Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (NCT03207815) | Clinical Trial Compass
TerminatedPhase 2
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Stopped: Development program terminated
United States74 participantsStarted 2017-07-26
Plain-language 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 as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24