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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
    		 2021-006902-61
    Trial protocol
    		 PL  
    Global end of trial date
    30 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2024
    First version publication date
    08 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARQ-151-311
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04773587
    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,, United States, 91361
    Public contact
    Arcutis Medical Information, Arcutis Biotherapeutics, Inc., +1 (844) 692-6729, information@arcutis.com
    Scientific contact
    Arcutis Medical Information, Arcutis Biotherapeutics, Inc., +1 (844) 692-6729, 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
    30 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this study was to 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 was a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects 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
    12 Jan 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: 24
    Country: Number of subjects enrolled
    Canada: 132
    Country: Number of subjects enrolled
    United States: 498
    Worldwide total number of subjects
    654
    EEA total number of subjects
    24
    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)
    130
    Adolescents (12-17 years)
    166
    Adults (18-64 years)
    324
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at 65 centers in the United States, 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 with mild to moderate AD applied roflumilast cream 0.15% once daily (QD) for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast cream 0.15%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Applied to affected areas QD for 4 weeks

    Arm title
    		 Vehicle Cream
    Arm description
    		 Participants with mild to moderate AD applied 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
    Applied to affected areas QD for 4 weeks.

    Number of subjects in period 1
    		Roflumilast Cream 0.15% Vehicle Cream
    Started
    433
    221
    Completed
    404
    208
    Not completed
    29
    13
         Consent withdrawn by subject
    4
    5
         Consent withdrawn due to AE
    1
    -
         Adverse event, non-fatal
    6
    3
         Lost to follow-up
    11
    3
         Noncompliance
    1
    -
         Lack of efficacy
    5
    2
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Roflumilast Cream 0.15%
    Reporting group description
    		 Participants with mild to moderate AD applied roflumilast cream 0.15% once daily (QD) for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants with mild to moderate AD applied vehicle cream QD for 4 weeks.

    Reporting group values
    		 Roflumilast Cream 0.15% Vehicle Cream Total
    Number of subjects
    		 433 221 654
    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)
    		 88 42 130
        Adolescents (12-17 years)
    		 112 54 166
        Adults (18-64 years)
    		 209 115 324
        From 65-84 years
    		 24 10 34
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.1 ( 19.14 ) 28.5 ( 18.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 237 129 366
        Male
    		 196 92 288
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 99 56 155
        Not Hispanic or Latino
    		 333 164 497
        Unknown or Not reported
    		 1 1 2
    Race
    Units: Subjects
        White
    		 261 129 390
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 63 32 95
        Native Hawaiian or other Pacific Islander
    		 1 0 1
        Black or African American
    		 80 46 126
        Multiple
    		 12 6 18
        Other
    		 14 8 22
    validated Investigator's Global Assessment Scale for Atopic Dermatitis (vIGA-AD)
    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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.
    Units: Subjects
        Mild
    		 103 59 162
        Moderate
    		 330 162 492

    End points

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    End points reporting groups
    Reporting group title
    Roflumilast Cream 0.15%
    Reporting group description
    		 Participants with mild to moderate AD applied roflumilast cream 0.15% once daily (QD) for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants with mild to moderate AD applied 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 astatic evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear),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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    32.0 (27.79 to 36.63)
    15.2 (11.06 to 20.64)
    Statistical analysis title
    		 Difference in vIGA-AD Success at Week 4
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.881
         upper limit
    		 4.647
    Notes
    [1] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    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 (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. All randomized participants who were included in the "moderate" baseline vIGA-AD group during randomization are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    328
    164
    Units: percentage of participants
        number (confidence interval 95%)
    35.0 (29.97 to 40.36)
    17.5 (12.38 to 24.13)
    Statistical analysis title
    		 Difference in vIGA-AD Success at Week 4
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.15%
    Number of subjects included in analysis
    492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.64
         upper limit
    		 4.359
    Notes
    [2] - Stratified by pooled study site with multiple imputation of missing observations

    Secondary: Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

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    End point title
    		 Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4
    End point description
    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 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 ≥12 years of age with a baseline WI-NRS ≥4 are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    278
    135
    Units: percentage of participants
        number (confidence interval 95%)
    33.6 (28.19 to 39.41)
    20.7 (14.61 to 28.58)
    Statistical analysis title
    		 WI-NRS Success at Week 4
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0089 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.186
         upper limit
    		 3.319
    Notes
    [3] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    Secondary: Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

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    End point title
    		 Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4
    End point description
    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 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 ≥12 years of age with a baseline WI-NRS ≥4 are included.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    278
    135
    Units: percentage of participants
        number (confidence interval 95%)
    23.8 (19.14 to 29.24)
    9.8 (5.79 to 16.03)
    Statistical analysis title
    		 WI-NRS Success at Week 2
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.15%
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.45
         upper limit
    		 5.457

    Secondary: Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

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    End point title
    		 Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4
    End point description
    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 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 ≥12 years of age with a baseline WI-NRS ≥4 are included.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Roflumilast Cream 0.15% Vehicle Cream
    Number of subjects analysed
    278
    135
    Units: percentage of participants
        number (confidence interval 95%)
    9.5 (6.60 to 13.60)
    2.3 (0.77 to 6.41)
    Statistical analysis title
    		 WI-NRS Success at Week 1
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.15%
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0159 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.161
         upper limit
    		 12.511
    Notes
    [4] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

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

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    End point title
    		 Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
    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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    43.2 (38.54 to 47.94)
    22.0 (16.97 to 28.04)
    Statistical analysis title
    		 EASI-75 at Week 4
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.15%
    Number of subjects included in analysis
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.102
         upper limit
    		 4.795
    Notes
    [5] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    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 at Week 4 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 (0 'clear' to 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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    41.5 (36.93 to 46.25)
    25.2 (19.91 to 31.41)
    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
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.707
         upper limit
    		 3.843
    Notes
    [6] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    Secondary: Achievement of vIGA-AD Success at Week 2

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    End point title
    		 Achievement of vIGA-AD Success at Week 2
    End point description
    The percentage of participants achieving "success" on the VIGA-AD at Week 2 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 (0 'clear' to 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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    21.2 (17.57 to 25.33)
    6.4 (3.84 to 10.44)
    Statistical analysis title
    		 vIGA-AD Success at Week 2
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.15%
    Number of subjects included in analysis
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.31
         upper limit
    		 7.926

    Secondary: Achievement of vIGA-AD Success at Week 1

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    End point title
    		 Achievement of vIGA-AD Success at Week 1
    End point description
    The percentage of participants achieving "success" on the VIGA-AD at Week 1 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 (0 'clear' to 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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    8.1 (5.87 to 11.03)
    0.5 (0.08 to 2.52)
    Statistical analysis title
    		 vIGA-AD Success at Week 1
    Comparison groups
    Roflumilast Cream 0.15% v Vehicle Cream
    Number of subjects included in analysis
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    25.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.815
         upper limit
    		 229.388
    Notes
    [7] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    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 at Week 2 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 (0 'clear' to 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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    31.8 (27.58 to 36.38)
    13.6 (9.72 to 18.79)
    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
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.217
         upper limit
    		 5.911
    Notes
    [8] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    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 at Week 1 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 (0 'clear' to 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
    433
    221
    Units: percentage of participants
        number (confidence interval 95%)
    14.3 (11.33 to 17.93)
    5.9 (3.47 to 9.80)
    Statistical analysis title
    		 vIGA-AD 'Clear' or 'Almost Clear' at Week 1
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.15%
    Number of subjects included in analysis
    654
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.705
         upper limit
    		 7.007
    Notes
    [9] - Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to approximately 29 days
    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 with mild to moderate AD applied roflumilast cream 0.15% QD for 4weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants with mild to moderate AD applied 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 nonserious adverse events meeting the cutoff threshold.
    Serious adverse events
    		 Roflumilast Cream 0.15% Vehicle Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 433 (0.92%)
    0 / 221 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 221 (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 / 433 (0.00%)
    0 / 221 (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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