Purpose of this Study
We are doing this study to find out if an experimental drug called ESK-001 (the study drug) can help control moderate-to-severe plaque psoriasis. We want to know how well it works in comparison to apremilast (Otezla©) and placebo (inactive substance with no drug in it).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with plaque psoriasis
- Were diagnosed at least 6 months ago
- Have plaque lesions that cover at least 10% of the body
What is Involved?
Description
If you decide to join this study, your participation will last for at least 28 weeks and it will be broken up into 4 periods:
- Screening period
- Study drug period
- Follow-up period
- Long-term extension period
- Take the study drug; OR
- Take apremilast; OR
- Take a placebo
- If you are not eligible for the long-term extension period, you will enter the follow-up period and we will keep in touch with you to see how you are doing.
- If you are eligible for the long-term extension period, you will have the option of continuing to take the study drug indefinitely. You can take the study drug for as long as you feel that you are getting a benefit, or until the study is terminated for any reason, or until the study drug is approved and becomes commercially available in the United States (whichever comes first).
Study Details
Full 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
Principal Investigator
John
Murray
Protocol Number
PRO00115994
NCT ID
NCT05600036
Phase
III
Enrollment Status
Open to Enrollment