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    Clinical Trial Results:
    A phase IIIB trial investigating 3-year treatment efficacy, tolerability and safety of Grazax in children aged 5-18 years with grass pollen induced rhinoconjunctivitis with/without controlled asthma ( three consecutive pollen seasons treatment)

    Summary
    EudraCT number
    		 2009-014923-22
    Trial protocol
    		 IT  
    Global end of trial date
    31 Dec 2014

    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
    GT-23
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abellò S.p.A
    Sponsor organisation address
    Via Settembrini, 29, LAINATE, Italy, 20020
    Public contact
    Global Clinical Development, ALK, 45 45747576, ClinicalTrials@alk.net
    Scientific contact
    Global Clinical Development, ALK, 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
    31 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the 3 years efficacy, tolerability, safety of specific immunotherapy with Grazax compared to placebo on the top of rescue allergic symptomatic drugs in children with grass pollen induced rhinoconjunctivitis with or without controlled or partly controlled asthma.
    Protection of trial subjects
    Rescue medication allowed, safety monitoring
    Background therapy
    		 As required by the underlying clinical conditions (allergic rhinitis with or without allergic asthma)
    Evidence for comparator
    		 N/A. Placebo comparator
    Actual start date of recruitment
    03 Oct 2010
    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
    Italy: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    48
    Adolescents (12-17 years)
    20
    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
    		 -

    Pre-assignment
    Screening details
    		 Children were recruited in 11 different sites in Italy. The patients were recruited either prior to the 2010 grass pollen season or prior to the 2011 grass pollen season.

    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
    Placebo and active treatment were idential in colour, taste and appearance

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    One tablet per day; the tablet should be taken from the blister unit with dry fingers, and placed under the tongue, where it will disperse. Swallowing should be avoided for about 1 minute. Food and beverage should not be taken for the following 5 minutes.

    Arm title
    		 Grazax
    Arm description
    		 Active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    One tablet per day; the tablet should be taken from the blister unit with dry fingers, and placed under the tongue, where it will disperse. Swallowing should be avoided for about 1 minute. Food and beverage should not be taken for the following 5 minutes.

    Number of subjects in period 1
    		Placebo Grazax
    Started
    35
    33
    Completed
    26
    27
    Not completed
    9
    6
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    1
    1
         Never recieved IMP
    2
    -
         Amendment not approved by local EC
    2
    2
         Lost to follow-up
    1
    -
         history of anaphylaxis
    1
    -
         Protocol deviation
    1
    1
         Lack of efficacy
    1
    -

    Baseline characteristics

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

    Reporting group title
    Grazax
    Reporting group description
    		 Active treatment

    Reporting group values
    		 Placebo Grazax Total
    Number of subjects
    		 35 33 68
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 25 23 48
        Adolescents (12-17 years)
    		 10 10 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.6 ( 3.5 ) 9.7 ( 3.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 9 20
        Male
    		 24 24 48

    End points

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

    Reporting group title
    Grazax
    Reporting group description
    		 Active treatment

    Primary: IMP-related AEs

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    End point title
    		 IMP-related AEs [1]
    End point description
    Adverse events with possible causal relationship to IMP
    End point type
    Primary
    End point timeframe
    From randomisation to end of 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: GT-23 was changed to a safety and tolerability trial for two reasons: 1) after the first two years of recruitment, the sample size was underpowered to make any statistical analysis of endpoints originally chosen; 2) patients were recruited and studied in each site in different pollen seasons (2010, 2011, and 2012; or 2011, 2012, and 2013), thus exposing them to different pollen counts. Thus not formal statistical analyses was carried out and the primary endpoint was merely descriptive.
    End point values
    		 Placebo Grazax
    Number of subjects analysed
    35
    33
    Units: events
    2
    8
    No statistical analyses for this end point

    Secondary: Severe AE

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    End point title
    		 Severe AE
    End point description
    Adverse events assessed as severe
    End point type
    Secondary
    End point timeframe
    From randomisation to end of trial
    End point values
    		 Placebo Grazax
    Number of subjects analysed
    35
    33
    Units: events
    1
    1
    No statistical analyses for this end point

    Secondary: Global evaluation

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    End point title
    		 Global evaluation
    End point description
    In subjects opinion, 'much better' season than before treatment
    End point type
    Secondary
    End point timeframe
    3rd treatment year/grass pollen season
    End point values
    		 Placebo Grazax
    Number of subjects analysed
    26 [2]
    27 [3]
    Units: percent of subjects
        number (not applicable)
    3.8
    25.9
    Notes
    [2] - All subjects continuing in year 3
    [3] - All subjects continuing in year 3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from randomisation to end of trial (March 2010 to June 2014)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Grazax
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Grazax
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 33 (3.03%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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 Grazax
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
    5 / 33 (15.15%)
    Gastrointestinal disorders
    Lip pruritus
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 33 (9.09%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2012
    Changed with amendment-1 from phase IIIB efficacy study to safety study for 2 reasons: firstly, after the first two years of recruitment, the sample size was underpowered to make any statistical analysis of endpoints originally chosen; secondly, patients were recruited and studied in each Centre in different pollen seasons (2010, 2011, and 2012; or 2011, 2012, and 2013), thus exposing them to different pollen counts.

    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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    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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