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    Clinical Trial Results:
    A Phase II Randomized, Double-Blind, Placebo-Controlled, 26-Week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects with Idiopathic Pulmonary Fibrosis

    Summary
    EudraCT number
    2017-004302-18
    Trial protocol
    SK   SE   FR   BG   FI   HR   RO  
    Global end of trial date
    14 Aug 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jul 2021
    First version publication date
    30 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1205-CL-220
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03725852
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.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
    14 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of GLPG1205 treatment in participants with idiopathic pulmonary fibrosis (IPF) on pulmonary function as evaluated by forced vital capacity (FVC) compared to placebo over 26 weeks.
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the “Declaration of Helsinki” and its amendments in force at the time of the study (2013 version). It was also carried out in conformity with the protocol, the International Council for Harmonisation Guideline for Good Clinical Practice (ICH-GCP) E6 (R2), and local ethical and legal requirements. The investigator informed the participants of the risks and benefits of the study. The participants were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained a copy of the informed consent forms (ICFs), which are available to the sponsor for review. The participants were covered by the sponsor’s insurance according to local legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Sep 2018
    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
    Slovakia: 2
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Oman: 2
    Country: Number of subjects enrolled
    Romania: 8
    Country: Number of subjects enrolled
    Ukraine: 16
    Worldwide total number of subjects
    68
    EEA total number of subjects
    50
    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)
    12
    From 65 to 84 years
    56
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Bulgaria, Croatia, Finland, France, Oman, Romania, Slovakia, Sweden, and Ukraine. The first participant was screened on 27 Sep 2018. The last study visit occurred on 14 Aug 2020.

    Pre-assignment
    Screening details
    A total of 155 participants were screened, of which 86 participants were considered ineligible. Out of 69 enrolled participants, 1 participant met an exclusion criterion pre-dose and was therefore excluded.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GLPG1205 100 mg
    Arm description
    Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
    Arm type
    Experimental

    Investigational medicinal product name
    GLPG1205
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1205 was administered per dose and schedule specified in the arm description.

    Arm title
    Placebo
    Arm description
    Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching GLPG1205 was administered per dose and schedule specified in the arm description.

    Number of subjects in period 1
    GLPG1205 100 mg Placebo
    Started
    45
    23
    Completed
    41
    23
    Not completed
    4
    0
         Consent withdrawn by subject
    1
    -
         Death
    1
    -
         Travel restrictions due to COVID-19
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1205 100 mg
    Reporting group description
    Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Reporting group title
    Placebo
    Reporting group description
    Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Reporting group values
    GLPG1205 100 mg Placebo Total
    Number of subjects
    45 23 68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70.5 ( 6.8 ) 68.3 ( 5.5 ) -
    Gender categorical
    Units: Subjects
        Female
    12 6 18
        Male
    33 17 50
    Race
    Units: Subjects
        Asian
    2 0 2
        White
    32 17 49
        Unknown or Not Reported
    11 6 17
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    45 23 68

    End points

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    End points reporting groups
    Reporting group title
    GLPG1205 100 mg
    Reporting group description
    Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Reporting group title
    Placebo
    Reporting group description
    Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Subject analysis set title
    All Participants
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received either GLPG1205 100 mg (2 capsules x 50 mg), or GLPG1205 matching placebo, orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Primary: Change From Baseline in Forced Vital Capacity (FVC) at Week 26

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    End point title
    Change From Baseline in Forced Vital Capacity (FVC) at Week 26
    End point description
    Forced vital capacity (FVC) (milliliter [mL]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Participants in the full analysis set (FAS) (consisted of all randomized participants who received at least 1 dose of the study drug) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    45
    23
    Units: mL
    arithmetic mean (standard error)
        Baseline (n=45,23)
    2865.43 ( 103.544 )
    2817.08 ( 167.773 )
        Change at Week 26 (n=29,20)
    -31.29 ( 42.398 )
    -79.47 ( 32.838 )
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.495 [2]
    Method
    ANCOVA
    Parameter type
    Least square (LS) mean difference
    Point estimate
    42.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -81.84
         upper limit
    166.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    61.483
    Notes
    [1] - This analysis included 49 participants.
    [2] - P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A TEAE was any AE with an onset date on or after the start of study drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of study drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Participants in the FAS population were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    45
    23
    Units: participants
        TEAEs
    36
    18
        Serious TEAEs
    9
    1
        TEAEs related to study drug
    20
    3
        TEAEs leading to study drug discontinuation
    10
    0
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    TEAEs
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    Method
    Parameter type
    Difference in Percentage
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.3
         upper limit
    24.5
    Notes
    [3] - 95% CI for difference calculated using the method of Miettinen and Nurminen.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Serious TEAEs
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    Method
    Parameter type
    Difference in Percentage
    Point estimate
    15.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    30.7
    Notes
    [4] - 95% CI for difference calculated using the method of Miettinen and Nurminen.
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    TEAEs related to study drug
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    Method
    Parameter type
    Difference in Percentage
    Point estimate
    31.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.2
         upper limit
    49.4
    Notes
    [5] - 95% CI for difference calculated using the method of Miettinen and Nurminen.
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    TEAEs leading to study drug discontinuation
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    Method
    Parameter type
    Difference in Percentage
    Point estimate
    22.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.7
         upper limit
    36.4
    Notes
    [6] - 95% CI for difference calculated using the method of Miettinen and Nurminen.

    Secondary: Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratoryrelated Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations

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    End point title
    Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratoryrelated Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations
    End point description
    Treatment effect on time to death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related) were assessed using the log-rank test. Kaplan-Meier estimates were derived for the probability of death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related). Cumulative percentage of participants with all-cause deaths, respiratory-related deaths, all-cause hospitalizations, and respiratory-related hospitalizations were reported. Participants in the FAS population were analyzed. Here, the value '999999' signifies that 95% CI could not be estimated for the placebo group for deaths as all participants in this group were censored.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 30
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    45
    23
    Units: percentage of participants
    number (confidence interval 95%)
        All-cause deaths
    3.1 (0.4 to 20.2)
    0 (-999999 to 999999)
        Respiratory-related deaths
    3.1 (0.4 to 20.2)
    0 (-999999 to 999999)
        All-cause hospitalizations
    16.6 (8.3 to 31.9)
    4.3 (0.6 to 27.1)
        Respiratory-related hospitalizations
    2.8 (0.4 to 18.1)
    4.3 (0.6 to 27.1)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    All-cause deaths
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.397
    Method
    Logrank
    Confidence interval
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Respiratory-related deaths
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.397
    Method
    Logrank
    Confidence interval
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    All-cause hospitalizations
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.131
    Method
    Logrank
    Confidence interval
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    Respiratory-related hospitalizations
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.762
    Method
    Logrank
    Confidence interval

    Secondary: Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26

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    End point title
    Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
    End point description
    The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking. Participants in the FAS population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    45
    23
    Units: meters
    arithmetic mean (standard error)
        Baseline (n=45,23)
    412.6 ( 18.53 )
    391.8 ( 25.72 )
        Change at Week 26 (n=26,19)
    -16.6 ( 10.56 )
    -8.7 ( 10.43 )
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    = 0.565 [8]
    Method
    ANCOVA
    Parameter type
    Weighted LS mean difference
    Point estimate
    -9.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -40.87
         upper limit
    22.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    15.713
    Notes
    [7] - This analysis included 45 participants.
    [8] - P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.

    Secondary: Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26

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    End point title
    Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
    End point description
    The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. Participants in the FAS population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    45
    23
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline (n=45,23)
    45.363 ( 2.8518 )
    48.599 ( 3.9497 )
        Change at Week 26 (n=29,19)
    -3.797 ( 2.6683 )
    -1.424 ( 2.7151 )
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.673 [10]
    Method
    ANCOVA
    Parameter type
    Weighted LS mean difference
    Point estimate
    -1.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.06
         upper limit
    5.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.71
    Notes
    [9] - This analysis included 48 participants.
    [10] - P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.

    Secondary: Change From Baseline in SGRQ Domain Score at Week 26

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    End point title
    Change From Baseline in SGRQ Domain Score at Week 26
    End point description
    The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. Participants in the FAS population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    45
    23
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline (symptoms score) (n=45,23)
    49.454 ( 3.7439 )
    56.059 ( 4.3333 )
        Change at Week 26 (symptoms score) (n=29,19)
    -3.135 ( 2.6281 )
    -3.437 ( 4.4017 )
        Baseline (activity score) (n=45,23)
    58.243 ( 3.0224 )
    59.454 ( 4.6140 )
        Change at Week 26 (activity score) (n=29,20)
    -4.387 ( 3.5367 )
    1.156 ( 3.6228 )
        Baseline (impacts score) (n=45,23)
    36.409 ( 3.1765 )
    40.064 ( 4.2897 )
        Change at Week 26 (impacts score) (n=29,20)
    -3.460 ( 3.1330 )
    -1.412 ( 3.2971 )
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Symptoms score
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.875 [12]
    Method
    ANCOVA
    Parameter type
    Weighted LS mean difference
    Point estimate
    -0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.98
         upper limit
    8.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.591
    Notes
    [11] - This analysis included 48 participants.
    [12] - P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Activity score
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    P-value
    = 0.416 [14]
    Method
    ANCOVA
    Parameter type
    Weighted LS mean difference
    Point estimate
    -4.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.29
         upper limit
    6.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.038
    Notes
    [13] - This analysis included 49 participants.
    [14] - P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Impacts score
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [15]
    P-value
    = 0.961 [16]
    Method
    ANCOVA
    Parameter type
    Weighted LS mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.32
         upper limit
    7.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.029
    Notes
    [15] - This analysis included 49 participants.
    [16] - P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.

    Secondary: Percentage of SGRQ Responders

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    End point title
    Percentage of SGRQ Responders
    End point description
    The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. SGRQ responders are those with absolute change from baseline in SGRQ total score less than or equal to -4 percent (%) at least once. Participants in the FAS population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    GLPG1205 100 mg Placebo
    Number of subjects analysed
    40
    22
    Units: percentage of participants
        number (not applicable)
    40.0
    40.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1205 100 mg v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1
    Method
    Fisher exact
    Confidence interval

    Secondary: Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26

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    End point title
    Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26 [17]
    End point description
    GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). Participants in the pharmacokinetic (PK) analysis set (a subset of the FAS, including all participants who had available and evaluable plasma concentration data, excluding all protocol deviations or AEs that may have had an impact on the PK analysis) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 26 (pre-dose)
    Notes
    [17] - 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: The results for this endpoint were not reported for the placebo group as the participants in the placebo group did not receive GLPG1205.
    End point values
    GLPG1205 100 mg
    Number of subjects analysed
    25
    Units: nanograms per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    4979.9 ( 2279.5 )
    No statistical analyses for this end point

    Secondary: Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20

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    End point title
    Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20
    End point description
    Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). Participants in the PK analysis set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 20 (pre-dose)
    End point values
    All Participants
    Number of subjects analysed
    8
    Units: ng/mL
        arithmetic mean (standard deviation)
    14.37 ( 12.97 )
    No statistical analyses for this end point

    Secondary: Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20

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    End point title
    Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20
    End point description
    Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged). Participants in the PK analysis set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 20 (pre-dose)
    End point values
    All Participants
    Number of subjects analysed
    10
    Units: ng/mL
        arithmetic mean (standard deviation)
    2868.2 ( 2630.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
    Adverse event reporting additional description
    Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    GLPG1205 100 mg
    Reporting group description
    Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Reporting group title
    Placebo
    Reporting group description
    Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

    Serious adverse events
    GLPG1205 100 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 45 (20.00%)
    1 / 23 (4.35%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (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
    Bronchitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    GLPG1205 100 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 45 (80.00%)
    18 / 23 (78.26%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 23 (4.35%)
         occurrences all number
    10
    10
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    9 / 45 (20.00%)
    0 / 23 (0.00%)
         occurrences all number
    16
    0
    Chest pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Fatigue
         subjects affected / exposed
    6 / 45 (13.33%)
    0 / 23 (0.00%)
         occurrences all number
    7
    0
    Hunger
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Thirst
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 45 (13.33%)
    2 / 23 (8.70%)
         occurrences all number
    10
    2
    Dyspnoea
         subjects affected / exposed
    5 / 45 (11.11%)
    2 / 23 (8.70%)
         occurrences all number
    5
    2
    Epistaxis
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Interstitial lung disease
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Irritability
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 23 (0.00%)
         occurrences all number
    7
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Blood bilirubin increased
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Blood pressure increased
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Brain natriuretic peptide increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    6 / 45 (13.33%)
    1 / 23 (4.35%)
         occurrences all number
    6
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Rib fracture
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    6 / 45 (13.33%)
    2 / 23 (8.70%)
         occurrences all number
    16
    2
    Dyskinesia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    11 / 45 (24.44%)
    4 / 23 (17.39%)
         occurrences all number
    20
    11
    Paraesthesia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Parkinson's disease
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Immune thrombocytopenia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Leukocytosis
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Neutrophilia
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Normocytic anaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Panophthalmitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 45 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    Chronic gastritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    12 / 45 (26.67%)
    3 / 23 (13.04%)
         occurrences all number
    22
    4
    Dry mouth
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastric ulcer
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Mucous stools
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    13 / 45 (28.89%)
    2 / 23 (8.70%)
         occurrences all number
    19
    2
    Toothache
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    3
    Vomiting
         subjects affected / exposed
    4 / 45 (8.89%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hepatic mass
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Papule
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Rash
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Renal pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 23 (4.35%)
         occurrences all number
    3
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Neck pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 45 (6.67%)
    3 / 23 (13.04%)
         occurrences all number
    3
    3
    Diarrhoea infectious
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Erythema migrans
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gingival abscess
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Kidney infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 45 (13.33%)
    4 / 23 (17.39%)
         occurrences all number
    6
    5
    Oral candidiasis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Tracheitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    5 / 45 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Dyslipidaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2019
    − The secondary objective/endpoints evaluating time to major events were modified. − Eligibility criteria were modified. − Prohibition of medications known to prolong QT interval was removed. Instead, chronic use or initiation of such medications needed to be evaluated on a case-by-case basis. − Conditions leading to treatment discontinuation or withdrawal from the study were revised. − Conditions for rescreening were revised. − Timing for efficacy assessments (SGRQ and functional respiratory imaging [FRI]) were revised. − Safety assessments and normal ranges/thresholds for abnormalities were revised to better reflect the IPF participant population. − Definitions of populations for analyses were revised. − Definition of an acute IPF exacerbation was updated and contraindications for the 6MWT were corrected in the respective appendices.
    30 Apr 2020
    Urgent safety measures were included to mitigate the impact of the COVID-19 pandemic for the participating IPF participants. The urgent safety measures were implemented in compliance with local country and study center restrictions and regulations, which included an extension of certain visit windows, unscheduled virtual phone call or remote visits, alternative visit approach, shipment of the study drug to the participants etc.

    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.
    The study was not powered to detect statistical significance and was limited by its small sample size, high variability of the primary endpoint (FVC), and a high rate of early treatment discontinuations.
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    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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