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    Clinical Trial Results:
    A randomised, double blind, placebo-controlled phase I study investigating the safety of ALK HDM tablet in children

    Summary
    EudraCT number
    		 2007-000402-67
    Trial protocol
    		 ES  
    Global end of trial date
    01 Apr 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    26 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló S.A.
    Sponsor organisation address
    Miguel Fleta, 19, Madrid, Spain, E-28037
    Public contact
    Clinical Development, ALK, +45 45 74 75 76, ClinicalTrials@alk.net
    Scientific contact
    Clinical Development, ALK, +45 45 74 75 76, 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
    01 Apr 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify a dose range of the ALK house dust mite tablet (SQ HDM SLIT-tablet) that has a safety profile that will allow once-daily intake (as self-medication) by 5-14 year old children with allergic asthma (with or without rhinitis) due to house dust mites.
    Protection of trial subjects
    Dose groups were treated in a staggered manner at intervals of approximately 2 weeks. A safety committee reviewed the initial safety data of the previous dose (-s), and only by their approval did the trial enter the next (higher) level of dose strength.
    Background therapy
    		 Subjects being treated for asthma continued the prescribed asthma medication during the trial.
    Evidence for comparator
    		 Placebo comparator
    Actual start date of recruitment
    13 Sep 2007
    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: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    59
    Adolescents (12-17 years)
    13
    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 4 clinical groups in Spain

    Pre-assignment
    Screening details
    		 A total of 78 subjects were screened for this trial. Six subjects failed screening.

    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
    Blinding implementation details
    The IMPs were produced so that all tablets were identical in appearance, smell and taste. In order to maintain the blinding, subjects within each dose group received the same number of tablets, whether they received tablet containing active ingredient or not. Dose groups 0.5, 1, 3 and 6 SQ-HDM received one tablet daily and dose groups 9 and 12 SQ-HDM received two tablets daily to obtain a daily-dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 0.5 SQ-HDM
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    ALK HDM tablet
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Arm title
    		 1 SQ-HDM
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    ALK HDM tablet
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Arm title
    		 3 SQ-HDM
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    ALK HDM tablet
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Arm title
    		 6 SQ-HDM
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    ALK HDM tablet
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Arm title
    		 9 SQ-HDM
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    ALK HDM tablet
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Arm title
    		 12 SQ-HDM
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    SQ HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    ALK HDM tablet
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    The tablet (-s) were to be taken out of the blister pack with dry fingers and placed under the tongue (at the same time in the case of two tablets). After 1 minute the saliva was to be swallowed. Subjects were not to eat or drink for 5 minutes after administration of IMP. Administration was to take place at a time of the day when children were under observation. At days 1, 2, 8, 15 and 22, medication was performed at the trial site. At days 3-7, 9-14, 16-21 and 23-28, intake of the tablet was performed at home (self-medicating).

    Number of subjects in period 1
    		0.5 SQ-HDM 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM 9 SQ-HDM 12 SQ-HDM Placebo
    Started
    9
    9
    9
    9
    9
    9
    18
    Completed
    9
    9
    9
    9
    9
    9
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    0.5 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    1 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    3 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    6 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    9 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    12 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 0.5 SQ-HDM 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM 9 SQ-HDM 12 SQ-HDM Placebo Total
    Number of subjects
    		 9 9 9 9 9 9 18 72
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 7 8 8 7 8 6 15 59
        Adolescents (12-17 years)
    		 2 1 1 2 1 3 3 13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.9 ± 2.9 8.2 ± 2.2 8.6 ± 2.6 9.4 ± 2.4 9.1 ± 2 10.6 ± 2.7 9.6 ± 2.3 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4 2 3 3 2 4 22
        Male
    		 5 5 7 6 6 7 14 50

    End points

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    End points reporting groups
    Reporting group title
    0.5 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    1 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    3 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    6 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    9 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    12 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Specific IgE-blocking antibodies against D. farinae

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    End point title
    		 Specific IgE-blocking antibodies against D. farinae
    End point description
    IgE-blocking factor: the inhibitory capacity of competing components to specific IgE-allergen binding. IgE-blocking factor is a dimensionless number which varies theoretically from 0 (no presence of IgE-blocking components) to 1 (all allergen-specific IgE antibodies are blocked from binding to allergen). The primary objective of the trial was tolerability (descriptive statistics of adverse events only). In order to comply with system requirements of a primary endpoint, this endpoint has been promoted as the primary endpoint.
    End point type
    Primary
    End point timeframe
    change from baseline to end of trial
    End point values
    		 0.5 SQ-HDM 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM 9 SQ-HDM 12 SQ-HDM Placebo
    Number of subjects analysed
    9
    9
    9
    8 [1]
    9
    9
    18
    Units: dimensionless
        arithmetic mean (standard deviation)
    0.02 ± 0.08
    0.02 ± 0.08
    0.08 ± 0.1
    0.11 ± 0.1
    0.09 ± 0.14
    0.09 ± 0.08
    -0.01 ± 0.07
    Notes
    [1] - 1 sample was invalid
    Statistical analysis title
    		 IgE-blocking factor, 12 SQ-HDM vs placebo
    Statistical analysis description
    Analysis of difference (active vs. placebo) in change from baseline in IgE-blocking factor against D. farinae
    Comparison groups
    12 SQ-HDM v Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0048
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.035
         upper limit
    		 0.185
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 IgE-blocking factor, 9 SQ-HDM vs placebo
    Statistical analysis description
    Analysis of difference (active vs. placebo) in change from baseline in IgE-blocking factor against D. farinae
    Comparison groups
    Placebo v 9 SQ-HDM
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0174
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.094
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.017
         upper limit
    		 0.171
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 IgE-blocking factor, 6 SQ-HDM vs placebo
    Statistical analysis description
    Analysis of difference (active vs. placebo) in change from baseline in IgE-blocking factor against D. farinae
    Comparison groups
    Placebo v 6 SQ-HDM
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0029
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.115
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.041
         upper limit
    		 0.19
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 IgE-blocking factor, 3 SQ-HDM vs placebo
    Statistical analysis description
    Analysis of difference (active vs. placebo) in change from baseline in IgE-blocking factor against D. farinae
    Comparison groups
    Placebo v 3 SQ-HDM
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0184
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.016
         upper limit
    		 0.164
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 IgE-blocking factor, 1 SQ-HDM vs placebo
    Statistical analysis description
    Analysis of difference (active vs. placebo) in change from baseline in IgE-blocking factor against D. farinae
    Comparison groups
    Placebo v 1 SQ-HDM
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3453
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.039
         upper limit
    		 0.111
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 IgE-blocking factor, 0.5 SQ-HDM vs placebo
    Statistical analysis description
    Analysis of difference (active vs. placebo) in change from baseline in IgE-blocking factor against D. farinae
    Comparison groups
    Placebo v 0.5 SQ-HDM
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3861
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.034
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.043
         upper limit
    		 0.11
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from signing informed consent to end of trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    0.5 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    1 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    3 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    6 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    9 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    12 SQ-HDM
    Reporting group description
    		 active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 0.5 SQ-HDM 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM 9 SQ-HDM 12 SQ-HDM Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 0.5 SQ-HDM 1 SQ-HDM 3 SQ-HDM 6 SQ-HDM 9 SQ-HDM 12 SQ-HDM Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 9 (88.89%)
    9 / 9 (100.00%)
    8 / 9 (88.89%)
    9 / 9 (100.00%)
    8 / 9 (88.89%)
    9 / 9 (100.00%)
    17 / 18 (94.44%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    chest discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    2
    0
    Chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    2
    0
    Malaise
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    oedema mucosal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    3 / 9 (33.33%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    4
    0
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    6 / 18 (33.33%)
         occurrences all number
    1
    3
    1
    2
    0
    0
    6
    Asthma exercise induced
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    4 / 9 (44.44%)
    0 / 9 (0.00%)
    3 / 9 (33.33%)
    2 / 9 (22.22%)
    3 / 18 (16.67%)
         occurrences all number
    1
    4
    11
    0
    3
    2
    7
    Dry throat
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    5
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    hoarseness
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Nasal passage irritation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    19
    0
    1
    2
    0
    Pharyngolaryngeal irritation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    2
    Rhinitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    6
    0
    1
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    2
    Sneezing
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    7 / 9 (77.78%)
    4 / 9 (44.44%)
    4 / 9 (44.44%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    23
    40
    52
    37
    0
    throat secretion increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    1
    0
    2
    0
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    aphonia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    2
    Headache
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    5 / 18 (27.78%)
         occurrences all number
    1
    1
    0
    0
    3
    1
    11
    Syncope vasovagal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    3
    1
    5
    0
    26
    0
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    Conjunctival irritation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    2 / 18 (11.11%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    3
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    3
    0
    0
    1
    4
    eye redness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    6
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    2 / 18 (11.11%)
         occurrences all number
    0
    1
    0
    9
    1
    3
    17
    Abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    Glossodynia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    loose stools
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Oedema mouth
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    3 / 9 (33.33%)
    5 / 9 (55.56%)
    1 / 9 (11.11%)
    6 / 9 (66.67%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    8
    48
    4
    36
    0
    Stomatitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    6
    2
    3
    0
    Oral pruritus
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    8 / 9 (88.89%)
    6 / 9 (66.67%)
    6 / 9 (66.67%)
    6 / 9 (66.67%)
    4 / 18 (22.22%)
         occurrences all number
    5
    5
    59
    75
    51
    69
    6
    Swollen tongue
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    15
    0
    0
    0
    0
    Tongue disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    6
    0
    0
    0
    0
    Tongue eruption
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    mucosal inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Hepatobiliary disorders
    Sensation of foreign body
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 18 (0.00%)
         occurrences all number
    36
    0
    10
    0
    0
    3
    0
    Face oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    3
    2
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    3
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    5
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    neck pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    Bronchitis viral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    7
    2
    2
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2007
    The amendment was proposed after the evaluation of subjects included in the 2nd cohort (dose group 1 SQ-HDM).Inclusion of two additional dose groups: 9 SQ-HDM and 12 SQ-HDM. Both doses were below the maximum tolerable dose found in adults in the MT-01 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.
    Not applicable
    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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