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    Clinical Trial Results:
    Protection from food induced anaphylaxis by reducing serum level of specific IgE

    Summary
    EudraCT number
    		 2017-003627-30
    Trial protocol
    		 DK  
    Global end of trial date
    21 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2022
    First version publication date
    16 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20170367744
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03964051
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    Kløvervænget 15, Odense, Denmark, 5000
    Public contact
    Carsten Bindslev-Jensen, Odense Research Center of Anaphylaxis (ORCA), 0045 65413624, carsten.bindslev-jensen@rsyd.dk
    Scientific contact
    Carsten Bindslev-Jensen, Odense Research Center of Anaphylaxis (ORCA), 0045 65413624, carsten.bindslev-jensen@rsyd.dk
    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
    19 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim was to investigate if the combination of initial IgE-specific immunoadsorption and subsequent therapy with Omalizumab would increase the clinical threshold to the culprit food and thus prevent medical emergencies in patients with food anaphylaxis.
    Protection of trial subjects
    All procedures performed in the study were standard procedures. No specific measures were needed to protect trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Trial subjects were recruited from patients followed in The Allergy Centre, Odense University Hospital, Odense, Denmark. Recruitment period: 01-JUN-2018 - 22-FEB-2020.

    Pre-assignment
    Screening details
    		 Inclusion criteria were: 1) Age 18-70 years, 2) Verified food allergy with a specific IgE to the major allergen component of the culprit food of at least 10 kIU/l. All patients screened (n=10) were eligible and participated in the study.

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

    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 description
    		 Since the study was neither randomised nor controlled, there was just one study arm: All participants were planned to undergo the protocolled combined treatment of selective IgE apheresis followed by subsequent treatment with Omalizumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OMALIZUMAB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants received a dosage of 300 mg Omalizumab a total of 7 times with 2 weeks interval between injections

    Number of subjects in period 1
    		Treatment
    Started
    10
    Food challenge Tr0
    10
    Food challenge TrP
    8
    Food challenge TrX
    8
    Food challenge TrW
    7
    Completed
    7
    Not completed
    3
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    1

    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
    		 10 10
    Age categorical
    Age 18-64
    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)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 24 (20 to 42) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Since the study was neither randomised nor controlled, there was just one study arm: All participants were planned to undergo the protocolled combined treatment of selective IgE apheresis followed by subsequent treatment with Omalizumab.

    Primary: Fractional change in threshold (food challenge) between Tr0 and TrX (TrX/Tr0)

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    End point title
    		 Fractional change in threshold (food challenge) between Tr0 and TrX (TrX/Tr0) [1]
    End point description
    End point type
    Primary
    End point timeframe
    The threshold at food challenges (in milligrams) before any treatment (Tr0) was compared with threshold after the combined treatment with IgE apheresis and Omalizumab treatment (TrX). Change in threshold was expressed as a fraction/delta (TrX/Tr0)
    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: This study was designed with no planned statistical analyses to be performed for any endpoints due to the simple design and small number of participants
    End point values
    		 Treatment
    Number of subjects analysed
    8
    Units: Fractions
        median (inter-quartile range (Q1-Q3))
    7.8 (3.2 to 22.2)
    No statistical analyses for this end point

    Primary: Fractional change in level of total IgE between Tr0 and TrX (TrX/Tr0)

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    End point title
    		 Fractional change in level of total IgE between Tr0 and TrX (TrX/Tr0) [2]
    End point description
    End point type
    Primary
    End point timeframe
    The level of total IgE before any treatment (Tr0) was compared with the level of total IgE after the combined treatment with IgE apheresis and Omalizumab treatment (TrX). Change in level of total IgE was expressed as a fraction/delta (TrX/Tr0)
    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: This study was designed with no planned statistical analyses to be performed for any endpoints due to the simple design and small number of participants
    End point values
    		 Treatment
    Number of subjects analysed
    8
    Units: Fractions
        median (inter-quartile range (Q1-Q3))
    2.5 (1.2 to 2.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to 28 days after last dose of study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    Immune system disorders
    Rhinitis allergic
    Additional description: Symptoms of well-known allergic rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Food allergy
    Additional description: Allergic reaction due to accidental intake of a known food culprit (known food allergy)
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Asthma
    Additional description: Mild exacerbation in prior diagnosed/well-known asthma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Eczema
    Additional description: Flair in prior diagnosed/well-known atopic dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Infections and infestations
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vaginitis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Cystitis bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    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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