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    Clinical Trial Results:
    GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks

    Summary
    EudraCT number
    2018-002664-73
    Trial protocol
    IE   GB   FR   PL   ES   BE   IT  
    Global end of trial date
    17 May 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    19 May 2024
    First version publication date
    19 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GALACTIC-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03832946
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    124075: IND
    Sponsors
    Sponsor organisation name
    Galecto Biotech AB
    Sponsor organisation address
    Ole Maaloes Vej 3, Copenhagen, Denmark, DK
    Public contact
    Chief Medical Officer, Galecto Biotech AB, Clinicaltrials@galecto.com
    Scientific contact
    Chief Medical Officer, Galecto Biotech AB, Clinicaltrials@galecto.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
    13 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of GB0139 3 mg dry powder for inhalation compared with placebo over a 52-week treatment period on the annual rate of decline in forced vital capacity (FVC) in participants with IPF who were not treated with or could not tolerate nintedanib or pirfenidone. The secondary objective of the study was to further characterise the effect of GB0139 3 mg compared with placebo over a 52-week treatment period on FVC, also on the quality of life, time to respiratory-related hospitalisations and all-cause mortality.
    Protection of trial subjects
    This study was conducted in accordance with the International Council on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Feb 2019
    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
    Poland: 11
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 42
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    United States: 47
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Georgia: 9
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Ukraine: 6
    Country: Number of subjects enrolled
    Russian Federation: 8
    Worldwide total number of subjects
    172
    EEA total number of subjects
    34
    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)
    23
    From 65 to 84 years
    144
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    This study included participants with a diagnosis of IPF and was conducted in 16 countries (including Belarus where no participants were randomised and Belgium where no participants were enrolled after a change in trial design in protocol version 6.0)

    Pre-assignment
    Screening details
    825 participants were screened. 426 were enrolled and randomised. 424 received placebo or GB0139. By protocol amendment 6.0 the participants on SOC and the 10 mg arm were excluded. 173 participants were enrolled and randomised according to protocol v.6.0. 1 was randomised by error and didn't receive treatment. A population of 172 is presented here.

    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
    GB0139 3 mg
    Arm description
    Participants received 3 mg GB0139 administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Olitigaltin
    Investigational medicinal product code
    GB0139
    Other name
    TD139
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Inhalation use
    Dosage and administration details
    GB0139 3 mg was administered by inhalation once a day as two 1.5 mg capsules for 52 weeks. The study treatment was administered using the Plastiape RS01 Monodose DPI device.

    Arm title
    Placebo
    Arm description
    Participants received placebo administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered by inhalation once a day as two capsules for 52 weeks. The study treatment was administered using the Plastiape RS01 Monodose DPI device.

    Number of subjects in period 1
    GB0139 3 mg Placebo
    Started
    102
    70
    Completed
    55
    38
    Not completed
    47
    32
         Consent withdrawn by subject
    12
    9
         Adverse event
    3
    1
         Lost to follow-up
    1
    -
         Protocol change forbidding nintedanib/pirfenidone
    30
    22
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GB0139 3 mg
    Reporting group description
    Participants received 3 mg GB0139 administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.

    Reporting group values
    GB0139 3 mg Placebo Total
    Number of subjects
    102 70 172
    Age categorical
    Units: Subjects
        < 70 Years
    34 26 60
        ≥ 70 Years
    68 44 112
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    72.5 ( 7.56 ) 71.7 ( 7.36 ) -
    Gender categorical
    Units: Subjects
        Female
    27 22 49
        Male
    75 48 123
    Subject analysis sets

    Subject analysis set title
    Primary Population
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Patients randomised and received at least one dose of study drug.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Patients randomised and received at least one dose of study drug and grouped by treatment received.

    Subject analysis sets values
    Primary Population Safety Population
    Number of subjects
    172
    172
    Age categorical
    Units: Subjects
        < 70 Years
    60
    60
        ≥ 70 Years
    112
    112
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    49
    49
        Male
    123
    123

    End points

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    End points reporting groups
    Reporting group title
    GB0139 3 mg
    Reporting group description
    Participants received 3 mg GB0139 administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.

    Subject analysis set title
    Primary Population
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Patients randomised and received at least one dose of study drug.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Patients randomised and received at least one dose of study drug and grouped by treatment received.

    Primary: Annual Rate of Decline in Forced Vital Capacity (FVC)

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    End point title
    Annual Rate of Decline in Forced Vital Capacity (FVC)
    End point description
    End point type
    Primary
    End point timeframe
    52 weeks
    End point values
    GB0139 3 mg Placebo
    Number of subjects analysed
    100
    68
    Units: mL
        least squares mean (confidence interval 95%)
    -316.60 (-394.86 to -238.35)
    -127.41 (-221.12 to -33.71)
    Statistical analysis title
    Primary
    Statistical analysis description
    Comparing GB0139 vs. placebo
    Comparison groups
    GB0139 3 mg v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.003
    Method
    Coefficient Regression Model
    Parameter type
    Least Squares (LS) mean difference
    Point estimate
    -189.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -311.28
         upper limit
    -67.1
    Notes
    [1] - Coefficient Regression Model

    Secondary: Proportion of participants with an absolute decline from baseline in FVC (% predicted) of ≤10% at Week 52

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    End point title
    Proportion of participants with an absolute decline from baseline in FVC (% predicted) of ≤10% at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    GB0139 3 mg Placebo
    Number of subjects analysed
    102
    70
    Units: Participants
    43
    39
    Statistical analysis title
    Main
    Statistical analysis description
    Comparing GB0139 vs. placebo
    Comparison groups
    GB0139 3 mg v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.074
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.31
         upper limit
    1.06
    Notes
    [2] - Regression, logistic

    Secondary: Time to first hospitalisation (respiratory related, including acute exacerbation of IPF)

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    End point title
    Time to first hospitalisation (respiratory related, including acute exacerbation of IPF)
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    GB0139 3 mg Placebo
    Number of subjects analysed
    102
    70
    Units: Participants
    17
    5
    Statistical analysis title
    Main
    Statistical analysis description
    Comparing GB0139 vs. placebo
    Comparison groups
    GB0139 3 mg v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.081
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    6.62

    Secondary: Time to death (all causes)

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    End point title
    Time to death (all causes)
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    GB0139 3 mg Placebo
    Number of subjects analysed
    102
    70
    Units: Participants
    7
    4
    Statistical analysis title
    Main
    Statistical analysis description
    Comparing GB0139 vs. placebo
    Comparison groups
    GB0139 3 mg v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.656
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.39
         upper limit
    4.53

    Secondary: Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)

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    End point title
    Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
    End point description
    Change from baseline in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    GB0139 3 mg Placebo
    Number of subjects analysed
    102
    70
    Units: Score on a scale
        least squares mean (standard deviation)
    5.687 ( 25.5537 )
    -6.198 ( 20.0903 )
    Statistical analysis title
    Main
    Statistical analysis description
    Comparing GB0139 vs. placebo
    Comparison groups
    GB0139 3 mg v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.019
    Method
    Mixed models analysis
    Parameter type
    Least Squares (LS) mean difference
    Point estimate
    7.132
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.18
         upper limit
    13.084
    Notes
    [3] - 116 subjects reached this stage

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    GB0139 3 mg
    Reporting group description
    Participants received 3 mg GB0139 administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered as inhalation once a day for 52 Weeks. Participants were neither treated with nintedanib nor pirfenidone during the trial.

    Serious adverse events
    GB0139 3 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 102 (23.53%)
    11 / 70 (15.71%)
         number of deaths (all causes)
    8
    5
         number of deaths resulting from adverse events
    6
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to skin
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour of the lung
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral microangiopathy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pernicious anaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dyspnoea
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    8 / 102 (7.84%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pneumothorax
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (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
    Cellulitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    4 / 102 (3.92%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 102 (3.92%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    GB0139 3 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 102 (78.43%)
    50 / 70 (71.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Monoclonal Gammopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Hypotension
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 102 (3.92%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Fatigue
         subjects affected / exposed
    2 / 102 (1.96%)
    5 / 70 (7.14%)
         occurrences all number
    2
    5
    Feeling Cold
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Influenza Like Illness
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Oedema Peripheral
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 70 (2.86%)
         occurrences all number
    4
    2
    Pyrexia
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Vaccination Site Pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Vaccination Site Rash
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Autoimmune Disorder
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Seasonal Allergy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Prostatic atrophy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Prostatomegaly
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Bronchial Obstruction
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    17 / 102 (16.67%)
    9 / 70 (12.86%)
         occurrences all number
    24
    9
    Dysphonia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Dyspnoea
         subjects affected / exposed
    11 / 102 (10.78%)
    5 / 70 (7.14%)
         occurrences all number
    14
    5
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Haemoptysis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Hypoxia
         subjects affected / exposed
    3 / 102 (2.94%)
    1 / 70 (1.43%)
         occurrences all number
    3
    1
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    5 / 102 (4.90%)
    3 / 70 (4.29%)
         occurrences all number
    6
    3
    Nasal Congestion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pleuritic Pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    6 / 102 (5.88%)
    2 / 70 (2.86%)
         occurrences all number
    6
    2
    Pulmonary Embolism
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pulmonary Mass
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sputum discoloured
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sputum Increased
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Wheezing
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Psoriasis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Insomnia
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 70 (2.86%)
         occurrences all number
    1
    2
    Restlessness
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Sleep Disorder
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Suicidal Ideation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Forced vital capacity decreased
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 70 (2.86%)
         occurrences all number
    2
    2
    Heart rate increased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Occult blood positive
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    4 / 102 (3.92%)
    3 / 70 (4.29%)
         occurrences all number
    4
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eye Injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eyelid Contusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    5
    0
    Limb Injury
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Muscle Injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Procedural Pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rib Fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Road traffic accident
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin Laceration
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Spinal compression fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Tendon rupture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    3
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Bundle branch block left
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Coronary artery disease
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Myocardial hypoxia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 70 (2.86%)
         occurrences all number
    4
    2
    Essential Tremor
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    7 / 102 (6.86%)
    2 / 70 (2.86%)
         occurrences all number
    7
    5
    Hemiparesis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Memory Impairment
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Mental impairment
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Sensory Loss
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Polycythaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Excessive cerumen production
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vertigo positional
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Epiretinal membrane
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Episcleritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Eye haematoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Abdominal Pain
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    3
    1
    Constipation
         subjects affected / exposed
    4 / 102 (3.92%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    8 / 102 (7.84%)
    2 / 70 (2.86%)
         occurrences all number
    13
    2
    Diverticulum intestinal
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Gingival Cyst
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hiatus Hernia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Inguinal Hernia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    6
    0
    Reflux Gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Rash macular
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Renal Cyst
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Renal Failure
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hypothyroidism
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 102 (2.94%)
    2 / 70 (2.86%)
         occurrences all number
    3
    2
    Back pain
         subjects affected / exposed
    5 / 102 (4.90%)
    3 / 70 (4.29%)
         occurrences all number
    5
    3
    Chest wall haematoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Joint stiffness
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Joint Swelling
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Limb mass
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Muscle Spasms
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal Discomfort
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    6 / 102 (5.88%)
    3 / 70 (4.29%)
         occurrences all number
    8
    4
    Bronchitis Bacterial
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    13 / 102 (12.75%)
    3 / 70 (4.29%)
         occurrences all number
    14
    4
    COVID-19 Pneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Coronavirus Infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Gingivitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Helicobacter Infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Localised Infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    12 / 102 (11.76%)
    3 / 70 (4.29%)
         occurrences all number
    19
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 102 (3.92%)
    3 / 70 (4.29%)
         occurrences all number
    7
    4
    Oral herpes
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Root canal infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Tooth Abcess
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Tooth infection
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Tracheitis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 102 (4.90%)
    4 / 70 (5.71%)
         occurrences all number
    6
    4
    Urinary tract infection
         subjects affected / exposed
    5 / 102 (4.90%)
    1 / 70 (1.43%)
         occurrences all number
    8
    2
    Viral Infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Decreased Appetite
         subjects affected / exposed
    4 / 102 (3.92%)
    3 / 70 (4.29%)
         occurrences all number
    4
    3
    Folate deficiency
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 70 (1.43%)
         occurrences all number
    3
    2
    Hyperkalaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Increased appetite
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Iron deficiency
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Malnutrition
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Type 2 Diabetes mellitus
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 70 (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
    15 Nov 2018
    Protocol version 2.0: Removal of 12-week time limit for participants to be on stable background treatment, as the time needed to stabilise a participant on treatment can vary and should be the judgment of the principal investigator (treating physician) rather than within a prescribed time limit.
    10 Dec 2018
    Protocol version 3.0 Update to events schedule: - Laboratory test will be performed at Visit 2 (baseline) as, given length of screening window, it is considered appropriate to have a baseline sample immediately prior to the commencement of dosing. - Participants should be observed for 1 hour after the first dose to monitor for any acute adverse effects of study drug administration (e.g., bronchospasm), per a comment from the Food and Drug Administration regarding potential for bronchospasm.
    05 Jul 2019
    Protocol version 4.0: - Amendment to inclusion criteria 1, regarding the HRCT scan, to allow participants with a HRCT scan older than 12 months to undergo a HRCT scan and be considered for enrolment. - Dosing instructions changed from 2 inhalations with each capsule to 1 to 3 inhalations, to clarify that up to 3 inhalations may be required for proper dosing. HRCT=high resolution computerised tomography
    22 Apr 2020
    Global Addendum 1 and 2, dated 22 April 2020 and 31 March 2021, respectively: Amended due to the global coronavirus disease pandemic and its potential impact on participant safety, eligibility and recruitment, as follows: - Use of telephone clinical assessments in lieu of on-site visits, where not safe or feasible - If not randomised within the 12-week screening window, the participant could return for a rescreen once safe. - Completion of home-based spirometry and HRQoL questionnaires/dyspnoea assessments via iPad or ‘interview mode’. - Pregnancy monitoring at home and communicated during telephone assessments. HRQoL=health-related quality of life
    23 Jun 2020
    Protocol version 5.0: - Removal of stratified randomisation by SoC and increase in site number due to difficulties with enrolment in an acceptable timeframe, with no change in planned total number of participants. - Update to exclusion criteria to allow patients with squamous cell carcinoma to enrol, as no risk is foreseen. - Diffusion capacity for carbon monoxide and 6MWT added to withdrawal assessments as they are important assessments for IPF. - Addition and clarification of rescreen procedures to be performed which included DLCO and spirometry. SoC=standard of care; 6MWT=6-minute walk test; IPF=idiopathic pulmonary fibrosis; DLCO=diffusion capacity for carbon monoxide;
    07 Apr 2021
    Protocol version 6.0: - Following the DSMB’s recommendation, participants on SoC/approved treatment for IPF were excluded, and the GB0139 10 mg treatment arm was removed. Eligible participants were to be randomised in a 2:1 ratio to 1 of the 2 treatment arms, 3 mg and placebo, to maintain the chance (2/3) of receiving an active treatment at randomisation for individual participants, compared with the previous design - The primary objective was updated to reflect to the current study design - Key secondary endpoints were updated to include: - Change from baseline in SGRQ total score at Week 52 - Moved time to first hospitalisation, respiratory related to the key secondary endpoints - Exploratory endpoints were updated to include: - Time to initiation of pirfenidone or nintedanib treatment for SoC2 participants up to the time when SoC1 and SoC2 were removed - Time to termination of pirfenidone or nintedanib treatment for SoC1 participants up to the time when SoC1 and SoC2 were removed - Screening period duration was updated to 6 weeks - Change of follow-up to be conducted by phone call from 1 week and up to 2 weeks after the last study visit - Exclusion criteria were updated to exclude participants from the trial that: - Currently receiving nintedanib and pirfenidone - Previously using GB0139 or were randomised in GALACTIC-1 - Previously used nintedanib or pirfenidone within 7 days of initiation of screening - Previously used investigational drugs within 30 days of initiation of screening - Participate in another clinical trial - Have hypersensitivity to the active substance (GB0139) or the excipient (lactose) - Duration of IPF diagnosis to screening was changed from 3 to 5 years to facilitate enrolment under the updated patient selection criteria - Coronavirus disease vaccines were added under permitted medications No participants in Belgium enrolled in new trial design DSMB=Drug Safety Monitoring Board;SGRQ=St. George’s Respiratory Questionnaire
    28 Jan 2022
    Protocol version 7.0: - Exclusion criterion number 11 was updated to exclude only participants participating in another interventional clinical trial, based on the study investigator’s suggestion. - Correction of secondary endpoint – proportion of participants with an absolute decline from baseline in FVC% pred of ≤10% and ≤5 at Week 52 (from >10% and >5%, respectively). The revised wording is a definition of a responder, rather than a progressor. - Sample size justification updated. The level of significance and power of the study were revised to be more reflective of a Phase 2 study. As a result of increasing the significance level to 10% and reducing the power to 75%, the sample size decreased to 141 participants. The level of confidence was changed from 95% to 90% to reflect the new level of significance. - Time to termination of pirfenidone or nintedanib treatment was removed from exploratory endpoints as the use of these drugs had been systematically curtailed, so was no longer relevant. FVC=forced vital capacity

    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.
    A 10 mg dose arm and concomitant use of nintedanib and pirfinidone were removed from the trial design (protocol v. 6.0). The results presented reflects the modified trial design.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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