Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:July 26, 2017
End Date:July 2022
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis

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.


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), history of prior TB or latent TB meeting the
screening criteria

Key Exclusion Criteria:

- Elevated intraocular pressures and/or severe glaucoma at screening

- 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)

- Adults in whom anti-tumor necrosis factor (TNF) therapy has failed in controlling
uveitis (as determined by the investigator) or previous exposure to any biologic
therapy (except intravitreal anti-vascular endothelial growth factor (VEGF) therapy)
with a potential therapeutic impact on noninfectious uveitis within 90 days of Day 1/
Baseline are not eligible to participate

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
22
sites
Indianapolis, Indiana 46290
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600 North Wolfe Street
Baltimore, Maryland 21287
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9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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Boston, Massachusetts 02114
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Boston, MA
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243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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Chicago, Illinois 60611
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Chicago, IL
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Cleveland, OH
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Durham, North Carolina 27710
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Durham, NC
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1101 6th Avenue
Fort Worth, Texas 76104
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Golden, Colorado 80401
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Oak Park, Illinois 60304
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Palisades Park, New Jersey 07650
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Palisades Park, NJ
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2452 Watson Court
Palo Alto, California 94303
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Portland, OR
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Portland, Oregon 97210
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Royal Oak, Michigan 48073
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Salt Lake City, UT
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San Antonio, Texas
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Seattle, WA
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Sydney, New South Wales
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