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Uveitis

Trial

Clinical Trial Title

Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis

Trial Status

Open to Enrollment

Start Date

October 2, 2017

Trial Type

Ophthalmology

Specific Condition

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.

          

Arms 

Experimental: Filgotinib

All participants will receive a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule, to Week 15.

All participants will receive filgotinib for up to 52 weeks.

 

Assigned Interventions 

Drug: Filgotinib

200 mg tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Prednisone
Tablet(s) administered orally once daily

Placebo Comparator: Placebo

All participants will receive a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule, to Week 15.

All participants will receive placebo to match filgotinib for up to 52 weeks.


Drug: Prednisone

Tablet(s) administered orally once daily

Drug: Placebo to match filgotinib

Tablet(s) administered orally once daily

 


 

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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.

IRB Number

10811

Principal Investigator Name

James T. Rosenbaum, MD

Contact Name

Tammy Mayfield

Phone

503-413-7945

Contact Fax

503-413-6861

Contact E-Mail

tmayfiel@lhs.org

Last Updated: Tuesday, March 27, 2018 12:12:13 PM