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    Clinical Trial Results:
    An open trial to assess the tolerability of AVANZ® Cupressus immunotherapy

    Summary
    EudraCT number
    		 2013-004720-11
    Trial protocol
    		 ES  
    Global end of trial date
    11 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2016
    First version publication date
    20 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AV-X-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02069535
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló S.A.
    Sponsor organisation address
    Miguel Fleta, 19, Madrid, Spain, 28037
    Public contact
    clinicaltrials@alk.net, ALK-Abelló S.A., 0034 913276127, clinicaltrials@alk.net
    Scientific contact
    clinicaltrials@alk.net, ALK-Abelló S.A., 0034 913276127, 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
    11 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica.
    Protection of trial subjects
    Safety surveillance, use of symptomatic medication allowed. Telephone contact within 48h after IMP administration
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2014
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    52
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited inSpain

    Pre-assignment
    Screening details
    		 The trial population comprises adults suffering from allergic rhinoconjunctivitis with or without asthma due to sensitisation to Cupressus arizonica pollen.

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

    Arms
    Arm title
    		 ACTIVE TREATMENT
    Arm description
    		 AVANZ Cupressus arizonica, updosing treatment (5step) 1 maintenance dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    AVANZ Cupressus arizonica
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Weekly administration dose during up-dosing phase until reach the administration dose of 15000SQ+.

    Number of subjects in period 1
    		ACTIVE TREATMENT
    Started
    52
    Completed
    50
    Not completed
    2
         Adverse event, non-fatal
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Visit 1
    Reporting group description
    		 -

    Reporting group values
    		 Visit 1 Total
    Number of subjects
    		 52 52
    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)
    		 0 0
        Adults (18-64 years)
    		 52 52
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 31 31
        Male
    		 21 21
    Subject analysis sets

    Subject analysis set title
    VISIT 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects treated

    Subject analysis set title
    Visit 6
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who completed the clinical trial visits. Visit 6

    Subject analysis sets values
    		 VISIT 1 Visit 6
    Number of subjects
    52
    50
    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)
    0
    0
        Adults (18-64 years)
    52
    50
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    ACTIVE TREATMENT
    Reporting group description
    		 AVANZ Cupressus arizonica, updosing treatment (5step) 1 maintenance dose

    Subject analysis set title
    VISIT 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects treated

    Subject analysis set title
    Visit 6
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who completed the clinical trial visits. Visit 6

    Primary: Frequency of subjects with adverse drug reaction

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    End point title
    		 Frequency of subjects with adverse drug reaction [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks
    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 Statistical analysis provided for Frequency of Subjects with Adverse event Drug Reaction
    End point values
    		 ACTIVE TREATMENT
    Number of subjects analysed
    52
    Units: Frequency
    number (confidence interval 95%)
        Mild
    76.9 (63.2 to 87.5)
        Moderate
    11.5 (4.4 to 23.4)
        Severe
    1.9 (0 to 10.3)
    No statistical analyses for this end point

    Secondary: Frequency of subjects with systemic reaction

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    End point title
    		 Frequency of subjects with systemic reaction
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 ACTIVE TREATMENT
    Number of subjects analysed
    52
    Units: Frequency
        arithmetic mean (confidence interval 95%)
    9.6 (3.2 to 21)
    No statistical analyses for this end point

    Secondary: Change in IgG4 for Cupressus arizonica

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    End point title
    		 Change in IgG4 for Cupressus arizonica
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 VISIT 1 Visit 6
    Number of subjects analysed
    50
    50
    Units: mA/L
        median (standard deviation)
    0.03 ( 0.08 )
    0.19 ( 0.83 )
    Statistical analysis title
    		 Change in IgG4 Cupressus arizonica
    Statistical analysis description
    Increase in IgG4 Cupressus arizonica
    Comparison groups
    Visit 6 v VISIT 1
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.56
    Variability estimate
    Standard deviation

    Secondary: Change in IgE for Cupressus arizonica

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    End point title
    		 Change in IgE for Cupressus arizonica
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 VISIT 1 Visit 6
    Number of subjects analysed
    50
    50
    Units: ku/L
        median (standard deviation)
    8.13 ( 17.85 )
    25.16 ( 30.98 )
    Statistical analysis title
    		 Increase in IgE Cupressus arizonica
    Comparison groups
    VISIT 1 v Visit 6
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    19.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.24
         upper limit
    		 25.18
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 weeks
    Adverse event reporting additional description
    From the first trial related activity after the subject signed the informed consent until the follow up telephone contact
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 52 (76.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    15
    General disorders and administration site conditions
    Injection site pruritus
         subjects affected / exposed
    14 / 52 (26.92%)
         occurrences all number
    25
    Injection site reaction
         subjects affected / exposed
    31 / 52 (59.62%)
         occurrences all number
    62
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Pruritus generalised
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3

    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
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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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