Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (HUMBOLDT)

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Noninfectious Uveitis

Treatments: Drug: Prednisone; Drug: Placebo to match filgotinib; Drug: Filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03207815

2017-001485-17 (EudraCT Number)

GS-US-432-4097

Details and patient eligibility

About

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 as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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) or untreated latent TB

Key Exclusion Criteria:

• Participants with elevated intraocular pressures and/or severe glaucoma
• 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)

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Filgotinib

Experimental group

Description:

Participants will receive filgotinib 200 milligrams (mg) once daily for up to 52 weeks along with a standardized prednisone burst of 60 milligrams per day (mg/day) at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.

Treatment:

Drug: Filgotinib

Drug: Prednisone

Placebo

Placebo Comparator group

Description:

Participants will receive placebo to match filgotinib once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.

Treatment:

Drug: Prednisone

Drug: Placebo to match filgotinib