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    Clinical Trial Results:
    Extract allergen from Betula verrucosa. Test sensitivity and specificity of diagnostic in prick test preparation.

    Summary
    EudraCT number
    		 2013-005368-24
    Trial protocol
    		 ES  
    Global end of trial date
    30 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2021
    First version publication date
    12 Aug 2021
    Other versions
    Summary report(s)
    		 Summary results

    Trial information

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    Trial identification
    Sponsor protocol code
    T502-SSP-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02527187
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Inmunotek
    Sponsor organisation address
    Punto Mobi, 5, Alcalá de Henares, Spain, 28805
    Public contact
    Miguel Casanovas, Inmunotek, S.L., 34 91290 89 42153, sdelpozo@inmunotek.com
    Scientific contact
    Miguel Casanovas, Inmunotek, S.L., 34 91290 89 42153, sdelpozo@inmunotek.com
    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
    01 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To obtain the optimal birch allergen concentration for in vivo (skin prick test) diagnosis by assessing the Sensitivity and Specificity of 4 different concentrations of the skin prick test preparation of Betula verrucosa.
    Protection of trial subjects
    Although skin prick test is a safe and patients were already tested previously in the hospital, more attention was paid to the protecion of trial subjects. The investigator took special care in order to check for the presence of any unwanted reaction. Patients remained in the hospital facilities (at least 30 min after test) and were instructed to report, to the investigator, any adverse event occurring after leaving the hospital.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2015
    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: 201
    Worldwide total number of subjects
    201
    EEA total number of subjects
    201
    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)
    4
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    179
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was performed in the north of Spain, where birch pollen is relevant. All patients were skin prick tested by the same qualified and experienced nurse, between 9AM and 11AM, before birch pollen season to avoid the allergenic stimuli, circadian variations and differences due to the site of performing the test.

    Pre-assignment
    Screening details
    		 201 patients enrolled and were eligible and received the IMP

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

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 All patients included will receive the IMP, some were already diagnosed as "true allergic" to birh pollen (assigned as CH+) and others were already diagnosed to be “true non-allergic” to birch pollen (assigned as CH-) CH+ met the following criteria: o Clinical history of symptomatology related to the exposure to birch pollen. o Previous SPT positive reaction with the extract of Betula verrucosa in normal clinical conditions in the hospital. o Presence of serum specific IgE (CAP System) to the pollen of Betula verrucosa. o No immunotherapy treatment with an allergen extract of birch pollen. CH-met the following criteria: o o Previous skin prick test negative reaction with the extract of Betula verrucosa used in as diagnosis in normal clinical conditions in the hospital. o Absence or undetectable serum specific IgE (CAP System) to the pollen extract of Betula verrucosa. Test validation: A skin prick test reaction is positive when the mean wheal diameter is > 3 mm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Betula verrucosa 100 HEP/ml allergen extract
    Investigational medicinal product code
    SUB55247
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Prick test -Betula verruoca at 10,25, 50 and 100 HEP/mL, positive control (histamine dihydrochloride 10mg/mL), negative control (glycerinated phenol saline solution).

    Investigational medicinal product name
    Betula verrucosa 50 HEP/ml allergen extract/T502/Cutaneous solution
    Investigational medicinal product code
    SUB55247
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Solution for skin-prick test;drops

    Investigational medicinal product name
    Betula verrucosa 25 HEP/ml allergen extract/T502/Cutaneous solution
    Investigational medicinal product code
    SUB55247
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Solution for skin-prick test; drops

    Investigational medicinal product name
    Betula verrucosa 10 HEP/ml allergen extract/T502/Cutaneous solution
    Investigational medicinal product code
    SUB55247
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Solution for skin-prick test; drops

    Investigational medicinal product name
    Histamine dihydrochloride/Cutaneous solution
    Investigational medicinal product code
    SUB12022MIG
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Solution for skin-prick test; drops

    Investigational medicinal product name
    Glycerinated phenol saline solution/Negative control/Cutaneous solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Solution for skin-prick test; drops

    Number of subjects in period 1
    		Treatment arm
    Started
    201
    Completed
    201

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 All patients included will receive the IMP, some were already diagnosed as "true allergic" to birh pollen (assigned as CH+) and others were already diagnosed to be “true non-allergic” to birch pollen (assigned as CH-) CH+ met the following criteria: o Clinical history of symptomatology related to the exposure to birch pollen. o Previous SPT positive reaction with the extract of Betula verrucosa in normal clinical conditions in the hospital. o Presence of serum specific IgE (CAP System) to the pollen of Betula verrucosa. o No immunotherapy treatment with an allergen extract of birch pollen. CH-met the following criteria: o o Previous skin prick test negative reaction with the extract of Betula verrucosa used in as diagnosis in normal clinical conditions in the hospital. o Absence or undetectable serum specific IgE (CAP System) to the pollen extract of Betula verrucosa. Test validation: A skin prick test reaction is positive when the mean wheal diameter is > 3 mm.

    Reporting group values
    		 Treatment arm Total
    Number of subjects
    		 201 201
    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)
    		 4 4
        Adolescents (12-17 years)
    		 13 13
        Adults (18-64 years)
    		 179 179
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 122 122
        Male
    		 79 79
    Subject analysis sets

    Subject analysis set title
    Treatment arm
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A total of 201 subjects were all treated. There were no dropouts

    Subject analysis sets values
    		 Treatment arm
    Number of subjects
    201
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    4
        Adolescents (12-17 years)
    13
        Adults (18-64 years)
    179
        From 65-84 years
    5
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 All patients included will receive the IMP, some were already diagnosed as "true allergic" to birh pollen (assigned as CH+) and others were already diagnosed to be “true non-allergic” to birch pollen (assigned as CH-) CH+ met the following criteria: o Clinical history of symptomatology related to the exposure to birch pollen. o Previous SPT positive reaction with the extract of Betula verrucosa in normal clinical conditions in the hospital. o Presence of serum specific IgE (CAP System) to the pollen of Betula verrucosa. o No immunotherapy treatment with an allergen extract of birch pollen. CH-met the following criteria: o o Previous skin prick test negative reaction with the extract of Betula verrucosa used in as diagnosis in normal clinical conditions in the hospital. o Absence or undetectable serum specific IgE (CAP System) to the pollen extract of Betula verrucosa. Test validation: A skin prick test reaction is positive when the mean wheal diameter is > 3 mm.

    Subject analysis set title
    Treatment arm
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A total of 201 subjects were all treated. There were no dropouts

    Primary: Sensitivity

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    End point title
    		 Sensitivity [1]
    End point description
    It is the proportion of positives that are correctly identified by the test. The number of patients with a positive skin prick test (X) out of all true positives (CH +; patients with the clinical diagnosis of allergy to the pollen of Betula verrucosa n=75) 2 discrete categories: - The number of patients with a positive skin prick test (X) with the corresponding concentration (100 HEP) - All true positives (CH +; patients with the clinical diagnosis of allergy to the pollen of Betula verrucosa n=75) X/75
    End point type
    Primary
    End point timeframe
    15 minutes
    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: Primary efficacy endpoints were sensitivity and sensibility, score with absolute values are available on the charts attached in this report. No comparative statistics was performed.
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    201
    201
    Units: Rate
        number (not applicable)
    201
    201
    Attachments
    		 Sensitivity 100 HEP
    No statistical analyses for this end point

    Primary: Specificity

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    End point title
    		 Specificity [2]
    End point description
    It is the proportion of negatives that are correctly identified by the test. The number of patients with a negative skin prick test (X) out of all true negatives (CH - ; patients with the clinical diagnosis of non-allergic to the pollen of Betula verrucosa n=126) 2 discrete categories: - The number of patients with a negative skin prick test (X) with the corresponding concentration (100 HEP) - All true negatives(CH -; patients with the clinical diagnosis of non-allergic to the pollen of Betula verrucosa n=126) X/126
    End point type
    Primary
    End point timeframe
    15 minutes
    Notes
    [2] - 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: Primary efficacy endpoints were sensitivity and sensibility, score with absolute values are available on the charts attached in this report. No comparative statistics was performed.
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    201
    201
    Units: Score
        number (not applicable)
    201
    201
    Attachments
    		 Specificity charts
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From screening until 24 hours after
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Not applicable because there were no adverse events.

    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.
    No limitations or caveats were identified in the trial
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    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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