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    Clinical Trial Results:
    A Phase 2A Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis

    Summary
    EudraCT number
    		 2014-003263-37
    Trial protocol
    		 HU   DE   CZ   PL   GB   Outside EU/EEA  
    Global end of trial date
    13 Mar 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Oct 2020
    First version publication date
    30 Mar 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    R668-AD-1412
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02407756
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd., Tarrytown, United States, 10591
    Public contact
    Clinical Trial Administrator, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trial Administrator, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001501-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
    11 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the safety and pharmacokinetics (PK) of Dupilumab in pediatric subjects with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2015
    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
    Poland: 25
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Canada: 12
    Worldwide total number of subjects
    78
    EEA total number of subjects
    66
    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)
    38
    Adolescents (12-17 years)
    40
    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
    		 The study was conducted at 25 sites in 6 countries. A total of 88 subjects were screened between 17 Mar 2015 & 25 Sep 2015 of whom 78 subjects were randomized and 77 were treated. Ten subjects were screen failures as 5 were due to exclusion criteria met & inclusion criteria not met, 4 subjects withdrew consent and 1 subject was lost to follow-up.

    Pre-assignment
    Screening details
    		 A total of 40 adolescents (aged ≥12 to <18 years) and 38 children (aged ≥6 to <12 years) were enrolled and randomized to 2 sequential ascending dose cohorts: Cohort 1 (2 mg/kg) and Cohort 2 (4 mg/kg). Dosing started with cohort 1. Proceeding to the next cohort occurred once all initial 8 patients enrolled had been observed for at least 2 weeks.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dupilumab 2mg/kg: Adolescents
    Arm description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668, SAR231893
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs and upper arms.

    Arm title
    		 Dupilumab 2mg/kg: Children
    Arm description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668, SAR231893
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs and upper arms.

    Arm title
    		 Dupilumab 4mg/kg: Adolescents
    Arm description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668, SAR231893
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs and upper arms.

    Arm title
    		 Dupilumab 4mg/kg: Children
    Arm description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668, SAR231893
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs and upper arms.

    Number of subjects in period 1 [1]
    		Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Started
    20
    18
    20
    19
    Treated
    20
    18
    20
    19
    Completed
    20
    18
    20
    19
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject in the 4 mg/kg (Cohort 2b) arm did not receive study drug and was withdrawn from the study on study day 1 during Part A period due to withdrawal of consent (fear of study drug injection) and was not included in the analysis. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dupilumab 2mg/kg: Adolescents
    Reporting group description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.

    Reporting group title
    Dupilumab 2mg/kg: Children
    Reporting group description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.

    Reporting group title
    Dupilumab 4mg/kg: Adolescents
    Reporting group description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.

    Reporting group title
    Dupilumab 4mg/kg: Children
    Reporting group description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.

    Reporting group values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children Total
    Number of subjects
    		 20 18 20 19 77
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.7 ± 2.01 8.2 ± 1.62 14.3 ± 1.66 8.2 ± 1.99 -
    Gender categorical
    Units: Subjects
        Female
    		 11 9 11 8 39
        Male
    		 9 9 9 11 38
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 1 1
        Not Hispanic or Latino
    		 20 18 20 18 76
    Race
    Units: Subjects
        White
    		 17 17 15 18 67
        Black or African American
    		 0 0 1 1 2
        Asian
    		 2 0 3 0 5
        Other
    		 1 1 1 0 3
    Number of Subjects with Investigator Global Assessment (IGA) score of 3 or 4
    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF.
    Units: Subjects
        IGA score of 3
    		 8 1 11 0 20
        IGA score of 4
    		 12 17 9 19 57
    Eczema Area and Severity Index (EASI) score
    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on Safety Analysis set (SAF).
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 34.8 ± 17 32.9 ± 15.53 28.6 ± 14.7 38.8 ± 18.64 -
    Pruritus Numerical Rating Scale (NRS)
    Pruritus NRS scale is an assessment tool that is used to report the intensity of subject’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Weekly average obtained in the 7-day period prior to the baseline visit. Analysis was performed on SAF.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 6.1 ± 2.47 6.4 ± 2.23 6.9 ± 2.21 6.7 ± 2.35 -
    Body Surface Area (BSA) Involvement with Atopic Dermatitis (AD)
    BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF.
    Units: Percentage of body surface area
        arithmetic mean (standard deviation)
    		 52.2 ± 24.78 59 ± 22.49 45.9 ± 25.34 62.3 ± 30.34 -
    SCORing Atopic Dermatitis (SCORAD) Score
    SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23–31. 1993). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 [absent disease] to 103 [severe disease]). Analysis was performed on SAF.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 68 ± 13.19 66.4 ± 13.06 63 ± 14.43 72.7 ± 12.96 -

    End points

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    End points reporting groups
    Reporting group title
    Dupilumab 2mg/kg: Adolescents
    Reporting group description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.

    Reporting group title
    Dupilumab 2mg/kg: Children
    Reporting group description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.

    Reporting group title
    Dupilumab 4mg/kg: Adolescents
    Reporting group description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.

    Reporting group title
    Dupilumab 4mg/kg: Children
    Reporting group description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.

    Primary: Pharmacokinetics (PK) of dupilumab: Maximum plasma concentration observed (Cmax) after single administration

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    End point title
    		 Pharmacokinetics (PK) of dupilumab: Maximum plasma concentration observed (Cmax) after single administration [1]
    End point description
    Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
    End point type
    Primary
    End point timeframe
    Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is descriptive only. No formal statistical comparison was performed.
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20
    18
    20
    19
    Units: mg/L
        arithmetic mean (standard deviation)
    9.91 ± 2.15
    14.3 ± 5.9
    23.1 ± 8.71
    32.4 ± 7.04
    No statistical analyses for this end point

    Primary: PK of dupilumab: Area under the plasma concentration versus time curve (AUClast) after single administration

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    End point title
    		 PK of dupilumab: Area under the plasma concentration versus time curve (AUClast) after single administration [2]
    End point description
    Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
    End point type
    Primary
    End point timeframe
    Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is descriptive only. No formal statistical comparison was performed.
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20 [3]
    18 [4]
    20 [5]
    19 [6]
    Units: Day*mg/L
        arithmetic mean (standard deviation)
    104 ± 99999
    160 ± 99999
    362 ± 99999
    330 ± 99999
    Notes
    [3] - Standard deviation was not calculated
    [4] - Standard deviation was not calculated
    [5] - Standard deviation was not calculated
    [6] - Standard deviation was not calculated
    No statistical analyses for this end point

    Primary: PK of dupilumab: Trough dupilumab concentration in serum (Ctrough) before 3rd and 4th repeated dose

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    End point title
    		 PK of dupilumab: Trough dupilumab concentration in serum (Ctrough) before 3rd and 4th repeated dose [7]
    End point description
    Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.
    End point type
    Primary
    End point timeframe
    Pre-dose on Day 71 and Day 85
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is descriptive only. No formal statistical comparison was performed.
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20
    18
    20
    19
    Units: mg/L
    arithmetic mean (standard deviation)
        Day 71
    10.4 ± 7.16
    17.2 ± 8.44
    32.8 ± 18.9
    42.1 ± 19.4
        Day 85
    18.5 ± 12.4
    28 ± 12.9
    58.5 ± 24.4
    60.3 ± 36.3
    No statistical analyses for this end point

    Secondary: Percent reduction from baseline in Eczema Area and Severity Index (EASI) at Week 12

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    End point title
    		 Percent reduction from baseline in Eczema Area and Severity Index (EASI) at Week 12
    End point description
    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 (one week after last dose)
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20
    18
    20
    19
    Units: percent change
        arithmetic mean (standard deviation)
    -66.4 ± 29.25
    -76.2 ± 25.48
    -69.7 ± 24.48
    -63.4 ± 25.37
    No statistical analyses for this end point

    Secondary: Percent reduction from baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12

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    End point title
    		 Percent reduction from baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12
    End point description
    SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23–31. 1993). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 [absent disease] to 103 [severe disease]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 (one week after last dose)
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20
    18
    20
    19
    Units: percent change
        arithmetic mean (standard deviation)
    -47.7 ± 27.27
    -57.5 ± 23.1
    -43.4 ± 25.38
    -46.9 ± 24.31
    No statistical analyses for this end point

    Secondary: Percent reduction from baseline in Pruritus Numerical Rating Scale (NRS) at Week 12

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    End point title
    		 Percent reduction from baseline in Pruritus Numerical Rating Scale (NRS) at Week 12
    End point description
    Pruritus NRS scale is an assessment tool that is used to report the intensity of subject’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 (one week after last dose)
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20
    18
    20
    19
    Units: Percent change
        arithmetic mean (standard deviation)
    -30.8 ± 68.35
    -41.6 ± 35.32
    -37.6 ± 34.42
    -39.6 ± 40.88
    No statistical analyses for this end point

    Secondary: Percentage of subjects with Investigator Global Assessment (IGA) score of “0” or “1” (clear or almost clear) at Week 12

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    End point title
    		 Percentage of subjects with Investigator Global Assessment (IGA) score of “0” or “1” (clear or almost clear) at Week 12
    End point description
    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    20
    18
    20
    19
    Units: Percentage of subjects
        number (not applicable)
    10
    16.7
    35
    21.1
    No statistical analyses for this end point

    Secondary: Percent reduction from baseline in Body Surface Area (BSA) at week 12

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    End point title
    		 Percent reduction from baseline in Body Surface Area (BSA) at week 12
    End point description
    Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. Analysis was performed on SAF. Here "Number of subjects analyzed" = number of subjects who were evaluated for this specific endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4mg/kg: Adolescents Dupilumab 4mg/kg: Children
    Number of subjects analysed
    19
    16
    19
    19
    Units: Percentage of body surface area
        arithmetic mean (standard deviation)
    -61 ± 31.08
    -70 ± 31.93
    -60.4 ± 34.04
    -50 ± 30.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit [8 weeks after the last dose). Analysis was performed on SAF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Dupilumab 2mg/kg: Adolescents
    Reporting group description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.

    Reporting group title
    Dupilumab 2mg/kg: Children
    Reporting group description
    		 Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.

    Reporting group title
    Dupilumab 4 mg/kg: Adolescents
    Reporting group description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to <18 years.

    Reporting group title
    Dupilumab 4 mg/kg: Children
    Reporting group description
    		 Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period), then 4 repeated doses weekly in subjects aged between ≥6 to <12 years.

    Serious adverse events
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4 mg/kg: Adolescents Dupilumab 4 mg/kg: Children
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    2 / 19 (10.53%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis infected
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    1 / 1
         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
    		 Dupilumab 2mg/kg: Adolescents Dupilumab 2mg/kg: Children Dupilumab 4 mg/kg: Adolescents Dupilumab 4 mg/kg: Children
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 20 (55.00%)
    11 / 18 (61.11%)
    16 / 20 (80.00%)
    18 / 19 (94.74%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Chills
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    4
    0
    0
    2
    Injection site urticaria
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    3
    Injection site swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injection site irritation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Feeling of body temperature change
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Hypersensitivity
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Allergic oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Asthma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    7 / 19 (36.84%)
         occurrences all number
    0
    2
    2
    8
    Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    2
    Nasal disorder
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    1
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Protein urine present
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Contusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hand fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bone contusion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Post procedural inflammation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    3
    Akathisia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    2 / 19 (10.53%)
         occurrences all number
    2
    1
    1
    3
    Lethargy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Syncope
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eosinophilia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    3
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    2 / 20 (10.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    2
    3
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    2 / 20 (10.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    2
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Alopecia areata
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    2 / 20 (10.00%)
    5 / 18 (27.78%)
    3 / 20 (15.00%)
    5 / 19 (26.32%)
         occurrences all number
    2
    11
    6
    10
    Alopecia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin erosion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain of skin
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Solar dermatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitiligo
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Epiphysiolysis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Bacterial disease carrier
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    2
    Croup infectious
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    2 / 20 (10.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    4
    5
    Ear infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 20 (10.00%)
    5 / 18 (27.78%)
    8 / 20 (40.00%)
    10 / 19 (52.63%)
         occurrences all number
    3
    9
    11
    11
    Oral herpes
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    0
    2
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Skin bacterial infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    2
    Skin candida
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    1
    1
    Tonsillitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jun 2015
    Following changes were made: •Changes were made regarding the use of topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) were permitted during the study to avoid subjects being unnecessarily deprived of topical medication. •Clarified the use of prescription moisturizers started prior to the study were permitted to continue during the study, but initiation of prescription moisturizers during the study was not allowed. •Clarified the definition of “childbearing potential” for the purpose of the study, and added a note regarding additional requirement for adequate contraceptive methods in certain countries to avoid ambiguity in the interpretation of the relevant exclusion criterion. •Added assessment of body surface area (BSA) affected by AD, at the same time points other efficacy assessments were being performed; added BSA related secondary endpoint. •Clarified that only subjects with a history of active infection with hepatitis B or C or evidence of active disease at screening were excluded from the study. •Clarified the duration of close monitoring required after study drug administration and assessments performed during the monitoring period. • Added text regarding opportunity for subjects who completed the study to enroll into an open-label extension study to continue Dupilumab treatment. •Reduced the amount of information gathered from subjects on pruritus based on NRS. •Clarified cheek swab sample taken for DNA extraction (removed the options of taking whole blood or saliva sample).

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31595499
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