This study is in progress, not accepting new patients

A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis

a study on Uveitis

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around
Principal Investigator
by Sanjay Kedhar

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 or cerebrovascular 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
    Irvine California 92697 United States
  • Clinical Trial Site
    Sacramento California 92825 United States
  • Clinical Trial Site
    Fullerton California 92835 United States
  • Clinical Trial Site
    Los Angeles California 90095 United States

Lead Scientist at UC Irvine

  • Sanjay Kedhar
    Health Sciences Professor, Ophthalmology and Visual Sciences, School of Medicine. Authored (or co-authored) 33 research publications

Details

Status
in progress, not 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
About 371 people participating
Last Updated