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    Clinical Trial Results:
    Safety and tolerability of shortened up-dosing with Alutard SQ

    Summary
    EudraCT number
    		 2017-000971-97
    Trial protocol
    		 DE   ES  
    Global end of trial date
    22 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Dec 2018
    First version publication date
    08 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AL-X-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló A/S
    Sponsor organisation address
    Bøge Allé 1, Hørsholm, Denmark, 2970
    Public contact
    Global Pharmacovigilance and Clinical Development, ALK-Abelló A/S, 0045 45747576, clinicaltrials@alk.net
    Scientific contact
    Global Pharmacovigilance and Clinical Development, ALK-Abelló A/S, 0045 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
    31 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial is to evaluate the safety and tolerability of a 7-injection up-dosing schedule with Alutard SQ 6-grasses and rye, birch and house dust mite mix compared with the 11-injection up-dosing schedule established for pollen allergens.
    Protection of trial subjects
    Safety surveillance and access to rescue medication
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2017
    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
    Spain: 51
    Country: Number of subjects enrolled
    Germany: 290
    Worldwide total number of subjects
    341
    EEA total number of subjects
    341
    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)
    89
    Adults (18-64 years)
    252
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subject were recruited from 20 sites in Germany and 7 in Spain

    Pre-assignment
    Screening details
    		 Main selection criteria: Documented clinically relevant history of moderate-to-severe grass pollen, birch pollen or HDM-induced rhinoconjunctivitis with or without controlled asthma despite having received treatment with symptom-relieving medication during the previous 2 grass or birch pollen seasons or 2 years

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Grass-11
    Arm description
    		 Alutard SQ 6 grasses and rye, 11 updosing steps
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Alutard SQ 6 grasses and rye
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    11 updosing steps

    Arm title
    		 Grass-7
    Arm description
    		 Alutard SQ 6 grasses and rye, 7 updosing steps
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alutard SQ 6 grasses and rye
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 updosing steps

    Arm title
    		 Tree-7
    Arm description
    		 Alutard SQ birch, 7 updosing steps
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alutard SQ birch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 updosing steps

    Arm title
    		 HDM-7
    Arm description
    		 Alutard SQ house dust mite mix, 7 updosing steps
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alutard SQ HDM mix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    7 updosing steps

    Number of subjects in period 1
    		Grass-11 Grass-7 Tree-7 HDM-7
    Started
    85
    86
    87
    83
    Completed
    79
    73
    85
    78
    Not completed
    6
    13
    2
    5
         Consent withdrawn by subject
    1
    1
    -
    -
         Reason not given
    3
    2
    1
    2
         Adverse event, non-fatal
    2
    9
    -
    3
         Lost to follow-up
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Grass-11
    Reporting group description
    		 Alutard SQ 6 grasses and rye, 11 updosing steps

    Reporting group title
    Grass-7
    Reporting group description
    		 Alutard SQ 6 grasses and rye, 7 updosing steps

    Reporting group title
    Tree-7
    Reporting group description
    		 Alutard SQ birch, 7 updosing steps

    Reporting group title
    HDM-7
    Reporting group description
    		 Alutard SQ house dust mite mix, 7 updosing steps

    Reporting group values
    		 Grass-11 Grass-7 Tree-7 HDM-7 Total
    Number of subjects
    		 85 86 87 83 341
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 22 23 21 23 89
        Adults (18-64 years)
    		 63 63 66 60 252
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
        Age
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 42 44 44 43 173
        Male
    		 43 42 43 40 168

    End points

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    End points reporting groups
    Reporting group title
    Grass-11
    Reporting group description
    		 Alutard SQ 6 grasses and rye, 11 updosing steps

    Reporting group title
    Grass-7
    Reporting group description
    		 Alutard SQ 6 grasses and rye, 7 updosing steps

    Reporting group title
    Tree-7
    Reporting group description
    		 Alutard SQ birch, 7 updosing steps

    Reporting group title
    HDM-7
    Reporting group description
    		 Alutard SQ house dust mite mix, 7 updosing steps

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects included

    Primary: All treatment-related adverse events

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    End point title
    		 All treatment-related adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    Entire trial
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a safety trial with no formal statistical analysis planned. Only descriptive analyses were planned for the primary endpoint.
    End point values
    		 Grass-11 Grass-7 Tree-7 HDM-7
    Number of subjects analysed
    85
    85 [2]
    87
    83
    Units: events
    711
    561
    444
    446
    Notes
    [2] - 1 subject not treated
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire trial (only treatment emergent adverse events)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Grass-11
    Reporting group description
    		 Alutard SQ 6 grasses and rye, 11 updosing steps

    Reporting group title
    Grass-7
    Reporting group description
    		 Alutard SQ 6 grasses and rye, 7 updosing steps

    Reporting group title
    Tree-7
    Reporting group description
    		 Alutard SQ birch, 7 updosing steps

    Reporting group title
    HDM-7
    Reporting group description
    		 Alutard SQ house dust mite mix, 7 updosing steps

    Serious adverse events
    		 Grass-11 Grass-7 Tree-7 HDM-7
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 85 (4.71%)
    2 / 85 (2.35%)
    0 / 87 (0.00%)
    0 / 83 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Grass-11 Grass-7 Tree-7 HDM-7
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 85 (85.88%)
    79 / 85 (92.94%)
    75 / 87 (86.21%)
    74 / 83 (89.16%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 85 (14.12%)
    16 / 85 (18.82%)
    15 / 87 (17.24%)
    17 / 83 (20.48%)
         occurrences all number
    22
    31
    26
    28
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    42 / 85 (49.41%)
    35 / 85 (41.18%)
    41 / 87 (47.13%)
    45 / 83 (54.22%)
         occurrences all number
    188
    127
    113
    111
    Injection site oedema
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    6 / 83 (7.23%)
         occurrences all number
    2
    1
    0
    7
    Injection site pain
         subjects affected / exposed
    13 / 85 (15.29%)
    8 / 85 (9.41%)
    7 / 87 (8.05%)
    12 / 83 (14.46%)
         occurrences all number
    16
    12
    8
    19
    Injection site pruritus
         subjects affected / exposed
    39 / 85 (45.88%)
    43 / 85 (50.59%)
    41 / 87 (47.13%)
    48 / 83 (57.83%)
         occurrences all number
    178
    132
    118
    129
    Injection site swelling
         subjects affected / exposed
    49 / 85 (57.65%)
    49 / 85 (57.65%)
    41 / 87 (47.13%)
    49 / 83 (59.04%)
         occurrences all number
    238
    165
    129
    142
    Injection site warmth
         subjects affected / exposed
    7 / 85 (8.24%)
    4 / 85 (4.71%)
    3 / 87 (3.45%)
    2 / 83 (2.41%)
         occurrences all number
    25
    17
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 85 (2.35%)
    6 / 85 (7.06%)
    2 / 87 (2.30%)
    2 / 83 (2.41%)
         occurrences all number
    2
    6
    2
    2
    Nasal congestion
         subjects affected / exposed
    3 / 85 (3.53%)
    5 / 85 (5.88%)
    5 / 87 (5.75%)
    2 / 83 (2.41%)
         occurrences all number
    3
    5
    7
    3
    Oropharyngeal pain
         subjects affected / exposed
    5 / 85 (5.88%)
    7 / 85 (8.24%)
    4 / 87 (4.60%)
    3 / 83 (3.61%)
         occurrences all number
    6
    7
    5
    6
    Throat irritation
         subjects affected / exposed
    1 / 85 (1.18%)
    2 / 85 (2.35%)
    5 / 87 (5.75%)
    0 / 83 (0.00%)
         occurrences all number
    1
    2
    20
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 85 (1.18%)
    5 / 85 (5.88%)
    0 / 87 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    1
    5
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 85 (1.18%)
    5 / 85 (5.88%)
    5 / 87 (5.75%)
    2 / 83 (2.41%)
         occurrences all number
    1
    9
    5
    3
    Urticaria
         subjects affected / exposed
    6 / 85 (7.06%)
    9 / 85 (10.59%)
    1 / 87 (1.15%)
    1 / 83 (1.20%)
         occurrences all number
    11
    12
    2
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 85 (17.65%)
    15 / 85 (17.65%)
    13 / 87 (14.94%)
    13 / 83 (15.66%)
         occurrences all number
    20
    18
    17
    15
    Respiratory tract infection
         subjects affected / exposed
    5 / 85 (5.88%)
    4 / 85 (4.71%)
    0 / 87 (0.00%)
    5 / 83 (6.02%)
         occurrences all number
    6
    5
    0
    6
    Rhinitis
         subjects affected / exposed
    2 / 85 (2.35%)
    7 / 85 (8.24%)
    4 / 87 (4.60%)
    4 / 83 (4.82%)
         occurrences all number
    2
    9
    4
    5

    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
    For support, Contact us.
    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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