebo: 7.8 Percentage of Participants NUMBER Ixekizumab 80mg Q4W: 40.9 Percentage of Participants NCT04285229 ↗

registry analysis (superiority test); Placebo vs Ixekizumab 80mg Q4W; p <0.001; Odds Ratio (OR) 7.64 (95% CI 2.68 to 21.76); Regression, Logistic NCT04285229 ↗

Publications

• Sengupta R, Machado PM, Goupille P, Rudwaleit M, Sheesh M, Ng KJ, Ngantcha M, Yan Y, Russ H, Doridot G, Xue Y, Poddubnyy D, Baraliakos X, Navarro-Compan V. Efficacy of Ixekizumab in Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level: A Pooled Analysis of Phase III Trials. Rheumatol Ther. 2026 Jun 2. doi: 10.1007/s40744-026-00862-1. Online ahead of print.
• Zhu X, Hu J, Liu D, Li J, Wu H, Sun L, Dai L, Tan C, Li Z, Xiao Z, Wang Y, Dong L, Yan Y, Li H, Zou H. Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging. Rheumatol Ther. 2026 Apr;13(2):313-327. doi: 10.1007/s40744-025-00819-w. Epub 2026 Jan 6.
• Kong N, Hu J, Liu D, Li J, Wu H, Sun L, Lie D, Tan C, Li Z, Xiao Z, Huang C, Xu J, Yan Y, Li H, Zou H. Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level. Rheumatol Ther. 2025 Aug;12(4):627-639. doi: 10.1007/s40744-025-00765-7. Epub 2025 May 9.
• Zhu X, Hu J, Liu D, Li J, Wu H, Sun L, Dai L, Tan C, Li Z, Xiao Z, Li X, Yan Y, Dou G, Sun Y, Zou H. Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Aug;11(4):1011-1022. doi: 10.1007/s40744-024-00688-9. Epub 2024 Jun 21.
• Xue Y, Hu J, Liu D, Li J, Wu H, Tan C, Dai L, Sun L, Li Z, Xiao Z, Huang C, Yan Y, Ji F, Chen R, Zou H. Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. BioDrugs. 2024 Jan;38(1):145-156. doi: 10.1007/s40259-023-00625-2. Epub 2023 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixekizumab	Monoclonal antibody	80 mg	Subcutaneous

Indications