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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-001543-30
    Trial protocol
    		 DE   BE   ES   NL  
    Global end of trial date
    28 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Aug 2021
    First version publication date
    08 Aug 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R3500-AD-1798
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03736967
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, NY, 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
    28 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult subjects with moderate-to-severe atopic dermatitis (AD).
    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 Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2018
    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: 33
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Korea, Republic of: 54
    Country: Number of subjects enrolled
    United States: 46
    Country: Number of subjects enrolled
    Czechia: 28
    Worldwide total number of subjects
    206
    EEA total number of subjects
    106
    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)
    0
    Adults (18-64 years)
    194
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 299 subjects were screened at sites in Republic of Korea, United States of America, Germany, Poland, Czech Republic, Belgium, and Spain. Out of 299 subjects, 206 subjects met eligibility criteria and randomized in this study.

    Pre-assignment
    Screening details
    		 Subjects were randomized in a 1:1:1:1 ratio to 1 of the 4 treatment groups: Placebo every 2 weeks (Q2W); REGN3500 300 milligrams (mg) Q2W; Dupilumab 300 mg Q2W and combination of REGN3500 300 mg and Dupilumab 300 mg Q2W.

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Q2W
    Arm description
    		 Subjects received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matched to REGN3500
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of placebo matched to REGN3500 on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Investigational medicinal product name
    Placebo matched to Dupilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of placebo matched to dupilumab on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Arm title
    		 REGN3500 300 mg Q2W
    Arm description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo matched to Dupilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of placebo matched to dupilumab on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Investigational medicinal product name
    REGN3500
    Investigational medicinal product code
    Other name
    Itepekimab
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of REGN3500 on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Arm title
    		 Dupilumab 300 mg Q2W
    Arm description
    		 Subjects received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo matched to REGN3500
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of placebo matched to REGN3500 on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of Dupilumab on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Arm title
    		 REGN3500 300 mg + Dupilumab 300 mg Q2W
    Arm description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    REGN3500
    Investigational medicinal product code
    REGN3500
    Other name
    Itepekimab
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of REGN3500 on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of Dupilumab on different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms so that the same site was not injected for 2 consecutive administrations.

    Number of subjects in period 1
    		Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Started
    51
    52
    51
    52
    Completed
    20
    24
    27
    22
    Not completed
    31
    28
    24
    30
         Adverse event, serious fatal
    -
    -
    -
    1
         Physician decision
    1
    -
    -
    1
         Consent withdrawn by subject
    26
    25
    23
    26
         Adverse event, non-fatal
    -
    1
    -
    -
         Death
    -
    -
    -
    1
         Randomized but never treated
    1
    -
    -
    -
         Lost to follow-up
    3
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    		 Subjects received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    REGN3500 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.

    Reporting group title
    REGN3500 300 mg + Dupilumab 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.

    Reporting group values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W Total
    Number of subjects
    		 51 52 51 52 206
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 47 51 46 50 194
        From 65-84 years
    		 4 1 5 2 12
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.9 ( 14.04 ) 33.3 ( 12.19 ) 38.4 ( 15.89 ) 32.1 ( 12.10 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 19 16 23 22 80
        Male
    		 32 36 28 30 126
    Race, Customized
    Units: Subjects
        White
    		 26 29 38 31 124
        Black or African American
    		 1 6 3 2 12
        Asian
    		 24 16 10 19 69
        Other
    		 0 1 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 51 48 50 50 199
        Hispanic or Latino
    		 0 2 1 1 4
        Not reported/unknown
    		 0 2 0 1 3
    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, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Full Analysis Set (FAS) includes all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable at baseline. Here N= 50 for "Placebo Q2W" arm.
    Units: Scores on a Scale
        arithmetic mean (standard deviation)
    		 28.2 ( 9.537 ) 29.9 ( 13.02 ) 30.6 ( 13.86 ) 29.0 ( 10.74 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    		 Subjects received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    REGN3500 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14.

    Reporting group title
    REGN3500 300 mg + Dupilumab 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.

    Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 [1]
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and subjects with missing EASI score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, “Number of Subjects Analysed” signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 16
    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: Due to the premature discontinuation of the study, all analyses were change from hypothesis testing to descriptive.
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    19
    14
    22
    20
    Units: Percentage of Change
        arithmetic mean (standard deviation)
    -52.4 ( 31.86 )
    -66.6 ( 22.46 )
    -77.8 ( 23.73 )
    -76.9 ( 20.79 )
    No statistical analyses for this end point

    Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 [2]
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 16
    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: Due to the premature discontinuation of the study, all analyses were change from hypothesis testing to descriptive.
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    23
    23
    26
    24
    Units: Percentage of Change
        arithmetic mean (standard deviation)
    -46.6 ( 36.58 )
    -58.0 ( 29.69 )
    -77.4 ( 22.59 )
    -75.8 ( 19.66 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index- 50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent (%) Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index- 50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent (%) Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of subjects who achieved EASI-50 (≥ 50% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and subjects with missing EASI score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    19
    14
    22
    20
    Units: Percentage of Subjects
        number (not applicable)
    57.9
    78.6
    95.5
    85.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index- 50 (EASI-50) ≥ 50% Improvement From Baseline Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index- 50 (EASI-50) ≥ 50% Improvement From Baseline Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of subjects who achieved EASI-50 (≥ 50% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    23
    23
    26
    24
    Units: Percentage of Subjects
        number (not applicable)
    52.2
    65.2
    96.2
    87.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index- 75 (EASI-75) ≥ 75% Improvement From Baseline Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index- 75 (EASI-75) ≥ 75% Improvement From Baseline Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of subjects who achieved EASI-75 (≥ 75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and subjects with missing EASI score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    19
    14
    22
    20
    Units: Percentage of Subjects
        number (not applicable)
    31.6
    35.7
    63.6
    60.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index- 75 (EASI-75) ≥75% Improvement From Baseline Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index- 75 (EASI-75) ≥75% Improvement From Baseline Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of subjects who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. FAS included all randomized subjects and it was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    23
    23
    26
    24
    Units: Percentage of Subjects
        number (not applicable)
    26.1
    30.4
    61.5
    58.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index- 90 (EASI-90) ≥90% Improvement From Baseline Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index- 90 (EASI-90) ≥90% Improvement From Baseline Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of subjects who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and subjects with missing EASI score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    19
    14
    22
    20
    Units: Percentage of Subjects
        number (not applicable)
    10.5
    28.6
    40.9
    35.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index- 90 (EASI-90) ≥90% Improvement From Baseline Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index- 90 (EASI-90) ≥90% Improvement From Baseline Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of subjects who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    23
    23
    26
    24
    Units: Percentage of Subjects
        number (not applicable)
    8.7
    17.4
    38.5
    29.2
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing and subjects with missing EASI score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    19
    14
    22
    20
    Units: Scores on a Scale
        arithmetic mean (standard deviation)
    -13.25 ( 8.073 )
    -18.94 ( 9.383 )
    -25.40 ( 15.769 )
    -23.28 ( 9.177 )
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    The EASI score was used to measure the severity and extent of 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 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    23
    23
    26
    24
    Units: Scores on a Scale
        arithmetic mean (standard deviation)
    -12.18 ( 9.819 )
    -16.46 ( 10.002 )
    -24.06 ( 14.825 )
    -21.82 ( 9.008 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    IGA was 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 was an IGA score of 0 (clear) or 1 (almost clear). Subjects with both IGA score of "0" or "1"and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and subjects with missing IGA score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    19
    14
    22
    20
    Units: Percentage of Subjects
        number (not applicable)
    21.1
    28.6
    36.4
    35.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    IGA was 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 was an IGA score of 0 (clear) or 1 (almost clear). Subjects with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    23
    23
    26
    24
    Units: Percentage of Subjects
        number (not applicable)
    17.4
    21.7
    38.5
    29.2
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    Pruritus NRS was an assessment tool used to report the intensity of a subject’s pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Subjects were asked the following question: how would you rate your 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]). Absolute change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and subjects with missing NRS score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    15
    12
    17
    14
    Units: Scores on a Scale
        arithmetic mean (standard deviation)
    -2.08 ( 2.825 )
    -2.90 ( 1.781 )
    -3.16 ( 2.607 )
    -3.92 ( 2.433 )
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    Pruritus NRS was an assessment tool used to report the intensity of a subject’s pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Subjects were asked the following question: how would you rate your 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]). Absolute change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    18
    15
    18
    17
    Units: Scores on a Scale
        arithmetic mean (standard deviation)
    -2.11 ( 2.651 )
    -2.87 ( 1.743 )
    -3.19 ( 2.532 )
    -3.64 ( 2.326 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    Pruritus NRS was an assessment tool used to report the intensity of a subject’s pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Subjects were asked the following question: how would you rate your 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]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and subjects with missing NRS score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    15
    12
    17
    14
    Units: Percentage of Change
        arithmetic mean (standard deviation)
    -26.6 ( 36.71 )
    -38.0 ( 22.94 )
    -44.9 ( 35.73 )
    -60.2 ( 34.87 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    Pruritus NRS was an assessment tool used to report the intensity of a subject’s pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Subjects were asked the following question: how would you rate your 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]). Absolute change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    18
    15
    18
    17
    Units: Percentage of Change
        arithmetic mean (standard deviation)
    -27.6 ( 35.04 )
    -37.8 ( 21.88 )
    -45.1 ( 34.68 )
    -55.7 ( 34.22 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Improvement (Reduction from Baseline) of Weekly Average of Peak Daily Pruritus NRS ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects With Improvement (Reduction from Baseline) of Weekly Average of Peak Daily Pruritus NRS ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16
    End point description
    Pruritus NRS was an assessment tool used to report the intensity of a subject’s pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Subjects were asked the following question: how would you rate your 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]). Percentage of subjects with improvement of weekly average of daily peak pruritus NRS from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and subjects with missing NRS score at Week 16 were counted as non-responders. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    15
    12
    17
    14
    Units: Percentage of Subjects
        number (not applicable)
    26.7
    16.7
    35.3
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Improvement (Reduction from Baseline) of Weekly Average of Peak Daily Pruritus NRS ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16

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    End point title
    		 Percentage of Subjects With Improvement (Reduction from Baseline) of Weekly Average of Peak Daily Pruritus NRS ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16
    End point description
    Pruritus NRS was an assessment tool used to report the intensity of a subject’s pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Subjects were asked the following question: how would you rate your 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]). Percentage of subjects with improvement of weekly average of daily peak pruritus NRS from baseline to Week 16 based on all observed values regardless of rescue treatment were reported. FAS included all randomized subjects and was based on the treatment allocated (as randomized). Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    18
    15
    18
    17
    Units: Percentage of Subjects
        number (not applicable)
    27.8
    20.0
    33.3
    41.2
    No statistical analyses for this end point

    Secondary: Time to Onset of Effect on Pruritus (≥4-point reduction of weekly average of daily peak Pruritus NRS from baseline)

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    End point title
    		 Time to Onset of Effect on Pruritus (≥4-point reduction of weekly average of daily peak Pruritus NRS from baseline)
    End point description
    Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Subjects were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    51 [3]
    52 [4]
    51 [5]
    52 [6]
    Units: Hours
        median (full range (min-max))
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [3] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [4] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [5] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [6] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16

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    End point title
    		 Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    51 [7]
    52 [8]
    51 [9]
    52 [10]
    Units: Percentage of change
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    Notes
    [7] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [8] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [9] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [10] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16

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    End point title
    		 Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    51 [11]
    52 [12]
    51 [13]
    52 [14]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    Notes
    [11] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [12] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [13] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [14] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 16

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 16
    End point description
    AE: any untoward medical occurrence in a subject administered a study drug which may/may not have a causal relationship with study drug. Serious AE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-subject hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AEs starting/worsening after first intake of the study drug. TEAEs included: SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; Conjunctivitis and significant ALT elevation. Safety analysis set (SAF) included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to Week 16
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    50
    52
    51
    52
    Units: Subjects
    number (not applicable)
        Subjects with TEAEs
    25
    24
    29
    22
        Subjects with Serious TEAEs
    1
    0
    1
    1
        Subjects with AESIs
    2
    0
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 36

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 36
    End point description
    AE: any untoward medical occurrence in a subject administered a study drug which may/may not have a causal relationship with study drug. Serious AE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-subject hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AEs starting/worsening after first intake of the study drug. TEAEs included: SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; Conjunctivitis and significant ALT elevation. SAF included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    50
    52
    51
    52
    Units: Subjects
    number (not applicable)
        Subjects with TEAEs
    27
    26
    35
    28
        Subjects with Serious TEAEs
    1
    1
    2
    1
        Subjects with AESIs
    2
    0
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Changes From Baseline in Laboratory Parameters

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    End point title
    		 Number of Subjects With Clinically Significant Changes From Baseline in Laboratory Parameters
    End point description
    The laboratory measurements included hematology, blood chemistry, urinalysis and pregnancy testing. Number of subjects with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was decided by investigator. SAF included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    50
    52
    51
    52
    Units: Subjects
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Changes From Baseline in Vital Signs

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    End point title
    		 Number of Subjects With Clinically Significant Changes From Baseline in Vital Signs
    End point description
    Vital sign assessment included blood pressure, heart rate, body temperature and respiration rate. Number of subjects with clinically significant changes form baseline in vital signs were reported. Clinical significance was decided by Investigator. SAF included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    50
    52
    51
    52
    Units: Subjects
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Changes From Baseline in 12-lead Electrocardiogram (ECG)

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    End point title
    		 Number of Subjects With Clinically Significant Changes From Baseline in 12-lead Electrocardiogram (ECG)
    End point description
    ECG recordings included ventricular heart rate, PR interval, QRS interval, corrected QT interval. Number of subjects with clinically significant changes from baseline in ECG were reported. Clinical significance was decided by Investigator. SAF included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    50
    52
    51
    52
    Units: Subjects
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Changes From Baseline in Physical Examination Findings

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    End point title
    		 Number of Subjects With Clinically Significant Changes From Baseline in Physical Examination Findings
    End point description
    Number of subjects with clinically significant changes from baseline in physical examination findings were reported. Clinical significance was decided by Investigator. SAF included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    50
    52
    51
    52
    Units: Subjects
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive Treatment-Emergent Anti-drug Antibodies (ADA) to REGN3500 and Dupilumab

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    End point title
    		 Number of Subjects With Positive Treatment-Emergent Anti-drug Antibodies (ADA) to REGN3500 and Dupilumab
    End point description
    Treatment-Emergent (TE) ADA: any positive post baseline assay response when baseline results were negative/missing. TE ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). The ADA analysis set (AAS) included all subjects who received any study drug and had at least 1 non-missing ADA result in the respective ADA assays, after the first dose of the study drug. Here, “Number of Subjects Analysed” signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to week 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    43
    48
    44
    46
    Units: Subjects
    number (not applicable)
        Treatment-Emergent Response
    0
    0
    3
    6
    No statistical analyses for this end point

    Secondary: Serum Concentration of Functional REGN3500

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    End point title
    		 Serum Concentration of Functional REGN3500
    End point description
    Serum Concentration of Functional REGN3500 was reported. Pharmacokinetic (PK) analysis set included all randomized subjects who received any study drug (active or placebo [safety analysis set]) and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, "n" signifies those subjects who were evaluable at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    0 [15]
    52
    0 [16]
    52
    Units: Milligrams per Liter (mg/L)
    arithmetic mean (standard deviation)
        Week 0: (n = 52, 52)
    ( )
    0 ( 0 )
    ( )
    0.00373 ( 0.0269 )
        Week 2: (n = 52, 51)
    ( )
    22.8 ( 9.06 )
    ( )
    25.2 ( 9.58 )
        Week 4: (n = 48, 46)
    ( )
    41.6 ( 14.8 )
    ( )
    41.9 ( 16.4 )
        Week 8: (n = 39, 43)
    ( )
    58.8 ( 20.5 )
    ( )
    63.0 ( 22.8 )
        Week 12: (n = 30, 36)
    ( )
    67.4 ( 26.7 )
    ( )
    74.5 ( 25.7 )
        Week 16: (n = 16, 21)
    ( )
    73.9 ( 31.4 )
    ( )
    82.4 ( 33.5 )
        Week 20: (n = 9, 15)
    ( )
    33.3 ( 21.9 )
    ( )
    45.1 ( 24.2 )
        Week 24: (n = 8, 11)
    ( )
    13.1 ( 11.9 )
    ( )
    23.3 ( 14.4 )
        Week 28: (n = 5, 11)
    ( )
    7.31 ( 5.49 )
    ( )
    12.3 ( 12.5 )
        Week 32: (n = 6, 10)
    ( )
    4.61 ( 4.48 )
    ( )
    5.43 ( 4.12 )
        Week 36: (n = 7, 11)
    ( )
    2.42 ( 2.70 )
    ( )
    2.79 ( 2.48 )
    Notes
    [15] - Data was reported for REGN3500 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only
    [16] - Data was reported for REGN3500 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only
    No statistical analyses for this end point

    Secondary: Serum Concentration of Functional Dupilumab

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    End point title
    		 Serum Concentration of Functional Dupilumab
    End point description
    Serum Concentration of Functional Dupilumab was reported. PK analysis set included all randomized subjects who received any study drug (active or placebo [safety analysis set]) and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, "n" signifies those subjects who were evaluable at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36
    End point values
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg + Dupilumab 300 mg Q2W
    Number of subjects analysed
    0 [17]
    0 [18]
    51
    52
    Units: mg/L
    arithmetic mean (standard deviation)
        Week 0: (n = 51, 52)
    ( )
    ( )
    0 ( 0 )
    0.00219 ( 0.0158 )
        Week 2: (n = 50, 51)
    ( )
    ( )
    51.4 ( 19.0 )
    50.6 ( 19.0 )
        Week 4: (n = 47, 46)
    ( )
    ( )
    51.5 ( 23.6 )
    57.6 ( 26.1 )
        Week 8: (n = 40, 43)
    ( )
    ( )
    63.0 ( 32.5 )
    64.9 ( 26.3 )
        Week 12: (n = 37, 36)
    ( )
    ( )
    70.4 ( 37.8 )
    69.6 ( 29.2 )
        Week 16: (n = 23, 21)
    ( )
    ( )
    73.4 ( 39.2 )
    71.6 ( 30.9 )
        Week 20: (n = 15, 15)
    ( )
    ( )
    25.8 ( 26.9 )
    28.0 ( 24.8 )
        Week 24: (n = 14, 11)
    ( )
    ( )
    4.36 ( 8.97 )
    6.50 ( 12.5 )
        Week 28: (n = 14, 11)
    ( )
    ( )
    1.47 ( 3.86 )
    2.39 ( 7.93 )
        Week 32: (n = 14, 10)
    ( )
    ( )
    0.0227 ( 0.0850 )
    0 ( 0 )
        Week 36: (n = 11, 11)
    ( )
    ( )
    0 ( 0 )
    0 ( 0 )
    Notes
    [17] - Data was reported for Dupilumab 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only
    [18] - Data was reported for Dupilumab 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only
    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 end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
    Adverse event reporting additional description
    SAF included all randomized subjects who received any study drug and was based on the treatment received (as treated).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    		 Subjects received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    REGN3500 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14.

    Reporting group title
    REGN3500 300 mg and Dupilumab 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14.

    Serious adverse events
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg and Dupilumab 300 mg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    2 / 51 (3.92%)
    1 / 52 (1.92%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Goodpasture's syndrome
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Q2W REGN3500 300 mg Q2W Dupilumab 300 mg Q2W REGN3500 300 mg and Dupilumab 300 mg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 50 (34.00%)
    15 / 52 (28.85%)
    25 / 51 (49.02%)
    20 / 52 (38.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    4
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    2 / 51 (3.92%)
    3 / 52 (5.77%)
         occurrences all number
    0
    1
    3
    3
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    1 / 52 (1.92%)
         occurrences all number
    2
    2
    3
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    7 / 50 (14.00%)
    7 / 52 (13.46%)
    8 / 51 (15.69%)
    10 / 52 (19.23%)
         occurrences all number
    9
    8
    11
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 50 (16.00%)
    5 / 52 (9.62%)
    11 / 51 (21.57%)
    6 / 52 (11.54%)
         occurrences all number
    9
    5
    14
    6
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    3 / 52 (5.77%)
         occurrences all number
    2
    0
    2
    4
    Conjunctivitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    6 / 51 (11.76%)
    1 / 52 (1.92%)
         occurrences all number
    1
    0
    6
    1
    Oral herpes
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    4 / 51 (7.84%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    4
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    0
    3
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Sep 2018
    • Modified exclusion criterion #4 to decrease the length of the washout period from 12 weeks or 5 half-lives • Added an inclusion criteria of an Investigator’s Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at screening and baseline visits • Updated the randomization to include stratification by baseline disease severity (moderate [IGA=3] vs. severe [IGA=4] AD) • As per FDA comments, subject sample was positive in the REGN3500 ADA assay at Week 16 or the first time point analyzed, the Week 4 pharmacokinetic (PK) sample may be analyzed in the anti-drug antibody (ADA) assay • As per FDA request, physical examination added at Week 16
    10 Dec 2018
    • Revised text regarding onsite monitoring after each administration of study drug to indicate that the minimum 30 minutes monitoring may be extended to up to 2 hours as per country-specific requirements • Revised Inclusion Criterion number 1 to add an upper age limit of 75 years • Added text in Exclusion Criterion number 12 to specify that patients with a positive tuberculosis (TB) QuantiFERON test result will be excluded from the study • Added myocardial infarction, unstable arterial hypertension, unstable angina, and cerebrovascular accident as examples of uncontrolled cerebrocardiovascular conditions that will exclude a subject from the study
    23 Jan 2019
    • Added secondary safety and pharmacokinetic (PK) endpoints
    17 Jul 2019
    • The secondary safety endpoints were updated to include “incidence of treatment-emergent anti-drug antibodies (ADA) to REGN3500 and dupilumab over time” to reflect that this endpoint will be analyzed and to align with other ongoing studies in the REGN3500 clinical program • The neutrophil count qualifying for permanent discontinuation of study drug was changed from “≤0.5×10^3 per microliter (mcl)” to “≤1.0×10^3/mcl" • The exclusion criteria were updated to more broadly exclude subjects who have previously participated in any anti-IL-33 antibody class • Language was added to clarify that for the primary endpoint, the analysis will be comparing the REGN3500 300 mg every 2 weeks (Q2W) monotherapy treatment group to the placebo group

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Feb 2020
    The decision was made by the sponsor to terminate the study on 12 Feb 2020 due to lack of efficacy. Study enrollment was not complete at that time, therefore planned sample sizes were not met. Subjects discontinued study drug and transitioned into the post-treatment follow-up period.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As a result of the decision to terminate the study, all statistical analyses were descriptive and no hypothesis testing was performed.
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