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

Location

Doctors & Locations

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

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

Notes

https://clinicaltrials.gov/ct2/show/NCT03207815

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