OPTYK-1 (Non-Infectious Uveitis) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how well an investigational drug called ESK-001 (the study drug) can help control a condition called uveitis, which is inflammation in the eye. We want to know what effects it has when it is given in different doses.

What is the Condition Being Studied?

Active & Non-infectious Intermediate, Posterior, or Panuveitis

Who Can Participate in the Study?

Adults ages 18-70 who:

- Are diagnosed with active noninfectious intermediate, posterior, or panuveitis

- Do not have elevated pressure in their eye(s) or severe glaucoma

For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Group

What is Involved?

If you choose to join the study, you will:

- Get a random assignment (like a coin flip) to receive one of the 2 doses of the study drug (10 mg or 80 mg)

- Take one tablet of the study drug by mouth every day for 48 weeks

- Visit our clinic at the Duke Eye Center at least 17 times.

At various visits, you will have blood tests, electrocardiograms, eye exams and vision tests, and we will ask you to fill out some questionnaires.

Study Details

Full Title
A Proof-of-Concept, Randomized, Double-Masked Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Active Noninfectious Intermediate, Posterior, or Panuveitis (OPTYK-1) - ESK-001-014
Principal Investigator
Protocol Number
IRB: PRO00113836
Phase II
Enrollment Status
Open for Enrollment