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    Clinical Trial Results:
    Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract. Determination of the allergenic potency in vivo histamine equivalent units (HEP)

    Summary
    EudraCT number
    		 2013-005394-45
    Trial protocol
    		 ES  
    Global end of trial date
    07 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2021
    First version publication date
    02 Oct 2021
    Other versions
    Summary report(s)
    		 Resumen Informe Final

    Trial information

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    Trial identification
    Sponsor protocol code
    MM09-STD-011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    INMUNOTEK S.L
    Sponsor organisation address
    Punto Mobi, 5, Alcalá de Henares, Spain,
    Public contact
    Miguel Casanovas; Medical Director, Inmunotek, S.L., 34 912908942110, mcasanovas@inmunotek.com
    Scientific contact
    Miguel Casanovas; Medical Director, Inmunotek, S.L., 34 912908942110, mcasanovas@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
    28 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate the concentration of an allergenic mixture of mites extract of Dermatophagoides pteronyssinus and Dermatophagoides farinae necessary to produce a papule size equivalent to the one produced by a 10 mg/mL solution of histamine dihydrochloride.
    Protection of trial subjects
    All adverse events, whether observed by the researcher or reported by the subject, must be recorded in the corresponding section of the data collection notebook and evaluated by the researcher. The minimum information that must be specified will be the description, severity, duration, temporal sequence, treatment administered, and method of detection of the adverse event.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Positive clinical record of inhaled allergy (rhinitis / rhinoconjunctivitis / asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae. A positive prick-test (average of the papule ≥ 3 mm diameter) with an extract of the same allergen and / or the presence of specific IgE against the allergen.

    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
    		 PRICK TEST
    Arm description
    		 All study products were prepared in aqueous solution diluent. The composition of this diluent was 0.9% (w/v) Sodium Chloride, 0.4% (w/v) phenol plus 50% (v/v) glycerol. An allergen extract of Dermatophagoides farinae with a concentration of 400 µg/mL. Three dilutions of 40, 4 and 0,4 µg/mL were prepared from the allergen extract. An allergen extract of Dermatophagoides pteronyssinus with a concentration of 300 µg/mL. Three dilutions of 30, 3 and 0,3 µg/mL were prepared from the allergen extract. Histamine dihydrochloride concentrated at 10mg/mL and prepared in a glycerinated phenol saline solution. A glycerinated phenol saline solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dermatophagoides farinae Concentration No. 1 = 400 µg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop in duplicate on the forearm

    Investigational medicinal product name
    Dermatophagoides farinae Concentration No. 2 = 40 µg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop in duplicate on the forearm

    Investigational medicinal product name
    Dermatophagoides farinae Concentration No. 3 = 4 µg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop in duplicate on the forearm

    Investigational medicinal product name
    Dermatophagoides pteronyssinus concentration No. 1 =300 µg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop in duplicate on the forearm

    Investigational medicinal product name
    Dermatophagoides pteronyssinus concentration No. 2 =30 µg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop in duplicate on the forearm

    Investigational medicinal product name
    Dermatophagoides pteronyssinus concentration No. 3 =3 µg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop in duplicate on the forearm

    Investigational medicinal product name
    Histamine dichloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop on the forearm

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 drop on the forearm

    Number of subjects in period 1
    		PRICK TEST
    Started
    23
    Completed
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 23 23
    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)
    		 23 23
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 30 ± 6.4 -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    PRICK TEST
    Reporting group description
    		 All study products were prepared in aqueous solution diluent. The composition of this diluent was 0.9% (w/v) Sodium Chloride, 0.4% (w/v) phenol plus 50% (v/v) glycerol. An allergen extract of Dermatophagoides farinae with a concentration of 400 µg/mL. Three dilutions of 40, 4 and 0,4 µg/mL were prepared from the allergen extract. An allergen extract of Dermatophagoides pteronyssinus with a concentration of 300 µg/mL. Three dilutions of 30, 3 and 0,3 µg/mL were prepared from the allergen extract. Histamine dihydrochloride concentrated at 10mg/mL and prepared in a glycerinated phenol saline solution. A glycerinated phenol saline solution.

    Primary: Size of the wheal induced by each concentration

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    End point title
    		 Size of the wheal induced by each concentration [1]
    End point description
    The size of the wheal produced by each different concentration of the allergen extract and the controls through the prick test, to determine biological potency. 15 minutes after the application of each solution onto the skin, the contour of every wheal was encircled using the Prick-Film® System.
    End point type
    Primary
    End point timeframe
    Visit 1
    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: The calcule of the geometric mean of the two wheals produced by each allergen concentration (mm2) in relation with the positive (Histamine 10 mg/mL) and negative control (diluent’s solution). A linear regression analysis using the method of least squares was performed computing the constant a and b for each patient. The calcule of the individual bioequivalent dose of each allergenic extract to achieve a wheal the same size as the positive control (individual 10 HEP) was performed.
    End point values
    		 PRICK TEST
    Number of subjects analysed
    23
    Units: mm2
        number (not applicable)
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No adverse events during the reporting period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No adverse events occurred during the trial.

    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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