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    Clinical Trial Results:
    A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

    Summary
    EudraCT number
    2019-000750-63
    Trial protocol
    GB   HU   NL   BE   FR   PL   RO  
    Global end of trial date
    09 Jun 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Jun 2023
    First version publication date
    24 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M19-530
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhea, Maidenhead, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 0001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.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
    09 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective of the trial: Evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with varied dose levels of ABBV-2222 in adult subjects with CF who are homozygous for the F508del mutation.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Dec 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
    Belgium: 11
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Czechia: 2
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Serbia: 6
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    78
    EEA total number of subjects
    41
    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)
    77
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    In Part 1 participants received 2 different doses of ABBV-3067 as a single agent, and 5 different doses of ABBV-2222 as dual combination therapy with ABBV-3067 at a fixed dose. Part 2 of the study was not conducted as it was deemed not enrollable by the time Part 1 was completed, therefore only Part 1 is presented.

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ABBV-3067 50 mg + Placebo for ABBV-2222
    Arm description
    Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally

    Arm title
    ABBV-3067 150 mg + Placebo for ABBV-2222
    Arm description
    Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally

    Arm title
    ABBV-3067 150 mg + ABBV-2222 10 mg
    Arm description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally.

    Arm title
    ABBV-3067 150 mg + ABBV-2222 30 mg
    Arm description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally.

    Arm title
    ABBV-3067 150 mg + ABBV-2222 100 mg
    Arm description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally.

    Arm title
    ABBV-3067 150 mg + ABBV-2222 200 mg
    Arm description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally

    Arm title
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Arm description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally.

    Arm title
    Placebo for ABBV-3067 + Placebo for ABBV-2222
    Arm description
    Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo ABBV-3067
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet taken orally.

    Investigational medicinal product name
    Placebo ABBV-2222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule taken orally.

    Number of subjects in period 1
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Started
    6
    7
    5
    12
    11
    12
    14
    11
    Completed
    6
    7
    4
    12
    11
    12
    13
    10
    Not completed
    0
    0
    1
    0
    0
    0
    1
    1
         Reason Not Specified
    -
    -
    -
    -
    -
    -
    -
    1
         Never Received Study Drug
    -
    -
    1
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABBV-3067 50 mg + Placebo for ABBV-2222
    Reporting group description
    Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + Placebo for ABBV-2222
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 10 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 30 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 100 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 200 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

    Reporting group title
    Placebo for ABBV-3067 + Placebo for ABBV-2222
    Reporting group description
    Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222 Total
    Number of subjects
    6 7 5 12 11 12 14 11 78
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.5 ± 4.46 31.6 ± 7.39 36.4 ± 15.50 33.8 ± 12.67 32.5 ± 12.53 32.5 ± 13.13 31.8 ± 9.0 26.8 ± 6.68 -
    Gender categorical
    Units: Subjects
        Female
    5 3 2 6 5 2 3 4 30
        Male
    1 4 3 6 6 10 11 7 48
    Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1 ) at Baseline
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
    Units: percent predicted FEV1 (%)
        arithmetic mean (standard deviation)
    67.0 ± 15.89 68.6 ± 11.16 65.8 ± 18.96 64.6 ± 16.84 68.1 ± 14.48 62.0 ± 15.18 ± 67.8 ± 13.19 -
    Subject analysis sets

    Subject analysis set title
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

    Subject analysis sets values
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Number of subjects
    13
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1 ) at Baseline
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
    Units: percent predicted FEV1 (%)
        arithmetic mean (standard deviation)
    67.6 ± 17.83

    End points

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    End points reporting groups
    Reporting group title
    ABBV-3067 50 mg + Placebo for ABBV-2222
    Reporting group description
    Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + Placebo for ABBV-2222
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 10 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 30 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 100 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 200 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

    Reporting group title
    Placebo for ABBV-3067 + Placebo for ABBV-2222
    Reporting group description
    Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Subject analysis set title
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

    Primary: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

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    End point title
    Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 (Baseline) through Day 29
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be performed for this end point.
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: percent predicted FEV1 (%)
        least squares mean (confidence interval 95%)
    0.3 (-4.38 to 4.98)
    -2.2 (-7.03 to 2.66)
    2.0 (-5.07 to 9.07)
    4.5 (-0.16 to 9.08)
    0.3 (-3.13 to 3.68)
    4.0 (0.79 to 7.28)
    2.4 (-0.85 to 5.74)
    -2.2 (-5.83 to 1.43)
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)

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    End point title
    Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
    End point description
    Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) through Day 29
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: millimole per liter (mmol/L)
        least squares mean (confidence interval 95%)
    -4.5 (-15.78 to 6.81)
    -8.9 (-18.64 to 0.78)
    -2.3 (-16.76 to 12.25)
    -15.7 (-23.37 to -7.98)
    -12.3 (-20.34 to -4.26)
    -18.6 (-25.98 to -11.16)
    -19.9 (-27.17 to -12.64)
    -2.1 (-10.63 to 6.36)
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)

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    End point title
    Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
    End point description
    FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) through Day 29
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: liter (L)
        least squares mean (confidence interval 95%)
    0.0 (-0.22 to 0.23)
    -0.0 (-0.24 to 0.20)
    0.0 (-0.28 to 0.35)
    0.1 (-0.16 to 0.28)
    0.1 (-0.08 to 0.24)
    0.0 (-0.11 to 0.19)
    0.0 (-0.12 to 0.19)
    -0.2 (-0.38 to -0.03)
    No statistical analyses for this end point

    Secondary: Measure: Measure Title Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)

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    End point title
    Measure: Measure Title Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
    End point description
    FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) through Day 29
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: liter per seconds (L/sec)
        least squares mean (confidence interval 95%)
    0.0 (-0.27 to 0.29)
    -0.0 (-0.29 to 0.27)
    0.2 (-0.26 to 0.57)
    0.2 (-0.08 to 0.47)
    -0.0 (-0.23 to 0.18)
    0.3 (0.08 to 0.47)
    0.1 (-0.08 to 0.31)
    0.0 (-0.20 to 0.24)
    No statistical analyses for this end point

    Secondary: Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

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    End point title
    Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) through Day 29
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: percent predicted FEV1
        least squares mean (confidence interval 95%)
    1.0 (-6.22 to 8.22)
    -2.9 (-10.38 to 4.60)
    3.4 (-7.46 to 14.34)
    8.0 (0.87 to 15.14)
    1.4 (-3.82 to 6.69)
    5.7 (0.70 to 10.73)
    4.7 (-0.35 to 9.84)
    -3.3 (-8.86 to 2.34)
    No statistical analyses for this end point

    Secondary: Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)

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    End point title
    Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
    End point description
    FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) through Day 29
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: L/sec
        least squares mean (confidence interval 95%)
    0.8 (-18.01 to 19.55)
    -0.1 (-18.94 to 18.76)
    8.8 (-18.69 to 36.38)
    19.9 (1.61 to 38.28)
    0.1 (-13.46 to 13.65)
    18.5 (5.60 to 31.50)
    10.9 (-2.21 to 24.01)
    1.0 (-13.69 to 15.62)
    No statistical analyses for this end point

    Secondary: Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)

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    End point title
    Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
    End point description
    FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) through Day 29
    End point values
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Number of subjects analysed
    5
    5
    2
    5
    10
    11
    11
    9
    Units: liter
        least squares mean (confidence interval 95%)
    0.1 (-5.20 to 5.35)
    -1.0 (-6.38 to 4.30)
    0.2 (-7.37 to 7.82)
    2.2 (-3.03 to 7.43)
    2.2 (-1.51 to 6.01)
    0.9 (-2.77 to 4.54)
    1.1 (-2.58 to 4.73)
    -4.3 (-8.37 to -0.20)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of
    Adverse event reporting additional description
    All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    ABBV-3067 50 mg + Placebo for ABBV-2222
    Reporting group description
    Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + Placebo for ABBV-2222
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 10 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 30 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 100 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 200 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.

    Reporting group title
    ABBV-3067 150 mg + ABBV-2222 300 mg
    Reporting group description
    Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

    Reporting group title
    Placebo for ABBV-3067 + Placebo for ABBV-2222
    Reporting group description
    Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

    Serious adverse events
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    ILEUS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS ACUTE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 150 mg + ABBV-2222 300 mg Placebo for ABBV-3067 + Placebo for ABBV-2222
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    5 / 7 (71.43%)
    4 / 4 (100.00%)
    6 / 11 (54.55%)
    10 / 11 (90.91%)
    6 / 12 (50.00%)
    6 / 13 (46.15%)
    8 / 12 (66.67%)
    Vascular disorders
    FLUSHING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    0
    0
    CHEST PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    CHEST DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    PYREXIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 11 (18.18%)
    2 / 11 (18.18%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    2
    1
    0
    0
    BRONCHOSPASM
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    ASTHMA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    DRY THROAT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    HAEMOPTYSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    0
    3
    0
    0
    1
    EPISTAXIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    PHARYNGEAL ERYTHEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    PLEURITIC PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    PRODUCTIVE COUGH
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    RALES
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    SPUTUM INCREASED
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    WHEEZING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    PANIC ATTACK
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    BLOOD GLUCOSE DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    FORCED EXPIRATORY VOLUME DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    INTERNATIONAL NORMALISED RATIO INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    WHITE BLOOD CELL COUNT INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    NEUTROPHIL COUNT INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    LIMB INJURY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    MUSCLE STRAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Congenital, familial and genetic disorders
    CYSTIC FIBROSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 11 (18.18%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    2
    0
    1
    1
    DIZZINESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    PRESYNCOPE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Eye disorders
    MYOPIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    DYSPEPSIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    1
    0
    DIARRHOEA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    DRY MOUTH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 4 (50.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    1
    3
    NAUSEA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    FREQUENT BOWEL MOVEMENTS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    FAECES DISCOLOURED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    RETCHING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    VOMITING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    PAPULE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    ALOPECIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    ACNE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    RASH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    0
    URTICARIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    MYALGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    MYOSITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Infections and infestations
    BACTERIURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    2 / 11 (18.18%)
    3 / 11 (27.27%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    2
    3
    0
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    1
    SINUSITIS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    RASH PUSTULAR
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    ORAL HERPES
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    SIALOADENITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Metabolism and nutrition disorders
    INCREASED APPETITE
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    HYPOGLYCAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    DECREASED APPETITE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2019
    The following changes were implemented with Protocol amendment 1; Correcting minor clerical errors for consistency throughout the protocol in addition to the following, adding that the of oral cannabis is not allowed under Eligibility Criteria, a requirement was added for all females of childbearing potential to supplement with a barrier method when hormonal contraception methods are the preferred methods of birth control.
    04 Feb 2022
    The following changes were implemented with Protocol amendment 2: Modified rescreening language regarding SwCl test, added eligibility criteria to specify the requirements for subjects from Study M19-771, added Montelukast to prohibited medication list

    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
    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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