We are currently recruiting subjects aged 18 years and older with moderate to severe plaque psoriasis to participate in an investigational study. The primary purpose of this research is to evaluate the safety, tolerability (your immune response) and effectiveness of an oral (taken by mouth) investigational drug in participants with moderate to severe psoriasis.
The study consists of taking an oral study treatment twice daily. You will have a 4 in 5 chance of receiving the study treatment rather than placebo for the first 16 weeks of treatment.
Participation will last approximately 20 weeks and have a total of 8 visits, inclusive of the 16-week placebo-controlled treatment period.
Visits take approximately 30 minutes to 2.5 hours each, except for the screening visit which may take up to 3 hours.
Blood samples will be collected from all participants during all the 8 visits to evaluate the safety.
Tape strips will be collected from lesional skin and from nonlesional skin on day 1, week 16.
As an option, we will be conducting a sub-study that will include biopsy samples being taken. The sub-study will require 6 or 8 skin biopsies (4 mm pieces of skin sample) being collected from a psoriasis lesion and from normal-appearing skin at certain timepoints.
Optional medical photographic (full body, front and back) of the targeted areas will be taken, for the participant who consent, to illustrate the results of the treatment, on day 1, week 4 and week 16.
Compensation for time and travel may be available. There will be no cost to you for taking part in this study or the optional sub-studies. You will be provided with all study medication, examinations and medical care related to the study at no cost to you.
If interested, please contact our Research Coordinator at 416-633-0001 x 4 or e-mail [email protected].
