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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients with Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-001544-64
    Trial protocol
    		 DE   GB   ES   HU  
    Global end of trial date
    24 Jul 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    R3500-AD-1805
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03738423
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd., 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
    24 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to assess the efficacy of REGN3500 monotherapy in atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult subjects with moderate-to-severe 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
    13 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: 3
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Czechia: 18
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Japan: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 25
    Country: Number of subjects enrolled
    United States: 48
    Worldwide total number of subjects
    129
    EEA total number of subjects
    40
    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)
    122
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 238 subjects were screened at centers in North America (United States of America and Canada), Europe (Czech Republic, Germany, Hungary, Spain, and Poland), and Asia Pacific (Republic of Korea, Japan, and Australia). Out of which, 129 subjects met eligibility criteria and were randomized in this study.

    Pre-assignment
    Screening details
    		 Subjects were randomized in 1:1:1:1:1 ratio to 1 of the 5 treatment groups: Placebo every 2 weeks (Q2W); REGN3500 30 milligrams (mg) every 8 weeks (Q8W); REGN3500 100 mg every 4 weeks (Q4W); REGN3500 300 mg Q4W and REGN3500 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
    		 Investigator, Monitor, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Q2W
    Arm description
    		 Subjects received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 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.

    Arm title
    		 REGN3500 30 mg Q8W
    Arm description
    		 Subjects received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 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
    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.

    Arm title
    		 REGN3500 100 mg Q4W
    Arm description
    		 Subjects received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 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
    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.

    Arm title
    		 REGN3500 300 mg Q4W
    Arm description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 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
    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.

    Arm title
    		 REGN3500 300 mg Q2W
    Arm description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 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
    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.

    Number of subjects in period 1
    		Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Started
    25
    26
    27
    25
    26
    Treated
    25
    26
    26
    24
    26
    Completed
    11
    13
    14
    10
    11
    Not completed
    14
    13
    13
    15
    15
         Adverse event, serious fatal
    -
    -
    -
    -
    1
         Consent withdrawn by subject
    9
    12
    9
    12
    10
         Physician decision
    -
    -
    1
    -
    1
         Lost to follow-up
    1
    -
    1
    1
    -
         Randomized but never treated
    -
    -
    1
    1
    -
         Lack of efficacy
    3
    1
    1
    1
    2
         Protocol deviation
    1
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    		 Subjects received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.

    Reporting group title
    REGN3500 30 mg Q8W
    Reporting group description
    		 Subjects received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.

    Reporting group title
    REGN3500 100 mg Q4W
    Reporting group description
    		 Subjects received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.

    Reporting group title
    REGN3500 300 mg Q4W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.

    Reporting group title
    REGN3500 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.

    Reporting group values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W Total
    Number of subjects
    		 25 26 27 25 26 129
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.6 ( 14.22 ) 36.0 ( 16.41 ) 37.0 ( 14.48 ) 35.6 ( 12.56 ) 38.8 ( 15.44 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 13 12 14 15 68
        Male
    		 11 13 15 11 11 61
    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. The Full Analysis Set (FAS) includes all randomized subjects and was based on the treatment allocated (as randomized). Here, N = 24 for "REGN3500 300 mg Q4W" arm.
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    		 30.3 ( 11.88 ) 29.8 ( 12.00 ) 33.6 ( 11.01 ) 27.7 ( 10.68 ) 32.7 ( 15.13 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    		 Subjects received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.

    Reporting group title
    REGN3500 30 mg Q8W
    Reporting group description
    		 Subjects received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.

    Reporting group title
    REGN3500 100 mg Q4W
    Reporting group description
    		 Subjects received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.

    Reporting group title
    REGN3500 300 mg Q4W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.

    Reporting group title
    REGN3500 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 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 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. 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 statistical analyses were changed from hypothesis testing to descriptive.
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    10
    7
    7
    7
    9
    Units: Percentage of Change
        arithmetic mean (standard deviation)
    -33.5 ( 41.81 )
    -57.9 ( 31.65 )
    -52.7 ( 46.64 )
    -80.0 ( 10.54 )
    -54.0 ( 36.80 )
    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 statistical analyses were changed from hypothesis testing to descriptive.
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    12
    10
    8
    9
    10
    Units: Percentage of Change
        arithmetic mean (standard deviation)
    -18.9 ( 52.01 )
    -46.0 ( 45.35 )
    -48.7 ( 44.66 )
    -67.0 ( 28.74 )
    -56.1 ( 35.32 )
    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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    10
    7
    7
    7
    9
    Units: Percentage of Subjects
        number (not applicable)
    30.0
    71.4
    71.4
    100
    55.6
    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% 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) (Greater Than or Equal to [≥] 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    12
    10
    8
    9
    10
    Units: Percentage of Subjects
        number (not applicable)
    25.0
    60.0
    62.5
    77.8
    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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    10
    7
    7
    7
    9
    Units: Percentage of Subjects
        number (not applicable)
    20.0
    28.6
    28.6
    71.4
    44.4
    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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    12
    10
    8
    9
    10
    Units: Percentage of Subjects
        number (not applicable)
    16.7
    30.0
    25.0
    55.6
    40.0
    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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    10
    7
    7
    7
    9
    Units: Percentage of Subjects
        number (not applicable)
    10.0
    14.3
    28.6
    28.6
    33.3
    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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    12
    10
    8
    9
    10
    Units: Percentage of Subjects
        number (not applicable)
    8.3
    20.0
    25.0
    22.2
    30.0
    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 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
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    10
    7
    7
    7
    9
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -7.80 ( 10.225 )
    -14.64 ( 8.489 )
    -14.81 ( 12.614 )
    -18.19 ( 6.298 )
    -13.79 ( 9.534 )
    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, 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 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
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    12
    10
    8
    9
    10
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -4.10 ( 13.079 )
    -12.07 ( 11.764 )
    -13.83 ( 12.000 )
    -15.15 ( 8.299 )
    -14.68 ( 9.410 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 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 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). Percentage of 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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    10
    7
    7
    7
    9
    Units: Percentage of Subjects
        number (not applicable)
    10.0
    0.0
    28.6
    42.9
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Both 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 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). Percentage of 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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    12
    10
    8
    9
    10
    Units: Percentage of Subjects
        number (not applicable)
    8.3
    0.0
    25.0
    33.3
    30.0
    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 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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    9
    7
    7
    7
    8
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -0.53 ( 1.583 )
    -2.95 ( 3.791 )
    -4.22 ( 2.372 )
    -3.34 ( 2.628 )
    -3.12 ( 3.896 )
    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 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    11
    10
    8
    9
    8
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -0.51 ( 1.430 )
    -2.56 ( 3.563 )
    -4.19 ( 2.198 )
    -2.69 ( 2.799 )
    -3.12 ( 3.896 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in in Weekly Average of Daily Peak 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 in Weekly Average of Daily Peak 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    9
    7
    7
    7
    8
    Units: Percent Change
        arithmetic mean (standard deviation)
    -6.1 ( 20.65 )
    -31.6 ( 39.01 )
    -53.1 ( 29.65 )
    -43.1 ( 36.42 )
    -32.2 ( 47.46 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in in Weekly Average of Daily Peak 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 in Weekly Average of Daily Peak 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]). Percent 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 Analysed” signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    11
    10
    8
    9
    8
    Units: Percent Change
        arithmetic mean (standard deviation)
    -5.9 ( 18.62 )
    -27.5 ( 39.24 )
    -52.8 ( 27.47 )
    -33.9 ( 38.71 )
    -32.2 ( 47.46 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Improvement in Weekly Average of Peak Daily Pruritus NRS Score ≥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 in Weekly Average of Peak Daily Pruritus NRS Score ≥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 score ≥4 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    9
    7
    7
    7
    8
    Units: Percentage of Subjects
        number (not applicable)
    0.0
    42.9
    57.1
    28.6
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Improvement in Weekly Average of Daily Peak Pruritus NRS Score ≥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 in Weekly Average of Daily Peak Pruritus NRS Score ≥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 score ≥4 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    11
    10
    8
    9
    8
    Units: Percentage of Subjects
        number (not applicable)
    0.0
    40.0
    62.5
    22.2
    50.0
    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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25 [3]
    26 [4]
    27 [5]
    25 [6]
    26 [7]
    Units: Hours
        median (full range (min-max))
    99999 (99999 to 99999)
    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
    [7] - 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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25 [8]
    26 [9]
    27 [10]
    25 [11]
    26 [12]
    Units: Percent of change
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    Notes
    [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
    [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
    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 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25 [13]
    26 [14]
    27 [15]
    25 [16]
    26 [17]
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    Notes
    [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
    [15] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [16] - Due to premature discontinuation, all analyses were changed to descriptive and were not summarized
    [17] - 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) 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) 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 serious TEAEs and Non-serious TEAEs. 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
    Baseline up to Week 16
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
        Subjects with TEAEs
    9
    13
    12
    9
    15
        Subjects with Serious TEAEs
    0
    0
    0
    0
    2
        Subjects with AESIs
    0
    0
    1
    0
    0
    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) 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) 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 serious TEAEs and Non-serious TEAEs. 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
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
        Subjects with TEAEs
    11
    14
    14
    13
    15
        Subjects with Serious TEAEs
    0
    0
    0
    1
    2
        Subjects with AESIs
    0
    0
    1
    0
    0
    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
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
    0
    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
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
    0
    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
    The ECG recordings included ventricular heart rate, PR interval, QRS interval and 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
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Ophthalmological Symptoms Reported as TEAEs

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    End point title
    		 Number of Subjects With Ophthalmological Symptoms Reported as TEAEs
    End point description
    Number of subjects with ophthalmological symptoms (conjunctivitis, blepharitis, or keratitis) assessed as TEAEs were reported. 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
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
        Conjunctivitis
    0
    1
    0
    1
    0
        Conjunctivitis allergic
    0
    0
    0
    1
    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
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    25
    26
    26
    24
    26
    Units: Subjects
    0
    0
    0
    0
    0
    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 [18]
    End point description
    Serum Concentration of Functional REGN3500 was reported. The Pharmacokinetic (PK) analysis set included all randomized subjects who received any study drug 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
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Pharmacokinetic (PK) analysis set only included all randomized subjects who received any study drug and who had at least 1 non-missing study drug concentration result following the first dose of study drug.
    End point values
    		 REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    26
    26
    24
    26
    Units: Milligrams per Liter (mg/L)
    arithmetic mean (standard deviation)
        Week 0: (n = 26, 26, 24, 26)
    0 ( 0 )
    0.157 ( 0.800 )
    0 ( 0 )
    0 ( 0 )
        Week 2: (n = 25, 25, 22, 25)
    3.29 ( 2.70 )
    7.35 ( 5.65 )
    21.4 ( 9.83 )
    22.0 ( 11.0 )
        Week 4: (n = 22, 21, 23, 21)
    2.33 ( 1.82 )
    5.14 ( 3.73 )
    14.3 ( 7.05 )
    37.9 ( 15.2 )
        Week 8: (n = 19, 20, 22, 15)
    1.41 ( 1.99 )
    9.27 ( 5.33 )
    23.3 ( 10.4 )
    51.4 ( 20.7 )
        Week 12: (n = 14, 14, 17, 13)
    2.63 ( 2.20 )
    8.74 ( 6.37 )
    30.3 ( 12.0 )
    57.7 ( 26.3 )
        Week 16: (n = 11, 11, 12, 13)
    1.05 ( 0.733 )
    10.6 ( 4.91 )
    35.2 ( 17.3 )
    60.8 ( 33.3 )
        Week 20: (n = 13, 8, 9, 9)
    0.523 ( 0.441 )
    5.03 ( 3.93 )
    12.4 ( 6.58 )
    29.8 ( 23.5 )
        Week 24: (n = 8, 6, 8, 7)
    0.170 ( 0.157 )
    2.23 ( 1.24 )
    7.14 ( 5.22 )
    12.1 ( 14.4 )
        Week 28: (n = 8, 6, 6, 7)
    0.0838 ( 0.109 )
    1.08 ( 0.813 )
    3.49 ( 2.76 )
    6.70 ( 7.64 )
        Week 32: (n = 8, 6, 6, 8)
    0.0171 ( 0.0484 )
    0.625 ( 0.560 )
    1.93 ( 1.37 )
    3.73 ( 5.41 )
        Week 36: (n = 8, 6, 6, 7)
    0 ( 0 )
    0.299 ( 0.250 )
    0.960 ( 0.741 )
    1.02 ( 1.31 )
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)
    End point description
    Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or 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 Anti-drug Antibodies (ADA) analysis set included all treated subjects who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing anti-REGN3500 result following the first dose of study drug or placebo.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 36
    End point values
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Number of subjects analysed
    24
    25
    25
    22
    24
    Units: Subjects
        TE Persistent
    0
    0
    0
    0
    0
        TE Transient
    0
    0
    0
    0
    0
        TE Indeterminate
    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
    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 participants 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 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.

    Reporting group title
    REGN3500 30 mg Q8W
    Reporting group description
    		 Subjects received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.

    Reporting group title
    REGN3500 100 mg Q4W
    Reporting group description
    		 Subjects received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.

    Reporting group title
    REGN3500 300 mg Q4W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.

    Reporting group title
    REGN3500 300 mg Q2W
    Reporting group description
    		 Subjects received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.

    Serious adverse events
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    2 / 26 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Q2W REGN3500 30 mg Q8W REGN3500 100 mg Q4W REGN3500 300 mg Q4W REGN3500 300 mg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 25 (28.00%)
    11 / 26 (42.31%)
    9 / 26 (34.62%)
    8 / 24 (33.33%)
    10 / 26 (38.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    0
    0
    2
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    0
    0
    1
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    1
    0
    2
    Nausea
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 25 (12.00%)
    8 / 26 (30.77%)
    5 / 26 (19.23%)
    5 / 24 (20.83%)
    6 / 26 (23.08%)
         occurrences all number
    3
    9
    5
    5
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    4 / 26 (15.38%)
    2 / 24 (8.33%)
    3 / 26 (11.54%)
         occurrences all number
    0
    2
    4
    2
    3
    Bronchitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    0
    3
    Cellulitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    0
    2
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2018
    - Modified exclusion criterion #4 to decrease the length of the washout period from 12 weeks to 4 weeks before the baseline visit for immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma [IFN-gamma], Janus kinase inhibitors, azathioprine, methotrexate, etc) and phototherapy. These washout changes were consistent with the prior dupilumab adult atopic dermatitis phase 3 studies (eg, R668-AD-1224) and acceptable for subjects enrolled in this study - Updated exclusion criterion #11 to be consistent with prior dupilumab adult atopic dermatitis phase 3 studies (eg, R668-AD-1224). Active chronic or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks (was previously 8 weeks before the screening visit) before the baseline visit, or superficial skin infections within 1 week (was previously 4 weeks before the screening visit) before the baseline visit
    29 Nov 2018
    - Added text in Exclusion Criterion #12 to specify that subjects with a positive tuberculosis (TB) QuantiFERON test result will be excluded from the study - Exclusion Criterion # 20: 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 - Exclusion Criterion #25: Added clarification that the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient, based on Clinical Trial Facilitation Group guideline on contraception
    03 Jan 2019
    - Added secondary safety and pharmacokinetic (PK) endpoints

    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.
    For support, Contact us.
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