A Study to Evaluate ESK-001 in Adults with Moderate to Severe Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)
Purpose
The purpose of this study is to evaluate the efficacy of ESK-001
There may be a chance that you will be asked to come into the study site for unscheduled study visits that may include extra tests to assess for your safety.
The duration of the study will be a minimum of 28 weeks, if you participate in the long-term extension study, or 32 weeks if instead you enter the follow-up period. You will need to come to the study site at least 10 or 11 times respectively over this period.
Could this study be right for you?
- Subject must have a diagnosis of plaque psoriasis for at least 6 months
- Subjects must not have other immune-mediated conditions such as uveitis and inflammatory bowel disease (patients with psoriatic arthritis may participate)
- Subject must be in good general health with no history of tuberculosis, cancer, HIV, hepatitis B or C
- Subjects must have no history of unstable cardiac disease (for example, unstable angina or rapid atrial fibrillation) or cardiac hospitalization within 3 months
- Female subjects must not be pregnant or considering becoming pregnant for the duration of the study