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    Clinical Trial Results:
    A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis

    Summary
    EudraCT number
    		 2021-006885-19
    Trial protocol
    		 PL  
    Global end of trial date
    28 May 2024

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ARQ-151-313
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    28 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
    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
    25 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
    Canada: 221
    Country: Number of subjects enrolled
    United States: 773
    Country: Number of subjects enrolled
    Poland: 226
    Worldwide total number of subjects
    1220
    EEA total number of subjects
    226
    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)
    825
    Adolescents (12-17 years)
    219
    Adults (18-64 years)
    156
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were rolled over upon completion of parent studies ARQ-151-311 (NCT04773587), ARQ-151-312 (NCT03638258), and ARQ-151-315 (NCT04845620). Rollovers from 311/312 were analyzed separately from 315 rollovers.

    Pre-assignment
    Screening details
    		 Participants with atopic dermatitis were enrolled at 153 sites in the United States (US), Canada, and Poland.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARQ-151-311/312:RC/RC 0.15% Group
    Arm description
    		 Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast Cream
    Investigational medicinal product code
    Other name
    ARQ-151
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied once daily for up to 52 weeks.

    Arm title
    		 ARQ-151-311/312:VC/RC 0.15% Group
    Arm description
    		 Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast Cream
    Investigational medicinal product code
    Other name
    ARQ-151
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied once daily for up to 52 weeks.

    Arm title
    		 ARQ-151-315: RC/RC 0.05% or 0.15% Group
    Arm description
    		 Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast Cream
    Investigational medicinal product code
    Other name
    ARQ-151
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied once daily for up to 52 weeks.

    Arm title
    		 ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Arm description
    		 Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6years of age, and were then switched to 0.15%.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast Cream
    Investigational medicinal product code
    Other name
    ARQ-151
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied once daily for up to 52 weeks.

    Number of subjects in period 1 [1]
    		ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Started
    439
    218
    382
    180
    Completed
    289
    145
    254
    123
    Not completed
    150
    73
    128
    57
         Consent withdrawn by subject
    46
    26
    37
    21
         Physician decision
    3
    -
    5
    -
         Adverse event, non-fatal
    10
    10
    10
    7
         Miscellaneous
    7
    3
    4
    2
         Lost to follow-up
    47
    21
    30
    17
         Lack of efficacy
    28
    11
    37
    8
         Protocol deviation
    1
    -
    -
    1
         Noncompliance
    8
    2
    5
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant discontinued from the ARQ-151-311/312 VC/RC 0.15% arm prior to treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARQ-151-311/312:RC/RC 0.15% Group
    Reporting group description
    		 Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.

    Reporting group title
    ARQ-151-311/312:VC/RC 0.15% Group
    Reporting group description
    		 Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.

    Reporting group title
    ARQ-151-315: RC/RC 0.05% or 0.15% Group
    Reporting group description
    		 Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.

    Reporting group title
    ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Reporting group description
    		 Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6years of age, and were then switched to 0.15%.

    Reporting group values
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group Total
    Number of subjects
    		 439 218 382 180 1219
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 183 79 382 180 824
        Adolescents (12-17 years)
    		 140 79 0 0 219
        Adults (18-64 years)
    		 105 51 0 0 156
        From 65-84 years
    		 11 9 0 0 20
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.4 ( 16.4 ) 20.5 ( 17.9 ) 3.4 ( 1.11 ) 3.43 ( 1.17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 244 122 185 91 642
        Male
    		 195 96 197 89 577
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 75 34 70 25 204
        Not Hispanic or Latino
    		 361 182 310 155 1008
        Not Reported
    		 3 2 2 0 7
    Race
    Units: Subjects
        American Indian or Alaska native
    		 6 0 1 1 8
        Asian
    		 63 35 30 15 143
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 0 1
        Black or African American
    		 58 31 58 22 169
        White
    		 272 139 262 137 810
        Multiple
    		 20 7 25 3 55
        Not Reported
    		 19 6 6 2 33

    End points

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    End points reporting groups
    Reporting group title
    ARQ-151-311/312:RC/RC 0.15% Group
    Reporting group description
    		 Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.

    Reporting group title
    ARQ-151-311/312:VC/RC 0.15% Group
    Reporting group description
    		 Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.

    Reporting group title
    ARQ-151-315: RC/RC 0.05% or 0.15% Group
    Reporting group description
    		 Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.

    Reporting group title
    ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Reporting group description
    		 Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6years of age, and were then switched to 0.15%.

    Primary: Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)

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    End point title
    		 Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) [1]
    End point description
    The number of participants with ≥1 TEAE(s) is reported. All treated participants are included.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Number of subjects analysed
    439
    218
    382
    180
    Units: Participants
    151
    90
    189
    91
    No statistical analyses for this end point

    Primary: Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment

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    End point title
    		 Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment [2]
    End point description
    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 score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-weekcohorts. All participants in the safety analysis are included.
    End point type
    Primary
    End point timeframe
    Weeks 4, 12, 24, 36, and 52
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Number of subjects analysed
    439
    218
    382
    180
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    40.1 (35.61 to 44.83)
    35.7 (29.60 to 42.36)
    37.7 (32.98 to 42.77)
    40.8 (33.88 to 48.20)
        Week 12
    42.2 (37.42 to 47.08)
    36.9 (30.55 to 43.68)
    40.0 (35.10 to 45.07)
    53.0 (45.62 to 60.25)
        Week 24
    48.2 (43.25 to 53.18)
    46.3 (39.27 to 53.48)
    46.4 (41.25 to 51.54)
    54.3 (46.72 to 61.75)
        Week 36
    45.5 (38.75 to 52.33)
    49.6 (39.36 to 59.82)
    42.5 (37.31 to 47.82)
    47.6 (39.94 to 55.45)
        Week 52
    47.9 (40.82 to 55.07)
    45.0 (34.99 to 55.41)
    50.4 (44.86 to 55.99)
    56.9 (48.53 to 64.83)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With vIGA-AD Success

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    End point title
    		 Percentage of Participants With vIGA-AD Success
    End point description
    The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. All participants in the safety analysis are included.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12, 24, 36, and 52
    End point values
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Number of subjects analysed
    439
    218
    382
    180
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    30.8 (26.65 to 35.33)
    7.8 (4.86 to 12.23)
    28.7 (24.38 to 33.48)
    11.1 (7.32 to 16.57)
        Week 12
    33.7 (29.25 to 38.46)
    15.8 (11.46 to 21.48)
    29.5 (25.12 to 34.33)
    24.9 (19.01 to 31.93)
        Week 24
    39.7 (35.02 to 44.67)
    21.6 (16.30 to 28.15)
    36.1 (31.31 to 41.13)
    24.1 (18.16 to 31.22)
        Week 36
    37.4 (31.01 to 44.30)
    23.5 (15.60 to 33.77)
    34.4 (29.50 to 39.61)
    22.4 (16.45 to 29.70)
        Week 52
    42.7 (35.78 to 50.01)
    24.2 (16.20 to 34.53)
    42.5 (37.11 to 48.15)
    28.5 (21.41 to 36.79)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study

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    End point title
    		 Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
    End point description
    Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"), with lower scores indicating reduced symptom severity and vice versa. All participants who were ≥12 years of age at the start of the parent studies are included.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12, 24, 36, and 52
    End point values
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Number of subjects analysed
    256
    139
    0 [3]
    0 [4]
    Units: WI-NRS Score Change
    arithmetic mean (standard deviation)
        Week 4
    -2.1 ( 2.80 )
    -0.3 ( 2.23 )
    ( )
    ( )
        Week 12
    -2.4 ( 3.05 )
    -0.2 ( 2.65 )
    ( )
    ( )
        Week 24
    -2.7 ( 2.85 )
    -0.8 ( 2.69 )
    ( )
    ( )
        Week 36
    -2.6 ( 2.81 )
    -0.3 ( 2.40 )
    ( )
    ( )
        Week 52
    -3.2 ( 2.85 )
    -1.2 ( 2.41 )
    ( )
    ( )
    Notes
    [3] - Not included due to age ≤12 years at the start of parent study.
    [4] - Not included due to age ≤12 years at the start of parent study.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in EASI Score

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    End point title
    		 Percent Change From Baseline in EASI Score
    End point description
    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 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. All participants with data available are included.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12, 24, 36, and 52
    End point values
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC 0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Number of subjects analysed
    439
    218
    382
    180
    Units: Percent change in EASI score
    arithmetic mean (standard deviation)
        Week 4
    -63.23 ( 39.702 )
    -36.93 ( 63.272 )
    -59.51 ( 40.684 )
    -41.29 ( 53.042 )
        Week 12
    -68.39 ( 34.195 )
    -17.95 ( 152.845 )
    -62.02 ( 49.438 )
    -16.11 ( 241.787 )
        Week 24
    -72.81 ( 34.462 )
    -33.34 ( 116.997 )
    -71.04 ( 36.124 )
    -32.65 ( 16.532 )
        Week 36
    -73.81 ( 31.300 )
    -39.20 ( 104.744 )
    -69.75 ( 40.467 )
    -39.39 ( 148.094 )
        Week 52
    -74.57 ( 35.160 )
    -27.94 ( 137.809 )
    -77.78 ( 35.095 )
    -52.36 ( 74.751 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 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
    ARQ-151-311/312:RC/RC 0.15% Group
    Reporting group description
    		 Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.

    Reporting group title
    ARQ-151-311/312:VC/RC 0.15% Group
    Reporting group description
    		 Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.

    Reporting group title
    ARQ-151-315: RC/RC0.05% or 0.15% Group
    Reporting group description
    		 Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.

    Reporting group title
    ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Reporting group description
    		 Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6years of age, and were then switched to 0.15%.

    Serious adverse events
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 439 (1.14%)
    3 / 218 (1.38%)
    12 / 382 (3.14%)
    6 / 180 (3.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Abscess jaw
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penetrating abdominal trauma
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 439 (0.00%)
    1 / 218 (0.46%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Application site cellulitis
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    2 / 382 (0.52%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 439 (0.00%)
    1 / 218 (0.46%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 439 (0.00%)
    1 / 218 (0.46%)
    2 / 382 (0.52%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    1 / 382 (0.26%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 439 (0.23%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 439 (0.00%)
    0 / 218 (0.00%)
    0 / 382 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ARQ-151-311/312:RC/RC 0.15% Group ARQ-151-311/312:VC/RC 0.15% Group ARQ-151-315: RC/RC0.05% or 0.15% Group ARQ-151-315: VC/RC 0.05% or 0.15% Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 439 (4.10%)
    12 / 218 (5.50%)
    82 / 382 (21.47%)
    40 / 180 (22.22%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 439 (0.91%)
    1 / 218 (0.46%)
    18 / 382 (4.71%)
    10 / 180 (5.56%)
         occurrences all number
    4
    1
    18
    10
    Infections and infestations
    COVID-19
         subjects affected / exposed
    18 / 439 (4.10%)
    12 / 218 (5.50%)
    13 / 382 (3.40%)
    5 / 180 (2.78%)
         occurrences all number
    18
    12
    13
    5
    Influenza
         subjects affected / exposed
    7 / 439 (1.59%)
    3 / 218 (1.38%)
    10 / 382 (2.62%)
    11 / 180 (6.11%)
         occurrences all number
    7
    3
    10
    11
    Nasopharyngitis
         subjects affected / exposed
    12 / 439 (2.73%)
    8 / 218 (3.67%)
    23 / 382 (6.02%)
    5 / 180 (2.78%)
         occurrences all number
    12
    8
    23
    5
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 439 (2.05%)
    12 / 218 (5.50%)
    33 / 382 (8.64%)
    16 / 180 (8.89%)
         occurrences all number
    9
    12
    33
    16

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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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    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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