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    Clinical Trial Results:
    A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut’s Efficacy and Safety for treating peanut allergy in children and adults.

    Summary
    EudraCT number
    		 2011-002550-32
    Trial protocol
    		 NL   PL   DK  
    Global end of trial date
    31 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V712-202 (VIPES)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01675882
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    DBV Technologies
    Sponsor organisation address
    177-181 avenue Pierre Brossolette, Montrouge, France, 92120
    Public contact
    Chief Medical Officer, DBV Technologies, 33 1-55-42-78-78, clinicaltrials@dbv-technologies.com
    Scientific contact
    Chief Medical Officer, DBV Technologies, 33 1-55-42-78-78 , clinicaltrials@dbv-technologies.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001481-PIP01-13
    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
    31 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of several doses of Viaskin® Peanut (DBV712) to significantly desensitize peanut-allergic participants to peanut after 12 months of epicutaneous immunotherapy (EPIT).
    Protection of trial subjects
    The investigator was responsible for obtaining informed consent from each participant in the study, in accordance with the International Conference on Harmonisation-Good Clinical Practice (GCP) Guidelines, the Declaration of Helsinki, and applicable regulatory requirements. Before initiating a study, the investigator/institution had to have written and dated approval/favorable opinion from the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) for the study protocol/amendment(s), written informed consent form, any consent form updates, participant recruitment procedures, and any written information to be provided to participants and a statement from the IEC/IRB that they comply with GCP requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2012
    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
    Canada: 71
    Country: Number of subjects enrolled
    France: 37
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United States: 103
    Worldwide total number of subjects
    221
    EEA total number of subjects
    47
    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)
    113
    Adolescents (12-17 years)
    73
    Adults (18-64 years)
    35
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted in participants aged 6 to 55 years old with peanut allergy at 22 study centers in 5 countries. Study had a 4-week screening period, 52-week treatment period and 2-week follow-up period. All participants who completed the VIPES study up to Visit 11 (inclusive) were eligible for participation in the follow-up study (OLFUS-VIPES).

    Pre-assignment
    Screening details
    		 A total of 221 participants were randomized in 1:1:1:1 ratio into 4 treatment groups. Each participant underwent dose-escalating double-blind, placebo-controlled food challenge (DBPCFC) at screening and Month 12. At screening, a dose-escalating DBPCFC confirmed peanut allergy to an eliciting dose <=300 milligrams (mg) peanut protein.

    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, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Viaskin Peanut 50 μg
    Arm description
    		 Participants applied 1 new Viaskin Peanut 50 micrograms (μg) patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Viaskin Peanut
    Investigational medicinal product code
    Other name
    DBV712
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Epicutaneous use
    Dosage and administration details
    Viaskin Peanut cutaneous patch containing a dry deposit of a formulation of peanut protein extract applied on intact skin for 24 hours daily for 12 months. The drug substance is an unmodified, lyophilized peanut extract produced from the extraction and freeze drying of defatted peanut flour.

    Arm title
    		 Viaskin Peanut 100 μg
    Arm description
    		 Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Viaskin Peanut
    Investigational medicinal product code
    Other name
    DBV712
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Epicutaneous use
    Dosage and administration details
    Viaskin Peanut cutaneous patch containing a dry deposit of a formulation of peanut protein extract applied on intact skin for 24 hours daily for 12 months. The drug substance is an unmodified, lyophilized peanut extract produced from the extraction and freeze drying of defatted peanut flour.

    Arm title
    		 Viaskin Peanut 250 μg
    Arm description
    		 Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Viaskin Peanut
    Investigational medicinal product code
    Other name
    DBV712
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Epicutaneous use
    Dosage and administration details
    Viaskin Peanut cutaneous patch containing a dry deposit of a formulation of peanut protein extract applied on intact skin for 24 hours daily for 12 months. The drug substance is an unmodified, lyophilized peanut extract produced from the extraction and freeze drying of defatted peanut flour.

    Arm title
    		 Placebo
    Arm description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Epicutaneous use
    Dosage and administration details
    Placebo cutaneous patch applied on intact skin for 24 hours daily for 12 months.

    Number of subjects in period 1
    		Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Started
    53
    56
    56
    56
    Completed
    51
    49
    53
    54
    Not completed
    2
    7
    3
    2
         Adverse event, non-fatal
    -
    2
    1
    -
         Non-compliance
    -
    -
    -
    1
         Lost to follow-up
    -
    1
    -
    -
         Participant unwilling to continue
    2
    4
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Viaskin Peanut 50 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 50 micrograms (μg) patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Viaskin Peanut 100 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Viaskin Peanut 250 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo Total
    Number of subjects
    		 53 56 56 56 221
    Age categorical
    Units: Subjects
        Children (6-11 years)
    		 28 26 28 31 113
        Adolescents (12-17 years)
    		 18 19 18 18 73
        Adults (18-55 years)
    		 7 11 10 7 35
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.3 ± 6.72 13.9 ± 6.66 13.6 ± 7.48 12.5 ± 6.84 -
    Gender categorical
    Units: Subjects
        Female
    		 22 23 18 20 83
        Male
    		 31 33 38 36 138
    Race/Ethnicity
    The ethnicity of the participants at French local sites was not collected as it was not applicable as per local law. As such, these participants are included in the category of 'Not applicable'.
    Units: Subjects
        Caucasian
    		 39 33 32 31 135
        Black
    		 1 2 0 2 5
        Hispanic
    		 1 0 0 2 3
        Asian
    		 3 9 10 5 27
        Other
    		 2 4 4 4 14
        Not applicable
    		 7 8 10 12 37

    End points

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    End points reporting groups
    Reporting group title
    Viaskin Peanut 50 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 50 micrograms (μg) patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Viaskin Peanut 100 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Viaskin Peanut 250 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Primary: Percentage of Treatment Responders at Month 12; Analyzed in Overall Population

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    End point title
    		 Percentage of Treatment Responders at Month 12; Analyzed in Overall Population
    End point description
    A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized.
    End point type
    Primary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: percentage of participants
        number (confidence interval 95%)
    45.3 (31.56 to 59.55)
    41.1 (28.10 to 55.02)
    50.0 (36.34 to 63.66)
    25.0 (14.39 to 38.37)
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 μg versus placebo is statistically significant at p<0.05. The subsequent comparison of viaskin peanut 100 μg versus placebo is not statistically significant at p<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 μg vs placebo.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0292
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 3.11
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 μg versus placebo is statistically significant at p<0.05. The subsequent comparison of viaskin peanut 100 μg versus placebo is not statistically significant at p<0.05.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1074
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 2.85
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 μg versus placebo is statistically significant at p<0.05.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0108
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 3.38

    Secondary: Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)

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    End point title
    		 Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)
    End point description
    A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    28
    26
    28
    31
    Units: percentage of participants
        number (confidence interval 95%)
    57.1 (37.18 to 75.54)
    46.2 (26.59 to 66.63)
    53.6 (33.87 to 72.49)
    19.4 (7.45 to 37.47)
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0035
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    2.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 6.49
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0453
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    2.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 5.47
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0076
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 6.14

    Secondary: Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)

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    End point title
    		 Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)
    End point description
    A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    18
    19
    18
    18
    Units: percentage of participants
        number (confidence interval 95%)
    33.3 (13.34 to 59.01)
    10.5 (1.30 to 33.14)
    38.9 (17.30 to 64.25)
    22.2 (6.41 to 47.64)
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7112
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 4.43
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4048
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.28
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4705
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 4.95

    Secondary: Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)

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    End point title
    		 Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)
    End point description
    A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    7
    11
    10
    7
    Units: percentage of participants
        number (confidence interval 95%)
    28.6 (3.67 to 70.96)
    81.8 (48.22 to 97.72)
    60.0 (26.24 to 87.84)
    57.1 (18.41 to 90.10)
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5921
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 1.9
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.326
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 2.88
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 Relative risk
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.38

    Secondary: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population

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    End point title
    		 Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population
    End point description
    The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: mg
        arithmetic mean (standard deviation)
    453.8 ± 608.16
    539.7 ± 659.31
    621.4 ± 715.03
    283.7 ± 482.04
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0607 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    70.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.41
         upper limit
    		 193.69
    Notes
    [1] - P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    97.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.45
         upper limit
    		 237.82
    Notes
    [2] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    242.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 100.03
         upper limit
    		 482.65
    Notes
    [3] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.

    Secondary: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)

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    End point title
    		 Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)
    End point description
    The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    28
    26
    28
    31
    Units: mg
        arithmetic mean (standard deviation)
    397.1 ± 510.13
    441.2 ± 511.26
    652.5 ± 766.93
    160.5 ± 244.00
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0372 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    73.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.96
         upper limit
    		 225.85
    Notes
    [4] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0143 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    96.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.92
         upper limit
    		 278.11
    Notes
    [5] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    260.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 89.83
         upper limit
    		 625.95
    Notes
    [6] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.

    Secondary: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)

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    End point title
    		 Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)
    End point description
    The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    18
    19
    18
    18
    Units: mg
        arithmetic mean (standard deviation)
    501.7 ± 726.14
    281.6 ± 472.47
    573.9 ± 716.01
    331.8 ± 511.62
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6596 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    26.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59.58
         upper limit
    		 236
    Notes
    [7] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8702 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -65.9
         upper limit
    		 189.96
    Notes
    [8] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    158.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 562.31
    Notes
    [9] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.

    Secondary: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)

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    End point title
    		 Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)
    End point description
    The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    7
    11
    10
    7
    Units: mg
        arithmetic mean (standard deviation)
    557.1 ± 711.47
    1218.5 ± 822.74
    620.0 ± 619.68
    705.7 ± 893.01
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6776 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -80.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -237.22
         upper limit
    		 782.24
    Notes
    [10] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5068 [11]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    158.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -166.1
         upper limit
    		 1478.83
    Notes
    [11] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7972 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    53.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -193.9
         upper limit
    		 1085.38
    Notes
    [12] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.

    Secondary: Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population

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    End point title
    		 Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population
    End point description
    The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: mg
        arithmetic mean (standard deviation)
    730.8 ± 1020.53
    863.5 ± 1120.43
    1010.6 ± 1223.85
    451.4 ± 807.13
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0444 [13]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    120
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 321.8
    Notes
    [13] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0175 [14]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    147.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.67
         upper limit
    		 365.51
    Notes
    [14] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [15]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    386
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 159.67
         upper limit
    		 771.16
    Notes
    [15] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.

    Secondary: Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population

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    End point title
    		 Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population
    End point description
    The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). The full analysis set included all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1.9 ± 4.79
    -0.9 ± 4.21
    0.2 ± 4.65
    -1.4 ± 4.35
    Statistical analysis title
    		 Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.251 [16]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.55
         upper limit
    		 0.52
    Notes
    [16] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.682 [17]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 1.05
    Notes
    [17] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.
    Statistical analysis title
    		 Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2117 [18]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 2.47
    Notes
    [18] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.

    Secondary: Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population

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    End point title
    		 Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
    End point description
    The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as <=0.5 or >0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value. The full analysis set included all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: participants
        Month 3: undiluted; <= 0.5
    7
    9
    5
    4
        Month 3: undiluted; > 0.5
    46
    47
    51
    52
        Month 3: diluted (1:10); <= 0.5
    10
    5
    8
    4
        Month 3: diluted (1:10); > 0.5
    43
    51
    48
    52
        Month 3: diluted (1:100); <= 0.5
    13
    12
    15
    6
        Month 3: diluted (1:100); > 0.5
    39
    43
    41
    50
        Month 3: diluted (1:1000); <= 0.5
    13
    15
    24
    12
        Month 3: diluted (1:1000); > 0.5
    35
    35
    28
    40
        Month 3: diluted (1:10000); <= 0.5
    21
    17
    22
    15
        Month 3: diluted (1:10000); > 0.5
    21
    18
    20
    24
        Month 6: undiluted; <= 0.5
    14
    7
    7
    2
        Month 6: undiluted; > 0.5
    39
    49
    49
    54
        Month 6: diluted (1:10); <= 0.5
    9
    10
    9
    5
        Month 6: diluted (1:10); > 0.5
    44
    46
    47
    51
        Month 6: diluted (1:100); <= 0.5
    15
    16
    14
    4
        Month 6: diluted (1:100); > 0.5
    37
    39
    42
    52
        Month 6: diluted (1:1000); <= 0.5
    15
    11
    23
    11
        Month 6: diluted (1:1000); > 0.5
    33
    39
    29
    41
        Month 6: diluted (1:10000); <= 0.5
    21
    15
    22
    14
        Month 6: diluted (1:10000); > 0.5
    21
    20
    20
    25
        Month 12: undiluted; <= 0.5
    8
    4
    7
    2
        Month 12: undiluted; > 0.5
    45
    52
    49
    54
        Month 12: diluted (1:10); <= 0.5
    10
    6
    15
    3
        Month 12: diluted (1:10); > 0.5
    43
    50
    41
    53
        Month 12: diluted (1:100); <= 0.5
    11
    14
    13
    7
        Month 12: diluted (1:100); > 0.5
    41
    41
    43
    49
        Month 12: diluted (1:1000); <= 0.5
    14
    9
    18
    8
        Month 12: diluted (1:1000); > 0.5
    34
    41
    34
    44
        Month 12: diluted (1:10000); <= 0.5
    22
    14
    24
    13
        Month 12: diluted (1:10000); > 0.5
    20
    21
    18
    26
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population

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    End point title
    		 Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: kilo units per liter (kU/L)
    median (full range (min-max))
        Month 3
    32.3 (-375 to 676)
    29.9 (-118 to 1243)
    50.7 (-91 to 794)
    2.8 (-117 to 445)
        Month 6
    8.8 (-158 to 348)
    22.0 (-65 to 1464)
    29.5 (-93 to 747)
    -1.1 (-363 to 79)
        Month 12
    -0.2 (-211 to 305)
    4.9 (-146 to 245)
    5.2 (-382 to 598)
    -1.4 (-327 to 93)
    Statistical analysis title
    		 Month 12: Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0337 [19]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 38.82
    Notes
    [19] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.
    Statistical analysis title
    		 Month 12: Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [20]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    26.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.38
         upper limit
    		 49.45
    Notes
    [20] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.
    Statistical analysis title
    		 Month 12: Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012 [21]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.85
         upper limit
    		 40.91
    Notes
    [21] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.

    Secondary: Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)

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    End point title
    		 Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    28
    26
    28
    31
    Units: kU/L
    median (full range (min-max))
        Month 3
    63.6 (-375 to 676)
    63.1 (-27 to 1243)
    50.7 (-16 to 794)
    4.1 (-117 to 445)
        Month 6
    10.6 (-55 to 348)
    48.7 (-9 to 1464)
    21.2 (-70 to 291)
    -1.8 (-363 to 79)
        Month 12
    -3.1 (-211 to 305)
    3.5 (-146 to 150)
    1.0 (-136 to 485)
    -12.0 (-327 to 59)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)

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    End point title
    		 Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    18
    19
    18
    18
    Units: kU/L
    median (full range (min-max))
        Month 3
    11.5 (-99 to 248)
    62.0 (-118 to 303)
    135.5 (0 to 552)
    4.8 (-17 to 232)
        Month 6
    6.0 (-158 to 170)
    24.2 (-65 to 239)
    90.0 (-10 to 440)
    0.0 (-43 to 75)
        Month 12
    5.2 (-49 to 199)
    24.9 (-98 to 163)
    39.4 (-382 to 434)
    1.0 (-31 to 93)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)

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    End point title
    		 Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    7
    11
    10
    7
    Units: kU/L
    median (full range (min-max))
        Month 3
    65.3 (-76 to 183)
    12.3 (-1 to 169)
    3.1 (-91 to 471)
    0.1 (-34 to 13)
        Month 6
    34.4 (-0 to 214)
    3.6 (-4 to 377)
    1.6 (-93 to 747)
    -0.2 (-42 to 40)
        Month 12
    22.3 (-25 to 163)
    0.3 (-9 to 245)
    -2.0 (-148 to 598)
    0.9 (-107 to 39)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population

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    End point title
    		 Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    53
    56
    56
    56
    Units: mg per liter (mg/L)
    median (full range (min-max))
        Month 3
    0.4 (-1 to 6)
    0.4 (-18 to 4)
    0.8 (-1 to 14)
    0.0 (-3 to 2)
        Month 6
    0.8 (-2 to 6)
    0.8 (-19 to 8)
    1.4 (-6 to 19)
    0.0 (-2 to 3)
        Month 12
    1.0 (-2 to 12)
    0.9 (-9 to 10)
    1.6 (-3 to 17)
    0.0 (-3 to 1)
    Statistical analysis title
    		 Month 12: Viaskin peanut 50 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 50 μg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [22]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.9
    Notes
    [22] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.
    Statistical analysis title
    		 Month 12: Viaskin peanut 100 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 100 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [23]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 2.01
    Notes
    [23] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.
    Statistical analysis title
    		 Month 12: Viaskin peanut 250 μg versus Placebo
    Statistical analysis description
    The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.
    Comparison groups
    Viaskin Peanut 250 μg v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [24]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 3.11
    Notes
    [24] - P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.

    Secondary: Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)

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    End point title
    		 Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    28
    26
    28
    31
    Units: mg/L
    median (full range (min-max))
        Month 3
    0.6 (-1 to 6)
    0.4 (-18 to 4)
    1.7 (-1 to 14)
    0.0 (-1 to 1)
        Month 6
    1.1 (-2 to 6)
    1.1 (-19 to 8)
    4.4 (0 to 19)
    -0.1 (-1 to 2)
        Month 12
    2.0 (-2 to 12)
    1.6 (-9 to 10)
    6.3 (-1 to 17)
    -0.0 (-2 to 1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)

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    End point title
    		 Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    18
    19
    18
    18
    Units: mg/L
    median (full range (min-max))
        Month 3
    0.1 (-0 to 2)
    0.6 (-0 to 2)
    0.7 (-0 to 4)
    0.1 (-3 to 2)
        Month 6
    0.3 (-1 to 3)
    0.8 (0 to 2)
    0.7 (-6 to 6)
    0.1 (-2 to 3)
        Month 12
    0.4 (-1 to 8)
    0.7 (-1 to 3)
    0.9 (-3 to 9)
    0.1 (-3 to 1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)

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    End point title
    		 Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
    End point description
    Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Number of subjects analysed
    7
    11
    10
    7
    Units: mg/L
    median (full range (min-max))
        Month 3
    0.2 (0 to 3)
    0.5 (-0 to 2)
    0.4 (-0 to 1)
    0.1 (-0 to 0.4)
        Month 6
    0.5 (-0 to 3)
    0.5 (-0 to 1)
    0.6 (-0 to 6)
    0.0 (-0 to 1)
        Month 12
    0.6 (0 to 3)
    0.3 (0 to 1)
    0.9 (-0 to 8)
    0.1 (-0 to 0.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
    Adverse event reporting additional description
    The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Viaskin Peanut 50 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut (DBV712) 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Viaskin Peanut 100 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Viaskin Peanut 250 μg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.

    Serious adverse events
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 56 (1.79%)
    2 / 56 (3.57%)
    0 / 56 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Viaskin Peanut 50 μg Viaskin Peanut 100 μg Viaskin Peanut 250 μg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 53 (100.00%)
    55 / 56 (98.21%)
    56 / 56 (100.00%)
    51 / 56 (91.07%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    1
    1
    0
    3
    Ligament sprain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 56 (0.00%)
    3 / 56 (5.36%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    4
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 53 (20.75%)
    8 / 56 (14.29%)
    8 / 56 (14.29%)
    13 / 56 (23.21%)
         occurrences all number
    17
    16
    14
    27
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    5 / 53 (9.43%)
    6 / 56 (10.71%)
    8 / 56 (14.29%)
    3 / 56 (5.36%)
         occurrences all number
    5
    6
    9
    4
    Application site discolouration
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 56 (3.57%)
    4 / 56 (7.14%)
    1 / 56 (1.79%)
         occurrences all number
    1
    2
    4
    1
    Application site dryness
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 56 (0.00%)
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Application site eczema
         subjects affected / exposed
    7 / 53 (13.21%)
    8 / 56 (14.29%)
    10 / 56 (17.86%)
    1 / 56 (1.79%)
         occurrences all number
    9
    12
    17
    1
    Application site erythema
         subjects affected / exposed
    39 / 53 (73.58%)
    33 / 56 (58.93%)
    32 / 56 (57.14%)
    14 / 56 (25.00%)
         occurrences all number
    53
    68
    61
    21
    Application site irritation
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    1 / 56 (1.79%)
         occurrences all number
    2
    1
    3
    1
    Application site oedema
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 56 (3.57%)
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    1
    2
    3
    0
    Application site pain
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 56 (5.36%)
    0 / 56 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    0
    5
    0
    0
    Application site papules
         subjects affected / exposed
    6 / 53 (11.32%)
    8 / 56 (14.29%)
    9 / 56 (16.07%)
    1 / 56 (1.79%)
         occurrences all number
    6
    8
    12
    1
    Application site pruritus
         subjects affected / exposed
    18 / 53 (33.96%)
    23 / 56 (41.07%)
    23 / 56 (41.07%)
    7 / 56 (12.50%)
         occurrences all number
    23
    52
    38
    15
    Application site rash
         subjects affected / exposed
    7 / 53 (13.21%)
    1 / 56 (1.79%)
    1 / 56 (1.79%)
    6 / 56 (10.71%)
         occurrences all number
    11
    1
    2
    6
    Application site reaction
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 56 (3.57%)
    4 / 56 (7.14%)
    3 / 56 (5.36%)
         occurrences all number
    2
    4
    6
    6
    Application site swelling
         subjects affected / exposed
    5 / 53 (9.43%)
    8 / 56 (14.29%)
    12 / 56 (21.43%)
    3 / 56 (5.36%)
         occurrences all number
    6
    8
    15
    5
    Application site urticaria
         subjects affected / exposed
    2 / 53 (3.77%)
    5 / 56 (8.93%)
    5 / 56 (8.93%)
    2 / 56 (3.57%)
         occurrences all number
    3
    6
    7
    2
    Pyrexia
         subjects affected / exposed
    9 / 53 (16.98%)
    7 / 56 (12.50%)
    6 / 56 (10.71%)
    10 / 56 (17.86%)
         occurrences all number
    15
    8
    7
    12
    Immune system disorders
    Food allergy
         subjects affected / exposed
    8 / 53 (15.09%)
    11 / 56 (19.64%)
    7 / 56 (12.50%)
    10 / 56 (17.86%)
         occurrences all number
    11
    22
    11
    14
    Hypersensitivity
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 56 (5.36%)
    1 / 56 (1.79%)
    1 / 56 (1.79%)
         occurrences all number
    5
    3
    1
    2
    Seasonal allergy
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 56 (5.36%)
    6 / 56 (10.71%)
    3 / 56 (5.36%)
         occurrences all number
    9
    6
    7
    5
    Eye disorders
    Eye swelling
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 56 (3.57%)
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 56 (7.14%)
    3 / 56 (5.36%)
    7 / 56 (12.50%)
         occurrences all number
    2
    4
    3
    8
    Abdominal pain upper
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 56 (5.36%)
    2 / 56 (3.57%)
    3 / 56 (5.36%)
         occurrences all number
    9
    6
    2
    6
    Diarrhoea
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    3 / 56 (5.36%)
         occurrences all number
    6
    1
    3
    4
    Nausea
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 56 (3.57%)
    1 / 56 (1.79%)
    2 / 56 (3.57%)
         occurrences all number
    5
    2
    1
    2
    Oral pruritus
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Vomiting
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 56 (5.36%)
    2 / 56 (3.57%)
    4 / 56 (7.14%)
         occurrences all number
    8
    3
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    4 / 53 (7.55%)
    8 / 56 (14.29%)
    4 / 56 (7.14%)
    5 / 56 (8.93%)
         occurrences all number
    6
    9
    4
    6
    Cough
         subjects affected / exposed
    6 / 53 (11.32%)
    7 / 56 (12.50%)
    5 / 56 (8.93%)
    5 / 56 (8.93%)
         occurrences all number
    9
    7
    5
    15
    Nasal congestion
         subjects affected / exposed
    6 / 53 (11.32%)
    5 / 56 (8.93%)
    7 / 56 (12.50%)
    6 / 56 (10.71%)
         occurrences all number
    11
    7
    7
    7
    Oropharyngeal pain
         subjects affected / exposed
    5 / 53 (9.43%)
    4 / 56 (7.14%)
    7 / 56 (12.50%)
    4 / 56 (7.14%)
         occurrences all number
    7
    4
    7
    6
    Rhinitis allergic
         subjects affected / exposed
    6 / 53 (11.32%)
    9 / 56 (16.07%)
    1 / 56 (1.79%)
    6 / 56 (10.71%)
         occurrences all number
    6
    14
    1
    12
    Rhinorrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 56 (3.57%)
    0 / 56 (0.00%)
    4 / 56 (7.14%)
         occurrences all number
    4
    2
    0
    9
    Throat irritation
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 56 (1.79%)
    0 / 56 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    0
    1
    Wheezing
         subjects affected / exposed
    4 / 53 (7.55%)
    0 / 56 (0.00%)
    3 / 56 (5.36%)
    3 / 56 (5.36%)
         occurrences all number
    4
    0
    7
    10
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    6 / 53 (11.32%)
    3 / 56 (5.36%)
    5 / 56 (8.93%)
    4 / 56 (7.14%)
         occurrences all number
    6
    3
    7
    4
    Erythema
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 56 (1.79%)
    2 / 56 (3.57%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    2
    1
    Pruritus
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 56 (1.79%)
    5 / 56 (8.93%)
    4 / 56 (7.14%)
         occurrences all number
    5
    1
    5
    4
    Urticaria
         subjects affected / exposed
    8 / 53 (15.09%)
    3 / 56 (5.36%)
    8 / 56 (14.29%)
    8 / 56 (14.29%)
         occurrences all number
    16
    5
    9
    18
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 56 (3.57%)
    3 / 56 (5.36%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    3
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 56 (8.93%)
    1 / 56 (1.79%)
    5 / 56 (8.93%)
         occurrences all number
    5
    7
    1
    6
    Gastroenteritis
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 56 (5.36%)
    6 / 56 (10.71%)
    8 / 56 (14.29%)
         occurrences all number
    3
    4
    6
    8
    Gastroenteritis viral
         subjects affected / exposed
    6 / 53 (11.32%)
    4 / 56 (7.14%)
    4 / 56 (7.14%)
    2 / 56 (3.57%)
         occurrences all number
    8
    4
    4
    2
    Influenza
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 56 (5.36%)
    2 / 56 (3.57%)
    3 / 56 (5.36%)
         occurrences all number
    4
    3
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    12 / 53 (22.64%)
    9 / 56 (16.07%)
    10 / 56 (17.86%)
    18 / 56 (32.14%)
         occurrences all number
    13
    17
    15
    30
    Pharyngitis
         subjects affected / exposed
    5 / 53 (9.43%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    1 / 56 (1.79%)
         occurrences all number
    8
    1
    3
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 56 (7.14%)
    2 / 56 (3.57%)
    3 / 56 (5.36%)
         occurrences all number
    4
    5
    2
    4
    Rhinitis
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 56 (5.36%)
    1 / 56 (1.79%)
    2 / 56 (3.57%)
         occurrences all number
    0
    5
    1
    3
    Sinusitis
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
    2 / 56 (3.57%)
         occurrences all number
    3
    1
    3
    3
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 53 (26.42%)
    11 / 56 (19.64%)
    12 / 56 (21.43%)
    12 / 56 (21.43%)
         occurrences all number
    23
    18
    17
    25
    Urinary tract infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 56 (0.00%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    1
    4
    Viral infection
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 56 (8.93%)
    1 / 56 (1.79%)
    4 / 56 (7.14%)
         occurrences all number
    1
    6
    1
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 56 (3.57%)
    1 / 56 (1.79%)
    3 / 56 (5.36%)
         occurrences all number
    5
    3
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2013
    Study design modified to include an open-label follow-up study or extension study to the VIPES study (OLFUS-VIPES study). The OLFUS-VIPES study is for participants who were previously randomized and completed the VIPES study. Participants were offered enrollment in OLFUS-VIPES study to receive 24 months of Viaskin Peanut treatment. Participants formerly randomized to the placebo treatment group in the VIPES study crossed over to receive one of the 3 active doses of Viaskin Peanut.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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