ONWARD1

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
For more information, contact the study team at erin.campo@duke.edu.

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
During the screening period, you will visit our clinic for a physical exam and to have some tests done to find out if you are eligible. If you meet the study's criteria, you will proceed to the study drug period. During this period, you will get a random assignment (fair, equal chance) to either:
  • Take the study drug; OR
  • Take apremilast; OR
  • Take a placebo
The study drug period will last for 24 weeks. You will visit our clinic at least 6 times during the study drug period. These visits will last about 2 hours each time. If you were assigned to take a placebo, you will be switched the study drug after 16 weeks. If you are taking the study drug or apremilast, you will take these drugs for the entire study drug period. At the end of the study drug period, we will assess your eligibility to join the long-term extension period:
  • 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).
For people who choose to join the long-term extension period, the follow-up period will begin whenever your study participation ends.

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