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    Clinical Trial Results:
    A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects with Atopic Dermatitis

    Summary
    EudraCT number
    		 2021-006884-67
    Trial protocol
    		 PL  
    Global end of trial date
    29 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2025
    First version publication date
    24 Jan 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ARQ-151-312
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04773600
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 135681
    Sponsors
    Sponsor organisation name
    Arcutis Biotherapeutics, Inc.
    Sponsor organisation address
    3027 Townsgate Rd #300, Westlake Village, CA, United States, 91361
    Public contact
    Arcutis Medical Information, Arcutis Biotherapeutics, Inc., +1 8446926729, information@arcutis.com
    Scientific contact
    Arcutis Medical Information, Arcutis Biotherapeutics, Inc., +1 8446926729, information@arcutis.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
    29 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.
    Protection of trial subjects
    This study was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice, and all applicable local laws/regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 74
    Country: Number of subjects enrolled
    Canada: 160
    Country: Number of subjects enrolled
    United States: 449
    Worldwide total number of subjects
    683
    EEA total number of subjects
    74
    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)
    187
    Adolescents (12-17 years)
    132
    Adults (18-64 years)
    333
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at sites in the US, Canada, and Poland.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Roflumilast Cream 0.15%
    Arm description
    		 Participants applied roflumilast cream 0.15% qd for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast cream 0.15%
    Investigational medicinal product code
    Other name
    ARQ-151
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Roflumilast cream 0.15% for topical application

    Arm title
    		 Vehicle Cream
    Arm description
    		 Participants apply vehicle cream qd for 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Vehicle cream for topical application

    Number of subjects in period 1
    		Roflumilast Cream 0.15% Vehicle Cream
    Started
    451
    232
    Completed
    410
    211
    Not completed
    41
    21
         Consent withdrawn by subject
    15
    9
         Physician decision
    -
    1
         Adverse event, non-fatal
    8
    2
         Caregiver elected other therapy
    1
    -
         Lost to follow-up
    10
    6
         Emergency travel out of country
    1
    -
         Lack of efficacy
    2
    3
         Noncompliance
    2
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Roflumilast Cream 0.15%
    Reporting group description
    		 Participants applied roflumilast cream 0.15% qd for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants apply vehicle cream qd for 4 weeks.

    Reporting group values
    		 Roflumilast Cream 0.15% Vehicle Cream Total
    Number of subjects
    		 451 232 683
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 126 61 187
        Adolescents (12-17 years)
    		 80 52 132
        Adults (18-64 years)
    		 225 108 333
        From 65-84 years
    		 20 11 31
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27.7 ( 19.60 ) 26.2 ( 18.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 252 143 395
        Male
    		 199 89 288
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 51 16 67
        Not Hispanic or Latino
    		 397 213 610
        Unknown or Not Reported
    		 3 3 6
    Race
    Units: Subjects
        White
    		 268 138 406
        Black or African- American
    		 96 50 146
        Asian
    		 51 30 81
        American-Indian or Alaska Native
    		 5 1 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Multiple
    		 12 8 20
        other
    		 19 5 24
    Verified viGA Analyzed Baseline Score
    viGA-AD is a 5-point scale assessing the severity of AD, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. This is the baseline viGA data that have undergone data verification by the investigator.
    Units: Subjects
        Mild
    		 108 53 161
        Moderate
    		 343 179 522
    Baseline EASI Score
    EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head {10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
    Units: Units on a scale
        median (inter-quartile range (Q1-Q3))
    		 8.50 (6.2 to 12.3) 8.4 (6.45 to 12.00) -

    End points

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    End points reporting groups
    Reporting group title
    Roflumilast Cream 0.15%
    Reporting group description
    		 Participants applied roflumilast cream 0.15% qd for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants apply vehicle cream qd for 4 weeks.

    Primary: Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4

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    End point title
    		 Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
    End point description
    The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Primary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of participants
        number (confidence interval 95%)
    28.9 (24.83 to 33.40)
    12.0 (8.35 to 16.91)
    Statistical analysis title
    		 viGA Success at Week 4
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.962
         upper limit
    		 5.183
    Notes
    [1] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores

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    End point title
    		 Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores
    End point description
    The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    342
    179
    Units: Percentage of participants
        number (not applicable)
    32.9
    13.1
    Statistical analysis title
    		 viGA Success at Week 4 (Moderate Baseline)
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.996
         upper limit
    		 5.687
    Notes
    [2] - Stratified by pooled study site

    Secondary: Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants with Baseline WI-NRS Score ≥4

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    End point title
    		 Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants with Baseline WI-NRS Score ≥4
    End point description
    The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    264
    136
    Units: Percentage of participants
        number (confidence interval 95%)
    30.2 (24.77 to 36.31)
    12.4 (7.77 to 19.26)
    Statistical analysis title
    		 ≥4-Point Reduction in WI-NRS at Week 4
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0014 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.448
         upper limit
    		 5.066
    Notes
    [3] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of a 4-point Reduction at Week 2 in the Average, Weekly WI-NRS in Participants with Baseline WI-NRS Score ≥4

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    End point title
    		 Achievement of a 4-point Reduction at Week 2 in the Average, Weekly WI-NRS in Participants with Baseline WI-NRS Score ≥4
    End point description
    The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    264
    136
    Units: Percentage of participants
        number (confidence interval 95%)
    22.3 (17.66 to 27.82)
    6.9 (3.66 to 12.56)
    Statistical analysis title
    		 ≥4-Point Reduction in WI-NRS at Week 2
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0015 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.591
         upper limit
    		 7.927
    Notes
    [4] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of a 4-Point Reduction at Week 1 in the WI-NRS in Participants with Baseline WI-NRS ≥4

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    End point title
    		 Achievement of a 4-Point Reduction at Week 1 in the WI-NRS in Participants with Baseline WI-NRS ≥4
    End point description
    The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity). All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    264
    136
    Units: Percentage of participants
        number (confidence interval 95%)
    11.2 (7.89 to 15.57)
    1.6 (0.44 to 5.58)
    Statistical analysis title
    		 ≥4-Point Reduction in WI-NRS at Week 1
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    400
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.717
         upper limit
    		 35.764
    Notes
    [5] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of ≥75% Decrease from Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75)

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    End point title
    		 Achievement of ≥75% Decrease from Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75)
    End point description
    The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ~75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum =of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of participants
        number (confidence interval 95%)
    42.0 (37.45 to 46.72)
    19.7 (15.04 to 25.44)
    Statistical analysis title
    		 EASI-75 at Week 4
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.108
         upper limit
    		 4.964
    Notes
    [6] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4

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    End point title
    		 Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4
    End point description
    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of participants
        number (not applicable)
    39.0
    16.9
    Statistical analysis title
    		 vIGA-AD 'Clear' or 'Almost Clear' at Week 4
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.191
         upper limit
    		 5.24
    Notes
    [7] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2

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    End point title
    		 Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2
    End point description
    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of participants
        number (not applicable)
    27.6
    10.7
    Statistical analysis title
    		 vIGA-AD 'Clear' or 'Almost Clear' at Week 2
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.097
         upper limit
    		 5.854
    Notes
    [8] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1

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    End point title
    		 Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1
    End point description
    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of participants
        number (not applicable)
    14.2
    6.2
    Statistical analysis title
    		 vIGA-AD 'Clear' or 'Almost Clear' at Week 1
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.312
         upper limit
    		 4.993
    Notes
    [9] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: vIGA Success at Week 2

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    End point title
    		 vIGA Success at Week 2
    End point description
    The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of participants
        number (confidence interval 95%)
    17.7 (14.40 to 21.55)
    5.3 (3.06 to 9.01)
    Statistical analysis title
    		 vIGA Success at Week 2
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.281
         upper limit
    		 8.568
    Notes
    [10] - Stratified by pooled study site and vIGA-AD randomization strata

    Secondary: vIGA Success at Week 1

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    End point title
    		 vIGA Success at Week 1
    End point description
    The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as 0 = "clear'; 1 = "almost clear"; 2 = "mild"; 3 = "moderate"; and 4 = "severe"), with higher scores indicative of greater symptom severity. All randomized participants are included.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    451
    232
    Units: Percentage of Participants
        number (confidence interval 95%)
    5.9 (4.04 to 8.46)
    3.1 (1.52 to 6.29)
    Statistical analysis title
    		 vIGA Success at Week 1
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1156 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.832
         upper limit
    		 4.782
    Notes
    [11] - Stratified by pooled study site and vIGA-AD randomization strata

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to ~29 days
    Adverse event reporting additional description
    All randomized participants who received ≥1 dose of study intervention are included, according to actual treatment received. Note that 1 participant was randomized to vehicle but did not receive ≥1 dose of study treatment; one additional participant was randomized to vehicle but instead received active roflumilast.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Roflumilast Cream 0.15%
    Reporting group description
    		 Participants applied roflumilast cream 0.15% qd for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants apply vehicle cream qd for 4 weeks.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious events occurring in greater than 5% of participants in any arm.
    Serious adverse events
    		 Roflumilast Cream 0.15% Vehicle Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 452 (0.88%)
    0 / 230 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Nerve compression
         subjects affected / exposed
    1 / 452 (0.22%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 452 (0.22%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 452 (0.22%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal scalded skin syndrome
         subjects affected / exposed
    1 / 452 (0.22%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Roflumilast Cream 0.15% Vehicle Cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 452 (0.00%)
    0 / 230 (0.00%)

    More information

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

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

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