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Uveitis

Trial

Clinical Trial Title

Uveitis

Trial Status

Open to Enrollment

Start Date

October 2, 2017

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: Placebo to match filgotinib
Tablet(s) administered orally once daily
Drug: Prednisone
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: Thursday, September 21, 2017 10:09:49 AM