NCT00408187

Randomized, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

A Phase III, Randomized, Multicentre, Double-Blind, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.

Detailed description

Psoriasis is a chronic skin condition that can have a significant impact on a patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet ciclosporin, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as ciclosporin A, but also has an improved toxicity profile.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	voclosporin	voclosporin 0.4 mg/kg po BID
DRUG	Ciclosporin	ciclosporin 1.5 mg/kg po BID
DRUG	Placebo	Placebo

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-12-06
• Last updated: 2009-07-30

Locations

49 sites across 3 countries: Canada, Germany, Poland