A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis

Phase 2 Completed 124 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.

Timeline

Start: 2010-03-23
Primary completion: 2011-07-27
Completion: 2011-07-27

Outcome

Met primary endpoint

paper primary efficacy end point [mean change in Psoriasis Area and Severity Index score from baseline to end of treatment (EOT; day 42)] significantly favoured ASP015K PMID 25704750 ↗

Publications

Papp K, Pariser D, Catlin M, Wierz G, Ball G, Akinlade B, Zeiher B, Krueger JG. A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis. Br J Dermatol. 2015 Sep;173(3):767-76. doi: 10.1111/bjd.13745. Epub 2015 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	peficitinib	Small molecule	10 mg	Oral
Subject	peficitinib	Small molecule	25 mg	Oral
Subject	peficitinib	Small molecule	50 mg	Oral
Subject	peficitinib	Small molecule	60 mg	Oral
Subject	peficitinib	Small molecule	100 mg	Oral