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    Clinical Trial Results:
    OPEN CLINICAL TRIAL, MULTICENTER, WITH SUBCUTANEOUS IMMUNOTHERAPY IN DEPOT PRESENTATION, IN PATIENTS WITH ALLERGY RHINOCONJUNCTIVITIS SENSITIZED TO PARIETARIA JUDAICA

    Summary
    EudraCT number
    		 2014-001459-22
    Trial protocol
    		 ES  
    Global end of trial date
    11 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2021
    First version publication date
    02 Jul 2021
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    BIA-PAR-DEPOT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Roxall Medicina España S.A.
    Sponsor organisation address
    Parque Científico y Tecnológico de Bizkaia Edificio 401, Zamudio, Spain, 48170
    Public contact
    Clinical Project Manager, Roxall Medicina España S.A., +34 94443 80 00, Maricruz.gomez@roxall.es
    Scientific contact
    Clinical Project Manager, Roxall Medicina España S.A., +34 94443 80 00, Maricruz.gomez@roxall.es
    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 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of subcutaneous immunotherapy in depot presentation and guideline fast in patients with rhinoconjunctivitis with or without asthma sensitized to Parietaria judaica, aged between 18 and 60 through the identification and classification of adverse reactions throughout the duration of the clinical trial
    Protection of trial subjects
    All patients were provided written informed consent prior to their participation after having received information related with the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    		 -

    Pre-assignment
    Screening details
    		 2 months of prerecruitment

    Pre-assignment period milestones
    Number of subjects started
    		 51
    Number of subjects completed
    		 51

    Period 1
    Period 1 title
    Global clinical trial period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allrgovac Parietaria Depot
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1000 treatment units/ml

    Number of subjects in period 1
    		Treatment arm
    Started
    51
    Completed
    51
    Period 2
    Period 2 title
    Global clinical trial period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 Treatment with Parietaria Judaica.
    Arm type
    		 active

    Investigational medicinal product name
    Allrgovac Parietaria Depot
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1000 treatment units/ml

    Number of subjects in period 2
    		Treatment arm
    Started
    51
    Completed
    51

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 -
    Reporting group title
    Treatment arm
    Reporting group description
    		 Treatment with Parietaria Judaica.

    Primary: Number and percentage of adverse reactions

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    End point title
    		 Number and percentage of adverse reactions
    End point description
    End point type
    Primary
    End point timeframe
    During 4 and a half months.
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    51
    51
    Units: Percentage
    51
    51
    Statistical analysis title
    		 Tolerability and safety statistical analysis
    Statistical analysis description
    Descriptive and efficacy statistical analyses were performed using the intention-to-treat (ITT) population (patients who met all inclusion/exclusion criteria, received at least one dose of treatment and had available data on efficacy variables) and the per-protocol population (patients who met previous criteria and moreover achieved their target maintenance dose and completed the study without any major protocol deviations). The differences between gender groups for demographic parameters in
    Comparison groups
    Treatment arm v Treatment arm
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3886
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 100
         upper limit
    		 6000
    Variability estimate
    Standard deviation
    Notes
    [1] - Descriptive analysis

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During 4 and a half months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2014
    Reporting groups
    Reporting group title
    Non serious adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Non serious adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 3.8%
    Non-serious adverse events
    		 Non serious adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 51 (9.80%)
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    5 / 51 (9.80%)
         occurrences all number
    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.
    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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