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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03207815
Registration number
NCT03207815
Ethics application status
Date submitted
30/06/2017
Date registered
5/07/2017
Date last updated
21/01/2022
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
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Scientific title
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
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Secondary ID [1]
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2017-001485-17
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Secondary ID [2]
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GS-US-432-4097
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Universal Trial Number (UTN)
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Trial acronym
HUMBOLDT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Noninfectious Uveitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - Prednisone
Experimental: Filgotinib - 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.
Placebo Comparator: Placebo - 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: Drugs: Filgotinib
Tablet(s) administered orally
Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally
Treatment: Drugs: Prednisone
Tablet(s) administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
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Assessment method [1]
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Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Week (Wk) 6); Inability to achieve =Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in Anterior Chamber (AC) cell grade (Standardization of Uveitis Nomenclature [SUN] criteria)[AC cell grades range from 0 (0 cells) to 4+ (>50 cells), higher scores=severe uveitis]; Inability to achieve =Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in Vitreous Haze (VH) grade (National Eye Institute [NEI]/SUN criteria)[VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis]; Worsening of best corrected visual acuity (BCVA) by =15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis.
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Timepoint [1]
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Week 6 through Week 24
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Secondary outcome [1]
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Time to Treatment Failure on or After Week 6
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Assessment method [1]
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Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Wk 6); Inability to achieve =Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in AC cell grade (SUN criteria) [AC cell grades range from 0 (0 cells) to 4+ (>50 cells), higher scores=severe uveitis]; Inability to achieve =Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in VH grade (NEI/SUN criteria) [VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis]; Worsening of BCVA by =15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis.
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Timepoint [1]
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Week 6 through Week 52
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Secondary outcome [2]
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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)
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Assessment method [2]
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Grading of VH was based on the publication from the NEI which has also been adapted by the SUN working group. VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), with higher scores indicating greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement.
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Timepoint [2]
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Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
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Secondary outcome [3]
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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
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Assessment method [3]
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The number of AC cells observed within a 1 mm × 1 mm slit beam were recorded for each eye. The reported number was used to determine the grade according to the SUN criteria. AC cell grades range from 0 (0 cells in field) to 4+ (>50 cells in field), with higher scores indicating more cells visible in the AC and greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement.
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Timepoint [3]
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Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
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Secondary outcome [4]
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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
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Assessment method [4]
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BCVA is the best possible vision that an eye can achieve with the set of glasses or contact lenses. A refraction test was performed to measure the appropriate lens strength to focus light on the retina. Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In the ETDRS system, 15 letters is equal to a change in 3 lines of visual acuity. If the participant is unable to read letters on a testing chart, visual acuity is described as ranging from ability to count fingers, recognize hand movements, or light perception. The smaller BVCA score indicates greater severity of uveitis. A positive change from best state value obtained prior to Week 6 indicates improvement.
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Timepoint [4]
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Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
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Secondary outcome [5]
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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
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Assessment method [5]
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Central retinal thickness is measured by optical coherence tomography (OCT). Central retinal thickness is defined as the thickness of the retina in the center of the foveal pit (1 mm subfield). The larger central retinal thickness value indicates greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement.
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Timepoint [5]
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Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
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Secondary outcome [6]
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Time to Development of Macular Edema in At Least One Eye on or After Week 6
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Assessment method [6]
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Time in weeks until the development of Macular edema or Week 52 or EOT or ET. Macular edema is determined by OCT and is defined as central retinal thickness = 300 microns if using Cirrus machine, or = 315 microns if using Spectralis machine.
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Timepoint [6]
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Week 6 through Week 52
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Secondary outcome [7]
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Plasma Concentration of Filgotinib
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Assessment method [7]
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Timepoint [7]
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Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
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Secondary outcome [8]
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Plasma Concentration of Metabolite, GS-829845
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Assessment method [8]
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Timepoint [8]
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Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
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Eligibility
Key inclusion criteria
Key
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/04/2021
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Sample size
Target
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Accrual to date
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Final
74
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Lions Eye Institute - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Texas
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United States of America
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Wisconsin
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Canada
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Vancouver
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Germany
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Münster
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Israel
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Jerusalem
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New Zealand
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Remuera
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Galapagos NV
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03207815
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03207815
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