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    Clinical Trial Results:
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)

    Summary
    EudraCT number
    		 2016-003179-23
    Trial protocol
    		 GB   DE   CZ   ES   PL   HU   FR   AT   BE   IT  
    Global end of trial date
    20 Jul 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Sep 2021
    First version publication date
    04 Aug 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Outcome measures #2, 3 and 4: Update to the outcome measure description and unit of measure Outcome measures #8, 9 and 10: Update to the outcome measure descriptions Update to the number of participants who were screened

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-419-4015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03046056
    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
    20 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as crohn's disease activity index (CDAI) < 150, at Week 24 in participants with crohn's disease (CD) involving the small bowel. Participants had the option to enter a separate long-term extension study if they met the eligibility requirements.
    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
    11 Apr 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
    United States: 38
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Ukraine: 3
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    78
    EEA total number of subjects
    25
    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)
    71
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Canada, and Europe. The first participant was screened on 11 April 2017. The last study visit occurred on 20 July 2020.

    Pre-assignment
    Screening details
    		 198 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 200 mg
    Arm description
    		 Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for up to 27 weeks.
    Arm type
    		 Experimental

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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Arm title
    		 Filgotinib 100 mg
    Arm description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.
    Arm type
    		 Experimental

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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Arm title
    		 Placebo
    Arm description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Number of subjects in period 1
    		Filgotinib 200 mg Filgotinib 100 mg Placebo
    Started
    28
    32
    18
    Completed
    16
    16
    11
    Not completed
    12
    16
    7
         Withdrew Consent
    1
    -
    -
         Protocol-specified disease worsening
    3
    3
    1
         Adverse Event
    1
    5
    -
         Non-compliance with study drug
    -
    -
    2
         Protocol Violation
    1
    1
    -
         Non-responder at Week 10
    6
    6
    4
         Investigator's discretion
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for up to 27 weeks.

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.

    Reporting group values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo Total
    Number of subjects
    		 28 32 18 78
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46 ± 16.3 42 ± 12.9 45 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    		 19 23 9 51
        Male
    		 9 9 9 27
    Race
    Not Permitted means local regulators did not allow collection of race information.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Black or African American
    		 2 4 2 8
        Native Hawaiian or Pacific Islander
    		 0 0 0 0
        White
    		 25 28 16 69
        Other
    		 1 0 0 1
        Not Permitted
    		 0 0 0 0
    Ethnicity
    Not Permitted means local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Not Hispanic or Latino
    		 26 31 17 74
        Hispanic or Latino
    		 2 1 1 4
        Not Permitted
    		 0 0 0 0
    Crohn’s Disease Activity Index Score (CDAI)
    The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease.
    Units: score on scale
        arithmetic mean (standard deviation)
    		 309 ± 55.7 297 ± 64.9 300 ± 63.7 -

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for up to 27 weeks.

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.

    Primary: Percentage of Participants Who Achieved Clinical Remission at Week 24

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    End point title
    		 Percentage of Participants Who Achieved Clinical Remission at Week 24
    End point description
    The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease. Full Analysis Set included all the randomized participants who received at least one dose of the study drug.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: percentage of participants
        number (confidence interval 90%)
    25.0 (12.4 to 41.9)
    25.0 (13.1 to 40.6)
    16.7 (4.7 to 37.7)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    8.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 32.1
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    8.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -15.9
         upper limit
    		 32

    Secondary: Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24

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    End point title
    		 Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24
    End point description
    Magnetic resonance enterography (MRE) is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system, a composite index of 4 components. They are edema, ulcers, gut wall thickness, and relative contrast enhancement (RCE). A segmental MaRIA score is calculated at screening (used as the baseline) and Week 24 as a weighted sum of these components for the terminal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicates remission. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: score on scale
        least squares mean (standard error)
    -1.8 ± 1.51
    0.7 ± 1.39
    0.5 ± 1.64
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Difference in least squared means (Diff in LSM), and its 90% CI were from analysis of covariance (ANCOVA) model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -2.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.81
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 3.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.72

    Secondary: Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24

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    End point title
    		 Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24
    End point description
    MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: score on scale
        least squares mean (standard error)
    -1.1 ± 1.12
    -0.5 ± 1.08
    0.5 ± 1.26
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.38
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.32

    Secondary: Change From Baseline in Jejunum Segmental MaRIA Score at Week 24

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    End point title
    		 Change From Baseline in Jejunum Segmental MaRIA Score at Week 24
    End point description
    MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system.The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A positive change from baseline indicates disease worsening. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: score on scale
        least squares mean (standard error)
    0.4 ± 1.00
    0.6 ± 0.95
    0.5 ± 1.12
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.18

    Secondary: Percentage of Participants who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24

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    End point title
    		 Percentage of Participants who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in terminal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in terminal ileum segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    22
    30
    16
    Units: percentage of participants
        number (confidence interval 90%)
    4.5 (0.2 to 19.8)
    6.7 (1.2 to 19.5)
    6.3 (0.3 to 26.4)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -1.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -28.6
         upper limit
    		 25.5
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    0.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -24.5
         upper limit
    		 26.2

    Secondary: Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24

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    End point title
    		 Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in distal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in distal ileum segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    10
    8
    6
    Units: percentage of participants
        number (confidence interval 90%)
    10.0 (0.5 to 39.4)
    0 (0.0 to 31.2)
    16.7 (0.9 to 58.2)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -6.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -47.3
         upper limit
    		 37
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -16.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -58.2
         upper limit
    		 30

    Secondary: Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24

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    End point title
    		 Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in jejunum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in jejunum segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    6
    8
    3
    Units: percentage of participants
        number (confidence interval 90%)
    33.3 (6.3 to 72.9)
    0 (0.0 to 31.2)
    0 (0.0 to 63.2)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    33.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -32.4
         upper limit
    		 86.5

    Secondary: Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24

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    End point title
    		 Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ minimum detectable difference (MDD) units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the terminal ileum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in terminal ileum segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    22
    30
    16
    Units: percentage of participants
        number (confidence interval 90%)
    22.7 (9.4 to 42.0)
    10.0 (2.8 to 23.9)
    25.0 (9.0 to 48.4)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -2.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -28.6
         upper limit
    		 24.3
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -39.4
         upper limit
    		 11.3

    Secondary: Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24

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    End point title
    		 Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the distal ileum. For segments with baseline MaRIA score ≥ 15, the minimum detectable difference (MDD) is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in distal ileum segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    10
    8
    6
    Units: percentage of participants
        number (confidence interval 90%)
    20.0 (3.7 to 50.7)
    12.5 (0.6 to 47.1)
    16.7 (0.9 to 58.2)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    3.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -38.9
         upper limit
    		 45.7
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -4.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -47.5
         upper limit
    		 40.8

    Secondary: Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24

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    End point title
    		 Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A MaRIA score can be calculated at screening and Week 24 for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the jejunum. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in jejunum segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    6
    8
    3
    Units: percentage of participants
        number (confidence interval 90%)
    50.0 (15.3 to 84.7)
    12.5 (0.6 to 47.1)
    0 (0.0 to 63.2)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    50
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -16.8
         upper limit
    		 89.5
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    12.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -46.1
         upper limit
    		 63.3

    Secondary: Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24

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    End point title
    		 Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Small bowel MaRIA remission was defined as MaRIA score < 7 at Week 24 in each of the 3 small bowel segments, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in at least 1 small bowel segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    25
    32
    18
    Units: percentage of participants
        number (confidence interval 90%)
    8.0 (1.4 to 23.1)
    6.3 (1.1 to 18.4)
    0 (0.0 to 15.3)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -17.2
         upper limit
    		 32.6
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    6.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -18.1
         upper limit
    		 30.2

    Secondary: Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24

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    End point title
    		 Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24
    End point description
    The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Participant level small bowel MaRIA response was defined as all small bowel segments with baseline MaRIA score ≥7 achieve segment level MaRIA response, with no segment level disease worsening in any other segment(s) at Week 24, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline. Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in at least 1 small bowel segment at baseline, were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    25
    32
    18
    Units: percentage of participants
        number (confidence interval 90%)
    20.0 (8.2 to 37.5)
    12.5 (4.4 to 26.4)
    16.7 (4.7 to 37.7)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    3.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -22.1
         upper limit
    		 28.1
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    -4.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -28.1
         upper limit
    		 20.3

    Secondary: Percentage of Participants who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10

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    End point title
    		 Percentage of Participants who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
    End point description
    The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: percentage of participants
        number (confidence interval 90%)
    39.3 (23.8 to 56.5)
    25.0 (13.1 to 40.6)
    22.2 (8.0 to 43.9)
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    17.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 40.4
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk Difference in Proportions
    Point estimate
    2.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -21.2
         upper limit
    		 26.5

    Secondary: Change From Baseline in CDAI Scores at Week 10

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    End point title
    		 Change From Baseline in CDAI Scores at Week 10
    End point description
    The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 10
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: score on scale
        least squares mean (standard error)
    -105 ± 23.6
    -88 ± 22.3
    -57 ± 26.2
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -48
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -95
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    28.1
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -76
         upper limit
    		 15
    Variability estimate
    Standard error of the mean
    Dispersion value
    27.4

    Secondary: Change From Baseline in CDAI Scores at Week 24

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    End point title
    		 Change From Baseline in CDAI Scores at Week 24
    End point description
    The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    28
    32
    18
    Units: score on scale
        least squares mean (standard error)
    -86 ± 24.1
    -71 ± 22.8
    -66 ± 26.7
    Statistical analysis title
    		 Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -20
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -68
         upper limit
    		 28
    Variability estimate
    Standard error of the mean
    Dispersion value
    28.7
    Statistical analysis title
    		 Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -52
         upper limit
    		 42
    Variability estimate
    Standard error of the mean
    Dispersion value
    28

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days
    Adverse event reporting additional description
    All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily up to 27 weeks.

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily up to 26.3 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 PTM filgotinib 200 mg tablet +PTM filgotinib 100 mg tablet orally once daily up to 28.7 weeks.

    Serious adverse events
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 28 (14.29%)
    7 / 32 (21.88%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 32 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 32 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 28 (71.43%)
    24 / 32 (75.00%)
    13 / 18 (72.22%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    3
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 32 (3.13%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0
    Asthenia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 32 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    1
    2
    0
    Sinus congestion
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    1
    2
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 32 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 32 (12.50%)
    2 / 18 (11.11%)
         occurrences all number
    4
    4
    2
    Dizziness
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    2
    Tremor
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 32 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 28 (17.86%)
    6 / 32 (18.75%)
    1 / 18 (5.56%)
         occurrences all number
    5
    6
    2
    Crohn's disease
         subjects affected / exposed
    4 / 28 (14.29%)
    6 / 32 (18.75%)
    2 / 18 (11.11%)
         occurrences all number
    4
    6
    2
    Nausea
         subjects affected / exposed
    5 / 28 (17.86%)
    3 / 32 (9.38%)
    1 / 18 (5.56%)
         occurrences all number
    6
    3
    3
    Vomiting
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    2
    Abdominal distension
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 32 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Proctalgia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    2
    Anal incontinence
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    1
    Muscle spasms
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    2 / 18 (11.11%)
         occurrences all number
    0
    1
    2
    Pain in extremity
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 32 (6.25%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    1
    Arthralgia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Sacroiliitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    1
    Influenza
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 32 (3.13%)
    0 / 18 (0.00%)
         occurrences all number
    3
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 32 (12.50%)
    0 / 18 (0.00%)
         occurrences all number
    0
    4
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 32 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    1
    3
    0
    Ear infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 32 (6.25%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 32 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2016
    • Added a data monitoring committee (DMC) • Updated secondary endpoints language for consistency with the secondary objectives and the definition of terms • Moved definitions of efficacy related to MaRIA scores from the study objectives to the definition of terms • Added requirement to assess coagulation parameters for instances where aspartate transaminase (AST) or alanine transaminase (ALT) is >3 * upper limit of normal (ULN) • Extended requirement for maintaining a stable prescribed dose of corticosteroids prior to randomization • Updated requirements for storage and handling of study drugs • Added natalizumab, leflunomide, and lymphocyte-depleting therapies to the list of prohibited concomitant medications • Provided a rationale for the exclusion of potent P-gp inducers • Deleted appendix 5 and renumbered subsequent appendices. Moved information pertaining to subject preparation for MRE acquisition from appendix 5 to Section 6. Removed technical aspects of MRE acquisition • Added hepatitis B virus (HBV) surface antibody test and HBV core antibody test to screening • Removed details of MaRIA segmental score calculation from appendix 5
    26 Jun 2017
    • Added study duration • Updated background information with emerging relevant clinical data and to ensure consistency with Edition 12 of the Investigator’s Brochure for filgotinib • Added formula for creatinine clearance (CLcr) calculation • Updated biomarker language to align with Gilead’s current protocol template • Updated inclusion criterion to add ustekinumab as possible therapy of previously demonstrated inadequate response • Updated inclusion criterion to clarify that QuantiFERON tuberculosis testing may not berepeated except in the case of a single repeat for indeterminate results • Added a new inclusion criterion to ensure standard of care colorectal cancer screening for patient population • Updated exclusion criteria to remove tattoo as a contraindication to MRE examination • Updated exclusion criteria to clarify exclusion of subjects with subtotal colectomy • Updated exclusion criteria to clarify the required washout period before entry of subjects who have been previously treated with ustekinumab • Added guidance for missed doses • Added guidance for initiation of new induction therapies prior to screening • Added instructions for budesonide taper • Added detailed descriptions of key assessments • Updated safety reporting language to align with Gilead’s current protocol template • Added wording to the informed consent process to ensure investigators counsel male participants on the associated risks of male infertility • Added urinalysis to Week 24 • Separated fasting lipids from serum chemistry • Defined the duration of fasting • Removed fasting requirement from screening • Updated Appendix 7 based on findings of a drug-drug interaction (DDI) study for filgotinib and hormonal contraceptives and to clarify the definitions of childbearing potential
    04 Feb 2020
    • Updated study secondary and exploratory endpoints • Updates were made to include discontinuation criteria for thromboembolic events at the request of US Food and Drug Administration (FDA) • Included a criterion to trigger an ad hoc DMC meeting at the request of the US FDA • Added description of a cardiovascular safety endpoint adjudication committee (CVEAC) that Gilead established at the request of the US FDA • Included new guidance for HBV deoxyribonucleic acid (DNA) screening and surveillance

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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