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PVT-2201-303: CLARITY Study for Non-Infectious Uveitis - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called brepocitinib (the study drug) is a safe and effective option people with non-infectious uveitis (NIU).

What is the Condition Being Studied?

Non-Infectious Uveitis (NIU)

Who Can Participate in the Study?

Adults ages 18-75 who:

  • Are diagnosed with NIU
  • Do not have high eye pressure
  • Have not been diagnosed or treated for any type of cancer in the past 5 years

For more information, contact the study team at DEC-RA@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to either:

  • Take the study drug; OR
  • Take a placebo (inactive substance with no drug)

Study participation is expected to last for up to 104 weeks (about 2 years). At first, visits will be scheduled about every 2 to 4 weeks. Later in the study, visits will be scheduled every 4 to 12 weeks. You will not need to make any changes to your routine medications if you join this study.

Study Details

Full Title
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis - CLARITY
Principal Investigator
Ophthalmologist
Protocol Number
IRB: PRO00115979
NCT: NCT06431373
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon