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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Moderate-to-Severe Atopic Hand and Foot Dermatitis

    Summary
    EudraCT number
    		 2019-003088-22
    Trial protocol
    		 DE   PL  
    Global end of trial date
    23 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2023
    First version publication date
    07 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R668-AD-1924
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04417894
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of dupilumab on skin lesions in participants with atopic hand and foot dermatitis
    Protection of trial subjects
    It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 28
    Country: Number of subjects enrolled
    Japan: 13
    Country: Number of subjects enrolled
    Poland: 44
    Country: Number of subjects enrolled
    Germany: 48
    Worldwide total number of subjects
    133
    EEA total number of subjects
    92
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    27
    Adults (18-64 years)
    102
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 170 participants were screened, 37 participants failed screening, and 133 participants were randomized. Of the 37 screen failures: 2 withdrew consent, 33 did not meet inclusion/exclusion criteria, 1 was lost to follow-up and 1 was for an unknown reason.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Matching Placebo
    Arm description
    		 Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC Q2W, following a loading dose on Day 1

    Arm title
    		 dupilumab
    Arm description
    		 Administered SC Q2W, following a loading dose on Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    dupilumab
    Investigational medicinal product code
    REGN668
    Other name
    DUPIXENT® SAR231893
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC Q2W, following a loading dose on Day 1

    Number of subjects in period 1
    		Matching Placebo dupilumab
    Started
    66
    67
    Completed
    53
    60
    Not completed
    13
    7
         Consent withdrawn by subject
    7
    6
         Lost to follow-up
    3
    -
         Lack of efficacy
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Matching Placebo
    Reporting group description
    		 Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1

    Reporting group title
    dupilumab
    Reporting group description
    		 Administered SC Q2W, following a loading dose on Day 1

    Reporting group values
    		 Matching Placebo dupilumab Total
    Number of subjects
    		 66 67 133
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 13 14 27
        Adults (18-64 years)
    		 52 50 102
        From 65-84 years
    		 1 3 4
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.4 ( 14.66 ) 35.8 ( 17.07 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 38 45 83
        Male
    		 28 22 50
    Race (NIH/OMB
    Units: Subjects
        White
    		 53 53 106
        Black or African American
    		 4 3 7
        Asian
    		 8 9 17
        American Indian or Alaska Native
    		 0 1 1
        Other
    		 1 1 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 63 64 127
        Hispanic or Latino
    		 2 3 5
        Unknown
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Matching Placebo
    Reporting group description
    		 Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1

    Reporting group title
    dupilumab
    Reporting group description
    		 Administered SC Q2W, following a loading dose on Day 1

    Subject analysis set title
    Matching Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (as treated) rather than as randomized.

    Subject analysis set title
    Dupilumab 300 mg - Adult Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Adult participants were administered 300 mg SC Q2W, following a loading dose on Day 1

    Subject analysis set title
    Dupilumab 200 mg - Adolescent Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Adolescent participants were administered 200 mg SC Q2W, following a loading dose on Day 1

    Subject analysis set title
    Dupilumab 300 mg - Adolescent Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Adolescent participants were administered 300 mg SC Q2W, following a loading dose on Day 1

    Primary: Percentage of Participants with Hand and Foot IGA 0 or 1 at Week 16

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    End point title
    		 Percentage of Participants with Hand and Foot IGA 0 or 1 at Week 16
    End point description
    IGA is an assessment scale used to determine severity of hand and foot 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. The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of participants
        number (not applicable)
    16.7
    40.3
    Statistical analysis title
    		 Matching placebo vs. dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Mantel-Haenszel
    Confidence interval

    Secondary: Percent Change from Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS

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    End point title
    		 Percent Change from Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
    End point description
    Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of change
        arithmetic mean (standard deviation)
    -19.3 ( 32.91 )
    -56.5 ( 35.28 )
    Statistical analysis title
    		 Matching Placebo vs. dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -36.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.8
         upper limit
    		 -24.61

    Secondary: Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS of ≥4 Points from Baseline to Week 16

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    End point title
    		 Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS of ≥4 Points from Baseline to Week 16
    End point description
    Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of participants
        number (not applicable)
    13.6
    52.2
    Statistical analysis title
    		 Matching placebo vs. dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    38.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.06
         upper limit
    		 53.15

    Secondary: Percentage of Participants with Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 from Baseline to Week 16

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    End point title
    		 Percentage of Participants with Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 from Baseline to Week 16
    End point description
    Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of participants
        number (not applicable)
    16.7
    61.2
    Statistical analysis title
    		 Matching Placebo vs. dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Mean Change from Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement with AD

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    End point title
    		 Mean Change from Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement with AD
    End point description
    The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percent surface area
        least squares mean (standard error)
    -10.01 ( 2.388 )
    -16.70 ( 2.375 )
    Statistical analysis title
    		 Matching Placebo vs dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0067
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -6.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.526
         upper limit
    		 -1.852

    Secondary: Mean Change from Baseline to Week 16 in Weekly Average of Daily Sleep NRS

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    End point title
    		 Mean Change from Baseline to Week 16 in Weekly Average of Daily Sleep NRS
    End point description
    Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep. The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Score on a scale
        least squares mean (standard error)
    -0.00 ( 0.335 )
    0.88 ( 0.334 )
    Statistical analysis title
    		 Matching Placebo vs dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0115
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.199
         upper limit
    		 1.576

    Secondary: Percent Change from Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS

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    End point title
    		 Percent Change from Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
    End point description
    Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of change
        least squares mean (standard error)
    -1.93 ( 0.432 )
    -4.66 ( 0.426 )
    Statistical analysis title
    		 Matching Placebo vs dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.614
         upper limit
    		 -1.844

    Secondary: Percent Change in mTLSS for Hand/Foot Lesions from Baseline to Week 16

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    End point title
    		 Percent Change in mTLSS for Hand/Foot Lesions from Baseline to Week 16
    End point description
    mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of change
        arithmetic mean (standard deviation)
    -24.9 ( 40.01 )
    -63.8 ( 25.68 )
    Statistical analysis title
    		 Matching Placebo vs Dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Proportion of Participants with Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 from Baseline to Week 4

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    End point title
    		 Proportion of Participants with Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 from Baseline to Week 4
    End point description
    Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of participants
        number (not applicable)
    9.1
    34.3
    Statistical analysis title
    		 Matching Placebo vs dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.78
         upper limit
    		 11.98

    Secondary: Percent change from baseline to week 4 in weekly average of daily hand and foot peak Pruritus NRS

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    End point title
    		 Percent change from baseline to week 4 in weekly average of daily hand and foot peak Pruritus NRS
    End point description
    Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of change
        least squares mean (standard error)
    -25.6 ( 5.42 )
    -47.2 ( 5.37 )
    Statistical analysis title
    		 Matching Placebo vs dupilumab
    Comparison groups
    Matching Placebo v dupilumab
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -21.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.43
         upper limit
    		 -10.64

    Secondary: Percent Change from Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants with Hand Dermatitis

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    End point title
    		 Percent Change from Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants with Hand Dermatitis
    End point description
    For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    65
    64
    Units: Percentage of change
        arithmetic mean (standard deviation)
    -33.8 ( 42.21 )
    -68.2 ( 25.56 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with HECSI-90 at Week 16

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    End point title
    		 Percentage of Participants with HECSI-90 at Week 16
    End point description
    HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis. The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    65
    64
    Units: Percentage of participants
        number (not applicable)
    9.2
    18.8
    No statistical analyses for this end point

    Secondary: Proportion of Participants with HECSI-75 at Week 16

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    End point title
    		 Proportion of Participants with HECSI-75 at Week 16
    End point description
    HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis. The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    65
    64
    Units: Percentage of participants
        number (not applicable)
    21.5
    46.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants with HECSI-50 at Week 16

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    End point title
    		 Percentage of Participants with HECSI-50 at Week 16
    End point description
    HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis. The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    65
    64
    Units: Percentage of participants
        number (not applicable)
    30.8
    75.0
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)

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    End point title
    		 Change from Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
    End point description
    For participants with hand dermatitis QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in participants suffering from hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    65
    64
    Units: Score on a scale
        arithmetic mean (standard error)
    -13.36 ( 21.222 )
    -38.70 ( 23.920 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)

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    End point title
    		 Mean Change from Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
    End point description
    WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all. Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Score on a scale
        least squares mean (standard error)
    -21.26 ( 3.761 )
    -36.39 ( 3.649 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-Emergent Anti-Drug Antibody (ADA)

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    End point title
    		 Percentage of Participants with Treatment-Emergent Anti-Drug Antibody (ADA)
    End point description
    The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (as treated) rather than as randomized. Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Up to Week 28
    End point values
    		 Matching Placebo Dupilumab 300 mg - Adult Participants Dupilumab 200 mg - Adolescent Participants Dupilumab 300 mg - Adolescent Participants
    Number of subjects analysed
    55
    49
    6
    6
    Units: Percentage
    number (not applicable)
        Persistent TE Response (n = 55, 49, 6, 6)
    0.0
    4.1
    0.0
    0.0
        Transient TE Response (n = 55, 49, 6, 6)
    1.8
    0.0
    0.0
    0.0
        Indeterminate TE Response (n = 55, 49, 6, 6)
    0.0
    10.2
    0.0
    16.7
    No statistical analyses for this end point

    Secondary: Trough Concentration of Functional Dupilumab in Serum at Various Time Points

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    End point title
    		 Trough Concentration of Functional Dupilumab in Serum at Various Time Points
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 28
    End point values
    		 Dupilumab 300 mg - Adult Participants Dupilumab 200 mg - Adolescent Participants Dupilumab 300 mg - Adolescent Participants
    Number of subjects analysed
    49
    6
    6
    Units: Milligrams per Liter (mg/L)
    arithmetic mean (standard deviation)
        Week 0; (n = 43, 6, 6)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Week 16; (n = 48, 6, 4)
    51.2 ( 22.0 )
    34.0 ( 10.7 )
    37.1 ( 15.9 )
        Week 28; (n = 43, 2, 5)
    7.37 ( 25.0 )
    60.0 ( 84.9 )
    7.54 ( 16.9 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) Through Week 16

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    End point title
    		 Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) Through Week 16
    End point description
    End point type
    Secondary
    End point timeframe
    Through Week 16
    End point values
    		 Matching Placebo dupilumab
    Number of subjects analysed
    66
    67
    Units: Percentage of participants
        number (not applicable)
    74.2
    65.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-Emergent ADA by Maximum Titer Category

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    End point title
    		 Percentage of Participants with Treatment-Emergent ADA by Maximum Titer Category
    End point description
    The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (as treated) rather than as randomized. Here 'n' = number of evaluable participants at a specified point in time.
    End point type
    Secondary
    End point timeframe
    Up to Week 28
    End point values
    		 Matching Placebo Dupilumab 300 mg - Adult Participants Dupilumab 200 mg - Adolescent Participants Dupilumab 300 mg - Adolescent Participants
    Number of subjects analysed
    55
    49
    6
    6
    Units: Percentage
    number (not applicable)
        Low (<1,000)
    1.8
    14.3
    0.0
    16.7
        Moderate (1,000 to 10,000)
    0.0
    0.0
    0.0
    0.0
        High (>10,000)
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to week 28
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Matching Placebo
    Reporting group description
    		 Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1

    Reporting group title
    Dupilumab
    Reporting group description
    		 Administered SC Q2W, following a loading dose on Day 1

    Serious adverse events
    		 Matching Placebo Dupilumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 66 (1.52%)
    3 / 67 (4.48%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Matching Placebo Dupilumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 66 (51.52%)
    33 / 67 (49.25%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 66 (1.52%)
    4 / 67 (5.97%)
         occurrences all number
    1
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    16 / 66 (24.24%)
    6 / 67 (8.96%)
         occurrences all number
    18
    6
    Infections and infestations
    COVID-19
         subjects affected / exposed
    14 / 66 (21.21%)
    11 / 67 (16.42%)
         occurrences all number
    14
    11
    Nasopharyngitis
         subjects affected / exposed
    8 / 66 (12.12%)
    16 / 67 (23.88%)
         occurrences all number
    13
    18
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 66 (4.55%)
    7 / 67 (10.45%)
         occurrences all number
    3
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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