Clinical trial NCT03207815: Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Official title: A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Noninfectious Uveitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2017-07-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
timeFrame: Week 6 through Week 24
Secondary outcomes:
measure: Time to Treatment Failure on or After Week 6
timeFrame: Week 6 through Week 52
measure: Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET)
timeFrame: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
measure: Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
timeFrame: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
measure: Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
timeFrame: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
measure: Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
timeFrame: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
measure: Time to Development of Macular Edema in At Least One Eye on or After Week 6
timeFrame: Week 6 through Week 52
measure: Plasma Concentration of Filgotinib
timeFrame: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
measure: Plasma Concentration of Metabolite, GS-829845
timeFrame: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Byers Eye Institute
state: California
city: Golden
country: United States
facility: Colorado Retina Associates PC
state: Colorado
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Royal Oak
country: United States
facility: Associated Retinal Consultants PC
state: Michigan
city: Palisades Park
country: United States
facility: Metropolitan Eye Research and Surgery Institute
state: New Jersey
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation-Cole Eye Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science University-Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Fort Worth
country: United States
facility: Texas Retina Associates - Fort Worth
state: Texas
city: San Antonio
country: United States
facility: Foresight Studies, LLC
state: Texas
city: Madison
country: United States
facility: university of Wisconsin-Madison
state: Wisconsin
city: Nedlands
country: Australia
facility: Lions Eye Institute
state: Western Australia
city: Vancouver
country: Canada
facility: Retina Consultants
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Remuera
country: New Zealand
facility: Auckland Eye
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Mancester Hospitals NHS Foundation Trust, Manchester Royal Eye Hospital
city: Oxford
country: United Kingdom
facility: Eye Research Group Oxford, Oxford Eye Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: