Efficacy and Safety of Filgotinib in Adults With Active Non-Infectious Uveitis

Description

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

Study Start Date

July, 26 2017

Estimated Completion Date

June 2021

Interventions

  • Drug: Filgotinib
  • Drug: Prednisone
  • Drug: Placebo to match filgotinib

Study ID

Gilead Sciences -- GS-US-432-4097

Status

Recruiting

Trial ID

NCT03207815

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

110

Sponsor

Gilead Sciences

Key

Inclusion Criteria

  • Is diagnosed with non-infectious 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 or more of maintenance therapy with oral prednisone (? 10 mg/day to ? 60 mg/day) or 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

  • Adults with severe glaucoma at screening are not eligible to participate
  • severe glaucoma is defined as:
  • Intraocular pressure of ? 25 mmHg and on ? 2 glaucoma medications and/or
  • Any evidence of glaucomatous optic nerve injury
  • 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 with a prior failure of anti-tumor necrosis factor (TNF) therapy or previous exposure to any biologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF] therapy) with a potential therapeutic impact on non-infectious uveitis within 90 days of Day 1/ Baseline are not eligible to participate NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (48)

Study Location Distance Name Phone Email
Ophthalmic Consultants of Boston - Boston, Massachusetts 2.8 miles None None None
Ophthalmic Consultants of Boston - Boston, Massachusetts 2.8 miles None None None
Ophthalmic Consultants of Boston - Boston, Massachusetts 2.8 miles None None None
Metropolitan Eye Research and Surgery Institute - Palisades Park, New Jersey 183.0 miles None None None
Metropolitan Eye Research and Surgery Institute - Palisades Park, New Jersey 183.0 miles None None None
Metropolitan Eye Research and Surgery Institute - Palisades Park, New Jersey 183.0 miles None None None
Wilmer Eye Institute Johns Hopkins Medicine - Baltimore, Maryland 356.0 miles None None None
Wilmer Eye Institute Johns Hopkins Medicine - Baltimore, Maryland 356.0 miles None None None
Wilmer Eye Institute Johns Hopkins Medicine - Baltimore, Maryland 356.0 miles None None None
Wilmer Eye Institute Johns Hopkins Medicine - Baltimore, Maryland 356.0 miles None None None
Wilmer Eye Institute Johns Hopkins Medicine - Baltimore, Maryland 356.0 miles None None None
Cleveland Clinic FoundationCole Eye Institute - Cleveland, Ohio 549.3 miles None None None
Cleveland Clinic FoundationCole Eye Institute - Cleveland, Ohio 549.3 miles None None None
Cleveland Clinic FoundationCole Eye Institute - Cleveland, Ohio 549.3 miles None None None
Cleveland Clinic FoundationCole Eye Institute - Cleveland, Ohio 549.3 miles None None None
Cleveland Clinic FoundationCole Eye Institute - Cleveland, Ohio 549.3 miles None None None
Associated Retinal Consultants PC - Royal Oak, Michigan 616.2 miles None None None
Associated Retinal Consultants PC - Royal Oak, Michigan 616.2 miles None None None
Associated Retinal Consultants PC - Royal Oak, Michigan 616.2 miles None None None
Midwest Eye Institute - Indianapolis, Indiana 804.6 miles None None None
Midwest Eye Institute - Indianapolis, Indiana 804.6 miles None None None
Midwest Eye Institute - Indianapolis, Indiana 804.6 miles None None None
Texas Retina Associates Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Retina Associates Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Retina Associates Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Retina Associates Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Retina Associates Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Foresight Studies LLC - San Antonio, Texas 1,769.8 miles None None None
Foresight Studies LLC - San Antonio, Texas 1,769.8 miles None None None
Foresight Studies LLC - San Antonio, Texas 1,769.8 miles None None None
Foresight Studies LLC - San Antonio, Texas 1,769.8 miles None None None
Foresight Studies LLC - San Antonio, Texas 1,769.8 miles None None None
Colorado Retina Associates PC - Golden, Colorado 1,779.3 miles None None None
University of Washington Medicine Eye Institute - Seattle, Washington 2,489.6 miles None None None
University of Washington Medicine Eye Institute - Seattle, Washington 2,489.6 miles None None None
University of Washington Medicine Eye Institute - Seattle, Washington 2,489.6 miles None None None
University of Washington Medicine Eye Institute - Seattle, Washington 2,489.6 miles None None None
Oregon Health Science UniversityCasey Eye Institute - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science UniversityCasey Eye Institute - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science UniversityCasey Eye Institute - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science UniversityCasey Eye Institute - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science UniversityCasey Eye Institute - Portland, Oregon 2,538.3 miles None None None
Legacy Devers Eye Institute - Portland, Oregon 2,538.8 miles None None None
Legacy Devers Eye Institute - Portland, Oregon 2,538.8 miles None None None
Legacy Devers Eye Institute - Portland, Oregon 2,538.8 miles None None None
Legacy Devers Eye Institute - Portland, Oregon 2,538.8 miles None None None
Legacy Devers Eye Institute - Portland, Oregon 2,538.8 miles None None None
Stanford Byers Eye Institute - Palo Alto, California 2,691.7 miles None None None

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