A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

Phase 2 Completed 289 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects

Timeline

Start: 2012-06-19
Primary completion: 2013-12-02
Completion: 2013-12-02

Outcome

Met primary endpoint

paper the peficitinib 100 mg and 150 mg groups achieved a rapid and statistically significant ACR20 response compared with those in the placebo group (P < 0.05) PMID 28118538 ↗

Publications

Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
Genovese MC, Greenwald M, Codding C, Zubrzycka-Sienkiewicz A, Kivitz AJ, Wang A, Shay K, Wang X, Garg JP, Cardiel MH. Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis. Arthritis Rheumatol. 2017 May;69(5):932-942. doi: 10.1002/art.40054.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	peficitinib	Small molecule	25 mg	Oral
Subject	peficitinib	Small molecule	50 mg	Oral
Subject	peficitinib	Small molecule	100 mg	Oral
Subject	peficitinib	Small molecule	150 mg	Oral