NCT00244842

Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

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. Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Conditions

• Psoriasis

Interventions

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

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-10-27
• Last updated: 2023-03-27
• Results posted: 2023-03-27

Locations

31 sites across 1 country: Canada