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    Clinical Trial Results:
    Food Allergy Surpression Therapy during protection with Xolair

    Summary
    EudraCT number
    		 2012-005625-78
    Trial protocol
    		 SE  
    Global end of trial date
    31 Oct 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    FASTXP2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02402231
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    Nobels väg 6, Stockholm, Sweden, 17177
    Public contact
    Caroline Nilsson, Karolinska Institutet, caroline.a.nilsson@regionstockholm.se
    Scientific contact
    Caroline Nilsson, Karolinska Institutet, caroline.a.nilsson@regionstockholm.se
    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
    31 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate whether individualized omalizumab treatment in combination with oral immunotherapy monitored by CDsens could be an effective intervention for suppression of allergic reactions to peanut.
    Protection of trial subjects
    The study was approved by the ethics committee in Stockholm; 2013/827-31/3, Swedish Drug Agency; 5.1-2013-46183. Patients and caregivers gave their written informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2013
    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
    Sweden: 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)
    17
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Severely peanut allergic adolescents, aged 12–19, were recruited in the Stockholm area, between Oct 2013 and October 2020.

    Pre-assignment
    Screening details
    		 Inclusion criteria were evident history of peanut-induced anaphylaxis within the last 5 years, anaphylaxis or symptoms of an impending anaphylaxis as defined by WAO at the open peanut challenge prior to inclusion. Exclusion criteria were severe non-atopic chronic disease, pregnancy or allergy/hypersensitivity to omalizumab.

    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 group (one-armed study)
    Arm description
    		 To evaluate whether individualized omalizumab treatment in combination with oral immunotherapy monitored by CDsens could be an effective intervention for suppression of allergic reactions to peanut.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xolair (omalizumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Phase 1: Severely peanut allergic adolescents (n = 23) were treated with omalizumab for 8 weeks, and CD-sens was analysed before and after. Based on whether CD-sens was suppressed after 8 weeks, the patients either were subject to a peanut challenge or received eight more weeks with increased dose of omalizumab, followed by peanut challenge or another 8-week cycle of omalizumab. Phase 2: Started peanut oral immunotherapy (pOIT) after an individualized omalizumab treatment. The pOIT dose was increased from 280 to 2800 mg peanut protein in 8 weeks followed by an individualized step‐wise withdrawal of omalizumab, based on clinical symptoms and CD‐sens levels. pOIT continued for 12 weeks followed by an open peanut challenge.7

    Number of subjects in period 1
    		Treatment group (one-armed study)
    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)
    		 17 17
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 17 (12 to 19) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 7 7
    IgE-ab Ara h 2
    Units: kUA/L
        median (full range (min-max))
    		 58 (16 to 220) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment group (one-armed study)
    Reporting group description
    		 To evaluate whether individualized omalizumab treatment in combination with oral immunotherapy monitored by CDsens could be an effective intervention for suppression of allergic reactions to peanut.

    Primary: Tolerating peanuts 12 weeks after stopping omalizumab

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    End point title
    		 Tolerating peanuts 12 weeks after stopping omalizumab [1]
    End point description
    Primary endpoint: Number of patients who succeeded to eat 10 grams of peanuts 12 weeks after discontinuing pOIT (peanut oral immunotherapy) and omalizumab. Treatment success: Patient succeeded to eat 10 grams of peanuts without an allercig reaction. Treatment Failure: Patient did not suceed to eat 10 grams of peanuts without an allergic reaction.
    End point type
    Primary
    End point timeframe
    12 weeks after discontinuing pOIT and omalizumab.
    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 end point is reported in numbers (number of patients who succeded or failed the peanut challenge). Therefore, a statistical analysis cannot be performed.
    End point values
    		 Treatment group (one-armed study)
    Number of subjects analysed
    17
    Units: Number
        Treatment Success
    11
        Treatment Failure
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole study period.
    Adverse event reporting additional description
    Patients reported adverse events (AE) by phone and/or at visits. Frequencies of specific symptoms apart from mild self‐resolving abdominal pain, mild emesis and oral pruritus were recorded. In case of emergency visits, medical records were independently reviewed by two physicians.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Did not use any
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Treatment group (one-armed study)
    Reporting group description
    		 To evaluate whether individualized omalizumab treatment in combination with oral immunotherapy monitored by CDsens could be an effective intervention for suppression of allergic reactions to peanut.

    Serious adverse events
    		 Treatment group (one-armed study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic reactions
    Additional description: Systemic allergic reactions Mild: ≥2 organ systems Moderate: ≥2 organ systems fulfilling the WAOcriteria for anaphylaxis and criteria for grade 1‐2 anaphylaxis Severe: ≥2 organ systems fulfilling WAOcriteria for anaphylaxis and grade 3 anaphylaxis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment group (one-armed study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 17 (88.24%)
    Respiratory, thoracic and mediastinal disorders
    Allercig reactions
    Additional description: Systemic allergic reactions Mild: ≥2 organ systems Moderate: ≥2 organ systems fulfilling the WAOcriteria for anaphylaxis and criteria for grade 1‐2 anaphylaxis Severe: ≥2 organ systems fulfilling WAOcriteria for anaphylaxis and grade 3 anaphylaxis
         subjects affected / exposed
    15 / 17 (88.24%)
         occurrences all number
    15

    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.
    Weaknesses include the small study population and lack of placebo arm; all results should be considered as exploratory and need to be further studied. The main rationale for not having a placebo arm was patient safety.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27883239
    http://www.ncbi.nlm.nih.gov/pubmed/31329313
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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
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