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    Clinical Trial Results:
    A 28-day, single-armed, open-label trial to evaluate safety of the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet in adolescent subjects (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis (AR/C) with or without asthma

    Summary
    EudraCT number
    		 2020-000446-34
    Trial protocol
    		 SK   DE   CZ  
    Global end of trial date
    24 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2021
    First version publication date
    04 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT-18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04541004
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló A/S
    Sponsor organisation address
    Bøge Allé 6-8, Hørsholm, Denmark, DK-2970
    Public contact
    Global pharmacovigilance & clinical development, ALK-Abelló A/S, +45 45747576, ClinicalTrials@alk.net
    Scientific contact
    Global pharmacovigilance & 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial was to evaluate safety and tolerability of the HDM SLIT-tablet in adolescents (12-17 years of age) with 28 days of treatment.
    Protection of trial subjects
    Safety surveillance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2020
    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
    Slovakia: 137
    Country: Number of subjects enrolled
    Czechia: 87
    Country: Number of subjects enrolled
    Germany: 29
    Worldwide total number of subjects
    253
    EEA total number of subjects
    253
    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)
    253
    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 25 trial sites in EU (the Czech Republic, Slovakia and Germany) First subject first visit: 23-September-2020 Last subject last visit: 19-April-2021 Last follow-up telephone call: 24-Apr-2021

    Pre-assignment
    Screening details
    		 Main selection criteria: - Adolescents (12-17 years) - History of allergic rhinitis/rhinoconjunctivitis to HDM of at least 1 year duration (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during 1 year prior to screening - Positive SPT against D. pteronyssinus and/or D. farinae

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

    Arms
    Arm title
    		 HDM SLIT-tablet arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    dose: 12 SQ-HDM administration: Prior to first IMP intake, an oropharyngeal examination had to be performed. The first intake of IMP had to be done at the clinic under medical supervision, with a subsequent observation period of at least 30 minutes. The IMP had to be taken with dry fingers from the blister unit immediately after opening the blister and placed under the tongue, where it disperses. Swallowing had to be avoided for approximately 1 minute. Food and beverages should not have been taken for the following 5 minutes after intake of IMP. The daily dose of IMP was 1 HDM SLIT-tablet, which should have preferably been taken in the morning.

    Number of subjects in period 1
    		HDM SLIT-tablet arm
    Started
    253
    Completed
    251
    Not completed
    2
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 253 253
    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)
    		 0 0
        Adolescents (12-17 years)
    		 253 253
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 101 101
        Male
    		 152 152
    Subject analysis sets

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of IMP. The safety analysis set (referred to as 'safety set') served the basis for evaluating the safety and tolerability of the HDM SLIT tablet in the trial.

    Subject analysis sets values
    		 Safety set
    Number of subjects
    253
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    253
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    101
        Male
    152

    End points

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    End points reporting groups
    Reporting group title
    HDM SLIT-tablet arm
    Reporting group description
    		 -

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of IMP. The safety analysis set (referred to as 'safety set') served the basis for evaluating the safety and tolerability of the HDM SLIT tablet in the trial.

    Primary: At least 1 TEAE

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    End point title
    		 At least 1 TEAE [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first IMP administration to 7 days after last IMP administration.
    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: No formal statistical analyses were performed in this trial, as this was a single-arm safety trial.
    End point values
    		 HDM SLIT-tablet arm Safety set
    Number of subjects analysed
    253
    253
    Units: events
    1940
    1940
    No statistical analyses for this end point

    Secondary: At least 1 solicited TEAE

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    End point title
    		 At least 1 solicited TEAE
    End point description
    End point type
    Secondary
    End point timeframe
    From first IMP administration to 7 days after last IMP administration.
    End point values
    		 HDM SLIT-tablet arm Safety set
    Number of subjects analysed
    253
    253
    Units: events
    1796
    1796
    No statistical analyses for this end point

    Secondary: At least 1 IMP-related AE

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    End point title
    		 At least 1 IMP-related AE
    End point description
    End point type
    Secondary
    End point timeframe
    From first IMP administration to 7 days after last IMP administration.
    End point values
    		 HDM SLIT-tablet arm Safety set
    Number of subjects analysed
    253
    253
    Units: events
    1863
    1863
    No statistical analyses for this end point

    Secondary: At least 1 treatment-emergent SAE

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    End point title
    		 At least 1 treatment-emergent SAE
    End point description
    End point type
    Secondary
    End point timeframe
    From first IMP administration to 7 days after last IMP administration.
    End point values
    		 HDM SLIT-tablet arm Safety set
    Number of subjects analysed
    253
    253
    Units: events
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from first IMP intake to 7 days after end-of-trial or discontinuation.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    HDM SLIT-tablet group
    Reporting group description
    		 -

    Serious adverse events
    		 HDM SLIT-tablet group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 253 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 HDM SLIT-tablet group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    223 / 253 (88.14%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    16 / 253 (6.32%)
         occurrences all number
    24
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    101 / 253 (39.92%)
         occurrences all number
    270
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    40 / 253 (15.81%)
         occurrences all number
    77
    Diarrhoea
         subjects affected / exposed
    24 / 253 (9.49%)
         occurrences all number
    30
    Enlarged uvula
         subjects affected / exposed
    14 / 253 (5.53%)
         occurrences all number
    38
    Glossodynia
         subjects affected / exposed
    41 / 253 (16.21%)
         occurrences all number
    87
    Lip oedema
         subjects affected / exposed
    11 / 253 (4.35%)
         occurrences all number
    15
    Lip swelling
         subjects affected / exposed
    40 / 253 (15.81%)
         occurrences all number
    89
    Mouth swelling
         subjects affected / exposed
    14 / 253 (5.53%)
         occurrences all number
    32
    Mouth ulceration
         subjects affected / exposed
    38 / 253 (15.02%)
         occurrences all number
    68
    Nausea
         subjects affected / exposed
    40 / 253 (15.81%)
         occurrences all number
    83
    Oedema mouth
         subjects affected / exposed
    21 / 253 (8.30%)
         occurrences all number
    35
    Oral pain
         subjects affected / exposed
    10 / 253 (3.95%)
         occurrences all number
    19
    Oral pruritus
         subjects affected / exposed
    169 / 253 (66.80%)
         occurrences all number
    421
    Swollen tongue
         subjects affected / exposed
    29 / 253 (11.46%)
         occurrences all number
    51
    Tongue eruption
         subjects affected / exposed
    6 / 253 (2.37%)
         occurrences all number
    16
    Tongue ulceration
         subjects affected / exposed
    42 / 253 (16.60%)
         occurrences all number
    79
    Vomiting
         subjects affected / exposed
    6 / 253 (2.37%)
         occurrences all number
    9
    Respiratory, thoracic and mediastinal disorders
    Pharyngeal paraesthesia
         subjects affected / exposed
    17 / 253 (6.72%)
         occurrences all number
    34
    Pharyngeal swelling
         subjects affected / exposed
    33 / 253 (13.04%)
         occurrences all number
    59
    Throat irritation
         subjects affected / exposed
    132 / 253 (52.17%)
         occurrences all number
    323
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    6 / 253 (2.37%)
         occurrences all number
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2020
    In this amendment, a section including COVID-19 related risks in context of the trial was inserted, and the mould allergen (Cladosporium herbarum) was removed from the SPT. The first amendment was made before FSFV and as such did not impact the conduct of the trial. This amendment applied to all countries.
    14 Sep 2020
    In this amendment, new wording for an inclusion criterion (I3) was adapted. This change intended to clarify that the medical history of HDM allergic rhinitis/rhinoconjunctivitis referred to patients with a moderate to severe medical history of HDM allergic rhinitis/rhinoconjunctivitis, to align with the approved indication in Germany. In addition, a minor revision was included to specify the guidance for re-screening procedures. This amendment applied to Germany only, and was based on feedback from Paul-Ehrlich Institut (PEI). There were no changes affecting subject information and assent forms and the amendment did not impact the conduct of the trial.

    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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