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    Clinical Trial Results:
    A Dose Response Evaluation of SLIToneULTRA HDM Mix Immunotherapy

    Summary
    EudraCT number
    		 2012-002177-62
    Trial protocol
    		 ES  
    Global end of trial date
    04 Sep 2013

    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
    SU-M-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 Clinical Development, ALK-Abelló A/S, +45 45747576, ClinicalTrials@alk.net
    Scientific contact
    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
    25 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLIToneULTRA house dust mite (HDM) mix in adult subjects with moderate to severe HDM allergic rhinitis.
    Protection of trial subjects
    Safety surveillance, use of symptomatic medications allowed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2012
    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: 91
    Country: Number of subjects enrolled
    France: 128
    Worldwide total number of subjects
    219
    EEA total number of subjects
    219
    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)
    218
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in France and Spain

    Pre-assignment
    Screening details
    		 The subjects eligible for the trial were adults with HDM allergic rhinitis. The clinical history was consistent with moderate to severe persistent HDM allergic rhinitis with or without asthma, with allergic rhinitis symptoms despite having received symptomatic treatment of at least one year prior to trial entry.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 50 SRU
    Arm description
    		 No updosing Maintenance: 50 SRU/day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    SLIToneULTRA HDM mix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral solution
    Routes of administration
    Sublingual use
    Dosage and administration details
    The solution was to be administered once daily. The solution was to be placed under the tongue (sublingual) and kept there for 2 minutes before swallowing. Eating and drinking was to be avoided for the next 5 minutes.

    Arm title
    		 150 SRU
    Arm description
    		 Updosing for 5 days: 50 SRU/day Maintenance for the rest of the trial: 150 SRU/day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    SLIToneULTRA HDM mix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral solution
    Routes of administration
    Sublingual use
    Dosage and administration details
    The solution was to be administered once daily. The solution was to be placed under the tongue (sublingual) and kept there for 2 minutes before swallowing. Eating and drinking was to be avoided for the next 5 minutes.

    Arm title
    		 300 SRU
    Arm description
    		 Updosing: 50 SRU/day for 5 days, then 150 SRU/day for 5 days Maintenance for the rest of the trial: 300 SRU/day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    SLIToneULTRA HDM mix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral solution
    Routes of administration
    Sublingual use
    Dosage and administration details
    The solution was to be administered once daily. The solution was to be placed under the tongue (sublingual) and kept there for 2 minutes before swallowing. Eating and drinking was to be avoided for the next 5 minutes.

    Number of subjects in period 1
    		50 SRU 150 SRU 300 SRU
    Started
    73
    73
    73
    Completed
    67
    65
    64
    Not completed
    6
    8
    9
         Consent withdrawn by subject
    1
    -
    -
         Lost to follow-up
    3
    -
    -
         Adverse event, non-fatal
    2
    3
    5
         Pregnancy
    -
    1
    -
         Lost to follow-up
    -
    2
    2
         Other causes, not specified
    -
    2
    -
         Protocol deviation
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    50 SRU
    Reporting group description
    		 No updosing Maintenance: 50 SRU/day

    Reporting group title
    150 SRU
    Reporting group description
    		 Updosing for 5 days: 50 SRU/day Maintenance for the rest of the trial: 150 SRU/day

    Reporting group title
    300 SRU
    Reporting group description
    		 Updosing: 50 SRU/day for 5 days, then 150 SRU/day for 5 days Maintenance for the rest of the trial: 300 SRU/day

    Reporting group values
    		 50 SRU 150 SRU 300 SRU Total
    Number of subjects
    		 73 73 73 219
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 73 73 72 218
        From 65-84 years
    		 0 0 1 1
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32 ± 10 32 ± 9 32 ± 10 -
    Gender categorical
    Units: Subjects
        Female
    		 41 39 38 118
        Male
    		 32 34 35 101

    End points

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    End points reporting groups
    Reporting group title
    50 SRU
    Reporting group description
    		 No updosing Maintenance: 50 SRU/day

    Reporting group title
    150 SRU
    Reporting group description
    		 Updosing for 5 days: 50 SRU/day Maintenance for the rest of the trial: 150 SRU/day

    Reporting group title
    300 SRU
    Reporting group description
    		 Updosing: 50 SRU/day for 5 days, then 150 SRU/day for 5 days Maintenance for the rest of the trial: 300 SRU/day

    Primary: Change in IgE-blocking factor for Dermatophagoides pteronyssinus

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    End point title
    		 Change in IgE-blocking factor for Dermatophagoides pteronyssinus
    End point description
    Change in IgE-blocking factor for Dermatophagoides pteronyssinus from baseline to end-of-trial using Last Observation Carried Forward (LOCF) for missing data
    End point type
    Primary
    End point timeframe
    Baseline to visit 4 (6 months)
    End point values
    		 50 SRU 150 SRU 300 SRU
    Number of subjects analysed
    73 [1]
    70 [2]
    72 [3]
    Units: kU/l
        arithmetic mean (standard deviation)
    0.09 ± 0.15
    0.14 ± 0.19
    0.17 ± 0.17
    Notes
    [1] - All subjects with valid samples
    [2] - All subjects with valid samples
    [3] - All subjects with valid samples
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Changes in IgE-blocking factor were assessed using Analysis of Covariance (ANCOVA) including group as factor and baseline IgE-blocking testing the hypothesis of no difference between doses with respect to IgE-blocking factor
    Comparison groups
    50 SRU v 150 SRU v 300 SRU
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.0152 [5]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - Test for overall difference between groups
    [5] - Significant overall difference between doses
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Pairwise comparison of 50 SRU and 300 SRU
    Comparison groups
    50 SRU v 300 SRU
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0075 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.06999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1211
         upper limit
    		 -0.01886
    Variability estimate
    Standard deviation
    Notes
    [6] - Significantly superior change in 300 SRU versus 50 SRU
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Pairwise comparison of 150 SRU and 300 SRU
    Comparison groups
    300 SRU v 150 SRU
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0602 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.04951
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1012
         upper limit
    		 0.0021
    Variability estimate
    Standard deviation
    Notes
    [7] - Not statistically significantly difference between 300 SRU and 150 SRU
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Pairwise comparison of 50 SRU and 150 SRU
    Comparison groups
    150 SRU v 50 SRU
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4342 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.02048
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0702
         upper limit
    		 0.03105
    Variability estimate
    Standard deviation
    Notes
    [8] - Not statistically significantly difference between 50 SRU and 150 SRU

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 6 months
    Adverse event reporting additional description
    From the first trial related activity after the subject signed the informed consent and until the follow up telephone contact
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    50 SRU
    Reporting group description
    		 No updosing Maintenance: 50 SRU/day

    Reporting group title
    150 SRU
    Reporting group description
    		 Updosing for 5 days: 50 SRU/day Maintenance for the rest of the trial: 150 SRU/day

    Reporting group title
    300 SRU
    Reporting group description
    		 Updosing: 50 SRU/day for 5 days, then 150 SRU/day for 5 days Maintenance for the rest of the trial: 300 SRU/day

    Serious adverse events
    		 50 SRU 150 SRU 300 SRU
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 50 SRU 150 SRU 300 SRU
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 73 (49.32%)
    36 / 73 (49.32%)
    41 / 73 (56.16%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    4 / 73 (5.48%)
    1 / 73 (1.37%)
    1 / 73 (1.37%)
         occurrences all number
    4
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 73 (2.74%)
    4 / 73 (5.48%)
    4 / 73 (5.48%)
         occurrences all number
    4
    9
    5
    Gastrointestinal disorders
    Oral pruritus
         subjects affected / exposed
    10 / 73 (13.70%)
    11 / 73 (15.07%)
    17 / 73 (23.29%)
         occurrences all number
    12
    12
    18
    Tongue pruritus
         subjects affected / exposed
    6 / 73 (8.22%)
    3 / 73 (4.11%)
    5 / 73 (6.85%)
         occurrences all number
    6
    3
    5
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    4 / 73 (5.48%)
    7 / 73 (9.59%)
    5 / 73 (6.85%)
         occurrences all number
    4
    9
    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.
    NA
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