Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis

• Status: Terminated
• Trial end date: 2021-04-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Prednisone

Criteria

Key Inclusion Criteria:

• Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis

• Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:

• Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion

• ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria

• ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria

• No evidence of active tuberculosis (TB) or untreated latent TB

Key Exclusion Criteria:

• Participants with elevated intraocular pressures and/or severe glaucoma

• Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.