Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

Phase 2/3 Completed 548 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Timeline

Start: 2021-06-09
Primary completion: 2023-11-03
Completion: 2024-02-28

Outcome

Met primary endpoint

paper At week 16, the ASAS20 response rate was significantly higher with vunakizumab, 120 mg vs placebo (193 [65.6%] vs 62 [42.5%], respectively; difference, 23.2% PMID 42101839 ↗

Publications

Zhu J, Zhao C, Mi C, Liu S, Wu R, Li T, Duan X, Sun L, Yang L, He X, Liu W, Li Y, Ma L, Du H, Liu Y, Chen G, Zhang H, Wang T, Liu X, Shi X, Liu J, Wu H, Sun H, Xue Y, Chai K, Li H, Hu J, Dong F, Lin L, Du Q, Bai X, Huang F. Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611632. doi: 10.1001/jamanetworkopen.2026.11632.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	vunakizumab	Protein / enzyme biologic	120 mg	Subcutaneous
Subject	vunakizumab	Protein / enzyme biologic	240 mg	Subcutaneous