A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

Summary

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.

Timeline

Start

2020-07-31

Primary completion

2023-01-30

Completion

2023-09-21

Outcome

Met primary endpoint

paper ACR20 response rates were significantly higher in the ivarmacitinib 4 mg (70.4%) and 8 mg (75.1%) groups compared with the placebo group (40.4%; both p<0.0001). PMID 39919893 ↗

Publications

• Liu J, Jiang Y, Zhang S, Liu S, Su J, Lin C, He X, Wu R, Yang L, Liu H, Duan X, Xu S, Luo H, Liu J, Xie Q, Mi C, Chen L, Zhang N, Gong H, Zhu J, Li Y, Wei H, Qian L, Wang J, Shi X, Jin H, Jiang Z, Xie X, Zhan F, Geng X, Zheng Z, Du Z, Dong G, Sun Y, Zeng X. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. 2025 Feb;84(2):188-200. doi: 10.1136/ard-2024-226385. Epub 2025 Jan 3.

Drugs

Indications