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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure

    Summary
    EudraCT number
    		 2020-000408-13
    Trial protocol
    		 DE  
    Global end of trial date
    28 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2024
    First version publication date
    28 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PQGrass309
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04687059
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergy Therapeutics
    Sponsor organisation address
    Dominion Way, West Sussex, BN14 8SA, Worthing, United Kingdom,
    Public contact
    Clinical Research Management, Bencard Allergie GmbH, pqgrass309@allergytherapeutics.com
    Scientific contact
    Clinical Research Management, Bencard Allergie GmbH, pqgrass309@allergytherapeutics.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
    28 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the efficacy of PQ Grass 27600 SU in grass pollen-induced seasonal allergic rhinitis and/or rhinoconjunctivitis in a field setting
    Protection of trial subjects
    This study will be conducted by the investigator and the study centre in full conformance with the International Council for Harmonisation E6 guideline for GCP and the principles of the Declaration of Helsinki or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. All subjects gave their written informed consent by personally dating and signing the ICF prior to admission to the clinical study and before any study protocol-specified procedures were carried out.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 77
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    119
    EEA total number of subjects
    77
    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)
    119
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was initiated on 19 October 2020 (first subject first visit [FSFV]) and the last subject last visit (LSLV).

    Pre-assignment
    Screening details
    		 196 screenings were performed, of these 193 subjects were screened as there were 3 re-screenings. Overall, 119 (100%) subjects (SAF/FAS) were randomised (77 subjects in Germany and 42 subjects in US).

    Pre-assignment period milestones
    Number of subjects started
    		 119
    Number of subjects completed
    		 119

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PQ Grass Conventional Dosing Regimen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PQ Grass
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cumulative dose 27600 SU

    Arm title
    		 PQ Grass Extended Dosing Regimen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PQ Grass
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cumulative dose 27600 SU

    Arm title
    		 Placebo (containing MCT)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo with MCT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo contained MCT contains 2% (w/v) L-tyrosine and 0.5% (w/v) phenol and was indistinguishable from the active treatment.

    Arm title
    		 Placebo (without MCT)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo with MCT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo without MCT contained a buffered saline solution with 0.5% (w/v) phenol. The solution was colourless in appearance and was easily distinguishable from the active treatment and the placebo containing MCT.

    Number of subjects in period 1
    		PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT) Placebo (without MCT)
    Started
    41
    40
    20
    18
    Completed
    41
    40
    20
    18
    Period 2
    Period 2 title
    Overall
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PQ Grass Conventional Dosing Regimen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PQ Grass
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cumulative dose 27600 SU

    Arm title
    		 PQ Grass Extended Dosing Regimen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PQ Grass
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cumulative dose 27600 SU

    Arm title
    		 Placebo (containing MCT)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo with MCT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo contained MCT contains 2% (w/v) L-tyrosine and 0.5% (w/v) phenol and was indistinguishable from the active treatment.

    Arm title
    		 Placebo (without MCT)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo with MCT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo without MCT contained a buffered saline solution with 0.5% (w/v) phenol. The solution was colourless in appearance and was easily distinguishable from the active treatment and the placebo containing MCT.

    Number of subjects in period 2
    		PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT) Placebo (without MCT)
    Started
    41
    40
    20
    18
    Completed
    41
    40
    20
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PQ Grass Conventional Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    PQ Grass Extended Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    Placebo (containing MCT)
    Reporting group description
    		 -

    Reporting group title
    Placebo (without MCT)
    Reporting group description
    		 -

    Reporting group values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT) Placebo (without MCT) Total
    Number of subjects
    		 41 40 20 18 119
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 41 40 20 18 119
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.5 ± 11.45 32.3 ± 10.23 34.3 ± 10.69 31.5 ± 13.79 -
    Gender categorical
    Units: Subjects
        Female
    		 28 21 9 10 68
        Male
    		 13 19 11 8 51
    Ethinicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 2 4
        Not Hispanic or Latino
    		 40 39 20 16 115
    Race
    Units: Subjects
        White
    		 38 37 18 15 108
        Black or African American
    		 1 2 1 1 5
        Asian
    		 2 0 1 0 3
        Other
    		 0 1 0 2 3
    Alcohol consumption and frequency
    Units: Subjects
        Never
    		 10 13 3 7 33
        Currently
    		 30 26 16 11 83
        Previously
    		 1 1 1 0 3
    Smoking consumption and frequency
    Units: Subjects
        Never
    		 29 32 15 17 93
        Currently
    		 6 3 3 0 12
        Previously
    		 6 5 2 1 14
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 170.86 ± 10.365 173.25 ± 9.072 174.20 ± 7.161 171.59 ± 10.958 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 76.30 ± 15.092 77.71 ± 16.336 76.95 ± 18.903 74.71 ± 11.815 -
    BMI
    Units: kilogram(s)/cubic metre
        arithmetic mean (standard deviation)
    		 26.11 ± 4.625 25.81 ± 4.696 25.15 ± 4.7441 25.38 ± 3.251 -

    End points

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    End points reporting groups
    Reporting group title
    PQ Grass Conventional Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    PQ Grass Extended Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    Placebo (containing MCT)
    Reporting group description
    		 -

    Reporting group title
    Placebo (without MCT)
    Reporting group description
    		 -
    Reporting group title
    PQ Grass Conventional Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    PQ Grass Extended Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    Placebo (containing MCT)
    Reporting group description
    		 -

    Reporting group title
    Placebo (without MCT)
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received at least 1 injection of the IMP. The analysis followed the intention-to-treat principle and analysed subjects according to the treatment group to which they were randomised.

    Subject analysis set title
    SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 injection of the IMP. Subjects were analysed according to the treatment that they actually received.

    Primary: CSMS Averaged Over the Peak GPS

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    End point title
    		 CSMS Averaged Over the Peak GPS
    End point description
    6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms.
    End point type
    Primary
    End point timeframe
    Approximately 2-5 weeks
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
        least squares mean (standard error)
    0.56 ± 0.263
    0.67 ± 0.264
    0 ± 0
    Statistical analysis title
    		 PQ Grass Conventional vs. Placebo containing MCT
    Comparison groups
    PQ Grass Conventional Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0325
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -33.1
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -48.8
         upper limit
    		 -17.4
    Statistical analysis title
    		 PQ Grass Extended vs Placebo containing MCT
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0112
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.5
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -54.7
         upper limit
    		 -24.4

    Secondary: CSMS Averaged Over the Entire (or Truncated) GPS

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    End point title
    		 CSMS Averaged Over the Entire (or Truncated) GPS
    End point description
    6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms).
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
        least squares mean (standard error)
    0.32 ± 0.25
    0.5 ± 0.215
    0 ± 0
    Statistical analysis title
    		 PQ Grass Conventional vs. Placebo containing MCT
    Comparison groups
    PQ Grass Conventional Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1314
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -25.1
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -43.3
         upper limit
    		 -6.8
    Statistical analysis title
    		 PQ Grass Extended vs Placebo containing MCT
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0197
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -38.8
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -55.8
         upper limit
    		 -21.7

    Secondary: TCS Averaged Over the Peak GPS

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    End point title
    		 TCS Averaged Over the Peak GPS
    End point description
    6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms).
    End point type
    Secondary
    End point timeframe
    Approximately 2-5 weeks
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
        least squares mean (standard error)
    3.8 ± 1.748
    4.42 ± 1.759
    0 ± 0
    Statistical analysis title
    		 PQ Grass Conventional vs. Placebo containing MCT
    Comparison groups
    PQ Grass Conventional Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0298
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -35
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -51.2
         upper limit
    		 -18.9
    Statistical analysis title
    		 PQ Grass Extended vs Placebo containing MCT
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -40.8
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -56.4
         upper limit
    		 -25.1

    Secondary: TCS Averaged Over Entire (or Truncated) GPS

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    End point title
    		 TCS Averaged Over Entire (or Truncated) GPS
    End point description
    6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
        least squares mean (standard error)
    2.23 ± 1.416
    3.29 ± 1.418
    0 ± 0
    Statistical analysis title
    		 PQ Grass Conventional vs. Placebo containing MCT
    Comparison groups
    PQ Grass Conventional Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1158
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -26.9
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -45.6
         upper limit
    		 -8.2
    Statistical analysis title
    		 PQ Grass Extended vs Placebo containing MCT
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0202
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.9
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -57.5
         upper limit
    		 -22.2

    Secondary: Daily Symptom Score (dSS) of the CSMS Averaged Over the Peak and Entire (or truncated) GPS

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    End point title
    		 Daily Symptom Score (dSS) of the CSMS Averaged Over the Peak and Entire (or truncated) GPS
    End point description
    Sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms assessed in CSMS divided by 6.
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS.
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
    least squares mean (standard error)
        CSMS-dSS over the peak GPS
    0.27 ± 0.150
    0.30 ± 0.151
    0 ± 0
        CSMS-dSS during entire GPS
    0.2 ± 0.128
    0.26 ± 0.129
    0 ± 0
    Statistical analysis title
    		 CSMS-dSS averaged over the peak GPS
    Comparison groups
    Placebo (containing MCT) v PQ Grass Conventional Dosing Regimen
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0474
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -29.2
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -44.7
         upper limit
    		 -13.7
    Statistical analysis title
    		 CSMS-dSS averaged over the entire GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0415
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -31.2
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -47.9
         upper limit
    		 -14.6

    Secondary: Daily Medication Score (dMS) of the CSMS Averaged Over the Peak and Entire (or Truncated) GPS

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    End point title
    		 Daily Medication Score (dMS) of the CSMS Averaged Over the Peak and Entire (or Truncated) GPS
    End point description
    Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day.
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks. Duration of the peak GPS to be determined as per pollen counts within the GPS.
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
    least squares mean (standard error)
        CSMS-dMS over peak GPS
    0.29 ± 1.41
    0.37 ± 0.142
    0 ± 0
        CSMS-dMS during entire GPS
    0.13 ± 0.112
    0.24 ± 0.112
    0 ± 0
    Statistical analysis title
    		 CSMS-dMS averaged over the peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0089
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -55.3
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -74
         upper limit
    		 -36.7
    Statistical analysis title
    		 CSMS-dMS averaged over the entire (truncated) GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0316
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -53.5
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -75.6
         upper limit
    		 -31.4

    Secondary: dSS of the TCS Averaged Over the Peak GPS and Entire (or Truncated) GPS

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    End point title
    		 dSS of the TCS Averaged Over the Peak GPS and Entire (or Truncated) GPS
    End point description
    Sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms (i.e. ranging from 0 to 18).
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS.
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
    least squares mean (standard error)
        TCS-dSS over the peak GPS
    1.62 ± 0.903
    1.84 ± 0.908
    0 ± 0
        TCS-dSS during the entire GPS
    1.21 ± 0.774
    1.60 ± 0.777
    0 ± 0
    Statistical analysis title
    		 TCS-dSS averaged over the peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0426
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -29.6
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -44.9
         upper limit
    		 -14.3
    Statistical analysis title
    		 TCS-dSS averaged during the entire (truncated) GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0396
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -31.3
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -47.8
         upper limit
    		 -14.8

    Secondary: dMS of the TCS Averaged Over the Peak GPS and Entire (or Truncated) GPS

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    End point title
    		 dMS of the TCS Averaged Over the Peak GPS and Entire (or Truncated) GPS
    End point description
    Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day.
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS.
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
    least squares mean (standard error)
        TCS-dMS over the peak GPS
    2.18 ± 1.025
    2.58 ± 1.034
    0 ± 0
        TCS-dMS during the entire GPS
    1.02 ± 0.798
    1.70 ± 0.797
    0 ± 0
    Statistical analysis title
    		 TCS-dMS averaged over the peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0127
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -55.8
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -75.4
         upper limit
    		 -36.2
    Statistical analysis title
    		 TCS-dMS averaged over the entire (truncated) GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0326
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -54.2
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -77.3
         upper limit
    		 -31.1

    Secondary: The Probability of Well Days and Severe Days During the Peak and Entire (or Truncated) GPS

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    End point title
    		 The Probability of Well Days and Severe Days During the Peak and Entire (or Truncated) GPS
    End point description
    A “well day” was defined based on CSMS as a day with: • No use of relief medication on the particular day, • And a total symptom score ≤2 out of 18 A “severe day” was based on CSMS and defined as a day with a symptom score of 3 in any of the 6 rhinitis/rhinoconjunctivitis symptoms. The probability of a well day or a severe day was analyzed using data on a by-day level per subject using generalized estimating equation (GEE) or similar approaches as appropriate. Well days and severe days were assessed during the peak GPS and entire (or truncated) GPS
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks.
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    37
    19
    Units: day
    arithmetic mean (standard deviation)
        Number of well days during peak GPS
    4.73 ± 6.693
    6.46 ± 6.539
    0 ± 0
        Number of severe days during peak GPS
    2.07 ± 4.491
    1.03 ± 1.818
    0 ± 0
        Number of well days during entire GPS
    20.10 ± 18.195
    25.03 ± 17.716
    0 ± 0
        Number of severe days during entire GPS
    5.39 ± 12.870
    2.76 ± 4.044
    0 ± 0
    Statistical analysis title
    		 Number of well days during the peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.86
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.958
         upper limit
    		 3.612
    Statistical analysis title
    		 Number of severe days during the peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.31
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.158
         upper limit
    		 0.607

    Secondary: Serum Ig Responses (Total IgE; Grass-specific IgE and IgG4; Specific IgE/Total IgE and Specific IgE/Specific IgG4) at Visit 12 and Visit 15

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    End point title
    		 Serum Ig Responses (Total IgE; Grass-specific IgE and IgG4; Specific IgE/Total IgE and Specific IgE/Specific IgG4) at Visit 12 and Visit 15
    End point description
    Immunological measurements (total IgE, grass-specific IgE and IgG4, specific IgE/total IgE and specific IgE/specific IgG4) and their changes between screening and post-treatment were analyzed descriptively. The change from baseline in immunoglobulin measurements was additionally analyzed using analysis of covariance (ANCOVA), including treatment groups and with baseline as covariate.
    End point type
    Secondary
    End point timeframe
    Approximately 10 week
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    37
    38
    20
    Units: unit(s)
    arithmetic mean (standard deviation)
        Serum total IgE [kU/L] - Visit 12
    13.31 ± 28.903
    3.14 ± 28.518
    -102.19 ± 39.327
        Serum total IgE [kU/L] - Visit 15
    40.86 ± 17.750
    27.53 ± 17.286
    -6.78 ± 24.155
        Serum grass-specific IgE [kU/L] - Visit 12
    9.24 ± 4.012
    9.24 ± 3.995
    -7.24 ± 4.860
        Serum grass-specific IgE [kU/L] - Visit 15
    18.66 ± 3.312
    17.96 ± 3.330
    11.36 ± 4.449
        Serum grass-specific IgG4 [mg/L] - Visit 12
    2.76 ± 0.673
    3.50 ± 0.670
    0.15 ± 0.871
        Serum grass-specific IgG4 [mg/L] - Visit 15
    1.93 ± 0.340
    2.04 ± 0.339
    0.33 ± 0.456
        Grass-specific IgE / total IgE - Visit 12
    0.04 ± 0.018
    0.04 ± 0.017
    0.01 ± 0.023
        Grass-specific IgE / total IgE - Visit 15
    0.10 ± 0.018
    0.09 ± 0.018
    0.09 ± 0.024
        Grass-specific IgE / grass-specific IgG4 -Visit 12
    -39.09 ± 7.658
    -39.17 ± 7.641
    -1.58 ± 10.107
        Grass-specific IgE / grass-specific IgG4 -Visit 15
    -22.72 ± 7.606
    -24.67 ± 7.602
    -7.19 ± 9.533
    Statistical analysis title
    		 Change from baseline to Visit 12 of serum IgG4
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.34
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 2.12
         upper limit
    		 4.56
    Statistical analysis title
    		 Change from baseline to Visit 15 of IgG4
    Comparison groups
    Placebo (containing MCT) v PQ Grass Conventional Dosing Regimen
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0033
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.71
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 2.45

    Secondary: RQLQ(S) During the Peak GPS

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    End point title
    		 RQLQ(S) During the Peak GPS
    End point description
    End point type
    Secondary
    End point timeframe
    Approximately 10 weeks
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    28
    30
    13
    Units: points
    least squares mean (standard error)
        RQLQ during peak GPS
    0.44 ± 0.316
    0.72 ± 0.314
    0 ± 0
    Statistical analysis title
    		 Extended vs. Placebo with MCT during peak GPS
    Comparison groups
    Placebo (containing MCT) v PQ Grass Extended Dosing Regimen
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0243
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -37.9
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -54.9
         upper limit
    		 -21.8
    Statistical analysis title
    		 Conventional vs Placebo with MCT during peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1706
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -22.9
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -41.1
         upper limit
    		 -4.7

    Secondary: aTCS Average During GPS

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    End point title
    		 aTCS Average During GPS
    End point description
    End point type
    Secondary
    End point timeframe
    Approximately 2-5 weeks
    End point values
    		 PQ Grass Conventional Dosing Regimen PQ Grass Extended Dosing Regimen Placebo (containing MCT)
    Number of subjects analysed
    41
    40
    20
    Units: Points
    least squares mean (standard deviation)
        aTCS during peak GPS
    3.98 ± 1.839
    4.63 ± 1.849
    0 ± 0
        aTCS during entire GPS
    2.36 ± 1.493
    3.47 ± 1.496
    0 ± 0
    Statistical analysis title
    		 aTCS average during peak GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0124
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -40.1
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -55.6
         upper limit
    		 -24.5
    Statistical analysis title
    		 aTCS average during entire GPS
    Comparison groups
    PQ Grass Extended Dosing Regimen v Placebo (containing MCT)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -39.3
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -56.8
         upper limit
    		 -21.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    375 days (study duration including safety follow-up)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    PQ Grass Standard Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    PQ Grass Extended Dosing Regimen
    Reporting group description
    		 -

    Reporting group title
    Placebo with MCT
    Reporting group description
    		 -

    Reporting group title
    Placebo without MCT
    Reporting group description
    		 -

    Serious adverse events
    		 PQ Grass Standard Dosing Regimen PQ Grass Extended Dosing Regimen Placebo with MCT Placebo without MCT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 21 (4.76%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 21 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 21 (4.76%)
    0 / 18 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PQ Grass Standard Dosing Regimen PQ Grass Extended Dosing Regimen Placebo with MCT Placebo without MCT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 40 (97.50%)
    38 / 40 (95.00%)
    21 / 21 (100.00%)
    18 / 18 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    2 / 21 (9.52%)
    2 / 18 (11.11%)
         occurrences all number
    1
    3
    5
    2
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 21 (14.29%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Injection site erythema
         subjects affected / exposed
    31 / 40 (77.50%)
    35 / 40 (87.50%)
    2 / 21 (9.52%)
    4 / 18 (22.22%)
         occurrences all number
    109
    126
    3
    6
    Injection site pain
         subjects affected / exposed
    21 / 40 (52.50%)
    19 / 40 (47.50%)
    8 / 21 (38.10%)
    2 / 18 (11.11%)
         occurrences all number
    48
    48
    18
    9
    Injection site pruritus
         subjects affected / exposed
    23 / 40 (57.50%)
    29 / 40 (72.50%)
    2 / 21 (9.52%)
    2 / 18 (11.11%)
         occurrences all number
    82
    93
    3
    3
    Injection site swelling
         subjects affected / exposed
    28 / 40 (70.00%)
    30 / 40 (75.00%)
    3 / 21 (14.29%)
    1 / 18 (5.56%)
         occurrences all number
    78
    102
    4
    1
    Injection site urticaria
         subjects affected / exposed
    10 / 40 (25.00%)
    9 / 40 (22.50%)
    1 / 21 (4.76%)
    1 / 18 (5.56%)
         occurrences all number
    32
    29
    1
    1
    Injection site warmth
         subjects affected / exposed
    3 / 40 (7.50%)
    5 / 40 (12.50%)
    0 / 21 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    3 / 21 (14.29%)
    1 / 18 (5.56%)
         occurrences all number
    1
    4
    5
    2
    Lacrimation increased
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    0 / 21 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    4 / 21 (19.05%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    8
    2
    Sneezing
         subjects affected / exposed
    1 / 40 (2.50%)
    4 / 40 (10.00%)
    1 / 21 (4.76%)
    2 / 18 (11.11%)
         occurrences all number
    2
    5
    2
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    2 / 21 (9.52%)
    3 / 18 (16.67%)
         occurrences all number
    2
    1
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    1 / 21 (4.76%)
    0 / 18 (0.00%)
         occurrences all number
    4
    3
    1
    0

    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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