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    Clinical Trial Results:
    A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy

    Summary
    EudraCT number
    2020-005339-56
    Trial protocol
    FR   ES   DE   IT   DK   NL  
    Global end of trial date
    27 Nov 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Jun 2024
    First version publication date
    07 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQGE031G12301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001811-PIP03-20
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of ligelizumab 240 mg and 120 mg (subcutaneous injection once every 4 weeks (SC q4w)) compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC) at Week 12
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Dec 2021
    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
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Japan: 7
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United States: 109
    Worldwide total number of subjects
    211
    EEA total number of subjects
    51
    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)
    119
    Adults (18-64 years)
    92
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study was conducted in 56 centers in 10 countries worldwide

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ligelizumab 240 mg
    Arm description
    ligelizumab 240 mg subcutaneous injection for 52 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    ligelizumab
    Investigational medicinal product code
    Other name
    QGE031
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL ligelizumab from Day 1 through Week 52

    Arm title
    ligelizumab 120 mg
    Arm description
    ligelizumab 120 mg subcutaneous injection for 52 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 injection of 1.0 mL placebo from Day 1 through Week 52

    Investigational medicinal product name
    ligelizumab
    Investigational medicinal product code
    Other name
    QGE031
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 injection of 1.0 mL ligelizumab from Day 1 through Week 52

    Arm title
    Placebo 8 weeks and ligelizumab 240 mg
    Arm description
    Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL placebo at Day 1 and Week 4

    Investigational medicinal product name
    ligelizumab
    Investigational medicinal product code
    Other name
    QGE031
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL ligelizumab from Week 8 through Week 52

    Arm title
    Placebo 8 weeks and ligelizumab 120 mg
    Arm description
    Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    ligelizumab
    Investigational medicinal product code
    Other name
    QGE031
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 injection of 1.0 mL ligelizumab from Week 8 through Week 52

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 injection of 1.0 mL placebo from Week 8 through Week 52

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL placebo at Day 1 and Week 4

    Arm title
    Placebo 16 weeks and ligelizumab 240 mg
    Arm description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL placebo at Day 1 and Week 12

    Investigational medicinal product name
    ligelizumab
    Investigational medicinal product code
    Other name
    QGE031
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL ligelizumab from Week 16 through Week 52

    Arm title
    Placebo 16 weeks and ligelizumab 120 mg
    Arm description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    ligelizumab
    Investigational medicinal product code
    Other name
    QGE031
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 injection of 1.0 mL ligelizumab from Week 16 through Week 52

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 injection of 1.0 mL placebo from Week 16 through Week 52

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 injections of 1.0 mL placebo at Day 1 and Week 12

    Number of subjects in period 1
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo 16 weeks and ligelizumab 240 mg Placebo 16 weeks and ligelizumab 120 mg
    Started
    47
    51
    46
    44
    11
    12
    Randomized Analysis Set (RAS)
    47
    51
    46
    44
    11
    12
    Full Analysis Set (FAS)
    47
    51
    46
    44
    11
    12
    Safety Set (SAF)
    47
    51
    46
    44
    11
    12
    Completed
    44
    40
    41
    37
    8
    11
    Not completed
    3
    11
    5
    7
    3
    1
         Physician decision
    1
    -
    -
    1
    -
    -
         Subject decision
    2
    10
    3
    3
    3
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    1
    -
    -
         Guardian decision
    -
    1
    -
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ligelizumab 240 mg
    Reporting group description
    ligelizumab 240 mg subcutaneous injection for 52 weeks

    Reporting group title
    ligelizumab 120 mg
    Reporting group description
    ligelizumab 120 mg subcutaneous injection for 52 weeks

    Reporting group title
    Placebo 8 weeks and ligelizumab 240 mg
    Reporting group description
    Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks

    Reporting group title
    Placebo 8 weeks and ligelizumab 120 mg
    Reporting group description
    Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks

    Reporting group title
    Placebo 16 weeks and ligelizumab 240 mg
    Reporting group description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks

    Reporting group title
    Placebo 16 weeks and ligelizumab 120 mg
    Reporting group description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks

    Reporting group values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo 16 weeks and ligelizumab 240 mg Placebo 16 weeks and ligelizumab 120 mg Total
    Number of subjects
    47 51 46 44 11 12 211
    Age Categorical
    Units: Participants
        12 - 17 years
    27 29 25 24 6 8 119
        18 - 55 years
    20 22 21 20 5 4 92
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    19.5 ( 7.50 ) 18.8 ( 6.27 ) 18.7 ( 6.95 ) 20.0 ( 7.75 ) 17.4 ( 4.57 ) 16.1 ( 3.58 ) -
    Sex: Female, Male
    Units: Participants
        Female
    25 25 19 20 3 6 98
        Male
    22 26 27 24 8 6 113
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0
        Asian
    8 10 2 1 2 2 25
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0
        Black or African American
    6 3 1 2 0 0 12
        White
    31 36 42 39 7 10 165
        More than one race
    1 1 0 2 1 0 5
        Unknown or Not Reported
    1 1 1 0 1 0 4
    Number of participants with at least one food allergy
    Units: Subjects
        1 food allergy
    12 15 13 11 5 3 59
        2 food allergies
    10 5 8 4 1 1 29
        3 food allergies
    5 5 2 5 3 1 21
        4 food allergies
    8 7 6 4 0 1 26
        5 food allergies
    0 4 4 3 1 2 14
        > 5 food allergies
    12 15 13 17 1 4 62
    MTD (maximum tolerated dose) of peanut protein (mg) - n (%)
    Units: Subjects
        < 1 mg
    2 5 2 2 1 0 12
        1 mg
    4 4 6 9 1 2 26
        3 mg
    14 14 11 11 1 1 52
        10 mg
    9 14 7 11 4 5 50
        30 mg
    18 14 20 11 4 4 71
    Poly-sensitized to food
    Poly-sensitization is defined as specific Immunoglobulin E (sIgE) >=0.35kUA/L for a food allergen in the panel other than peanut.
    Units: Subjects
        Poly-sensitized to food = Yes
    29 27 22 27 8 8 121
        Poly-sensitized to food = No
    18 24 24 17 3 4 90
    Poly-allergic to food
    Poly-allergic: Participants experiencing more than one food allergies in medical history.
    Units: Subjects
        Poly-allergic to food = Yes
    35 36 33 33 6 9 152
        Poly-allergic to food = No
    12 15 13 11 5 3 59
    History of anaphylactic reaction to food
    Units: Subjects
        History of anaphylactic reaction to food = Yes
    32 36 29 32 9 8 146
        History of anaphylactic reaction to food = No
    14 15 16 12 2 4 63
        History of anaphylactic reaction to food = Unknown
    1 0 1 0 0 0 2
    Time to diagnosis of peanut allergy
    Units: Years
        arithmetic mean (standard deviation)
    16.287 ( 7.9393 ) 16.381 ( 6.9248 ) 15.556 ( 7.5799 ) 17.748 ( 7.8969 ) 15.598 ( 5.3525 ) 14.971 ( 3.5291 ) -
    Peanut specific Immunoglobulin E (IgE)
    Units: IU/mL
        arithmetic mean (standard deviation)
    109.021 ( 147.9877 ) 80.644 ( 117.6312 ) 131.948 ( 189.7757 ) 116.198 ( 128.9151 ) 51.606 ( 48.6951 ) 262.136 ( 543.7764 ) -
    Total Immunoglobulin E (IgE)
    Units: IU/mL
        arithmetic mean (standard deviation)
    524.35 ( 444.009 ) 482.25 ( 478.047 ) 455.38 ( 397.960 ) 436.31 ( 335.113 ) 325.15 ( 208.482 ) 635.42 ( 535.099 ) -
    Peanut Skin Prick Test (SPT) (undiluted): Size of mean wheal diameter
    Size of Mean wheal diameter (mm) = [(Mean of peanut wheal longest diameter + Mean of peanut wheal orthogonal diameter)/2]- average of the non-missing negative control diameters
    Units: mm
        arithmetic mean (standard deviation)
    13.83 ( 5.720 ) 14.61 ( 6.007 ) 13.23 ( 6.414 ) 16.82 ( 8.262 ) 14.45 ( 4.845 ) 12.17 ( 3.664 ) -
    Peanut Skin Prick Test (SPT) (average across dilutions): Size of mean wheal diameter
    Size of Mean wheal diameter (mm) = [(Mean of peanut wheal longest diameter + Mean of peanut wheal orthogonal diameter)/2]- average of the non-missing negative control diameters. Range of dilutions (1:10 to 1:100,000).
    Units: mm
        arithmetic mean (standard deviation)
    7.232 ( 2.8339 ) 7.273 ( 2.7253 ) 7.508 ( 2.7624 ) 7.907 ( 2.8866 ) 6.575 ( 2.3809 ) 7.743 ( 2.3547 ) -
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis sets values
    Placebo Placebo Placebo Placebo Placebo Placebo Placebo
    Number of subjects
    23
    20
    19
    16
    9
    8
    5
    Age Categorical
    Units: Participants
        12 - 17 years
        18 - 55 years
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
        Male
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Native Hawaiian or Other Pacific Islander
        Black or African American
        White
        More than one race
        Unknown or Not Reported
    Number of participants with at least one food allergy
    Units: Subjects
        1 food allergy
        2 food allergies
        3 food allergies
        4 food allergies
        5 food allergies
        > 5 food allergies
    MTD (maximum tolerated dose) of peanut protein (mg) - n (%)
    Units: Subjects
        < 1 mg
        1 mg
        3 mg
        10 mg
        30 mg
    Poly-sensitized to food
    Poly-sensitization is defined as specific Immunoglobulin E (sIgE) >=0.35kUA/L for a food allergen in the panel other than peanut.
    Units: Subjects
        Poly-sensitized to food = Yes
        Poly-sensitized to food = No
    Poly-allergic to food
    Poly-allergic: Participants experiencing more than one food allergies in medical history.
    Units: Subjects
        Poly-allergic to food = Yes
        Poly-allergic to food = No
    History of anaphylactic reaction to food
    Units: Subjects
        History of anaphylactic reaction to food = Yes
        History of anaphylactic reaction to food = No
        History of anaphylactic reaction to food = Unknown
    Time to diagnosis of peanut allergy
    Units: Years
        arithmetic mean (standard deviation)
    1 ( )
    ( )
    ( )
    -2.38 ( 3.788 )
    ( )
    ( )
    ( )
    Peanut specific Immunoglobulin E (IgE)
    Units: IU/mL
        arithmetic mean (standard deviation)
    1 ( )
    ( )
    ( )
    -2.38 ( 3.788 )
    ( )
    ( )
    ( )
    Total Immunoglobulin E (IgE)
    Units: IU/mL
        arithmetic mean (standard deviation)
    1 ( )
    ( )
    ( )
    -2.38 ( 3.788 )
    ( )
    ( )
    ( )
    Peanut Skin Prick Test (SPT) (undiluted): Size of mean wheal diameter
    Size of Mean wheal diameter (mm) = [(Mean of peanut wheal longest diameter + Mean of peanut wheal orthogonal diameter)/2]- average of the non-missing negative control diameters
    Units: mm
        arithmetic mean (standard deviation)
    1 ( )
    ( )
    ( )
    -2.38 ( 3.788 )
    ( )
    ( )
    ( )
    Peanut Skin Prick Test (SPT) (average across dilutions): Size of mean wheal diameter
    Size of Mean wheal diameter (mm) = [(Mean of peanut wheal longest diameter + Mean of peanut wheal orthogonal diameter)/2]- average of the non-missing negative control diameters. Range of dilutions (1:10 to 1:100,000).
    Units: mm
        arithmetic mean (standard deviation)
    1 ( )
    ( )
    ( )
    -2.38 ( 3.788 )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    ligelizumab 240 mg
    Reporting group description
    ligelizumab 240 mg subcutaneous injection for 52 weeks

    Reporting group title
    ligelizumab 120 mg
    Reporting group description
    ligelizumab 120 mg subcutaneous injection for 52 weeks

    Reporting group title
    Placebo 8 weeks and ligelizumab 240 mg
    Reporting group description
    Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks

    Reporting group title
    Placebo 8 weeks and ligelizumab 120 mg
    Reporting group description
    Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks

    Reporting group title
    Placebo 16 weeks and ligelizumab 240 mg
    Reporting group description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks

    Reporting group title
    Placebo 16 weeks and ligelizumab 120 mg
    Reporting group description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

    Primary: Percentage of participants who tolerated a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12

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    End point title
    Percentage of participants who tolerated a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 [1]
    End point description
    Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo
    Number of subjects analysed
    47
    51
    23
    Units: Participants
    21
    8
    1
    Statistical analysis title
    Single dose of >= 600 mg without DLT at Week 12
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.073
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    100.98
    Statistical analysis title
    Single dose of >= 600 mg without DLT at Week 12
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.002
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    25.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.34
         upper limit
    506.78

    Secondary: Percentage of participants who tolerated a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12

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    End point title
    Percentage of participants who tolerated a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 [2]
    End point description
    Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo
    Number of subjects analysed
    47
    51
    23
    Units: Participants
    14
    6
    1
    Statistical analysis title
    Single dose of >= 1000 mg without DLT at Week 12
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.164
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    59.93
    Statistical analysis title
    Single dose of >= 1000 mg without DLT at Week 12
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.018
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    9.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.69
         upper limit
    188.85

    Secondary: Percentage of participants who tolerated a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12

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    End point title
    Percentage of participants who tolerated a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 [3]
    End point description
    Responder rate was defined as the percentage of participants tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo
    Number of subjects analysed
    47
    51
    23
    Units: Participants
    7
    5
    1
    Statistical analysis title
    Single dose of >= 3000 mg without DLT at Week 12
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.247
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.3
         upper limit
    45.56
    Statistical analysis title
    Single dose of >= 3000 mg without DLT at Week 12
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.138
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.51
         upper limit
    70.08

    Secondary: Percentage of maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12

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    End point title
    Percentage of maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12 [4]
    End point description
    Symptom severity occurring at any challenge dose of peanut protein up to and including 1000 mg during the DBPCFC conducted at Week 12 was categorized as 4 levels: None, Mild, Moderate, Severe. The CoFAR grading system was used to categorize the symptom severity as mild, moderate and severe. Symptom severity for participants who completed DBPCFC without any symptom were categorized as none.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo
    Number of subjects analysed
    47
    51
    23
    Units: Participants
        None
    5
    2
    0
        Mild
    15
    10
    2
        Moderate
    24
    37
    13
        Severe
    3
    2
    8
    Statistical analysis title
    Max. severity of symptoms at any dose at Week 12
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.001
    Method
    proportional odds model
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.8
         upper limit
    14.36
    Statistical analysis title
    Max. severity of symptoms at any dose at Week 12
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    proportional odds model
    Parameter type
    Odds ratio (OR)
    Point estimate
    10.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.63
         upper limit
    31.56

    Secondary: Percentage of participants who tolerated a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 after 4 weeks of Treatment

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    End point title
    Percentage of participants who tolerated a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 after 4 weeks of Treatment [5]
    End point description
    Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12 after 4 weeks of treatment (8 weeks of placebo + 4 weeks of ligelizumab treatment versus 12 weeks of placebo). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    46
    44
    23
    Units: Participants
    8
    1
    1
    Statistical analysis title
    >= 1000 mg without DLT at Week 12 after 4 wks Tx
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.082
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    93.16
    Statistical analysis title
    >= 1000 mg without DLT at Week 12 after 4 wks Tx
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.632
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.02
         upper limit
    16.43

    Secondary: Percentage of participants who tolerated the specified peanut protein dose without dose-limiting symptoms at Week 52

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    End point title
    Percentage of participants who tolerated the specified peanut protein dose without dose-limiting symptoms at Week 52 [6]
    End point description
    Responder rate was defined as the percentage of participants tolerating the specified peanut protein doses (>= 600 mg (1044 mg cumulative tolerated dose), >= 1000 mg (2044 mg cumulative tolerated dose) or 3000 mg (5044 mg cumulative tolerated dose)) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 52. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
    End point type
    Secondary
    End point timeframe
    Week 52
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg
    Number of subjects analysed
    3
    2
    2
    4
    Units: Participants
        MTD >= 600 mg
    2
    1
    0
    1
        MTD >= 1000 mg
    1
    1
    0
    0
        MTD = 3000 mg
    1
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 12 and Week 52

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    End point title
    Change from baseline in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 12 and Week 52 [7]
    End point description
    Change from baseline in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 12 and Week 52. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 52
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    45
    48
    46
    40
    20
    Units: mg
    geometric mean (geometric coefficient of variation)
        Week 12
    274.05 ( 501.051 )
    104.31 ( 794.248 )
    148.98 ( 754.171 )
    44.29 ( 768.803 )
    46.62 ( 555.207 )
        Week 52
    800.41 ( 178.687 )
    164.23 ( 459916.375 )
    89.55 ( 408.957 )
    146.48 ( 113.009 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Change from baseline in peanut-specific immunoglobulin E (IgE) at Week 12 and Week 52

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    End point title
    Change from baseline in peanut-specific immunoglobulin E (IgE) at Week 12 and Week 52 [8]
    End point description
    Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE)
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 52
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    44
    46
    45
    39
    20
    Units: kilounits per liter (kU/L)
    arithmetic mean (standard deviation)
        Week 12
    258.28 ( 282.477 )
    295.60 ( 321.451 )
    302.22 ( 323.846 )
    400.03 ( 611.676 )
    -35.52 ( 179.040 )
        Week 52
    362.36 ( 436.857 )
    297.94 ( 285.827 )
    338.63 ( 435.532 )
    361.44 ( 587.852 )
    174.75 ( 433.889 )
    No statistical analyses for this end point

    Secondary: Change from baseline in peanut-specific immunoglobulin G4 (IgG4) at Week 12 and Week 52

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    End point title
    Change from baseline in peanut-specific immunoglobulin G4 (IgG4) at Week 12 and Week 52 [9]
    End point description
    Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4)
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 52
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    46
    46
    45
    40
    19
    Units: mg/L
    arithmetic mean (standard deviation)
        Week 12
    -0.09 ( 0.65 )
    0.35 ( 3.178 )
    0.12 ( 0.903 )
    0.11 ( 0.789 )
    0.03 ( 0.469 )
        Week 52
    -0.01 ( 0.608 )
    0.73 ( 3.103 )
    0.21 ( 0.909 )
    0.01 ( 0.768 )
    -0.09 ( 1.126 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Skin Prick Test (SPT) mean wheal diameters at Week 16/Week 56

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    End point title
    Change from Baseline in Skin Prick Test (SPT) mean wheal diameters at Week 16/Week 56 [10]
    End point description
    An allergen specific SPT is a commonly used diagnostic tool. In this study a titration SPT using peanut allergen provided additional information on the impact of Immunoglobulin E (IgE) suppression on skin mast cells. The size of the wheal and flare (the longest diameter and the midpoint orthogonal diameter) at each site was evaluated. Considering the study termination, SPT originally scheduled at Week 56 was performed 4 weeks after Week 12 assessment in some patients.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16/Week 56
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    36
    40
    37
    36
    16
    Units: undiluted peanut protein (mm)
        arithmetic mean (standard deviation)
    -10.85 ( 6.423 )
    -8.40 ( 5.805 )
    -5.28 ( 5.237 )
    -7.25 ( 7.354 )
    -2.38 ( 3.788 )
    Statistical analysis title
    Skin Prick Test (SPT) at Week 16/Week 56
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -3.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.15
         upper limit
    -2.4
    Statistical analysis title
    Skin Prick Test (SPT) at Week 16/Week 56
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.13
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -1.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.62
         upper limit
    1.25
    Statistical analysis title
    Skin Prick Test (SPT) at Week 16/Week 56
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.015
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -3.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.08
         upper limit
    -0.32
    Statistical analysis title
    Skin Prick Test (SPT) at Week 16/Week 56
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -4.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.77
         upper limit
    -2.09

    Secondary: Change from baseline in total and domain scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)

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    End point title
    Change from baseline in total and domain scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) [11]
    End point description
    The Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) completed by adolescents aged 13-17 is a self-reported instrument intended to assess the effect of food allergy on the participant’s health-related quality of life (HRQoL). Each question is scored on a 7-point scale (coded as 1-7 in analysis, with a higher level indicating greater impairment in HRQoL). The total score and the domain scores are the arithmetic average of all completed items: Emotional impact (EI) (item no. 5, 12, 19-23), Allergen avoidance and dietary restrictions (AADR) (item no. 1-4, 6-10, 16), Risk of accidental exposure (RAE) (item no. 11, 13-15, 17, 18). If more than one item in any domain is missing, a domain score should not be calculated for that case. A total score could still be calculated if 20% or fewer of the items are missing.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    17
    20
    15
    16
    9
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12 Part 1 - Total Score
    -0.09 ( 0.833 )
    -0.01 ( 0.779 )
    -0.30 ( 0.647 )
    -0.07 ( 0.972 )
    0.27 ( 0.835 )
        Week 12 Part 2 - Total Score
    -0.49 ( 0.839 )
    -0.13 ( 0.869 )
    -0.08 ( 0.879 )
    0.04 ( 1.255 )
    0.09 ( 0.954 )
        Week 12 Part 1 - EI
    -0.03 ( 0.896 )
    -0.12 ( 0.846 )
    -0.40 ( 0.745 )
    -0.11 ( 1.062 )
    0.27 ( 1.034 )
        Week 12 Part 2 - EI
    -0.51 ( 1.057 )
    -0.19 ( 0.875 )
    -0.23 ( 0.737 )
    -0.05 ( 1.348 )
    -0.04 ( 1.486 )
        Week 12 Part 1 - AADR
    -0.15 ( 0.873 )
    0.02 ( 0.977 )
    -0.35 ( 0.988 )
    -0.11 ( 1.130 )
    0.11 ( 0.599 )
        Week 12 Part 2 - AADR
    -0.61 ( 0.946 )
    -0.14 ( 1.004 )
    -0.08 ( 1.291 )
    0.12 ( 1.235 )
    0.25 ( 0.628 )
        Week 12 Part 1 - RAE
    -0.07 ( 1.085 )
    0.08 ( 0.868 )
    -0.10 ( 0.796 )
    0.02 ( 1.016 )
    0.54 ( 1.204 )
        Week 12 Part 2 - RAE
    -0.28 ( 0.718 )
    -0.04 ( 1.028 )
    0.08 ( 0.733 )
    0.03 ( 1.366 )
    -0.04 ( 1.253 )
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.173
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.03
         upper limit
    0.36
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.202
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.96
         upper limit
    0.39
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.123
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.16
         upper limit
    0.3
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.258
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.94
         upper limit
    0.47
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.324
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.92
         upper limit
    0.58
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.473
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.78
         upper limit
    0.73
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.151
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.09
         upper limit
    0.34
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.264
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.94
         upper limit
    0.49

    Secondary: Change from baseline in total and domain scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)

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    End point title
    Change from baseline in total and domain scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) [12]
    End point description
    The Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) completed by adults aged 18-55 is a self-reported instrument intended to assess the effect of food allergy on the participant’s health-related quality of life (HRQoL). Each question is scored on a 7-point scale (coded as 1-7 in analysis, with a higher level indicating greater impairment in HRQoL). The total score and domain scores are the arithmetic average of all completed items: Emotional impact (EI) (item no. 5, 24-29), Allergen avoidance and dietary restrictions (AADR) (item no. 1-4, 6, 8-12, 20), Risk of Accidental Exposure (RAE) (item no. 7, 13-18, 21), Food allergy related health (FAH) (item no. 19, 22, 23). If more than one item in any domain is missing, a domain score should not be calculated for that case. A total score could still be calculated if 20% or fewer of the items are missing.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    16
    17
    19
    17
    9
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12 Part 1 - Total Score
    -0.01 ( 0.560 )
    -0.40 ( 0.439 )
    -0.20 ( 0.601 )
    0.00 ( 0.656 )
    0.00 ( 0.330 )
        Week 12 Part 2 - Total Score
    -0.16 ( 0.742 )
    -0.55 ( 0.671 )
    -0.60 ( 0.783 )
    -0.22 ( 0.727 )
    -0.14 ( 0.542 )
        Week 12 Part 1 - EI
    0.07 ( 0.747 )
    -0.31 ( 0.838 )
    -0.35 ( 0.601 )
    -0.04 ( 0.857 )
    -0.06 ( 0.358 )
        Week 12 Part 2 - EI
    -0.11 ( 0.980 )
    -0.47 ( 1.006 )
    -0.90 ( 1.027 )
    -0.26 ( 0.828 )
    0.00 ( 0.553 )
        Week 12 Part 1 - AADR
    -0.07 ( 0.609 )
    -0.41 ( 0.526 )
    -0.31 ( 0.805 )
    -0.12 ( 0.731 )
    -0.05 ( 0.508 )
        Week 12 Part 2 - AADR
    -0.10 ( 0.788 )
    -0.74 ( 0.585 )
    -0.70 ( 1.106 )
    -0.20 ( 0.749 )
    -0.15 ( 0.532 )
        Week 12 Part 1 - RAE
    0.06 ( 0.647 )
    -0.40 ( 0.427 )
    0.02 ( 0.834 )
    0.18 ( 0.794 )
    0.10 ( 0.471 )
        Week 12 Part 2 - RAE
    -0.15 ( 0.750 )
    -0.31 ( 0.917 )
    -0.34 ( 0.468 )
    -0.26 ( 0.821 )
    -0.33 ( 0.549 )
        Week 12 Part 1 - FAH
    -0.17 ( 1.082 )
    -0.53 ( 0.717 )
    -0.05 ( 0.788 )
    0.06 ( 1.056 )
    0.04 ( 1.073 )
        Week 12 Part 2 - FAH
    -0.47 ( 0.864 )
    -0.73 ( 0.854 )
    -0.22 ( 0.770 )
    -0.06 ( 1.153 )
    0.07 ( 1.140 )
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.597
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.44
         upper limit
    0.57
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.064
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.89
         upper limit
    0.11
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.191
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.72
         upper limit
    0.28
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.368
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.68
         upper limit
    0.48
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.537
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.57
         upper limit
    0.62
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.141
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.91
         upper limit
    0.27
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.063
    Method
    ANCOVA
    Parameter type
    LS Meand difference
    Point estimate
    -0.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.04
         upper limit
    0.13
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.472
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.51
         upper limit
    0.48

    Secondary: Change from baseline in total scores in the Food Allergy Independent Measure (FAIM) – Teenager Form (FAIM-TF)

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    End point title
    Change from baseline in total scores in the Food Allergy Independent Measure (FAIM) – Teenager Form (FAIM-TF) [13]
    End point description
    The Food Allergy Independent Measure (FAIM) – Teenager Form (FAIM-TF) completed by adolescents aged 13-17 reflects the participant’s perceived food allergy severity and food allergy-related risk. It consists of six questions (the first four of them assess participant's food allergy expectation outcomes, and the other two reflect aspects of the perceived severity of food allergy). Each question is scored on a 7-point scale (coded as 1-7 in analysis, with a greater score indicating a higher level of perceived risk or chance of adverse events occurring). The total score is the arithmetic average of all completed items. If less than 80% of the items within the score are complete, it was not calculated.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    17
    19
    15
    14
    9
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12 Part 1 - Total Score
    -0.03 ( 0.751 )
    -0.11 ( 0.760 )
    -0.04 ( 0.529 )
    0.31 ( 0.989 )
    0.19 ( 0.930 )
        Week 12 Part 2 - Total Score
    -0.31 ( 0.952 )
    0.31 ( 0.784 )
    -0.07 ( 0.524 )
    0.39 ( 1.133 )
    0.25 ( 1.306 )
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.225
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.87
         upper limit
    0.39
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.179
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.95
         upper limit
    0.34
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.514
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    0.72
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.06
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.18
         upper limit
    0.14
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.404
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.72
         upper limit
    0.56
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.135
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.06
         upper limit
    0.3
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.153
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.93
         upper limit
    0.3
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.631
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.55
         upper limit
    0.77

    Secondary: Change from baseline in total scores in the Food Allergy Independent Measure (FAIM) – Adult Form (FAIM-AF)

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    End point title
    Change from baseline in total scores in the Food Allergy Independent Measure (FAIM) – Adult Form (FAIM-AF) [14]
    End point description
    The Food Allergy Independent Measure (FAIM) – Adult Form (FAIM-AF) completed by adults aged 18-55 reflects the participant’s perceived food allergy severity and food allergy-related risk. It consists of six questions (the first four of them assess participant's food allergy expectation outcomes, and the other two reflect aspects of the perceived severity of food allergy). Each question is scored on a 7-point scale (coded as 1-7 in analysis, with a greater score indicating a higher level of perceived risk or chance of adverse events occurring). The total score is the arithmetic average of all completed items. If less than 80% of the items within the score are complete, it was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    16
    17
    16
    17
    8
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12 Part 1 - Total Score
    0.17 ( 0.574 )
    -0.23 ( 0.496 )
    -0.09 ( 0.694 )
    0.00 ( 0.489 )
    0.17 ( 0.309 )
        Week 12 Part 2 - Total Score
    -0.23 ( 0.681 )
    -0.36 ( 0.562 )
    -0.27 ( 0.492 )
    -0.24 ( 0.479 )
    0.07 ( 0.703 )
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.574
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.42
         upper limit
    0.51
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.069
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.83
         upper limit
    0.12
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.056
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.83
         upper limit
    0.09
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.048
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.06
         upper limit
    0.09
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.071
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.98
         upper limit
    0.14
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    ligelizumab 240 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.248
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.76
         upper limit
    0.37
    Statistical analysis title
    Week 12 Part 2 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.142
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.85
         upper limit
    0.25
    Statistical analysis title
    Week 12 Part 1 - Total Score
    Comparison groups
    Placebo 8 weeks and ligelizumab 120 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.205
    Method
    ANCOVA
    Parameter type
    LS Mean difference
    Point estimate
    -0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.65
         upper limit
    0.27

    Secondary: Change from baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS)

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    End point title
    Change from baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) [15]
    End point description
    The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It is designed for use in surveys of general and specific populations, health policy evaluations and clinical practice and research. It contains 8 scales and 2 component summary indices evaluating physical, social and emotional functioning in addition to general health perceptions and mental health. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) and mental component summary (MCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS and MCS scores range 0 to 100).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, Placebo 8 weeks and ligelizumab 240 mg, Placebo 8 weeks and ligelizumab 120 mg and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands).
    End point values
    ligelizumab 240 mg ligelizumab 120 mg Placebo 8 weeks and ligelizumab 240 mg Placebo 8 weeks and ligelizumab 120 mg Placebo
    Number of subjects analysed
    10
    11
    10
    12
    5
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Physical Component Score
    0.51 ( 8.022 )
    0.38 ( 2.912 )
    2.13 ( 3.909 )
    -2.19 ( 5.090 )
    3.15 ( 5.342 )
        Mental Component Score
    -0.15 ( 9.950 )
    -0.12 ( 8.175 )
    -1.78 ( 8.458 )
    -3.26 ( 8.256 )
    -9.43 ( 14.662 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication, up to approximately 22 months.
    Adverse event reporting additional description
    Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo controlled period (Up to Week 8) QGE031 240 mg SCq4w
    Reporting group description
    Placebo controlled period (Up to Week 8) QGE031 240 mg SCq4w

    Reporting group title
    Placebo controlled period (Up to Week 8) QGE031 120 mg SCq4w
    Reporting group description
    Placebo controlled period (Up to Week 8) QGE031 120 mg SCq4w

    Reporting group title
    Placebo controlled period (Up to Week 8) Placebo
    Reporting group description
    Placebo controlled period (Up to Week 8) Placebo

    Reporting group title
    Entire study period (Up to Week 68) QGE031 120 mg SCq4w
    Reporting group description
    Entire study period (Up to Week 68) QGE031 120 mg SCq4w

    Reporting group title
    Placebo controlled period (Up to Week 16) QGE031 120 mg SCq4w
    Reporting group description
    Placebo controlled period (Up to Week 16) QGE031 120 mg SCq4w

    Reporting group title
    Placebo controlled period (Up to Week 16) Placebo
    Reporting group description
    Placebo controlled period (Up to Week 16) Placebo

    Reporting group title
    Entire study period (Up to Week 68) QGE031 240 mg SCq4w
    Reporting group description
    Entire study period (Up to Week 68) QGE031 240 mg SCq4w

    Reporting group title
    Placebo controlled period (Up to Week 16) QGE031 240 mg SCq4w
    Reporting group description
    Placebo controlled period (Up to Week 16) QGE031 240 mg SCq4w

    Serious adverse events
    Placebo controlled period (Up to Week 8) QGE031 240 mg SCq4w Placebo controlled period (Up to Week 8) QGE031 120 mg SCq4w Placebo controlled period (Up to Week 8) Placebo Entire study period (Up to Week 68) QGE031 120 mg SCq4w Placebo controlled period (Up to Week 16) QGE031 120 mg SCq4w Placebo controlled period (Up to Week 16) Placebo Entire study period (Up to Week 68) QGE031 240 mg SCq4w Placebo controlled period (Up to Week 16) QGE031 240 mg SCq4w
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    0 / 113 (0.00%)
    1 / 101 (0.99%)
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 99 (0.00%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural complication
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    0 / 113 (0.00%)
    1 / 101 (0.99%)
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 99 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo controlled period (Up to Week 8) QGE031 240 mg SCq4w Placebo controlled period (Up to Week 8) QGE031 120 mg SCq4w Placebo controlled period (Up to Week 8) Placebo Entire study period (Up to Week 68) QGE031 120 mg SCq4w Placebo controlled period (Up to Week 16) QGE031 120 mg SCq4w Placebo controlled period (Up to Week 16) Placebo Entire study period (Up to Week 68) QGE031 240 mg SCq4w Placebo controlled period (Up to Week 16) QGE031 240 mg SCq4w
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 47 (44.68%)
    17 / 51 (33.33%)
    27 / 113 (23.89%)
    53 / 101 (52.48%)
    20 / 51 (39.22%)
    9 / 23 (39.13%)
    57 / 99 (57.58%)
    26 / 47 (55.32%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 51 (0.00%)
    1 / 113 (0.88%)
    2 / 101 (1.98%)
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    3 / 99 (3.03%)
    3 / 47 (6.38%)
         occurrences all number
    2
    0
    1
    2
    0
    0
    3
    3
    Headache
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 51 (5.88%)
    5 / 113 (4.42%)
    12 / 101 (11.88%)
    4 / 51 (7.84%)
    1 / 23 (4.35%)
    10 / 99 (10.10%)
    4 / 47 (8.51%)
         occurrences all number
    2
    3
    7
    22
    6
    1
    14
    4
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 51 (0.00%)
    2 / 113 (1.77%)
    2 / 101 (1.98%)
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    9 / 99 (9.09%)
    3 / 47 (6.38%)
         occurrences all number
    4
    0
    2
    2
    1
    0
    15
    4
    Injection site erythema
         subjects affected / exposed
    5 / 47 (10.64%)
    7 / 51 (13.73%)
    0 / 113 (0.00%)
    13 / 101 (12.87%)
    8 / 51 (15.69%)
    0 / 23 (0.00%)
    15 / 99 (15.15%)
    6 / 47 (12.77%)
         occurrences all number
    6
    8
    0
    28
    13
    0
    27
    8
    Injection site swelling
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 51 (7.84%)
    0 / 113 (0.00%)
    4 / 101 (3.96%)
    4 / 51 (7.84%)
    0 / 23 (0.00%)
    6 / 99 (6.06%)
    2 / 47 (4.26%)
         occurrences all number
    3
    4
    0
    7
    5
    0
    8
    3
    Pyrexia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 51 (0.00%)
    0 / 113 (0.00%)
    1 / 101 (0.99%)
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    5 / 99 (5.05%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    5
    1
    Injection site pruritus
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 51 (0.00%)
    0 / 113 (0.00%)
    1 / 101 (0.99%)
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    4 / 99 (4.04%)
    3 / 47 (6.38%)
         occurrences all number
    3
    0
    0
    2
    0
    0
    4
    3
    Injection site pain
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 51 (5.88%)
    4 / 113 (3.54%)
    4 / 101 (3.96%)
    3 / 51 (5.88%)
    0 / 23 (0.00%)
    6 / 99 (6.06%)
    3 / 47 (6.38%)
         occurrences all number
    2
    4
    4
    10
    4
    0
    12
    3
    Injection site oedema
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 51 (1.96%)
    0 / 113 (0.00%)
    3 / 101 (2.97%)
    2 / 51 (3.92%)
    0 / 23 (0.00%)
    7 / 99 (7.07%)
    4 / 47 (8.51%)
         occurrences all number
    6
    1
    0
    7
    2
    0
    14
    9
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    3 / 113 (2.65%)
    1 / 101 (0.99%)
    0 / 51 (0.00%)
    2 / 23 (8.70%)
    1 / 99 (1.01%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    3
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 51 (1.96%)
    1 / 113 (0.88%)
    4 / 101 (3.96%)
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    5 / 99 (5.05%)
    2 / 47 (4.26%)
         occurrences all number
    1
    1
    1
    4
    1
    0
    6
    2
    Cough
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 51 (0.00%)
    3 / 113 (2.65%)
    2 / 101 (1.98%)
    0 / 51 (0.00%)
    2 / 23 (8.70%)
    7 / 99 (7.07%)
    4 / 47 (8.51%)
         occurrences all number
    1
    0
    3
    3
    0
    2
    7
    4
    Asthma
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 51 (0.00%)
    1 / 113 (0.88%)
    3 / 101 (2.97%)
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    7 / 99 (7.07%)
    2 / 47 (4.26%)
         occurrences all number
    2
    0
    1
    4
    0
    0
    11
    4
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    5 / 47 (10.64%)
    1 / 51 (1.96%)
    1 / 113 (0.88%)
    6 / 101 (5.94%)
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    11 / 99 (11.11%)
    7 / 47 (14.89%)
         occurrences all number
    8
    1
    1
    8
    1
    0
    14
    10
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 51 (3.92%)
    2 / 113 (1.77%)
    14 / 101 (13.86%)
    5 / 51 (9.80%)
    0 / 23 (0.00%)
    7 / 99 (7.07%)
    5 / 47 (10.64%)
         occurrences all number
    1
    2
    2
    14
    5
    0
    7
    5
    Influenza
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 51 (1.96%)
    0 / 113 (0.00%)
    6 / 101 (5.94%)
    3 / 51 (5.88%)
    0 / 23 (0.00%)
    5 / 99 (5.05%)
    2 / 47 (4.26%)
         occurrences all number
    1
    1
    0
    6
    3
    0
    5
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    2 / 113 (1.77%)
    1 / 101 (0.99%)
    0 / 51 (0.00%)
    2 / 23 (8.70%)
    2 / 99 (2.02%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    2
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 51 (5.88%)
    7 / 113 (6.19%)
    9 / 101 (8.91%)
    4 / 51 (7.84%)
    2 / 23 (8.70%)
    8 / 99 (8.08%)
    3 / 47 (6.38%)
         occurrences all number
    1
    4
    8
    15
    8
    3
    12
    6
    Nasopharyngitis
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 51 (3.92%)
    5 / 113 (4.42%)
    14 / 101 (13.86%)
    3 / 51 (5.88%)
    3 / 23 (13.04%)
    19 / 99 (19.19%)
    8 / 47 (17.02%)
         occurrences all number
    4
    2
    6
    17
    3
    4
    23
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2022
    The main purpose of Protocol Amendment 1 was to: • Change the data review mode for the DMC from semi-blinded to unblinded as per request of the DMC from 12-Oct-2021; • Adjust inclusion criterion number 4: The amended cutoff for positive peanut-specific IgE (peanut sIgE) was set at ≥ 0.35 kUA/L at Screening Visit 1 to avoid excluding participants with otherwise strong evidence supporting the diagnosis of peanut allergy (based on medical history and SPT); • Clarify and harmonize usage of prohibited medication and medication allowed under certain conditions; • Add serum tryptase as biomarker; • Reduce the number of stool samples required to determine participant eligibility at screening from three to one in asymptomatic participants; • Define two entry timepoints for participants who wish to enter the Extension study: at Week 68 (end of follow-up) for the first one third of participants or Week 52 (end of treatment) for the remaining participants. It also included other clarifications, minor updates, and corrections of typographical errors across the document.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/#/ for complete trial results.
    For support, Contact us.
    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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