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    Clinical Trial Results:
    Efficacy and safety of the SQ tree sublingual immunotherapy tablet in children and adolescents (5 through 17 years of age) with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group. P/0030/2018; P/0434/2020

    Summary
    EudraCT number
    		 2020-004372-17
    Trial protocol
    		 DE   LT   HU   SK   PL   AT   DK   BE   NL  
    Global end of trial date
    31 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2024
    First version publication date
    15 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TT-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04878354
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló A/S
    Sponsor organisation address
    Bøge Allé 6-8, Hørsholm, Denmark, 2970
    Public contact
    Head of Clinical Operations Strategy, ALK-Abelló A/S, clinicaltrials@alk.net
    Scientific contact
    Head of Clinical Operations Strategy, ALK-Abelló A/S, clinicaltrials@alk.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001879-PIP01-15
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of the SQ tree sublingual immunotherapy (SLIT)-tablet to placebo in the treatment of moderate to severe allergic rhinitis and/or conjunctivitis (AR/C) induced by pollen from birch and trees belonging to the birch homologous group in children and adolescents (5 through 17 years of age) based on the average allergic rhinoconjunctivitis daily total combined score (TCS*) during the birch pollen season (BPS). *TCS = daily symptoms score (DSS) + daily medication score (DMS)
    Protection of trial subjects
    Safety surveillance. Access to rescue/reliever medication.
    Background therapy
    		 AR/C rescue medication: Subjects were provided with rescue medication (antihistamine/nasal corticosteroid) to relieve AR/C symptoms. The rescue medication was provided before the start of the tree pollen season and could be used as needed in accordance with the label. The subjects were instructed to start with antihistamine and continue with nasal corticosteroids only if antihistamine could not alleviate the symptoms. Asthma rescue medication: Prior to start of tree pollen season, subjects with a diagnosis of asthma were provided with short-acting β2-agonist (SABA), which was to be used when necessary and in accordance with the label. Subjects who were taking low or medium daily dose inhaled corticosteriods (ICS) alone or in combination with long-acting β2-agonist (LABA) for asthma management were allowed to continue with the same medications during the trial. Subjects had to be on a stable regimen (daily dose unchanged) for at least 4 weeks before randomisation.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 446
    Country: Number of subjects enrolled
    Slovakia: 79
    Country: Number of subjects enrolled
    Austria: 10
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Denmark: 18
    Country: Number of subjects enrolled
    Germany: 89
    Country: Number of subjects enrolled
    Hungary: 45
    Country: Number of subjects enrolled
    Lithuania: 92
    Country: Number of subjects enrolled
    Canada: 87
    Country: Number of subjects enrolled
    Russian Federation: 77
    Worldwide total number of subjects
    952
    EEA total number of subjects
    788
    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)
    597
    Adolescents (12-17 years)
    355
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 80 sites in 11 countries (Austria, Belgium, Canada, Denmark, Germany, Hungary, Lithuania, Netherlands, Poland, Russia and Slovakia). First subject first visit: 08-Apr-2021 Last subject last visit/contact: 31-Jul-2023

    Pre-assignment
    Screening details
    		 *Male or female aged ≥5 to <18 years *Documented, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite treatment with symptom-relieving medication *Positive SPT and IgE against Betula verrucosa *Presence of at least 1 ARIA quality of life item due to AR/C during the previous BPS

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subjects were instructed that IMP should preferably be taken in the morning and that food and beverages should not be taken for 5 minutes after intake of IMP. The tablet should be placed under the tongue and swallowing should be avoided for approximately 1 minute. When the first dose was administered at site, the subject was under medical supervision for 30 minutes after the tablet intake.

    Arm title
    		 SQ tree SLIT-tablet
    Arm description
    		 SQ tree SLIT-tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ tree SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subjects were instructed that IMP should preferably be taken in the morning and that food and beverages should not be taken for 5 minutes after intake of IMP. The tablet should be placed under the tongue and swallowing should be avoided for approximately 1 minute. When the first dose was administered at site, the subject was under medical supervision for 30 minutes after the tablet intake.

    Number of subjects in period 1
    		Placebo SQ tree SLIT-tablet
    Started
    479
    473
    Completed
    458
    456
    Not completed
    21
    17
         Consent withdrawn by subject
    15
    13
         Reason stated as "other" in CRF
    2
    -
         Adverse event, non-fatal
    -
    3
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    SQ tree SLIT-tablet
    Reporting group description
    		 SQ tree SLIT-tablet

    Reporting group values
    		 Placebo SQ tree SLIT-tablet Total
    Number of subjects
    		 479 473 952
    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)
    		 300 297 597
        Adolescents (12-17 years)
    		 179 176 355
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 194 185 379
        Male
    		 285 288 573
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomised subjects. Subjects were analysed as randomised i.e., according to their randomised assignment of treatment.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set definded as all randomised subjects who received at least one dose of IMP. Subjects were analysed as treated i.e., according to treatment they actually received.

    Subject analysis sets values
    		 Full analysis set Safety analysis set
    Number of subjects
    952
    952
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    597
    597
        Adolescents (12-17 years)
    355
    355
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    379
    379
        Male
    573
    573

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    SQ tree SLIT-tablet
    Reporting group description
    		 SQ tree SLIT-tablet

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomised subjects. Subjects were analysed as randomised i.e., according to their randomised assignment of treatment.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set definded as all randomised subjects who received at least one dose of IMP. Subjects were analysed as treated i.e., according to treatment they actually received.

    Primary: Average total combined score (TCS) during the birch pollen season (BPS)

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    End point title
    		 Average total combined score (TCS) during the birch pollen season (BPS)
    End point description
    The primary endpoint of the trial was the average total combined rhinoconjunctivitis symptoms and medication score (TCS) during the birch pollen season (BPS). The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the SQ tree SLIT-tablet if it is taken as instructed.
    End point type
    Primary
    End point timeframe
    During the birch pollen season
    End point values
    		 Placebo SQ tree SLIT-tablet
    Number of subjects analysed
    479
    473
    Units: Adjusted mean
        least squares mean (standard error)
    5.88 ( 0.33 )
    4.60 ( 0.29 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age-group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.
    Comparison groups
    Placebo v SQ tree SLIT-tablet
    Number of subjects included in analysis
    952
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Linear mixed effect (LME)
    Parameter type
    		 Absolute difference
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 2

    Secondary: Average total combined score (TCS) during the tree pollen season (TPS)

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    End point title
    		 Average total combined score (TCS) during the tree pollen season (TPS)
    End point description
    Average total combined score (TCS) measured in the tree pollen season (TPS). TPS includes hazel, alder, birch and oak pollen seasons. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the SQ tree SLIT-tablet if it is taken as instructed.
    End point type
    Secondary
    End point timeframe
    During the tree pollen season (TPS)
    End point values
    		 Placebo SQ tree SLIT-tablet
    Number of subjects analysed
    479
    473
    Units: Adjusted mean
        least squares mean (standard error)
    4.51 ( 0.25 )
    3.66 ( 0.22 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age-group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.
    Comparison groups
    SQ tree SLIT-tablet v Placebo
    Number of subjects included in analysis
    952
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Linear mixed effect (LME)
    Parameter type
    		 Absolute difference
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 1.35

    Secondary: Average daily symptoms score (DSS) during the birch pollen season (BPS)

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    End point title
    		 Average daily symptoms score (DSS) during the birch pollen season (BPS)
    End point description
    Average rhinoconjunctivitis daily symptoms score (DSS) during the birch pollen season (BPS) evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the SQ tree SLIT-tablet if it is taken as instructed.
    End point type
    Secondary
    End point timeframe
    During the birch pollen season (BPS)
    End point values
    		 Placebo SQ tree SLIT-tablet
    Number of subjects analysed
    479
    473
    Units: Adjusted mean
        least squares mean (standard error)
    2.75 ( 0.16 )
    2.39 ( 0.15 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age-group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.
    Comparison groups
    Placebo v SQ tree SLIT-tablet
    Number of subjects included in analysis
    952
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0354
    Method
    		 Linear mixed effect (LME)
    Parameter type
    		 Absolute difference
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.71

    Secondary: Average daily symptoms score (DSS) during the tree pollen season (TPS)

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    End point title
    		 Average daily symptoms score (DSS) during the tree pollen season (TPS)
    End point description
    Average rhinoconjunctivitis daily symptoms score (DSS) during the tree pollen season (TPS) evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more severe symptoms. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the SQ tree SLIT-tablet if it is taken as instructed.
    End point type
    Secondary
    End point timeframe
    During the tree pollen season (TPS)
    End point values
    		 Placebo SQ tree SLIT-tablet
    Number of subjects analysed
    479
    473
    Units: Adjusted mean
        least squares mean (standard error)
    2.28 ( 0.14 )
    2.04 ( 0.13 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age-group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.
    Comparison groups
    Placebo v SQ tree SLIT-tablet
    Number of subjects included in analysis
    952
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0734
    Method
    		 Linear mixed effect
    Parameter type
    		 Absolute difference
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.5

    Secondary: Average daily medication score (DMS) during the birch pollen season (BPS)

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    End point title
    		 Average daily medication score (DMS) during the birch pollen season (BPS)
    End point description
    Average rhinoconjunctivitis daily medication score (DMS) during the birch pollen season (BPS) evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). Higher scores indicate more medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the SQ tree SLIT-tablet if it is taken as instructed.
    End point type
    Secondary
    End point timeframe
    During the birch pollen season (BPS)
    End point values
    		 Placebo SQ tree SLIT-tablet
    Number of subjects analysed
    479
    473
    Units: Adjusted mean
        least squares mean (standard error)
    2.42 ( 0.23 )
    1.55 ( 0.18 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age-group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.
    Comparison groups
    Placebo v SQ tree SLIT-tablet
    Number of subjects included in analysis
    952
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Linear mixed effect (LME)
    Parameter type
    		 Absolute difference
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.28

    Secondary: Average daily medication score (DMS) during the tree pollen season (TPS)

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    End point title
    		 Average daily medication score (DMS) during the tree pollen season (TPS)
    End point description
    Average rhinoconjunctivitis daily medication score (DMS) during the tree pollen season (TPS) evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the SQ tree SLIT-tablet if it is taken as instructed.
    End point type
    Secondary
    End point timeframe
    During the tree pollen season (TPS)
    End point values
    		 Placebo SQ tree SLIT-tablet
    Number of subjects analysed
    479
    473
    Units: Adjusted mean
        least squares mean (standard error)
    1.72 ( 0.16 )
    1.18 ( 0.13 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age-group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.
    Comparison groups
    Placebo v SQ tree SLIT-tablet
    Number of subjects included in analysis
    952
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Linear mixed effect (LME)
    Parameter type
    		 Absolute difference
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 0.82

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from informed consent to last contact with subject. Only treatment-emergent AEs are presented, i.e. AEs with start date/time on/after time of first IMP administration and no later than 7 days after IMP administration.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    SQ tree SLIT-tablet
    Reporting group description
    		 SQ tree SLIT-tablet

    Serious adverse events
    		 Placebo SQ tree SLIT-tablet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 479 (1.25%)
    5 / 473 (1.06%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 473 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Foot operation
         subjects affected / exposed
    0 / 479 (0.00%)
    1 / 473 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 473 (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
    0 / 479 (0.00%)
    1 / 473 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 479 (0.00%)
    1 / 473 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 479 (0.00%)
    1 / 473 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 479 (0.00%)
    1 / 473 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 473 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph node abscess
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 473 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 473 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 479 (0.21%)
    0 / 473 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo SQ tree SLIT-tablet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    194 / 479 (40.50%)
    315 / 473 (66.60%)
    Gastrointestinal disorders
    Oral pruritus
         subjects affected / exposed
    17 / 479 (3.55%)
    114 / 473 (24.10%)
         occurrences all number
    19
    136
    Tongue pruritus
         subjects affected / exposed
    6 / 479 (1.25%)
    60 / 473 (12.68%)
         occurrences all number
    6
    76
    Paraesthesia oral
         subjects affected / exposed
    8 / 479 (1.67%)
    28 / 473 (5.92%)
         occurrences all number
    8
    34
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    18 / 479 (3.76%)
    112 / 473 (23.68%)
         occurrences all number
    19
    140
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    82 / 479 (17.12%)
    81 / 473 (17.12%)
         occurrences all number
    124
    109
    Upper respiratory tract infection
         subjects affected / exposed
    43 / 479 (8.98%)
    42 / 473 (8.88%)
         occurrences all number
    55
    53
    Pharyngitis
         subjects affected / exposed
    21 / 479 (4.38%)
    32 / 473 (6.77%)
         occurrences all number
    23
    35
    COVID-19
         subjects affected / exposed
    43 / 479 (8.98%)
    27 / 473 (5.71%)
         occurrences all number
    44
    28
    Influenza
         subjects affected / exposed
    25 / 479 (5.22%)
    17 / 473 (3.59%)
         occurrences all number
    27
    18

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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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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