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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 0.05% Administered QD in Subjects with Atopic Dermatitis

    Summary
    EudraCT number
    		 2021-006903-14
    Trial protocol
    		 PL  
    Global end of trial date
    01 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2026
    First version publication date
    18 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARQ-151-315
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04804605
    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 8054185006, information@arcutis.com
    Scientific contact
    Arcutis Medical Information, Arcutis Biotherapeutics, Inc., +1 8054185006, 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
    01 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study assessed the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).
    Protection of trial subjects
    This study was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice, and all applicable local laws/regulation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 447
    Country: Number of subjects enrolled
    Poland: 152
    Country: Number of subjects enrolled
    Canada: 53
    Worldwide total number of subjects
    652
    EEA total number of subjects
    152
    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)
    652
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who were 2 to 5 years of age at Screening with atopic dermatitis (AD) were recruited in Canada, Poland, and the United States.

    Pre-assignment
    Screening details
    		 Male and female participants 2 to 5 years of age with atopic dermatitis for at least 6 weeks were recruited.

    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 0.05%
    Arm description
    		 Participants applied roflumilast cream 0.05% qd for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast Cream 0.05%
    Investigational medicinal product code
    Other name
    ARQ-151
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Roflumilast cream for topical application.

    Arm title
    		 Vehicle Cream
    Arm description
    		 Participants 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
    Vehicle cream matched to roflumilast cream for topical application.

    Number of subjects in period 1
    		Roflumilast Cream 0.05% Vehicle Cream
    Started
    437
    215
    Completed
    410
    192
    Not completed
    27
    23
         Physician decision
    2
    1
         Consent withdrawn by subject
    11
    10
         Adverse event, non-fatal
    5
    4
         Lost to follow-up
    5
    4
         Lack of efficacy
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Roflumilast Cream 0.05%
    Reporting group description
    		 Participants applied roflumilast cream 0.05% qd for 4 weeks.

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

    Reporting group values
    		 Roflumilast Cream 0.05% Vehicle Cream Total
    Number of subjects
    		 437 215 652
    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)
    		 437 215 652
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.3 ( 1.09 ) 3.2 ( 1.10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 211 99 310
        Male
    		 226 116 342
    Race
    Units: Subjects
        White
    		 295 156 451
        Black or African American
    		 68 32 100
        Asian
    		 37 17 54
        Multiple
    		 28 4 32
        Other
    		 8 4 12
        American Indian or Alaska native
    		 1 2 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 82 31 113
        Not Hispanic or Latino
    		 352 184 536
        Not reported
    		 3 0 3

    End points

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    End points reporting groups
    Reporting group title
    Roflumilast Cream 0.05%
    Reporting group description
    		 Participants applied roflumilast cream 0.05% qd for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants 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 with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline. All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
    End point type
    Primary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: percentage of participants
        number (confidence interval 97.5%)
    25.4 (20.95 to 30.34)
    10.7 (6.77 to 16.45)
    Statistical analysis title
    		 vIGA Success at Week 4
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.89
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.648
         upper limit
    		 5.064
    Notes
    [1] - Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations

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

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    End point title
    		 Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD
    End point description
    The percentage of participants with vIGA-AD success at Week 4 who had 'moderate' vIGA-AD score (vIGA score of 3) at baseline is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline in participants with moderate vIGA-AD baseline. All randomized participants with a baseline vIGA score of 'moderate' are included.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    333
    171
    Units: percentage of participants
        number (confidence interval 97.5%)
    27.7 (22.55 to 33.62)
    11.0 (6.67 to 17.73)
    Statistical analysis title
    		 vIGA Success at Week 4 'Moderate' baseline scores
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.662
         upper limit
    		 5.772
    Notes
    [2] - Multiple imputation of missing observations

    Secondary: Achievement of 75% Reduction in the Eczema Area and Severity Index(EASI-75) at Week 4 in Participants With 'Moderate' Baseline vIGA

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    End point title
    		 Achievement of 75% Reduction in the Eczema Area and Severity Index(EASI-75) at Week 4 in Participants With 'Moderate' Baseline vIGA
    End point description
    The percentage of participants with a moderate baseline vIGA-AD score who achieved EASI-75 is presented. 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. All randomized participants are included, with the exception of 1 participant in the Roflumilast Cream 0.05% arm who was inadvertently treated prior to randomization and thus excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: percentage of participants
        number (confidence interval 97.5%)
    39.4 (34.21 to 44.81)
    20.6 (15.06 to 27.55)
    Statistical analysis title
    		 EASI-75 at Week 4
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.47
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.578
         upper limit
    		 3.87
    Notes
    [3] - Stratified by randomized baseline vIGA-AD 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 with vIGA-AD score of 'clear' or 'almost clear' at Week 4 is presented. The vIGA is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: percentage of participant
        number (confidence interval 97.5%)
    35.4 (30.39 to 40.66)
    14.6 (9.94 to 20.86)
    Statistical analysis title
    		 vIGA Score of 'Clear' or 'Almost Clear' at Week 4
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.29
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 5.475
    Notes
    [4] - Stratified by randomized baseline vIGA-AD 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 with vIGA-AD success at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline. All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: percentage of participants
        number (confidence interval 97.5%)
    21.2 (17.13 to 25.98)
    6.8 (3.85 to 11.88)
    Statistical analysis title
    		 vIGA Success at Week 2
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.74
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.912
         upper limit
    		 7.313
    Notes
    [5] - Stratified by baseline vIGA-AD with multiple imputation of missing observations

    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 with vIGA-AD success at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-gradeimprovement from baseline. All randomized participants are included, 1 participant in the Roflumilast Cream 0.05%arm was inadvertently treated prior to randomization and thus excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: Percentage of Participants
        number (confidence interval 97.5%)
    9.4 (6.72 to 13.02)
    0.9 (0.22 to 3.88)
    Statistical analysis title
    		 vIGA-AD Success at Week 1
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.44
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 2.216
         upper limit
    		 59.101
    Notes
    [6] - Stratified by randomized baseline vIGA-AD with multiple imputation of missing data

    Secondary: Achievement of vIGA-AD of ‘Clear’ or ‘Almost Clear’ at Week 2

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    End point title
    		 Achievement of vIGA-AD of ‘Clear’ or ‘Almost Clear’ at Week 2
    End point description
    The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity). All randomized participants are included, 1 participant in the Roflumilast Cream 0.05%arm was inadvertently treated prior to randomization and thus excluded from analysis
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: Percentage of Participants
        number (confidence interval 97.5%)
    30.4 (25.67 to 35.58)
    10.6 (6.74 to 16.42)
    Statistical analysis title
    		 vIGA-AD of Clear or Almost Clear at Week 2
    Comparison groups
    Vehicle Cream v Roflumilast Cream 0.05%
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.8
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 2.137
         upper limit
    		 6.761
    Notes
    [7] - Stratified by randomized baseline vIGA-AD with multiple imputation of missing data

    Secondary: Achievement of vIGA-AD of ‘Clear’ or ‘Almost Clear’ at Week 1

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    End point title
    		 Achievement of vIGA-AD of ‘Clear’ or ‘Almost Clear’ at Week 1
    End point description
    The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity). All randomized participants are included, 1 participant in the Roflumilast Cream 0.05%arm was inadvertently treated prior to randomization and thus excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Roflumilast Cream 0.05% Vehicle Cream
    Number of subjects analysed
    436
    215
    Units: Percentage of Participants
        number (confidence interval 97.5%)
    17.00 (13.32 to 21.37)
    3.7 (1.73 to 7.83)
    Statistical analysis title
    		 vIGA-AD of Clear or Almost Clear at Week 1
    Comparison groups
    Roflumilast Cream 0.05% v Vehicle Cream
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.75
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 2.342
         upper limit
    		 14.113
    Notes
    [8] - Stratified by baseline vIGA-AD with multiple imputation of missing data

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to ~6 weeks
    Adverse event reporting additional description
    All treated participants are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Roflumilast Cream 0.05%
    Reporting group description
    		 Participants applied roflumilast cream 0.05% qd for 4 weeks.

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Participants 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: No events met the 5% reporting cutoff in any arm.
    Serious adverse events
    		 Roflumilast Cream 0.05% Vehicle Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 437 (0.23%)
    0 / 215 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Cellulitis
         subjects affected / exposed
    1 / 437 (0.23%)
    0 / 215 (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 0.05% Vehicle Cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 437 (0.00%)
    0 / 215 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2021
    The primary purposes of AM1 were to update Sponsor address.
    10 Apr 2023
    The primary purpose of AM2 was to modify the hierarchical order of secondary endpoints.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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