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    Clinical Trial Results:
    A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

    Summary
    EudraCT number
    		 2016-003679-23
    Trial protocol
    		 IE   FR   DE   NL  
    Global end of trial date
    27 Apr 2022

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

    Trial information

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    Trial identification
    Sponsor protocol code
    EPITOPE-V712-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03211247
    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, +33 155 42 78 78, clinicaltrials@dbv-technologies.com
    Scientific contact
    Chief Medical Officer, DBV Technologies, +33 155 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to assess the efficacy and safety of DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic participants 1 to 3 years of age after a 12-month treatment period with epicutaneous immunotherapy (EPIT).
    Protection of trial subjects
    This study was conducted in accordance with the Note for Guidance on GCP International Council for Harmonization Harmonized Tripartite Guideline E6 R1/Integrated Addendum E6; R2 United States Food and Drug Administration (FDA) Code of Federal Regulations (Title 21 Parts 50, 56, 312), requirements for the conduct of clinical studies as provided in the European Union Directive 2001/20/EC; the general guidelines indicated in the Declaration of Helsinki; and all applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2017
    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
    Netherlands: 10
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Ireland: 15
    Country: Number of subjects enrolled
    Australia: 59
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    United States: 207
    Worldwide total number of subjects
    362
    EEA total number of subjects
    37
    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)
    126
    Children (2-11 years)
    236
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase III, study was conducted in participants aged 1 to 3 years with peanut-allergy at 51 centers. The duration of study was approximately 62 weeks (6-week: screening period; 12-month treatment period; and 4-week follow-up period).

    Pre-assignment
    Screening details
    		 A total of 362 participants were randomized in a 2:1 ratio to receive Viaskin™ Peanut (DBV712) 250 mcg or placebo.

    Period 1
    Period 1 title
    Overall (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 250 mcg
    Arm description
    		 Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
    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
    The Viaskin peanut patch contained a dry deposit of a formulation of peanut protein extract. The drug substance is an unmodified, lyophilized peanut extract produced from the extraction and freeze drying of defatted peanut flour. Application of the DBV712 patch at a similar time for each daily application (morning or evening) was recommended.

    Arm title
    		 Placebo
    Arm description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
    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
    The placebo treatment consists of a matching cutaneous patch and dry deposit formulation. Application of the placebo patch at a similar time for each daily application (morning or evening) was recommended.

    Number of subjects in period 1
    		Viaskin Peanut 250 mcg Placebo
    Started
    244
    118
    Completed
    208
    99
    Not completed
    36
    19
         Physician decision
    1
    2
         Participant withdrawal by Parent or Caregiver
    18
    13
         Adverse event, non-fatal
    8
    -
         Noncompliance with study drug
    2
    -
         Participant did not complete oral food challenge
    5
    2
         Lost to follow-up
    2
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Viaskin Peanut 250 mcg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

    Reporting group values
    		 Viaskin Peanut 250 mcg Placebo Total
    Number of subjects
    		 244 118 362
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.52 ( 0.872 ) 2.43 ( 0.868 ) -
    Gender categorical
    Units: Subjects
        Female
    		 79 34 113
        Male
    		 165 84 249
    Race
    Units: Subjects
        White
    		 159 70 229
        Black or African American
    		 1 1 2
        Asian
    		 41 24 65
        Other
    		 35 17 52
        Not collected
    		 8 6 14

    End points

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    End points reporting groups
    Reporting group title
    Viaskin Peanut 250 mcg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

    Primary: Percentage of Treatment Responders at Month 12

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    End point title
    		 Percentage of Treatment Responders at Month 12
    End point description
    A participant was defined as a treatment responder if the initial eliciting dose (ED) was > 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12. The FAS comprised of all participants who were randomized in the study.
    End point type
    Primary
    End point timeframe
    Month 12
    End point values
    		 Viaskin Peanut 250 mcg Placebo
    Number of subjects analysed
    244
    118
    Units: percentage of participants
        number (confidence interval 95%)
    67.0 (60.93 to 73.01)
    33.5 (24.84 to 42.24)
    Statistical analysis title
    		 Difference between Viaskin 250 mcg and Placebo
    Statistical analysis description
    Difference between the percentage of treatment responders in Viaskin 250 mcg compared to placebo.
    Comparison groups
    Viaskin Peanut 250 mcg v Placebo
    Number of subjects included in analysis
    362
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wald test
    Parameter type
    		 Proportion difference
    Point estimate
    33.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.36
         upper limit
    		 44.49

    Secondary: Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model

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    End point title
    		 Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
    End point description
    The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model. The FAS comprised of all participants who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Viaskin Peanut 250 mcg Placebo
    Number of subjects analysed
    244
    118
    Units: milligram (mg)
        geometric mean (confidence interval 95%)
    1010.31 (842.18 to 1212.01)
    322.57 (248.37 to 418.94)
    No statistical analyses for this end point

    Secondary: Change From Baseline in CRD of Peanut Protein to Month 12

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    End point title
    		 Change From Baseline in CRD of Peanut Protein to Month 12
    End point description
    The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The FAS comprised of all participants who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Month 12
    End point values
    		 Viaskin Peanut 250 mcg Placebo
    Number of subjects analysed
    244
    118
    Units: mg
        median (inter-quartile range (Q1-Q3))
    1300.0 (140.0 to 3000.0)
    0.0 (0.0 to 1000.0)
    No statistical analyses for this end point

    Secondary: ED of Peanut Protein at Month 12 Using ANCOVA Model

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    End point title
    		 ED of Peanut Protein at Month 12 Using ANCOVA Model
    End point description
    The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model. The FAS comprised of all participants who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Viaskin Peanut 250 mcg Placebo
    Number of subjects analysed
    244
    118
    Units: mg
        geometric mean (confidence interval 95%)
    659.36 (553.84 to 784.99)
    223.12 (173.40 to 287.09)
    No statistical analyses for this end point

    Secondary: Change From Baseline in ED of Peanut Protein to Month 12

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    End point title
    		 Change From Baseline in ED of Peanut Protein to Month 12
    End point description
    The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The FAS comprised of all participants who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Month 12
    End point values
    		 Viaskin Peanut 250 mcg Placebo
    Number of subjects analysed
    244
    118
    Units: mg
        median (inter-quartile range (Q1-Q3))
    900.0 (90.0 to 1700.0)
    0.0 (0.0 to 700.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge

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    End point title
    		 Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
    End point description
    The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms). With the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=” absent”, 1=” mild”, 2=” moderate” or 3=” severe”. For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. The FAS comprised of all participants who were randomized in the study. Only data from the participants analyzed were reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Month 12
    End point values
    		 Viaskin Peanut 250 mcg Placebo
    Number of subjects analysed
    244
    118
    Units: percentage of participants
    number (not applicable)
        Baseline: Absent (n=244, 118)
    0
    0
        Baseline: Mild (n=244, 118)
    7.0
    7.6
        Baseline: Moderate (n=244, 118)
    68.4
    67.8
        Baseline: Severe (n=244, 118)
    24.6
    24.6
        Month 12: Absent (n=200, 98)
    16.0
    6.1
        Month 12: Mild (n=200, 98)
    20.5
    14.3
        Month 12: Moderate (n=200, 98)
    51.0
    51.0
        Month 12: Severe (n=200, 98)
    12.5
    28.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The TEAEs were collected from Day 1 up to Month 12
    Adverse event reporting additional description
    The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Viaskin Peanut 250 mcg
    Reporting group description
    		 Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

    Serious adverse events
    		 Viaskin Peanut 250 mcg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 244 (8.61%)
    3 / 118 (2.54%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Medication error
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Aplasia pure red cell
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction to food
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 118 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylaxis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    6 / 244 (2.46%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Viaskin Peanut 250 mcg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    244 / 244 (100.00%)
    117 / 118 (99.15%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    10 / 244 (4.10%)
    12 / 118 (10.17%)
         occurrences all number
    12
    18
    General disorders and administration site conditions
    Application site discolouration
         subjects affected / exposed
    15 / 244 (6.15%)
    0 / 118 (0.00%)
         occurrences all number
    16
    0
    Application site eczema
         subjects affected / exposed
    34 / 244 (13.93%)
    10 / 118 (8.47%)
         occurrences all number
    66
    12
    Application site erosion
         subjects affected / exposed
    32 / 244 (13.11%)
    5 / 118 (4.24%)
         occurrences all number
    44
    6
    Application site erythema
         subjects affected / exposed
    239 / 244 (97.95%)
    107 / 118 (90.68%)
         occurrences all number
    2182
    760
    Application site oedema
         subjects affected / exposed
    58 / 244 (23.77%)
    21 / 118 (17.80%)
         occurrences all number
    504
    105
    Application site papules
         subjects affected / exposed
    41 / 244 (16.80%)
    9 / 118 (7.63%)
         occurrences all number
    63
    10
    Application site pruritus
         subjects affected / exposed
    231 / 244 (94.67%)
    72 / 118 (61.02%)
         occurrences all number
    2925
    523
    Application site swelling
         subjects affected / exposed
    177 / 244 (72.54%)
    46 / 118 (38.98%)
         occurrences all number
    2044
    278
    Application site urticaria
         subjects affected / exposed
    68 / 244 (27.87%)
    3 / 118 (2.54%)
         occurrences all number
    152
    3
    Application site vesicles
         subjects affected / exposed
    43 / 244 (17.62%)
    11 / 118 (9.32%)
         occurrences all number
    179
    21
    Pyrexia
         subjects affected / exposed
    84 / 244 (34.43%)
    50 / 118 (42.37%)
         occurrences all number
    150
    83
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    18 / 244 (7.38%)
    2 / 118 (1.69%)
         occurrences all number
    24
    2
    Food allergy
         subjects affected / exposed
    33 / 244 (13.52%)
    13 / 118 (11.02%)
         occurrences all number
    64
    20
    Hypersensitivity
         subjects affected / exposed
    24 / 244 (9.84%)
    11 / 118 (9.32%)
         occurrences all number
    30
    22
    Seasonal allergy
         subjects affected / exposed
    28 / 244 (11.48%)
    3 / 118 (2.54%)
         occurrences all number
    50
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    22 / 244 (9.02%)
    11 / 118 (9.32%)
         occurrences all number
    48
    21
    Teething
         subjects affected / exposed
    12 / 244 (4.92%)
    7 / 118 (5.93%)
         occurrences all number
    32
    12
    Vomiting
         subjects affected / exposed
    56 / 244 (22.95%)
    21 / 118 (17.80%)
         occurrences all number
    87
    34
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    22 / 244 (9.02%)
    9 / 118 (7.63%)
         occurrences all number
    35
    30
    Cough
         subjects affected / exposed
    48 / 244 (19.67%)
    24 / 118 (20.34%)
         occurrences all number
    91
    42
    Nasal congestion
         subjects affected / exposed
    15 / 244 (6.15%)
    9 / 118 (7.63%)
         occurrences all number
    21
    14
    Rhinitis allergic
         subjects affected / exposed
    22 / 244 (9.02%)
    10 / 118 (8.47%)
         occurrences all number
    28
    17
    Rhinorrhoea
         subjects affected / exposed
    36 / 244 (14.75%)
    23 / 118 (19.49%)
         occurrences all number
    66
    35
    Wheezing
         subjects affected / exposed
    21 / 244 (8.61%)
    6 / 118 (5.08%)
         occurrences all number
    39
    15
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    9 / 244 (3.69%)
    6 / 118 (5.08%)
         occurrences all number
    15
    7
    Eczema
         subjects affected / exposed
    59 / 244 (24.18%)
    30 / 118 (25.42%)
         occurrences all number
    125
    67
    Erythema
         subjects affected / exposed
    36 / 244 (14.75%)
    15 / 118 (12.71%)
         occurrences all number
    49
    27
    Pruritus
         subjects affected / exposed
    23 / 244 (9.43%)
    13 / 118 (11.02%)
         occurrences all number
    39
    13
    Rash
         subjects affected / exposed
    37 / 244 (15.16%)
    14 / 118 (11.86%)
         occurrences all number
    55
    24
    Urticaria
         subjects affected / exposed
    85 / 244 (34.84%)
    44 / 118 (37.29%)
         occurrences all number
    244
    96
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    14 / 244 (5.74%)
    1 / 118 (0.85%)
         occurrences all number
    15
    1
    Croup infectious
         subjects affected / exposed
    12 / 244 (4.92%)
    12 / 118 (10.17%)
         occurrences all number
    13
    15
    Ear infection
         subjects affected / exposed
    23 / 244 (9.43%)
    15 / 118 (12.71%)
         occurrences all number
    42
    28
    Gastroenteritis
         subjects affected / exposed
    31 / 244 (12.70%)
    13 / 118 (11.02%)
         occurrences all number
    41
    17
    Gastroenteritis viral
         subjects affected / exposed
    22 / 244 (9.02%)
    3 / 118 (2.54%)
         occurrences all number
    23
    7
    Influenza
         subjects affected / exposed
    14 / 244 (5.74%)
    5 / 118 (4.24%)
         occurrences all number
    14
    6
    Nasopharyngitis
         subjects affected / exposed
    53 / 244 (21.72%)
    18 / 118 (15.25%)
         occurrences all number
    102
    35
    Otitis media
         subjects affected / exposed
    21 / 244 (8.61%)
    4 / 118 (3.39%)
         occurrences all number
    33
    8
    Otitis media acute
         subjects affected / exposed
    1 / 244 (0.41%)
    6 / 118 (5.08%)
         occurrences all number
    1
    7
    Pneumonia
         subjects affected / exposed
    6 / 244 (2.46%)
    6 / 118 (5.08%)
         occurrences all number
    6
    7
    Respiratory tract infection viral
         subjects affected / exposed
    29 / 244 (11.89%)
    8 / 118 (6.78%)
         occurrences all number
    54
    21
    Upper respiratory tract infection
         subjects affected / exposed
    102 / 244 (41.80%)
    43 / 118 (36.44%)
         occurrences all number
    239
    129
    Viral infection
         subjects affected / exposed
    47 / 244 (19.26%)
    19 / 118 (16.10%)
         occurrences all number
    76
    25
    Viral upper respiratory tract infection
         subjects affected / exposed
    30 / 244 (12.30%)
    13 / 118 (11.02%)
         occurrences all number
    46
    21

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2017
    The sample size of the study was revised to reflect changes in the statistical methods for primary efficacy analysis following FDA’s recommendations. The total number of participants needed was increased from 241 to 331 participants. The statistical methods for primary efficacy analysis, including the sensitivity analyses on the primary endpoint, the subgroup analyses, and the secondary efficacy analyses, were revised to take into account FDA’s recommendations.
    11 Sep 2017
    Administrative changes and minor typographical and grammar changes were incorporated. Definition for DBPCFC was updated. The definition of treatment response was adapted, with the terms “objective symptoms leading to DBPCFC stop” being replaced by “symptoms leading to DBPCFC stop”. The evaluation of the change in severity of objective symptoms elicited during DBPCFCs was enlarged to that of symptoms elicited during the DBPCFCs. Inclusion criterion definition updated and exclusion criterion replaced. Description of the DBPCFC procedure updated for additional clarification. The description of the severity score based on the grades of objective symptoms elicited during the DBPCFCs was enlarged to that of symptoms elicited during the DBPCFCs. Part IV of the Oral Food Challenge Symptom Score Sheet was modified.
    09 Nov 2017
    Packaging, labelling and storage conditions of Viaskin peanut were updated. An erroneous study timepoint for the Investigator assessment of patch adhesion was also corrected, and an administrative change was introduced.
    18 Jun 2018
    Minor clarification in study design was added. Sample size was increased. Modification of reporting of pre-specified local skin reactions at patch application sites by the parents/guardians: extension to the whole treatment duration for participants. Quality of life questionnaire was added. Modification of patch adhesion assessment by parents/guardians : extension to the whole treatment duration for participants. Further clarified the exclusion criterion related to concomitant treatment for asthma and precision of exclusion criterion related to prior oral immunotherapy. Three endpoints from secondary endpoints were moved to other efficacy endpoints. The definition of AEs of special interest was updated. Immunological markers assessment was updated. Exploratory variables regarding gene mutation analysis were removed. Quality of life analysis and exploratory blood assessment were added. The statistical methods section was modified. Administrative changes, and clarifications regarding study personnel were incorporated. Minor precision in the title of Appendix 6 was incorporated. Appendix 8, 9 and 10 details were added. Administrative changes and typographical corrections updated.
    28 Aug 2018
    Sample size was updated. The acceptability criterion for epicutaneous system adhesion was removed. The hierarchical order for the analysis of efficacy endpoints were shortened. All statistical analytical details (other than primary efficacy analysis) were removed from the protocol and planned to be detailed in the statistical analysis plan. Modification of epicutaneous system adhesion assessments by parents/caregivers. Addition of solicited AEs during the study for both local (application site reactions) and systemic allergic AEs of the study, per FDA’s request. The intent-to-treat (ITT) Population was replaced by a modified intent-to-treat (mITT) population.
    15 Nov 2019
    Study duration for each participant was increased by 2 weeks. Subgroup analyses on secondary efficacy endpoints were removed. The hierarchical order of efficacy analyses was updated.

    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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