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

    Summary
    EudraCT number
    		 2019-001517-16
    Trial protocol
    		 DE   HU   CZ   AT   PL  
    Global end of trial date
    01 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2024
    First version publication date
    16 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PQGrass306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05540717
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergy Therapeutics (UK) Ltd.
    Sponsor organisation address
    Dominion Way, Worthing BN14 8SA, West Sussex, United Kingdom,
    Public contact
    Clinical Research Management, Bencard Allergie GmbH, pqgrass306@allergytherapeutics.com
    Scientific contact
    Clinical Research Management, Bencard Allergie GmbH, pqgrass306@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
    15 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy: To evaluate the efficacy of PQ Grass 27600 SU in subjects with grass pollen induced SAR and/or rhinoconjunctivitis based on symptoms and medications. Safety: To evaluate the safety and tolerability of PQ Grass in subjects with grass pollen induced SAR and/or rhinoconjunctivitis.
    Protection of trial subjects
    The risk of anaphylaxis was mitigated by carefully selecting sites with trained personnel and specific equipment to manage anaphylaxis, by excluding high-risk participants and by providing specific instructions to participants in order to minimise the risk. An independent Adjudication Committee was installed to evaluate any important safety information. A Trial Oversight Committee with regular meetings was installed to oversee the safety of the participants during the conduct of the study. Participants were monitored from the time of ICF signature throughout the study for the detection of exacerbations of pre-existing allergy symptoms. The use of placebo was mitigated by providing subjects with relief medication during the grass pollen season and by extensive safety monitoring.
    Background therapy
    		 Participants were provided relief medication including oral and ocular antihistamine, and nasal and oral coricosteroids.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Aug 2022
    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
    Poland: 153
    Country: Number of subjects enrolled
    Austria: 25
    Country: Number of subjects enrolled
    Czechia: 67
    Country: Number of subjects enrolled
    Germany: 242
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    United States: 67
    Worldwide total number of subjects
    555
    EEA total number of subjects
    488
    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)
    555
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The clinical trial was conducted at 89 sites (65 in Europe and 24 in the United States) and overall, 555 subjects were randomised and included in the FAS and the SAF. There was a near equal assignment of subjects to PQ Grass and placebo. One subject randomised to placebo received PQ Grass therefore, 279 subjects were treated with PQ Grass.

    Pre-assignment
    Screening details
    		 Male or female aged 18 to 65 years with a positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to grass pollen exposure requiring treatment for at least two consecutive seasons prior to study.

    Period 1
    Period 1 title
    Period 1 (Screening)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PQ Grass 27600 SU
    Arm description
    		 6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU
    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
    6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

    Arm title
    		 Placebo
    Arm description
    		 6 pre-seasonal injections of placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 doses of placebo

    Number of subjects in period 1
    		PQ Grass 27600 SU Placebo
    Started
    278
    277
    Completed
    278
    277
    Period 2
    Period 2 title
    Period 2 (randomisation and treatment)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PQ Grass 27600 SU
    Arm description
    		 6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU
    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
    6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

    Arm title
    		 Placebo
    Arm description
    		 6 pre-seasonal injections of placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 injections of placebo

    Number of subjects in period 2
    		PQ Grass 27600 SU Placebo
    Started
    278
    277
    Completed
    250
    257
    Not completed
    28
    20
         Consent withdrawn by subject
    6
    4
         Adverse event, non-fatal
    4
    5
         Sponsor request
    2
    3
         Study terminated by sponsor
    3
    3
         other, unknown
    12
    4
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PQ Grass 27600 SU
    Reporting group description
    		 6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

    Reporting group title
    Placebo
    Reporting group description
    		 6 pre-seasonal injections of placebo

    Reporting group values
    		 PQ Grass 27600 SU Placebo Total
    Number of subjects
    		 278 277 555
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 278 277 555
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.8 ( 10.02 ) 34.8 ( 10.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 123 126 249
        Male
    		 155 151 306
    Race
    Units: Subjects
        White
    		 268 265 533
        Black or African American
    		 4 5 9
        Asian
    		 3 3 6
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or other Pacific Islander
    		 0 1 1
        Other
    		 3 3 6
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 4 2 6
        Not Hispanic or Latino
    		 274 275 549
    Alcohol consumption
    Units: Subjects
        Never
    		 56 59 115
        Currently - Daily
    		 3 6 9
        Currently - Weekly
    		 30 29 59
        Currently - Monthly
    		 29 26 55
        Currently - Occasionally
    		 144 146 290
        Previously - Daily
    		 1 0 1
        Previously - Weekly
    		 1 1 2
        Previously - Monthly
    		 8 7 15
        Previously - Occasonally
    		 6 3 9
    Smoking habit
    Units: Subjects
        Never
    		 209 204 413
        Currently - Daily
    		 25 24 49
        Currently - Weekly
    		 3 2 5
        Currently - Monthly
    		 0 1 1
        Currently - Occasionally
    		 9 16 25
        Previously - Daily
    		 16 20 36
        Previously - Weekly
    		 1 2 3
        Previously - Monthly
    		 1 1 2
        Previously - Occasionally
    		 14 7 21
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 26.45 ( 5.874 ) 26.32 ( 5.018 ) -
    Height
    Units: centimetres
        arithmetic mean (standard deviation)
    		 174.1 ( 9.70 ) 173.8 ( 9.72 ) -
    Weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    		 80.44 ( 19.546 ) 79.69 ( 17.327 ) -
    grass-specific IgE values
    Units: kUA/L
        arithmetic mean (standard deviation)
    		 28.5 ( 32.4617 ) 27.2 ( 30.7472 ) -

    End points

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    End points reporting groups
    Reporting group title
    PQ Grass 27600 SU
    Reporting group description
    		 6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

    Reporting group title
    Placebo
    Reporting group description
    		 6 pre-seasonal injections of placebo
    Reporting group title
    PQ Grass 27600 SU
    Reporting group description
    		 6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

    Reporting group title
    Placebo
    Reporting group description
    		 6 pre-seasonal injections of placebo

    Primary: Combined symptom and medication score Averaged Over Peak GPS

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    End point title
    		 Combined symptom and medication score Averaged Over Peak GPS
    End point description
    The combined symptom and medication score was calculated as an average score during the Grass pollen season (GPS).
    End point type
    Primary
    End point timeframe
    The combined symptom and medication score was was recorded during the peak GPS. The peak GPS timeframe was dependent on each geographical region with an average of approximately 3-4 weeks
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    278 [1]
    277 [2]
    Units: score on a scale
        least squares mean (confidence interval 95%)
    1.07 (0.84 to 1.30)
    1.34 (1.12 to 1.57)
    Notes
    [1] - The analysis of CSMS is reported on the full analysis set. See justification
    [2] - The analysis of CSMS is reported on the full analysis set, see justification
    Statistical analysis title
    		 Comparison of CSMS averaged over the peak GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    555
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.00048
    Method
    		 Mixed models analysis
    Parameter type
    		 relative difference (%)
    Point estimate
    -20.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31
         upper limit
    		 -9.49
    Notes
    [3] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect

    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
    End point type
    Secondary
    End point timeframe
    The CSMS was recorded during the entire GPS. The entire GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 13-14 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    267
    266
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.99 ( 0.786 )
    1.23 ( 0.965 )
    Statistical analysis title
    		 Comparison of CSMS averaged over the entire GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.00032
    Method
    		 Mixed models analysis
    Parameter type
    		 relative difference (%)
    Point estimate
    -20.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.13
         upper limit
    		 -10.27
    Notes
    [4] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect

    Secondary: dSS component of the CSMS averaged over the peak GPS

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    End point title
    		 dSS component of the CSMS averaged over the peak GPS
    End point description
    End point type
    Secondary
    End point timeframe
    The dSS component of the CSMS was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    265
    266
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.82 ( 0.589 )
    0.95 ( 0.640 )
    Statistical analysis title
    		 Comparison of dSS of CSMS on peak GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.00223
    Method
    		 Mixed models analysis
    Parameter type
    		 relative difference (%)
    Point estimate
    -16.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.27
         upper limit
    		 -6.44
    Notes
    [5] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect

    Secondary: dSS component of the CSMS averaged over the entire GPS

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    End point title
    		 dSS component of the CSMS averaged over the entire GPS
    End point description
    End point type
    Secondary
    End point timeframe
    The dSS component of the CSMS was recorded during the entire GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 13-14 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    267
    266
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.65 ( 0.478 )
    0.78 ( 0.564 )
    Statistical analysis title
    		 Comparison of dSS of CSMS on entire GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.00076
    Method
    		 Mixed models analysis
    Parameter type
    		 relative difference (%)
    Point estimate
    -16.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.66
         upper limit
    		 -7.5
    Notes
    [6] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect

    Secondary: dMS component of the CSMS averaged over the peak GPS

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    End point title
    		 dMS component of the CSMS averaged over the peak GPS
    End point description
    End point type
    Secondary
    End point timeframe
    The dMS component of the CSMS was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    265
    266
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.47 ( 0.554 )
    0.59 ( 0.589 )
    Statistical analysis title
    		 Comparison of dMS of CSMS on peak GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.0008
    Method
    		 Mixed models analysis
    Parameter type
    		 relative difference (%)
    Point estimate
    -26.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.15
         upper limit
    		 -11.94
    Notes
    [7] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect

    Secondary: dMS component of the CSMS averaged over the entire GPS

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    End point title
    		 dMS component of the CSMS averaged over the entire GPS
    End point description
    End point type
    Secondary
    End point timeframe
    The dMS component of the CSMS was recorded during the entire GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 13-14 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    267
    266
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.33 ( 0.393 )
    0.46 ( 0.485 )
    Statistical analysis title
    		 Comparison of dMS of CSMS on entire GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.00031
    Method
    		 Mixed models analysis
    Parameter type
    		 relative difference (%)
    Point estimate
    -26.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.49
         upper limit
    		 -12.72
    Notes
    [8] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect.

    Secondary: Number of well days during peak GPS

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    End point title
    		 Number of well days during peak GPS
    End point description
    End point type
    Secondary
    End point timeframe
    The number of well days was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    265
    266
    Units: day
        median (standard deviation)
    6.6 ( 8.16 )
    5.5 ( 7.11 )
    Statistical analysis title
    		 Probability of well days during peak GPS
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.10846 [9]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.254
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.951
         upper limit
    		 1.652
    Notes
    [9] - GEE model for binary response with treatment as fixed effect, pooled geographical region and grass pollen count per day as covariates, and assuming a within-subject working correlation.

    Secondary: RQLQ(S) measured within the peak GPS

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    End point title
    		 RQLQ(S) measured within the peak GPS
    End point description
    End point type
    Secondary
    End point timeframe
    Rhinoconjunctivitis Quality of Life Questionnaire with standardised activities (RQLQ) was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    169
    171
    Units: score on a scale
        least squares mean (standard error)
    1.26 ( 0.160 )
    1.77 ( 0.160 )
    Statistical analysis title
    		 Comparison of average total RQLQ
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    340
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.00009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 -0.25
    Notes
    [10] - Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect

    Secondary: Serum grass specific IgG4 at Baseline and Visit 7

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    End point title
    		 Serum grass specific IgG4 at Baseline and Visit 7
    End point description
    End point type
    Secondary
    End point timeframe
    Measurement of grass-specific IgG4 was performed at baseline and visit 7.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    229
    243
    Units: mg/L
        median (standard deviation)
    4.516 ( 6.0466 )
    0.627 ( 1.0170 )
    Statistical analysis title
    		 Change of serum grass-specific IgG4 levels
    Comparison groups
    PQ Grass 27600 SU v Placebo
    Number of subjects included in analysis
    472
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.00001
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    3.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.28
         upper limit
    		 4.7
    Notes
    [11] - Linear mixed model using treatment group as fixed effect, Baseline serum grass-specific IgG4 [mg/L] as a covariate and pooled geographical region as random effect

    Secondary: Frequency, severity and relationship of AEs to treatment

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    End point title
    		 Frequency, severity and relationship of AEs to treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Adverse events were reported from baseline to the last follow-up visit.
    End point values
    		 PQ Grass 27600 SU Placebo
    Number of subjects analysed
    278 [12]
    277 [13]
    Units: subjects
        Any AE
    232
    163
        Any AESI
    0
    0
        Any serious AE
    6
    4
        AE leading to premature treatment discontinuation
    4
    5
        AE leading to premature study discontinuation
    1
    3
        AE definitively related to treatment
    144
    53
        AE probably related to treatment
    34
    23
        AE possibly related to treatment
    34
    31
        AE unlikely related to treatment
    1
    4
        AE not related to treatment
    19
    43
    Notes
    [12] - The AEs are reported on the number of subjects receiving the active treatment (n=279)
    [13] - The number of AEs are reported on the subjects receiving placebo (n=276)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE reporting was performed throughout the study, which had an overall duration of 387 days.
    Adverse event reporting additional description
    One subject randomised to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    PQ Grass 27600 SU
    Reporting group description
    		 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

    Reporting group title
    Placebo
    Reporting group description
    		 6 injections of placebo

    Serious adverse events
    		 PQ Grass 27600 SU Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 279 (2.15%)
    8 / 276 (2.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Rhythm idioventricular
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PQ Grass 27600 SU Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    226 / 279 (81.00%)
    155 / 276 (56.16%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 279 (9.32%)
    20 / 276 (7.25%)
         occurrences all number
    64
    38
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    183 / 279 (65.59%)
    28 / 276 (10.14%)
         occurrences all number
    755
    62
    Injection site swelling
         subjects affected / exposed
    161 / 279 (57.71%)
    43 / 276 (15.58%)
         occurrences all number
    607
    80
    Injection site pain
         subjects affected / exposed
    123 / 279 (44.09%)
    65 / 276 (23.55%)
         occurrences all number
    307
    151
    Injection site pruritus
         subjects affected / exposed
    133 / 279 (47.67%)
    24 / 276 (8.70%)
         occurrences all number
    433
    32
    Injection site warmth
         subjects affected / exposed
    19 / 279 (6.81%)
    5 / 276 (1.81%)
         occurrences all number
    47
    11
    Injection site urticaria
         subjects affected / exposed
    16 / 279 (5.73%)
    1 / 276 (0.36%)
         occurrences all number
    38
    2
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    23 / 279 (8.24%)
    23 / 276 (8.33%)
         occurrences all number
    45
    44
    Lacrimation increased
         subjects affected / exposed
    14 / 279 (5.02%)
    10 / 276 (3.62%)
         occurrences all number
    17
    24
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    35 / 279 (12.54%)
    25 / 276 (9.06%)
         occurrences all number
    55
    91
    Sneezing
         subjects affected / exposed
    34 / 279 (12.19%)
    27 / 276 (9.78%)
         occurrences all number
    55
    69
    Nasal congestion
         subjects affected / exposed
    21 / 279 (7.53%)
    26 / 276 (9.42%)
         occurrences all number
    40
    78
    Nasal pruritus
         subjects affected / exposed
    16 / 279 (5.73%)
    23 / 276 (8.33%)
         occurrences all number
    36
    60
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    28 / 279 (10.04%)
    22 / 276 (7.97%)
         occurrences all number
    31
    27

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2022
    Version 3.0_Global was created to harmonize the protocol so that all the updates included in the different versions of the protocol (as stipulated in the tables below) that are currently in use in the different regions can be in one global version. Furthermore, additional updates were made to the Version 3.0_Global clinical trial protocol as indicated in the table below. Administrative edits were also made as needed all through the document.
    20 Jun 2023
    Version 4.0_Global was created to incorporate an interim analysis in the ongoing clinical trial and to provide the option of a second season (Year 2) for the clinical trial if needed as it was not possible to recruit the initially planned number of subjects within one year (Year 1). The amendment includes a description of the changes if a second season will become part of the trial, and it describes the process for an interim analysis that is planned to be performed based on Year 1 data. Administrative edits were also made as needed all through the document.

    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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