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    Clinical Trial Results:
    Randomized, double-blind, parallel group, Phase 2b dose-finding, efficacy and safety study of 12-week twice daily oral administration of BAY 1817080 compared to placebo in the treatment of refractory and/or unexplained chronic cough (RUCC)

    Summary
    EudraCT number
    		 2019-004169-42
    Trial protocol
    		 DE   GB   IT   NL   CZ   HU   SK   BE   PL   FR  
    Global end of trial date
    23 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2022
    First version publication date
    04 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1817080/20393
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04562155
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.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
    23 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to identify the optimal dose of P2X3 receptor antagonist eliapixant in patients with RUCC and further assess efficacy and characterize safety and tolerability profile of eliapixant. The primary objective was to assess the efficacy of P2X3 receptor antagonist eliapixant as compared with placebo in terms of change in 24-hour cough count from baseline to week 12.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Australia: 26
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Hungary: 12
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Japan: 23
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    Slovakia: 9
    Country: Number of subjects enrolled
    Turkey: 17
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    310
    EEA total number of subjects
    143
    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)
    193
    From 65 to 84 years
    117
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 99 centers in 19 countries/regions with first subject first visit on 02-Oct-2020 and last subject last visit on 23-Jul-2021.

    Pre-assignment
    Screening details
    		 Overall, 399 subjects were screened, 89 of whom were screening failures. The remaining 310 subjects were randomized to 4 treatment groups (75 to eliapixant 25 mg BID, 78 to eliapixant 75 mg BID, 80 to eliapixant 150 mg BID, and 77 to placebo).

    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
    		 Investigator, Monitor, Data analyst, Assessor, Subject
    Blinding implementation details
    After randomization, subject, investigator and sponsor were blinded for the intervention subject received

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eliapixant 25 mg BID
    Arm description
    		 Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eliapixant 25 mg tablets were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food. There were no dose modifications; subjects stayed on the dose which they were randomized to.

    Arm title
    		 Eliapixant 75 mg BID
    Arm description
    		 Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eliapixant tablets totaling 75 mg were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food. There were no dose modifications; subjects stayed on the dose which they were randomized to.

    Arm title
    		 Eliapixant 150 mg BID
    Arm description
    		 Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eliapixant tablets totaling 150 mg were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food. There were no dose modifications; subjects stayed on the dose which they were randomized to.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for eliapixant
    Investigational medicinal product code
    Not applicable
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for eliapixant tablets were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food.

    Number of subjects in period 1
    		Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Started
    75
    78
    80
    77
    Completed
    64
    69
    67
    71
    Not completed
    11
    9
    13
    6
         COVID-19 pandemic
    -
    -
    -
    1
         Consent withdrawn by subject
    3
    6
    3
    3
         Adverse event, non-fatal
    7
    3
    8
    1
         Other
    1
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eliapixant 25 mg BID
    Reporting group description
    		 Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Eliapixant 75 mg BID
    Reporting group description
    		 Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Eliapixant 150 mg BID
    Reporting group description
    		 Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo Total
    Number of subjects
    		 75 78 80 77 310
    Age categorical
    Used full analysis set
    Units: Subjects
        Adults (18-64 years)
    		 45 50 49 49 193
        From 65-84 years
    		 30 28 31 28 117
    Age continuous
    Used full analysis set
    Units: years
        arithmetic mean (standard deviation)
    		 61.81 ( 9.64 ) 58.62 ( 12.7 ) 58.98 ( 11.8 ) 56.91 ( 12.4 ) -
    Gender categorical
    Used full analysis set
    Units: Subjects
        Female
    		 56 63 61 61 241
        Male
    		 19 15 19 16 69
    Baseline 24-hour coughs per hour
    Used per protocol set (PPS) Eliapixant 25 mg BID (N=67), Eliapixant 75 mg BID (N=69), Eliapixant 150 mg BID (N=73), Placebo (N=74)
    Units: 24-hour cough count per hour
        geometric mean (standard deviation)
    		 17.49 ( 2.94 ) 19.23 ( 2.94 ) 15.61 ( 2.34 ) 17.63 ( 3.07 ) -
    Baseline Leicester Cough Questionnaire (LCQ) Total Score
    Used per protocol set (PPS) Eliapixant 25 mg BID (N=67), Eliapixant 75 mg BID (N=69), Eliapixant 150 mg BID (N=73), Placebo (N=74)
    Units: Score of LCQ
        arithmetic mean (standard deviation)
    		 12.00 ( 2.54 ) 11.76 ( 2.77 ) 11.15 ( 2.56 ) 11.53 ( 3.27 ) -
    Baseline awake cough count per hour
    Used per protocol set (PPS) Eliapixant 25 mg BID (N=67), Eliapixant 75 mg BID (N=69), Eliapixant 150 mg BID (N=73), Placebo (N=74)
    Units: Cough count per hour
        geometric mean (standard deviation)
    		 23.62 ( 3.02 ) 26.41 ( 2.97 ) 21.19 ( 2.39 ) 24.01 ( 3.18 ) -
    Baseline Cough Severity Visual Analogue Scale [VAS] Value
    Used per protocol set (PPS) - Included the subjects in PPS with valid VAS value. Eliapixant 25 mg BID (N=62), Eliapixant 75 mg BID (N=68), Eliapixant 150 mg BID (N=67), Placebo (N=69)
    Units: Score of VAS
        arithmetic mean (standard deviation)
    		 65.51 ( 14.64 ) 67.08 ( 14.89 ) 66.79 ( 15.86 ) 61.52 ( 18.51 ) -

    End points

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    End points reporting groups
    Reporting group title
    Eliapixant 25 mg BID
    Reporting group description
    		 Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Eliapixant 75 mg BID
    Reporting group description
    		 Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Eliapixant 150 mg BID
    Reporting group description
    		 Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects randomly assigned to study intervention. Subjects were analyzed according to the intervention they were randomized to.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects randomly assigned to study intervention and who took at least one tablet of study intervention. Subjects were analyzed according to the intervention they actually received.

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects randomly assigned to study intervention who did not have validity findings affecting efficacy. subjects were analyzed according to the intervention they actually received. If a subject received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the subjects from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 subjects, 4.8%) or that the subject had used prohibited concomitant medication (9 subjects, 2.9%).

    Primary: Change from baseline in 24-hour cough count after 12 weeks of intervention

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    End point title
    		 Change from baseline in 24-hour cough count after 12 weeks of intervention
    End point description
    Measured by cough recording digital wearable monitoring device. btw = between geo = geometric
    End point type
    Primary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    64 [1]
    68 [2]
    72 [3]
    73 [4]
    Units: Ratio btw geoMeans of 24h cough count
        geometric mean (standard deviation)
    0.56 ( 0.9191 )
    0.47 ( 0.9019 )
    0.52 ( 0.8608 )
    0.64 ( 0.7855 )
    Notes
    [1] - PPS
    [2] - PPS
    [3] - PPS
    [4] - PPS
    Statistical analysis title
    		 Detection of dose-response: Emax model (ED50=30)
    Statistical analysis description
    Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).
    Comparison groups
    Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0345 [5]
    Method
    		 MCP-Mod method
    Confidence interval
    Notes
    [5] - Adjusted p-value
    Statistical analysis title
    		 DoD: sigm. Emax model (ED50=30, h=3)
    Statistical analysis description
    DoD = Detection of dose-response sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).
    Comparison groups
    Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0319 [6]
    Method
    		 MCP-Mod method
    Confidence interval
    Notes
    [6] - Adjusted p-value
    Statistical analysis title
    		 DoD: sigm. Emax model (ED50=60, h=5)
    Statistical analysis description
    DoD = Detection of dose-response sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).
    Comparison groups
    Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0603 [7]
    Method
    		 MCP-Mod method
    Confidence interval
    Notes
    [7] - Adjusted p-value
    Statistical analysis title
    		 Detection of dose-response: Emax model (ED50=50)
    Statistical analysis description
    Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).
    Comparison groups
    Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0376 [8]
    Method
    		 MCP-Mod method
    Confidence interval
    Notes
    [8] - Adjusted p-value

    Secondary: Percentage of subjects with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention

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    End point title
    		 Percentage of subjects with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention
    End point description
    Measured by cough recording digital wearable monitoring device
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    67 [9]
    69 [10]
    73 [11]
    74 [12]
    Units: Percentage
        number (confidence interval 95%)
    52.24 (39.67 to 64.60)
    63.77 (51.31 to 75.01)
    53.42 (41.37 to 65.20)
    45.95 (34.29 to 57.93)
    Notes
    [9] - PPS
    [10] - PPS
    [11] - PPS
    [12] - PPS
    No statistical analyses for this end point

    Secondary: Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention

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    End point title
    		 Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention
    End point description
    Measured by cough recording digital wearable monitoring device btw = between geo = geometric Number of subjects analysed at Week 2: Eliapixant 25 mg BID (N=66), Eliapixant 75 mg BID (N=67), Eliapixant 150 mg BID (N=72), Placebo (N=73) Number of subjects analysed at Week 4: Eliapixant 25 mg BID (N=66), Eliapixant 75 mg BID (N=66), Eliapixant 150 mg BID (N=68), Placebo (N=71) Number of subjects analysed at Week 8: Eliapixant 25 mg BID (N=64), Eliapixant 75 mg BID (N=65), Eliapixant 150 mg BID (N=69), Placebo (N=72)
    End point type
    Secondary
    End point timeframe
    From baseline up to 2 weeks, 4 weeks and 8 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    67 [13]
    69 [14]
    73 [15]
    74 [16]
    Units: Ratio btw geoMeans of 24h cough count
    geometric mean (standard deviation)
        Week 2
    0.75 ( 0.6134 )
    0.58 ( 0.8209 )
    0.61 ( 0.6636 )
    0.75 ( 0.4762 )
        Week 4
    0.64 ( 0.7237 )
    0.51 ( 0.8192 )
    0.58 ( 0.8589 )
    0.69 ( 0.6657 )
        Week 8
    0.55 ( 0.8737 )
    0.46 ( 0.9484 )
    0.51 ( 0.8827 )
    0.70 ( 0.6451 )
    Notes
    [13] - PPS
    [14] - PPS
    [15] - PPS
    [16] - PPS
    No statistical analyses for this end point

    Secondary: Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention

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    End point title
    		 Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention
    End point description
    Measured by cough recording digital wearable monitoring device btw = between geo = geometric Number of subjects analysed at Week 2: Eliapixant 25 mg BID (N=65), Eliapixant 75 mg BID (N=67), Eliapixant 150 mg BID (N=72), Placebo (N=73) Number of subjects analysed at Week 4: Eliapixant 25 mg BID (N=66), Eliapixant 75 mg BID (N=66), Eliapixant 150 mg BID (N=68), Placebo (N=71) Number of subjects analysed at Week 8: Eliapixant 25 mg BID (N=64), Eliapixant 75 mg BID (N=65), Eliapixant 150 mg BID (N=69), Placebo (N=72) Number of subjects analysed at Week 12: Eliapixant 25 mg BID (N=64), Eliapixant 75 mg BID (N=68), Eliapixant 150 mg BID (N=72), Placebo (N=73)
    End point type
    Secondary
    End point timeframe
    From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    67 [17]
    69 [18]
    73 [19]
    74 [20]
    Units: Ratio btw geoMeans of 24h cough count
    geometric mean (standard deviation)
        Week 2
    0.78 ( 0.6324 )
    0.60 ( 0.8295 )
    0.60 ( 0.6695 )
    0.77 ( 0.4660 )
        Week 4
    0.67 ( 0.7390 )
    0.53 ( 0.8128 )
    0.57 ( 0.8983 )
    0.72 ( 0.6637 )
        Week 8
    0.55 ( 0.9274 )
    0.47 ( 0.9576 )
    0.50 ( 0.9154 )
    0.72 ( 0.6698 )
        Week 12
    0.56 ( 0.9582 )
    0.47 ( 0.9051 )
    0.47 ( 1.1338 )
    0.65 ( 0.7926 )
    Notes
    [17] - PPS
    [18] - PPS
    [19] - PPS
    [20] - PPS
    No statistical analyses for this end point

    Secondary: Change from baseline in cough related quality of life after 12 weeks of intervention

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    End point title
    		 Change from baseline in cough related quality of life after 12 weeks of intervention
    End point description
    Measured by Leicester Cough Questionnaire [LCQ]
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    67 [21]
    69 [22]
    73 [23]
    74 [24]
    Units: Score of the Questionnaire
        arithmetic mean (standard deviation)
    2.18 ( 3.44 )
    2.50 ( 3.29 )
    2.73 ( 3.53 )
    2.16 ( 3.12 )
    Notes
    [21] - PPS
    [22] - PPS
    [23] - PPS
    [24] - PPS
    No statistical analyses for this end point

    Secondary: Change from baseline in cough severity after 12 weeks of intervention

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    End point title
    		 Change from baseline in cough severity after 12 weeks of intervention
    End point description
    Measured by Cough Severity Visual Analogue Scale [VAS]
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    61 [25]
    68 [26]
    67 [27]
    68 [28]
    Units: Score of VAS
        arithmetic mean (standard deviation)
    -17.69 ( 23.87 )
    -22.66 ( 22.98 )
    -22.87 ( 24.54 )
    -17.02 ( 21.88 )
    Notes
    [25] - PPS
    [26] - PPS
    [27] - PPS
    [28] - PPS
    No statistical analyses for this end point

    Secondary: Percentage of subjects with a ≥30 scale units reduction from baseline after 12 weeks of intervention

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    End point title
    		 Percentage of subjects with a ≥30 scale units reduction from baseline after 12 weeks of intervention
    End point description
    Measured by cough Severity VAS
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    67 [29]
    69 [30]
    73 [31]
    74 [32]
    Units: Percentage
        number (confidence interval 95%)
    26.87 (16.76 to 39.10)
    36.23 (24.99 to 48.69)
    27.40 (17.61 to 39.09)
    20.27 (11.81 to 31.22)
    Notes
    [29] - PPS
    [30] - PPS
    [31] - PPS
    [32] - PPS
    No statistical analyses for this end point

    Secondary: Percentage of subjects with a ≥1.3-point increase from baseline after 12 weeks of intervention

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    End point title
    		 Percentage of subjects with a ≥1.3-point increase from baseline after 12 weeks of intervention
    End point description
    Measured with LCQ Total Score
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    67 [33]
    69 [34]
    73 [35]
    74 [36]
    Units: Percentage
        number (confidence interval 95%)
    47.76 (35.40 to 60.33)
    60.87 (48.37 to 72.40)
    64.38 (52.31 to 75.25)
    51.35 (39.44 to 63.15)
    Notes
    [33] - PPS
    [34] - PPS
    [35] - PPS
    [36] - PPS
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-emergent adverse events (TEAEs) and associated severity

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAEs) and associated severity
    End point description
    End point type
    Secondary
    End point timeframe
    From the start of study intervention administration until 14 days after the last study medication intake
    End point values
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Number of subjects analysed
    75 [37]
    78 [38]
    80 [39]
    77 [40]
    Units: Subjects
        Any TEAE
    43
    51
    51
    39
        Maximum intensity for any TEAE - mild
    21
    32
    23
    18
        Maximum intensity for any TEAE - moderate
    22
    16
    25
    20
        Maximum intensity for any TEAE - severe
    0
    3
    3
    1
        Any serious TEAE
    0
    1
    2
    1
    Notes
    [37] - SAF
    [38] - SAF
    [39] - SAF
    [40] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of study intervention administration until 14 days after the last study medication intake
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Eliapixant 25 mg BID
    Reporting group description
    		 Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Eliapixant 75 mg BID
    Reporting group description
    		 Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Eliapixant 150 mg BID
    Reporting group description
    		 Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

    Serious adverse events
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Eliapixant 25 mg BID Eliapixant 75 mg BID Eliapixant 150 mg BID Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 75 (42.67%)
    37 / 78 (47.44%)
    45 / 80 (56.25%)
    25 / 77 (32.47%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Weight increased
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    2
    0
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    2
    1
    Dizziness
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 78 (2.56%)
    1 / 80 (1.25%)
    5 / 77 (6.49%)
         occurrences all number
    2
    2
    1
    5
    Dysgeusia
         subjects affected / exposed
    1 / 75 (1.33%)
    9 / 78 (11.54%)
    13 / 80 (16.25%)
    1 / 77 (1.30%)
         occurrences all number
    1
    9
    14
    1
    Headache
         subjects affected / exposed
    6 / 75 (8.00%)
    5 / 78 (6.41%)
    6 / 80 (7.50%)
    4 / 77 (5.19%)
         occurrences all number
    6
    10
    7
    4
    Hypogeusia
         subjects affected / exposed
    2 / 75 (2.67%)
    1 / 78 (1.28%)
    4 / 80 (5.00%)
    2 / 77 (2.60%)
         occurrences all number
    2
    1
    4
    2
    Balance disorder
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Taste disorder
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 78 (2.56%)
    1 / 80 (1.25%)
    1 / 77 (1.30%)
         occurrences all number
    0
    2
    1
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    2 / 75 (2.67%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 75 (2.67%)
    6 / 78 (7.69%)
    5 / 80 (6.25%)
    2 / 77 (2.60%)
         occurrences all number
    2
    6
    6
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 78 (2.56%)
    1 / 80 (1.25%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Pyrexia
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    3
    0
    0
    1
    Swelling face
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    3 / 75 (4.00%)
    3 / 78 (3.85%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         occurrences all number
    3
    3
    2
    1
    Diarrhoea
         subjects affected / exposed
    3 / 75 (4.00%)
    2 / 78 (2.56%)
    1 / 80 (1.25%)
    1 / 77 (1.30%)
         occurrences all number
    3
    2
    1
    1
    Dry mouth
         subjects affected / exposed
    1 / 75 (1.33%)
    3 / 78 (3.85%)
    2 / 80 (2.50%)
    4 / 77 (5.19%)
         occurrences all number
    1
    3
    2
    5
    Flatulence
         subjects affected / exposed
    2 / 75 (2.67%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 78 (2.56%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Nausea
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 78 (2.56%)
    5 / 80 (6.25%)
    1 / 77 (1.30%)
         occurrences all number
    2
    3
    5
    2
    Vomiting
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    3 / 80 (3.75%)
    0 / 77 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 75 (5.33%)
    7 / 78 (8.97%)
    7 / 80 (8.75%)
    3 / 77 (3.90%)
         occurrences all number
    4
    7
    7
    3
    Nasal dryness
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    0
    3
    Throat irritation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    2 / 77 (2.60%)
         occurrences all number
    3
    0
    1
    2
    Rash
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    4
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Insomnia
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 77 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 78 (2.56%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         occurrences all number
    2
    2
    2
    1
    Back pain
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    1
    2
    Myalgia
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    2
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    2 / 77 (2.60%)
         occurrences all number
    2
    0
    2
    2
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 75 (2.67%)
    3 / 78 (3.85%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         occurrences all number
    2
    3
    3
    1
    Sinusitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    1 / 77 (1.30%)
         occurrences all number
    1
    0
    2
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 78 (2.56%)
    3 / 80 (3.75%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    3
    0
    COVID-19
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    3 / 77 (3.90%)
         occurrences all number
    2
    2
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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