The Canadian late phase trial commenced on December 2, 2004 and includes a total of 453 patients with stable moderate to severe plaque psoriasis. The trial is currently being conducted at 32 sites over a 24 week period.
Based on blinded data the mean decrease in Psoriasis Area and Severity Index (PASI) scores for all four treatment groups combined (including the placebo group) was 38%. The blinded data has also indicated a generally good safety profile. However, five patients have been withdrawn from the trial due to a clinically significant effect on kidney function.
Dr Randall Yatscoff, Isotechnika’s president and COO, stated. “Based on the blinded data to date we are confident we will show a clinically and statistically significant difference in the number of patients achieving a 75% decrease in the PASI score at 12 weeks when compared to placebo when the results are unblinded later this fall. We expect to achieve this with minimal impact on kidney function.”
The final 24 week unblinded data set is expected to be released in the first half of 2006.