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    Clinical Trial Results:
    A randomised, parallel-group, double-blind, placebo-controlled phase III trial assessing the efficacy and safety of 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis

    Summary
    EudraCT number
    		 2020-000455-12
    Trial protocol
    		 EE   LT   LV   CZ   PL   FR  
    Global end of trial date
    26 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Oct 2024
    First version publication date
    12 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SU-G-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04881461
    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
    Senior Director, Clinical Data Science, Global Clinical Development, ALK-Abelló A/S, +45 45747576, clinicaltrials@alk.net
    Scientific contact
    Senior Director, Clinical Data Science, Global Clinical Development, ALK-Abelló A/S, +45 45747576, clinicaltrials@alk.net
    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
    30 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of 5-grass mix SLIT-drops (sublingual immunotherapy) to placebo in relieving grass rhinoconjunctivitis symptoms and in use of symptom-relief medication during the 2nd Peak Grass Pollen Season (PGPS)
    Protection of trial subjects
    Safety surveillance. Access to rescue/reliever medication.
    Background therapy
    		 Rhinoconjunctivitis rescue medication: Subjects were provided with rescue medication (antihistamine/nasal corticosteroid) to relieve rhinoconjunctivitis symptoms. The rescue medication was provided before the start of the grass 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.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 May 2021
    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: 233
    Country: Number of subjects enrolled
    Czechia: 113
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Latvia: 33
    Country: Number of subjects enrolled
    Lithuania: 51
    Worldwide total number of subjects
    445
    EEA total number of subjects
    445
    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)
    445
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 45 sites in 6 countries (Poland, Czechia, Estonia, France, Latvia and Lithuania). First subject first visit: 10-May-2021 Last subject last visit/contact: 26-Sep-2023

    Pre-assignment
    Screening details
    		 *Male or female aged ≥18 years *Clinical history of grass pollen-induced allergic rhinoconjunctivitis for ≥2 years (with or without asthma), which was severe and remained troublesome despite treatment with symptom-relieving medication during the previous grass pollen season. *Positive SPT and specific IgE against Phleum pratense

    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, 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 solution in single-dose container
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subjects were instructed to take IMP once daily and that eating and drinking should be avoided for the next 5 minutes. The entire content of the single-dose container should be placed under the tongue (sublingual) and swallowing should be avoided for 2 minutes. The first administration of IMP was done at the clinic under medical supervision with a subsequent 30-minute observation period.

    Arm title
    		 5-grass mix SLIT-drops
    Arm description
    		 5-grass mix SLIT-drops
    Arm type
    		 Experimental

    Investigational medicinal product name
    5-grass mix SLIT-drops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subjects were instructed to take IMP once daily and that eating and drinking should be avoided for the next 5 minutes. The entire content of the single-dose container should be placed under the tongue (sublingual) and swallowing should be avoided for 2 minutes. The first administration of IMP was done at the clinic under medical supervision with a subsequent 30-minute observation period.

    Number of subjects in period 1
    		Placebo 5-grass mix SLIT-drops
    Started
    223
    222
    Completed
    196
    193
    Not completed
    27
    29
         Consent withdrawn by subject
    19
    19
         Reason stated as "other" in CRF
    1
    2
         Adverse event, non-fatal
    2
    4
         Lost to follow-up
    4
    4
         Lack of efficacy
    1
    -

    Baseline characteristics

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

    Reporting group title
    5-grass mix SLIT-drops
    Reporting group description
    		 5-grass mix SLIT-drops

    Reporting group values
    		 Placebo 5-grass mix SLIT-drops Total
    Number of subjects
    		 223 222 445
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 223 222 445
    Gender categorical
    Units: Subjects
        Female
    		 105 95 200
        Male
    		 118 127 245
    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
    445
    445
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    445
    445
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    200
    200
        Male
    245
    245

    End points

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

    Reporting group title
    5-grass mix SLIT-drops
    Reporting group description
    		 5-grass mix SLIT-drops

    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 daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd peak grass pollen season (PGPS)

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    End point title
    		 Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd peak grass pollen season (PGPS)
    End point description
    The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
    End point type
    Primary
    End point timeframe
    During the 2nd PGPS (14 days)
    End point values
    		 Placebo 5-grass mix SLIT-drops
    Number of subjects analysed
    192
    187
    Units: Adjusted mean
        least squares mean (standard error)
    7.10 ( 0.51 )
    5.22 ( 0.42 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    The endpoint was analysed using primary (trial product) estimand. The null hypothesis was defined as "no differences in means between treatment arms". The endpoint analysis was based on a 5% significance level. The endpoint was analysed using a linear mixed effects model with the following covariates: treatment, season and their interaction, ongoing asthma status, and country and season interaction.
    Comparison groups
    Placebo v 5-grass mix SLIT-drops
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0036 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Absolute difference
    Point estimate
    1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 3.17
    Notes
    [1] - Adjusted p-value

    Secondary: Average weekly overall rhinoconjunctivitis quality of life questionnaire (RQLQ) score during the 2nd peak grass pollen season (PGPS)

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    End point title
    		 Average weekly overall rhinoconjunctivitis quality of life questionnaire (RQLQ) score during the 2nd peak grass pollen season (PGPS)
    End point description
    The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.
    End point type
    Secondary
    End point timeframe
    During the 2nd PGPS (14 days)
    End point values
    		 Placebo 5-grass mix SLIT-drops
    Number of subjects analysed
    187
    182
    Units: Adjusted mean
        least squares mean (standard error)
    1.04 ( 0.08 )
    0.86 ( 0.08 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    The endpoint was analysed using primary (trial product) estimand. The null hypothesis was defined as "no differences in means between treatment arms". The endpoint analysis was based on a 5% significance level. The endpoint was analysed using a linear mixed effects model with the following covariates: treatment, season and their interaction, ongoing asthma status, and country and season interaction.
    Comparison groups
    Placebo v 5-grass mix SLIT-drops
    Number of subjects included in analysis
    369
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1111 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Absolute difference
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.39
    Notes
    [2] - Adjusted p-value

    Secondary: Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 1st peak grass pollen season (PGPS)

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    End point title
    		 Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 1st peak grass pollen season (PGPS)
    End point description
    The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
    End point type
    Secondary
    End point timeframe
    During the 1st PGPS (14 days)
    End point values
    		 Placebo 5-grass mix SLIT-drops
    Number of subjects analysed
    207
    203
    Units: Adjusted mean
        least squares mean (standard error)
    8.10 ( 0.54 )
    6.76 ( 0.42 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    The endpoint was analysed using primary (trial product) estimand. The null hypothesis was defined as "no differences in means between treatment arms". The endpoint analysis was based on a 5% significance level. The endpoint was analysed using a linear mixed effects model with the following covariates: treatment, season and their interaction, ongoing asthma status, and country and season interaction.
    Comparison groups
    Placebo v 5-grass mix SLIT-drops
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0417 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Absolute difference
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 2.67
    Notes
    [3] - Observed p-value

    Secondary: Average weekly overall rhinoconjunctivitis quality of life questionnaire (RQLQ) score during the 1st peak grass pollen season (PGPS)

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    End point title
    		 Average weekly overall rhinoconjunctivitis quality of life questionnaire (RQLQ) score during the 1st peak grass pollen season (PGPS)
    End point description
    The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.
    End point type
    Secondary
    End point timeframe
    During the 1st PGPS (14 days)
    End point values
    		 Placebo 5-grass mix SLIT-drops
    Number of subjects analysed
    205
    197
    Units: Adjusted mean
        least squares mean (standard error)
    1.26 ( 0.09 )
    1.19 ( 0.08 )
    Statistical analysis title
    		 Trial product estimand - Main estimator
    Statistical analysis description
    The endpoint was analysed using primary (trial product) estimand. The null hypothesis was defined as "no differences in means between treatment arms". The endpoint analysis was based on a 5% significance level. The endpoint was analysed using a linear mixed effects model with the following covariates: treatment, season and their interaction, ongoing asthma status, and country and season interaction.
    Comparison groups
    Placebo v 5-grass mix SLIT-drops
    Number of subjects included in analysis
    402
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4984 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Absolute difference
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.3
    Notes
    [4] - Observed p-value

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from informed consent to last follow-up contact with subject. Only treatment-emergent AEs are presented, i.e. AEs starting on/after time of first IMP administration and no later than 7 days after last 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
    5-grass mix SLIT-drops
    Reporting group description
    		 5-grass mix SLIT-drops

    Serious adverse events
    		 Placebo 5-grass mix SLIT-drops
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 223 (2.69%)
    4 / 222 (1.80%)
         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)
    Breast cancer
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 222 (0.45%)
         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
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal procedural complication
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 222 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Varicose vein
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 222 (0.45%)
         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
    1 / 223 (0.45%)
    1 / 222 (0.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Choking
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 222 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 222 (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
    Diverticulitis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 222 (0.45%)
         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
    		 Placebo 5-grass mix SLIT-drops
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    144 / 223 (64.57%)
    167 / 222 (75.23%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 223 (8.52%)
    11 / 222 (4.95%)
         occurrences all number
    30
    11
    Gastrointestinal disorders
    Oral pruritus
         subjects affected / exposed
    11 / 223 (4.93%)
    40 / 222 (18.02%)
         occurrences all number
    12
    49
    Oral discomfort
         subjects affected / exposed
    1 / 223 (0.45%)
    15 / 222 (6.76%)
         occurrences all number
    1
    18
    Mouth swelling
         subjects affected / exposed
    0 / 223 (0.00%)
    13 / 222 (5.86%)
         occurrences all number
    0
    15
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    4 / 223 (1.79%)
    16 / 222 (7.21%)
         occurrences all number
    4
    16
    Infections and infestations
    COVID-19
         subjects affected / exposed
    43 / 223 (19.28%)
    41 / 222 (18.47%)
         occurrences all number
    50
    44
    Nasopharyngitis
         subjects affected / exposed
    43 / 223 (19.28%)
    38 / 222 (17.12%)
         occurrences all number
    75
    67
    Viral infection
         subjects affected / exposed
    7 / 223 (3.14%)
    14 / 222 (6.31%)
         occurrences all number
    8
    15
    Influenza
         subjects affected / exposed
    11 / 223 (4.93%)
    12 / 222 (5.41%)
         occurrences all number
    13
    12
    Upper respiratory tract infection
         subjects affected / exposed
    15 / 223 (6.73%)
    10 / 222 (4.50%)
         occurrences all number
    20
    19
    Bronchitis
         subjects affected / exposed
    14 / 223 (6.28%)
    7 / 222 (3.15%)
         occurrences all number
    15
    9
    Pharyngitis
         subjects affected / exposed
    20 / 223 (8.97%)
    4 / 222 (1.80%)
         occurrences all number
    25
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2021
    The amendment was issued after first subject first visit and prior to unblinding. The main changes were: 1. Visit windows changed from 7 to 14 days for the pre-EGPS visits (V4 and V7). 2. A telephone contact between randomisation (V2) and 1st off-season visit (V3) was changed to optional. 3. The definition of end of trial changed from the last subject last physical visit to the last subject follow-up telephone contact. 4. Restricted and prohibited concomitant medication was updated to only include those medications that would impact the safety of the subject and significantly impact the endpoints. 5. Medical history re. asthma: it was clarified that only subjects diagnosed/treated in adulthood should be stratified as asthmatic. 6. Additional specification of events of special interest form and procedure (administrative). 7. Updated contact info on laboratory due to change of vendor.

    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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