A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)

Summary

The purpose of this study is to verify the superiority of ASP015K in combination with MTX or with other disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response or intolerance to MTX, as measured by the American College of Rheumatology (ACR) 20 response rate at Week 24. This study will also evaluate the pharmacokinetics and safety of ASP015K as well as efficacy and safety of long-term treatment with ASP015K (52 weeks).

Timeline

Start

2018-09-27

Primary completion

2021-04-01

Completion

2021-11-02

Outcome

Met primary endpoint

paper ACR20 responses were statistically significantly higher in both peficitinib 100 mg (56.6%) and 150 mg (56.3%) groups versus placebo (24.2%); PMID 38357391 ↗

Publications

• Yang Y, Li J, Liu J, Liu L, Wang Y, Hu J, Li Z, Gu J, Zhang X, Xiao Z, Zheng J, Liu L, Li Z, Wei JC. Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study. Lancet Reg Health West Pac. 2023 Oct 18;42:100925. doi: 10.1016/j.lanwpc.2023.100925. eCollection 2024 Jan.

Drugs

Indications