NCT01096862

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

A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed the study.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	peficitinib	oral
DRUG	Placebo	oral

Timeline

• Start date: 2010-03-23
• Primary completion: 2011-07-27
• Completion: 2011-07-27
• First posted: 2010-03-31
• Last updated: 2024-10-21

Locations

11 sites across 1 country: United States