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    Clinical Trial Results:
    A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation

    Summary
    EudraCT number
    2017-002181-42
    Trial protocol
    DE  
    Global end of trial date
    10 Apr 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Mar 2019
    First version publication date
    16 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG2737-CL-202
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03474042
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@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
    27 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To assess changes in sweat chloride concentration as a biomarker of CFTR ion channel function after administration of repeated doses of GLPG2737 compared to placebo in Orkambi-treated adult subjects with CF homozygous for the F508del mutation on Day 28. Secondary Objectives: - To evaluate safety and tolerability of GLPG2737. - To assess changes in sweat chloride concentration. - To assess changes in pulmonary function. - To assess changes in respiratory symptoms. - To characterize the pharmacokinetics (PK) of GLPG2737 and its active metabolite G1125498 (M4), ivacaftor, and lumacaftor.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) (Committee for Medicinal Products for Human Use [CHMP]/ICH/135/1995) and with the applicable local laws and regulatory requirements. Prior to the performance of any study-specific procedures, written informed consent was obtained from each subject. The subject was informed about the nature and purpose of the study, as well as of its risks and benefits. It was explained that the subject could withdraw from the study at any time for any reason and that this would not have any effect on potential future medical care.
    Background therapy
    Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at seven study centers from 29 November 2017 (date the first subject signed the ICF) to 10 April 2018 (date of last visit/contact with any subject).

    Pre-assignment
    Screening details
    In total, 29 subjects were screened and 22 subjects were enrolled.

    Period 1
    Period 1 title
    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
    GLPG2737 group
    Arm description
    GLPG2737 75 mg b.i.d. in addition to a stable treatment with Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)
    Arm type
    Experimental

    Investigational medicinal product name
    GLPG2737
    Investigational medicinal product code
    G1117337
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received GLPG2737 75 mg b.i.d. GLPG2737 was provided as capsules for oral use, containing 75 mg G1117337 (G1117337 is the compound code for GLPG2737).

    Arm title
    Placebo group
    Arm description
    Placebo b.i.d. in addition to a stable treatment with Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo b.i.d. Placebo was provided as capsules for oral use.

    Number of subjects in period 1
    GLPG2737 group Placebo group
    Started
    14
    8
    Completed
    14
    7
    Not completed
    0
    1
         Subject request: medical emergency in family
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG2737 group
    Reporting group description
    GLPG2737 75 mg b.i.d. in addition to a stable treatment with Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)

    Reporting group title
    Placebo group
    Reporting group description
    Placebo b.i.d. in addition to a stable treatment with Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)

    Reporting group values
    GLPG2737 group Placebo group Total
    Number of subjects
    14 8 22
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    14 8 22
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    21.5 (19 to 42) 28.5 (19 to 38) -
    Gender categorical
    Units: Subjects
        Female
    5 3 8
        Male
    9 5 14
    Race
    Units: Subjects
        White
    14 8 22
    BMI
    Units: kg/m2
        median (full range (min-max))
    21.1 (18 to 29) 20.3 (17 to 24) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG2737 group
    Reporting group description
    GLPG2737 75 mg b.i.d. in addition to a stable treatment with Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)

    Reporting group title
    Placebo group
    Reporting group description
    Placebo b.i.d. in addition to a stable treatment with Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.)

    Primary: Efficacy - Sweat chloride concentration

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    End point title
    Efficacy - Sweat chloride concentration
    End point description
    Change from baseline (pre-morning dose on Day 1) in sweat chloride concentration on Day 28 (primary endpoint) and on Day 14 (secondary endpoint) compared to placebo.
    End point type
    Primary
    End point timeframe
    Baseline, Day 14 and Day 28
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14
    8 [1]
    Units: mmol/l
    arithmetic mean (standard error)
        Baseline (actual value)
    86.0 ( 4.50 )
    84.3 ( 4.85 )
        Day 14
    -18.9 ( 5.11 )
    0.6 ( 6.97 )
        Day 28
    -22.1 ( 3.79 )
    -6.3 ( 4.28 )
    Notes
    [1] - N=7 on Day 14; N=6 on Day 28
    Statistical analysis title
    GLPG2737 vs Placebo - Day 28 (Primary endpoint)
    Statistical analysis description
    A mixed-effect model approach with treatment and day (Day 14 and Day 28) as fixed effects, treatment*day as interaction, subjects as random effect and baseline as covariate.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.021
    Method
    Mixed models analysis
    Parameter type
    LS-mean
    Point estimate
    -19.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -36
         upper limit
    -3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.99
    Statistical analysis title
    GLPG2737 vs Placebo - Day 14 (Secondary endpoint)
    Statistical analysis description
    A mixed-effect model approach with treatment and day (Day 14 and Day 28) as fixed effects, treatment*day as interaction, subjects as random effect and baseline as covariate.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0191
    Method
    Mixed models analysis
    Parameter type
    LS-mean
    Point estimate
    -19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.3
         upper limit
    -3.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.72

    Secondary: Safety - AEs

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    End point title
    Safety - AEs
    End point description
    Safety and tolerability, assessed by the number of subjects with adverse events (AEs). An analysis of the treatment-emergent adverse events (TEAEs) was performed, selecting only those AEs that started on or after the first dose of IMP. AEs emerging prior to the first dose (during the screening period) were only listed. The safety assessments were based on adverse events, laboratory assessments, 12-lead ECG, vital signs, spirometry, oxygen saturation by pulse oximetry, and weight were summarized using descriptive statistics. Physical examination data were only listed.
    End point type
    Secondary
    End point timeframe
    From first study drug administration until the last follow-up visit.
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14
    8
    Units: Subjects
        Any TEAE
    10
    8
        Severe TEAE
    0
    0
        Serious TEAE
    0
    0
        Treatment related TEAE
    3
    1
        Discontinuation due to AE
    0
    0
    No statistical analyses for this end point

    Secondary: Efficacy - %pFEV1

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    End point title
    Efficacy - %pFEV1
    End point description
    Change from baseline (pre-morning dose on Day 1) in percent predicted forced expiratory volume in 1 second (%pFEV1) through 28 days.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14 and Day 28.
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14 [2]
    8 [3]
    Units: percent
    arithmetic mean (standard error)
        Baseline (actual value)
    55.7 ( 4.49 )
    68.8 ( 6.20 )
        Day 14
    4.4 ( 1.51 )
    1.0 ( 1.05 )
        Day 28
    1.8 ( 1.20 )
    -1.8 ( 1.01 )
    Notes
    [2] - N=12 at Day 14 and 28
    [3] - N=7 at Day 14; N=6 at Day 28
    Statistical analysis title
    GLPG2737 vs Placebo - Day 14
    Statistical analysis description
    A mixed-effects model approach. P-values were provided for the point estimates (PEs) of the difference in change from baseline in %pFEV1 between the GLPG2737 and placebo group.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0617
    Method
    Mixed models analysis
    Parameter type
    LS-mean
    Point estimate
    3.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    7.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.87
    Statistical analysis title
    GLPG2737 vs Placebo - Day 28
    Statistical analysis description
    A mixed-effects model approach. P-values were provided for the point estimates (PEs) of the difference in change from baseline in %pFEV1 between the GLPG2737 and placebo group.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0848
    Method
    Mixed models analysis
    Parameter type
    LS-mean
    Point estimate
    3.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    7.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.92

    Secondary: CFQ-R

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    End point title
    CFQ-R
    End point description
    Change from baseline (pre-morning dose on Day 1) in the respiratory domain of the cystic fibrosis questionnaire-revised (CFQ-R) on Day 28.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 28.
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14
    8 [4]
    Units: percent
    arithmetic mean (standard error)
        Baseline (actual value)
    68.0 ( 4.83 )
    69.4 ( 5.26 )
        Day 28
    -1.3 ( 6.48 )
    -0.7 ( 1.30 )
    Notes
    [4] - N=7 at Day 28
    Statistical analysis title
    GLPG2737 vs Placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline on Day 28, with treatment as factor and baseline value as covariate, was applied.
    Comparison groups
    Placebo group v GLPG2737 group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.9125
    Method
    ANCOVA
    Parameter type
    LS-mean
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -21
         upper limit
    18.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.48

    Secondary: PK - Cmax

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    End point title
    PK - Cmax
    End point description
    Determine Cmax on Day 14 of GLPG2737, its active metabolite G1125498 (M4), ivacaftor, and lumacaftor.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14
    7
    Units: ng/ml
    arithmetic mean (standard deviation)
        GLPG2737
    293 ( 113 )
    0 ( 0 )
        G1125498
    422 ( 155 )
    0 ( 0 )
        ivacaftor
    720 ( 237 )
    714 ( 726 )
        lumacaftor
    24000 ( 8010 )
    17000 ( 2950 )
    Statistical analysis title
    GLPG2737 vs Placebo - Ivacaftor
    Statistical analysis description
    An analysis of variance (ANOVA) model with treatment arm (GLPG2737 group and placebo group) as a factor. The PEs were calculated as the geometric mean ratio of GLPG2737 group relative to placebo group with corresponding 90% CI.
    Comparison groups
    Placebo group v GLPG2737 group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric means
    Point estimate
    1.396
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.834
         upper limit
    2.337
    Statistical analysis title
    GLPG2737 vs Placebo - Lumacaftor
    Statistical analysis description
    An analysis of variance (ANOVA) model with treatment arm (GLPG2737 group and placebo group) as a factor. The PEs were calculated as the geometric mean ratio of GLPG2737 group relative to placebo group with corresponding 90% CI.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric means
    Point estimate
    1.349
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.042
         upper limit
    1.745

    Secondary: PK - AUC0-8h

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    End point title
    PK - AUC0-8h
    End point description
    Determine AUC0-8h on Day 14 of GLPG2737, its active metabolite G1125498 (M4), ivacaftor, and lumacaftor.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14
    7
    Units: ng.h/ml
    arithmetic mean (standard deviation)
        GLPG2737
    1510 ( 551 )
    0 ( 0 )
        G1125498
    2740 ( 1100 )
    0 ( 0 )
        ivacaftor
    3230 ( 986 )
    3720 ( 4040 )
        lumacaftor
    141000 ( 52100 )
    97800 ( 23500 )
    Statistical analysis title
    GLPG2737 vs Placebo - Ivacaftor
    Statistical analysis description
    An analysis of variance (ANOVA) model with treatment arm (GLPG2737 group and placebo group) as a factor. The PEs were calculated as the geometric mean ratio of GLPG2737 group relative to placebo group with corresponding 90% CI.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric means
    Point estimate
    1.205
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.733
         upper limit
    1.981
    Statistical analysis title
    GLPG2737 vs Placebo - Lumacaftor
    Statistical analysis description
    An analysis of variance (ANOVA) model with treatment arm (GLPG2737 group and placebo group) as a factor. The PEs were calculated as the geometric mean ratio of GLPG2737 group relative to placebo group with corresponding 90% CI.
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric means
    Point estimate
    1.371
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.025
         upper limit
    1.834

    Secondary: PK - Ctrough

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    End point title
    PK - Ctrough
    End point description
    Determine Ctrough through 28 days of GLPG2737, its active metabolite G1125498 (M4), ivacaftor, and lumacaftor.
    End point type
    Secondary
    End point timeframe
    Days 1, 14 and 28.
    End point values
    GLPG2737 group Placebo group
    Number of subjects analysed
    14
    8 [5]
    Units: ng/ml
    arithmetic mean (standard deviation)
        GLPG2737 - Day 14
    83.8 ( 68.0 )
    0 ( 0 )
        GLPG2737 - Day 28
    93.2 ( 60.3 )
    0 ( 0 )
        G1125498 - Day 14
    259 ( 150 )
    0 ( 0 )
        G1125498 - Day 28
    294 ( 153 )
    0 ( 0 )
        ivacaftor - Day 1
    192 ( 197 )
    53.2 ( 47.7 )
        ivacaftor - Day 14
    84.2 ( 62.5 )
    74.3 ( 53.2 )
        ivacaftor - Day 28
    108 ( 73 )
    66.8 ( 37.6 )
        lumacaftor - Day 1
    17000 ( 14200 )
    6950 ( 4050 )
        lumacaftor - Day 14
    11600 ( 6970 )
    7290 ( 4980 )
        lumacaftor - Day 28
    13500 ( 7110 )
    7600 ( 2750 )
    Notes
    [5] - N=7 at Days 14 and 28
    Statistical analysis title
    Day 14 vs Day 1 - Ivacaftor
    Statistical analysis description
    A mixed effect model with subject as random effect and day as fixed effect. The PEs were calculated as the geometric mean ratio of Day 28 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone) and Day 14 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone), with corresponding 90% confidence interval (CI).
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric mean ratio
    Point estimate
    0.489
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.264
         upper limit
    0.906
    Statistical analysis title
    Day 28 vs Day 1 - Ivacaftor
    Statistical analysis description
    A mixed-effects model with subject as random effect and day as fixed effect. The PEs were calculated as the geometric mean ratio of Day 28 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone) and Day 14 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone), with corresponding 90% confidence interval (CI).
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric mean ratio
    Point estimate
    0.787
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.425
         upper limit
    1.458
    Statistical analysis title
    Day 14 vs Day 1 - Lumacaftor
    Statistical analysis description
    A mixed-effects model with subject as random effect and day as fixed effect. The PEs were calculated as the geometric mean ratio of Day 28 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone) and Day 14 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone), with corresponding 90% confidence interval (CI).
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric mean ratio
    Point estimate
    0.919
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.521
         upper limit
    1.619
    Statistical analysis title
    Day 28 vs Day 1
    Statistical analysis description
    A mixed-effects model with subject as random effect and day as fixed effect. The PEs were calculated as the geometric mean ratio of Day 28 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone) and Day 14 (coadministration of Orkambi+GLPG2737) relative to Day 1 (Orkambi alone), with corresponding 90% confidence interval (CI).
    Comparison groups
    GLPG2737 group v Placebo group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-geometric mean ratio
    Point estimate
    1.309
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.742
         upper limit
    2.306

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first study drug administration until last follow-up visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    GLPG2737 group
    Reporting group description
    Subjects received GLPG2737 mg b.i.d.

    Reporting group title
    Placebo group
    Reporting group description
    Subjects received placebo b.i.d.

    Serious adverse events
    GLPG2737 group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    GLPG2737 group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 14 (71.43%)
    8 / 8 (100.00%)
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Fatigue
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Testicular pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 8 (12.50%)
         occurrences all number
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Sputum increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dysphonia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nasal dryness
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Painful respiration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Rales
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Sputum retention
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood albumin decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood calcium decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood calcium increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Crystal urine present
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Eosinophil count abnormal
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    High density lipoprotein decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Lymphocyte percentage decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Protein total decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 8 (25.00%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 14 (21.43%)
    4 / 8 (50.00%)
         occurrences all number
    3
    5
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Epididymitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Oct 2017
    The initially proposed dose regimen was changed from 150 mg GLPG2737 q.d. to 75 mg GLPG2737 b.i.d. The lower bound for heart rate range was changed from 40 to 50 bpm.
    24 Oct 2017
    Erratum: The lower bound for heart rate range was changed from 40 to 50 bpm for the ECG parameter ‘heart rate’.

    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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    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
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