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    Clinical Trial Results:
    A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Noninfectious Uveitis

    Summary
    EudraCT number
    		 2017-001485-17
    Trial protocol
    		 GB  
    Global end of trial date
    22 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-432-4097
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03207815
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 62
    Worldwide total number of subjects
    74
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    66
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, the United Kingdom, Canada, Australia, Germany, Israel, and New Zealand. The first participant was screened on 26 July 2017. The last study visit occurred on 22 April 2021.

    Pre-assignment
    Screening details
    		 116 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Filgotinib
    Arm description
    		 Participants received filgotinib 200 milligrams (mg) tablet orally, 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg administered once on Day 1/Baseline

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo to match filgotinib tablet orally, 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.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg administered once on Day 1/Baseline

    Number of subjects in period 1 [1]
    		Filgotinib Placebo
    Started
    37
    35
    Completed
    30
    29
    Not completed
    7
    6
         Withdrew Consent
    1
    -
         Adverse Event
    1
    2
         Investigator's Discretion
    1
    1
         Pregnancy/Partner Pregnancy
    1
    -
         Protocol Violation
    2
    -
         Lost to follow-up
    1
    2
         Lack of efficacy
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 2 participants who were enrolled but not treated were not included in the disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib
    Reporting group description
    		 Participants received filgotinib 200 milligrams (mg) tablet orally, 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.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo to match filgotinib tablet orally, 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.

    Reporting group values
    		 Filgotinib Placebo Total
    Number of subjects
    		 37 35 72
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48 ( 15.1 ) 43 ( 15.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 20 43
        Male
    		 14 15 29
    Race
    Units: Subjects
        Asian
    		 4 0 4
        Black or African American
    		 2 8 10
        Native Hawaiian or Pacific Islander
    		 1 0 1
        White
    		 29 26 55
        Other
    		 1 1 2
    Ethnicity
    Not Permitted = local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    		 4 10 14
        Not Hispanic or Latino
    		 32 25 57
        Not Permitted
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib
    Reporting group description
    		 Participants received filgotinib 200 milligrams (mg) tablet orally, 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.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo to match filgotinib tablet orally, 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.

    Primary: Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24

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    End point title
    		 Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
    End point description
    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)/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)/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. Evaluable Analysis Set.
    End point type
    Primary
    End point timeframe
    Week 6 through Week (Wk) 24
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: percentage of participants
        number (confidence interval 95%)
    37.5 (19.2 to 55.8)
    67.6 (50.5 to 84.8)
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0064 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Treatment Failure Rate
    Point estimate
    -30.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -56.2
         upper limit
    		 -4.1
    Notes
    [1] - P-value was estimated from the Cochran-Mantel-Haenszel (CMH) test, adjusted for the stratification factors.

    Secondary: Time to Treatment Failure on or After Week 6

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    End point title
    		 Time to Treatment Failure on or After Week 6
    End point description
    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. Participants in the Evaluable Analysis Set were analyzed. 9999=Not Available as the calculated percentiles of event rate were not reached.
    End point type
    Secondary
    End point timeframe
    Week 6 through Week 52
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    9999 (24.1 to 9999)
    22.0 (12.1 to 47.0)
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0014 [2]
    Method
    		 Stratified Log-Rank Test
    Parameter type
    		 Stratified Hazard Ratio
    Point estimate
    0.309
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.144
         upper limit
    		 0.663
    Notes
    [2] - P-value was derived from the log rank test stratified by the stratification factors.

    Secondary: 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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    End point title
    		 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)
    End point description
    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 (cha) from the best value obtained prior to Week 6 indicates improvement. Participants in the Evaluable Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: score
    arithmetic mean (standard deviation)
        Left Eye: Best State Prior to Wk 6 N=32,33
    0.3 ( 0.40 )
    0.2 ( 0.33 )
        Right Eye: Best State Prior to Wk 6
    0.3 ( 0.36 )
    0.3 ( 0.45 )
        Lef Eye Cha From Best State at Wk52/EOT/ET N=32,33
    0.1 ( 0.79 )
    0.3 ( 0.75 )
        Rig Eye Cha From Best State at Wk52/EOT/ET N=32,33
    0.1 ( 0.62 )
    0.2 ( 0.66 )
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.355 [3]
    Method
    		 Repeated Measure ANCOVA
    Parameter type
    		 Least Squares Mean Treatment Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [3] - P-value was estimated using a repeated measure Analysis of Covariance (ANCOVA) model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.

    Secondary: 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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    End point title
    		 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
    End point description
    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 the best state value obtained prior to Week 6 indicates improvement. Participants in the Evaluable Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: score
    arithmetic mean (standard deviation)
        Left Eye: Best State Prior to Wk 6
    0.0 ( 0.09 )
    0.1 ( 0.19 )
        Right Eye: Best State Prior to Wk 6
    0.0 ( 0.12 )
    0.1 ( 0.25 )
        Left Eye: Change From Best State at Wk 52/EOT/ET
    0.2 ( 0.59 )
    0.6 ( 0.87 )
        Right Eye: Change From Best State at Wk 52/EOT/ET
    0.2 ( 0.53 )
    0.7 ( 1.05 )
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0145 [4]
    Method
    		 Repeated Measure ANCOVA
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Notes
    [4] - P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.

    Secondary: 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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    End point title
    		 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
    End point description
    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. Participants in the Evaluable Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: logMAR
    arithmetic mean (standard deviation)
        Left Eye: Best State Prior to Wk 6
    0.09 ( 0.195 )
    0.07 ( 0.209 )
        Right Eye: Best State Prior to Wk 6
    0.09 ( 0.193 )
    0.12 ( 0.280 )
        Left Eye: Change From Best State at Wk 52/EOT/ET
    0.03 ( 0.154 )
    0.05 ( 0.112 )
        Right Eye: Change From Best State at Wk 52/EOT/ET
    -0.01 ( 0.116 )
    0.07 ( 0.144 )
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0389 [5]
    Method
    		 Repeated Measure ANCOVA
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Notes
    [5] - P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.

    Secondary: 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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    End point title
    		 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
    End point description
    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 (cha) from best state value obtained prior to Week 6 indicates improvement. Participants in the Evaluable Analysis Set with the available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: log microns
    arithmetic mean (standard deviation)
        Left Eye: Best State Prior to Wk 6
    2.45 ( 0.059 )
    2.46 ( 0.097 )
        Right Eye: Best State Prior to Wk 6
    2.47 ( 0.056 )
    2.44 ( 0.104 )
        Lef Eye Cha From Best State at Wk52/EOT/ET N=32,32
    0.01 ( 0.062 )
    0.04 ( 0.080 )
        Rig Eye Cha From Best State at Wk52/EOT/ET N=32,32
    0.01 ( 0.049 )
    0.03 ( 0.055 )
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034 [6]
    Method
    		 Repeated Measure ANCOVA
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.011
    Notes
    [6] - P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, OCT machine, and best state value.

    Secondary: Time to Development of Macular Edema in At Least One Eye on or After Week 6

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    End point title
    		 Time to Development of Macular Edema in At Least One Eye on or After Week 6
    End point description
    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. Participants in the Evaluable Analysis Set were analyzed. 9999=Not Available as the calculated percentiles of event rate were not reached.
    End point type
    Secondary
    End point timeframe
    Week 6 through Week 52
    End point values
    		 Filgotinib Placebo
    Number of subjects analysed
    32
    34
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    7.8 (6.1 to 9999)
    12.3 (6.1 to 9999)
    Statistical analysis title
    		 Filgotinib vs Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5893 [7]
    Method
    		 Stratified Log-Rank Test
    Parameter type
    		 Stratified Hazard Ratio
    Point estimate
    1.193
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.625
         upper limit
    		 2.277
    Notes
    [7] - P-value was derived from the log rank test stratified by the stratification factors.

    Secondary: Plasma Concentration of Filgotinib

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    End point title
    		 Plasma Concentration of Filgotinib [8]
    End point description
    Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), Early Termination at any time
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Plasma concentrations were collected and analyzed for filgotinib arm group.
    End point values
    		 Filgotinib
    Number of subjects analysed
    37
    Units: nanograms per millilitre (ng/ml)
    arithmetic mean (standard deviation)
        Day 1 Postdose
    748.5 ( 1043.84 )
        Week 4 Predose (N=29)
    173.3 ( 364.46 )
        Week 6 Predose (N=28)
    133.9 ( 306.18 )
        Week 12 Postdose (N=27)
    1088.7 ( 856.57 )
        Week 24 Single Anytime (N=21)
    397.5 ( 561.57 )
        Week 36 Single Anytime (N=14)
    295.7 ( 420.25 )
        Week 52 (EOT) Single Anytime (N=22)
    195.2 ( 344.54 )
        Early Termination Single Anytime (N=3)
    434.8 ( 478.72 )
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Metabolite, GS-829845

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    End point title
    		 Plasma Concentration of Metabolite, GS-829845 [9]
    End point description
    Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), Early Termination at any time
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Plasma concentrations were collected and analyzed for filgotinib arm group.
    End point values
    		 Filgotinib
    Number of subjects analysed
    37
    Units: ng/ml
    arithmetic mean (standard deviation)
        Day 1 Postdose
    230.8 ( 317.98 )
        Week 4 Predose (N=29)
    2085.6 ( 924.91 )
        Week 6 Predose (N=28)
    2107.7 ( 749.28 )
        Week 12 Postdose (N=27)
    3237.0 ( 1180.74 )
        Week 24 Single Anytime (N=21)
    3478.1 ( 1137.63 )
        Week 36 Single Anytime (N=14)
    2944.3 ( 1130.84 )
        Week 52 (EOT) Single Anytime (N=22)
    2510.7 ( 1732.59 )
        Early Termination Single Anytime (N=3)
    2171.0 ( 1224.77 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks
    Adverse event reporting additional description
    Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All- Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Filgotinib
    Reporting group description
    		 Participants received filgotinib 200 mg tablet orally, 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.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo to match filgotinib tablet orally, 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.

    Serious adverse events
    		 Filgotinib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 37 (13.51%)
    2 / 35 (5.71%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal vasculitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inflammatory bowel disease
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder prolapse
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal stenosis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Covid-19
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Filgotinib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 37 (75.68%)
    19 / 35 (54.29%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Weight increased
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 35 (2.86%)
         occurrences all number
    3
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 37 (2.70%)
    3 / 35 (8.57%)
         occurrences all number
    2
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 37 (8.11%)
    7 / 35 (20.00%)
         occurrences all number
    4
    7
    Dizziness
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 37 (8.11%)
    3 / 35 (8.57%)
         occurrences all number
    3
    3
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 37 (5.41%)
    4 / 35 (11.43%)
         occurrences all number
    2
    4
    Visual impairment
         subjects affected / exposed
    5 / 37 (13.51%)
    1 / 35 (2.86%)
         occurrences all number
    5
    1
    Chorioretinal disorder
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Eye irritation
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Uveitis
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Vitreous floaters
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 35 (2.86%)
         occurrences all number
    3
    1
    Anterior chamber inflammation
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    Cataract
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Eye pain
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Macular oedema
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Photopsia
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    Chalazion
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Ocular hyperaemia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Photophobia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Vitreous haze
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 37 (10.81%)
    1 / 35 (2.86%)
         occurrences all number
    4
    1
    Abdominal pain
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Dyspepsia
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 35 (2.86%)
         occurrences all number
    3
    1
    Abdominal distension
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Upper-airway cough syndrome
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 37 (10.81%)
    4 / 35 (11.43%)
         occurrences all number
    4
    4
    Anxiety
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Depression
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 35 (5.71%)
         occurrences all number
    4
    2
    Back pain
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 35 (2.86%)
         occurrences all number
    3
    1
    Pain in extremity
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    Myalgia
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    Muscle spasms
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 37 (10.81%)
    3 / 35 (8.57%)
         occurrences all number
    6
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 35 (5.71%)
         occurrences all number
    3
    3
    Bronchitis
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    Covid-19
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2017
    • ECG collection at the Screening visit only. • Allowed for the safety laboratory assessments to be performed locally or centrally at Screening visit only. • Removed lens photography and reduced fundus photography assessments. • Removed sarcoidosis assessments and sarcoidosis imaging requirements. • Clarified requirements for Unscheduled visits related to uveitis symptoms. • Updated Inclusion criteria to clarify oral corticosteroid requirements prior to Day 1 dosing. • Updated Exclusion criteria to clarify severe glaucoma. • Updated Inclusion criteria to clarify QuantiFERON® TB Gold and TB testing requirements. • Updated Exclusion criteria to clarify immunosuppressive therapy. • Updated Exclusion criteria to clarify concomitant immunosuppressive therapy. • Updated Exclusion criteria to exclude eyelid surgery from prior ocular surgery. • Updated Exclusion criteria to exclude eyelid surgery from planned (elective) eye surgery. • Updated Exclusion criteria to clarify HIV and Syphilis testing requirements. • Updated Exclusion criteria to define marijuana and tobacco use. • Updated storage and handling conditions for filgotinib. • Updated tonometry requirements. • Updated Fluorescein Angiogram requirements. • Updated risk/benefit assessment language. • Updated study drug return or disposal language. • Updated study schema. • Updated prohibited medications. • Updated study title. • Updated pregnancy precautions, definition for female of childbearing potential, and contraceptive requirements. • Updated clinical laboratory assessment table. • Updated references. • Added Ct.gov NCT number.
    18 Dec 2017
    • Updated synopsis, study design to correct inconsistencies made when incorporating changes into protocol amendment 1. • Updated synopsis and main eligibility criteria to correct inconsistencies between changes outlined in the summary of changes document and protocol amendment 1. • Updated synopsis, study procedures/frequency to delete lipid profile from screening. • Updated Inclusion criteria to correct inconsistencies made when incorporating changes into protocol amendment 1. • Updated subscripts to provide clarity around HBV Viral Monitoring and also, childbearing potential. • Updated to clarify the definition of childbearing potential.
    12 Dec 2019
    • Relaxation of entry criteria to allow participants that have previously failed anti-TNF treatment. • Relaxation of entry criteria to allow participants with previously treated active or latent TB. • DSPH (Drug Safety and Public Health) was replaced by PVE (Pharmacovigilance & Epidemiology) within the whole document.
    17 Mar 2020
    • Expand the sample size to N = 248 participants. • Expand the number of sites globally to approximately 75 centers. • Incorporate an independent adjudication committee to review major adverse cardiovascular events and thromboembolic events. • Add a new study drug discontinuation criterion: any thromboembolic events meeting serious adverse event (SAE) reporting criteria. • Language regarding independent adjudication committee reviews for major adverse cardiovascular events and thromboembolic events has been updated throughout the protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Mar 2020
    There were global interruptions to enrollment due to corona virus disease 2019 (COVID-19) outbreak, measures were taken to introduce a global screening halt. Decision to restart enrolment was made on data monitoring committee (DMC) recommendation.
    21 May 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was terminated early due to termination of the development program. Due to early termination and small sample size, PK analysis was not performed for this study.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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