NCT00258713

A 36-Week Extension to Protocol ISA04-03

A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 66 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 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 cyclosporine, 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 cyclosporine A, but also has an improved toxicity profile.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	voclosporin	voclosporin 0.2, 0.3, or 0.4 mg/kg BID

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-11-28
• Last updated: 2008-09-29

Locations

29 sites across 1 country: Canada