Canadian Phase 3 Psoriasis Study

Trial Design:
The trial included a total of 453 patients with stable moderate to severe plaque psoriasis. The trial was conducted at 32 sites across Canada over a 24 week period. This randomized, double-blind, trial examined the efficacy of 3 dosing groups of voclosporin (0.2 mg/kg, 0.3mg/kg and 0.4 mg/kg twice daily) compared to placebo with equal numbers of patients assigned to each of the four treatment groups. Subsequent to the first 12 weeks of the trial, those patients who received placebo were administered the mid-dose of 0.3 mg/kg twice daily for the remaining 12 weeks.
Primary Endpoint: To show a clinically and statistically significant difference in the number of patients achieving a 75% decrease in the Psoriasis Area and Severity Index (PASI) score at 12 weeks when compared to placebo.
Secondary Endpoint: Maintenance of stable kidney function and assessment of quality of life.
Final Safety and Efficacy Results Patients received continuous treatment with voclosporin for a total of 60 weeks.  Over the course of the 24-week Phase 3 trial, patients exhibited a 60% mean improvement in Psoriasis Area and Severity Index (PASI) scores.  After an additional 36 weeks of treatment, there was a 54% mean improvement in PASI scores indicating continued therapeutic benefit.  This beneficial effect was still observed twelve weeks after discontinuing voclosporin treatment; mean PASI scores remained at 35% below pre-treatment scores.

Subsequent to 60 weeks of continuous treatment, there were no clinically significant changes in kidney function, cholesterol, triglycerides, new onset diabetes, infectious complications, or other laboratory parameters.  This supports the long term safety of voclosporin.

Note: All clinical trial photos shown here are untouched. These photos represent the results of one patient only and should not be considered to represent the results of all patients enrolled in the clinical trial.

Last updated March 27, 2008