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

    Summary
    EudraCT number
    		 2013-001728-20
    Trial protocol
    		 ES  
    Global end of trial date
    31 Oct 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    AV-X-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02065856
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló S.A.
    Sponsor organisation address
    Miguel Fleta, 19, Madrid, Spain, 28037
    Public contact
    Departamento Médico, ALK-Abelló S. A., +34 913276127NA, clinicaltrials@alk.net
    Scientific contact
    Departamento Médico, ALK-Abelló S. A., +34 913276127NA, 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
    05 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2014
    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® Salsola kali. The frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.
    Protection of trial subjects
    Safety surveillance, use of symptomatic medications allowed. Telephone contact within 48h after IMP administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 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: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    51
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in Spain

    Pre-assignment
    Screening details
    		 The subjects eligible for the trial were adults with a clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry, a positive skin prick test (SPT) to Salsola kali pollen, and a positive specific IgE against Salsola kali pollen (≥ IgE class 2; ≥0.70 KU/L).

    Period 1
    Period 1 title
    Visit 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Trial is one arm only

    Arms
    Arm title
    		 ACTIVE TREATMENT
    Arm description
    		 AVANZ Salsola kali, updosing treament (5 step) and 1 maintenance dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AVANZ Salsola kali
    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 15000 SQ+.

    Number of subjects in period 1
    		ACTIVE TREATMENT
    Started
    51
    Completed
    51

    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
    		 51 51
    Age categorical
    The trial population included had a mean age of 36 years.
    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)
    		 51 51
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36 ( 10.7 ) -
    Gender categorical
    Overall the trial population included 27 (52.9%) women and 24 (47.1%) men
    Units: Subjects
        Female
    		 27 27
        Male
    		 24 24
    Subject analysis sets

    Subject analysis set title
    AVANZ Salsola
    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 performed visit 6

    Subject analysis sets values
    		 AVANZ Salsola Visit 6
    Number of subjects
    51
    50
    Age categorical
    The trial population included had a mean age of 36 years.
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    51
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Overall the trial population included 27 (52.9%) women and 24 (47.1%) men
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    ACTIVE TREATMENT
    Reporting group description
    		 AVANZ Salsola kali, updosing treament (5 step) and 1 maintenance dose.

    Subject analysis set title
    AVANZ Salsola
    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 performed visit 6

    Primary: Frequency of Subject with adverse drug reaction

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    End point title
    		 Frequency of Subject with adverse drug reaction [1]
    End point description
    Frequency of patients with adverse drug reactions, local or systemic
    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 provide fro Frequency of Subjects with Adverse Drug Reactions
    End point values
    		 AVANZ Salsola
    Number of subjects analysed
    51
    Units: Frequency
    number (confidence interval 95%)
        Mild
    68.6 (54.1 to 80.9)
        Moderate
    7.8 (2.2 to 18.9)
        Severe
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Frequency of subjects with systemic reactions

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    End point title
    		 Frequency of subjects with systemic reactions
    End point description
    Frequency of patients with systemic reactions, based on EAACI classification: Grade I(mild systemic reaction) to IV(anaphylactic shoc)
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 AVANZ Salsola
    Number of subjects analysed
    51
    Units: Frequency
        number (confidence interval 95%)
    13.7 (5.7 to 26.3)
    No statistical analyses for this end point

    Secondary: Change in IgG4 for Salsola kali

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    End point title
    		 Change in IgG4 for Salsola kali
    End point description
    Increase in IgG4 for Salsola kali from baseline to final
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 AVANZ Salsola Visit 6
    Number of subjects analysed
    50
    50
    Units: mga/L
        median (standard deviation)
    0.02 ( 0.18 )
    0.19 ( 0.62 )
    Statistical analysis title
    		 Student-t Test
    Statistical analysis description
    Increase in IgG4 Salsola kali
    Comparison groups
    AVANZ Salsola v Visit 6
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.005
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.4
    Variability estimate
    Standard deviation

    Secondary: Change in IgE for Salsola kali

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    End point title
    		 Change in IgE for Salsola kali
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to visit 6
    End point values
    		 AVANZ Salsola Visit 6
    Number of subjects analysed
    50
    50
    Units: ku/L
        median (standard deviation)
    5.32 ( 10.92 )
    11.49 ( 18.03 )
    Statistical analysis title
    		 Increase in IgE Salsola kali
    Comparison groups
    AVANZ Salsola 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
    8.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.49
         upper limit
    		 12.4
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 6 weeks
    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
    16.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 51 (1.96%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Colitis ulcerative
    Additional description: Ulcerative colitis moderate outbreak
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 51 (90.20%)
    Nervous system disorders
    Headache
    Additional description: Headache and Dizziness
         subjects affected / exposed
    18 / 51 (35.29%)
         occurrences all number
    33
    General disorders and administration site conditions
    Injection site reaction
    Additional description: Injection Site pruritus and Injection site swelling
         subjects affected / exposed
    41 / 51 (80.39%)
         occurrences all number
    84
    Eye disorders
    eye pruritus
         subjects affected / exposed
    10 / 51 (19.61%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
    Additional description: Cough and Sneezing
         subjects affected / exposed
    20 / 51 (39.22%)
         occurrences all number
    28

    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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