Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Edmund Tsui, MD (ucla)
Headshot of Edmund Tsui
Edmund Tsui

Description

Summary

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Official 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

Keywords

Uveitis, Posterior, Uveitis, Intermediate, Uveitis, Posterior Uveitis, Intermediate Uveitis, Brepocitinib PO QD

Eligibility

You can join if…

Open to people ages 18-75

  • Adult subjects (18-75 years old)
  • Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
  • Active uveitic disease in at least 1 eye
  • Weight > 40 kg with a body mass index ≤ 40 kg/m2

You CAN'T join if...

Has confirmed or suspected current diagnosis of infectious uveitis History of or have:

  1. Lymphoproliferative disorder
  2. active malignancy
  3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
  4. thrombosis orand cerebrovascularardiovascular ischemic event disease within the last 12 months
  5. a high risk for herpes zoster reactivation
  6. active or recent infections

Locations

  • Clinical Trial Site accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • Clinical Trial Site accepting new patients
    Irvine 5359777 California 5332921 92697 United States
  • Clinical Trial Site accepting new patients
    Beverly Hills 5328041 California 5332921 90211 United States
  • Clinical Trial Site accepting new patients
    La Jolla 5363943 California 5332921 92093 United States
  • Clinical Trial Site accepting new patients
    Los Angeles 5368361 California 5332921 90033 United States
  • Clinical Trial Site accepting new patients
    Sacramento 5389489 California 5332921 92825 United States
  • Clinical Trial Site accepting new patients
    Fullerton 5351247 California 5332921 92835 United States

Lead Scientist at University of California Health

  • Edmund Tsui, MD (ucla)
    Associate Professor-in-residence, Ophthalmology, Medicine. Authored (or co-authored) 97 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Priovant Therapeutics, Inc.
Links
Related Info
ID
NCT06431373
Phase
Phase 3 Uveitis Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated