A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study

Eye Care
Sanjay Kedhar
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
Eye - Ophthalmologic
Uveitis

Study Description

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

Eligibility

  1. Adult subjects (18-74 years old)
  2. Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
  3. Active uveitic disease in at least 1 eye.
  4. Weight > 40 kg with a body mass index < 40 kg/m2.
  1. Has confirmed or suspected current diagnosis of infectious uveitis
  2. History of or have:
  • Lymphoproliferative disorder
  • active malignancy;
  • 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.)
  • thrombosis and cardiovascular disease within the last 12 months
  • a high risk for herpes zoster reactivation
  • active or recent infections
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