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

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).

Who Can Participate?

Eligibility

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 Range

18-75

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Dilraj
Grewal

Protocol Number

PRO00115979

NCT ID

NCT06431373

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov