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    Clinical Trial Results:
    Biological Standardization of Ambrosia elatior (ragweed) Allergen Extract. Determination of the Biological Activity in HEP units. An Open Monocenter Study.

    Summary
    EudraCT number
    		 2011-002096-42
    Trial protocol
    		 DE  
    Global end of trial date
    10 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2018
    First version publication date
    10 May 2018
    Other versions
    Summary report(s)
    		 Standardization Ambrosia elat. (2) Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    6057-PR-PRI-188
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LETI Pharma GmbH
    Sponsor organisation address
    Stockumer Str. 28, Witten, Germany, 58453
    Public contact
    Medical Department, LETI Pharma GmbH, 0049 02302202860,
    Scientific contact
    Medical Department, LETI Pharma GmbH, 0049 02302202860,
    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
    08 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify the concentration of a native Ambrosia elatior extract inducing the same wheal size as provoked by 10mg/ml Histamine hydrochloride
    Protection of trial subjects
    Each potential subject was adequately informed of the aims, method, anticipated benefits and potential hazards of the study and the discomfort that it might entail. All of them were informed that they were free to participate in the study and stop their participation at any time. Participants had the opportunity to make all kind of questions about the study, and every subject confirmed his or her participation by filling in and signing the informed consent form. Written informed consent was obtained from each subject prior to the performance of any study-specific procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2012
    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
    Germany: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 30 patients enrolled, 30 patients were eligible and received study medication (ITT).

    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
    		 Only one arm, all patients received Ambrosia elatior skin prick test.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prick Test Ambrosia elatior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Prick Test Ambrosia elatior LETI at 15, 10, 1.0, 0.1 and 0.01 mg/mL, positive control (histamine dihydrochloride(10mg/mL)), negative control (glycerinated phenol saline solution).

    Number of subjects in period 1
    		treatment arm
    Started
    30
    Completed
    30

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    treatment arm
    Reporting group description
    		 Only one arm, all patients received Ambrosia elatior skin prick test.

    Subject analysis set title
    treatment arm (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A total of 30 patients were enrolled in 1 study site in Germany. A total number of 30 patients received the study medication (ITT population/Safety population). Nine of them were excluded after receiving the study medication from the PP population (n = 21) since they did not meet Nordic Guideline criteria.

    Primary: wheal size area

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    End point title
    		 wheal size area [1]
    End point description
    End point type
    Primary
    End point timeframe
    2 hours
    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 endpoint was the wheal size area (mm2) provoked on skin, by all tested allergen concentrations and histamine, at the site of puncture during the immediate phase in the patient analysed population. This endpoint was used to estimate the concentration of Ambrosia elatior allergen extract that elicits a wheal of the same size as the positive control. Analysis has been performed using a protected spreadsheet (Excel) designed specifically to analyse Standardization clinical trials.
    End point values
    		 treatment arm treatment arm (PP)
    Number of subjects analysed
    21
    21
    Units: mm
        geometric mean (standard deviation)
    16958.51 ( 75012.57 )
    16958.51 ( 75012.57 )
    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 48 hours after test.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    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: No adverse events were reported in the clinical 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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