Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (HUMBOLDT)
Noninfectious Uveitis
About this trial
This is an interventional treatment trial for Noninfectious Uveitis
Eligibility 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.
Sites / Locations
- Stanford Byers Eye Institute
- Colorado Retina Associates PC
- Northwestern Medical Group
- Illinois Retina Associates
- Ophthalmic Consultants of Boston
- Associated Retinal Consultants PC
- Metropolitan Eye Research and Surgery Institute
- Duke University Eye Center
- Wake Forest Baptist Medical Center
- Cleveland Clinic Foundation-Cole Eye Institute
- Oregon Health Science University-Casey Eye Institute
- Mid Atlantic Retina
- Texas Retina Associates - Fort Worth
- Foresight Studies, LLC
- university of Wisconsin-Madison
- Lions Eye Institute
- Retina Consultants
- St. Franziskus Hospital
- Hadassah Medical Center
- Auckland Eye
- Royal Liverpool University Hospital
- Moorfields Eye Hospital NHS Foundation Trust
- Central Mancester Hospitals NHS Foundation Trust, Manchester Royal Eye Hospital
- Eye Research Group Oxford, Oxford Eye Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Filgotinib
Placebo
Participants will receive filgotinib 200 milligrams (mg) once daily for up to 52 weeks along with a standardized prednisone burst of 60 milligrams per day (mg/day) at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Participants will receive placebo to match filgotinib once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.