Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis

Summary

This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.

Timeline

Start

2021-10-22

Primary completion

2024-06-05

Completion

2024-06-05

Outcome

Met primary endpoint

paper At week 12, ACR20 response rates were higher in the vunakizumab 120 mg (47.4%) or 240 mg (59.5%) groups vs placebo group (21.6%; P = 0.02 and P = 0.001, respectively). PMID 41632483 ↗

Publications

• Xue Y, Sun L, Zhang N, Chen H, Shi X, Liu S, Chen L, Ma X, Wei H, Jiang Z, Li X, Fan H, Li H, Li J, Wu R, Shi G, Zhu J, Kong X, Lu Y, Liu P, Zheng Q, Bai X, Zhang S, Wan W, Zou H. Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study. Rheumatology (Oxford). 2026 Feb 4;65(2):keag060. doi: 10.1093/rheumatology/keag060.

Drugs

Indications