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    Clinical Trial Results:
    A phase 2b, double-blind, randomised, 5-arm, vehicle-controlled, dose-ranging trial to evaluate the efficacy and safety of twice daily topical application of delgocitinib cream 1, 3, 8, and 20 mg/g for 16 weeks in adult subjects with mild to severe chronic hand eczema

    Summary
    EudraCT number
    		 2018-000900-40
    Trial protocol
    		 DK  
    Global end of trial date
    20 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2021
    First version publication date
    12 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LP0133-1273
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03683719
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Disclosure, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.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
    14 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.
    Protection of trial subjects
    This clinical trial was conducted to conform to the principles of the Declaration of Helsinki, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, in compliance with the approved protocol, and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2018
    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
    Denmark: 58
    Country: Number of subjects enrolled
    Germany: 179
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    258
    EEA total number of subjects
    237
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    233
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 258 participants from 26 sites in 3 countries (U.S., Denmark, Germany) were randomised in this trial. The first participant was screened on 28-Nov-2018 and the last participant completed the trial on 20-Apr-2020.

    Pre-assignment
    Screening details
    		 305 participants were screened for this trial. Of these, 47 participants (15.4%) were screening failures. The main reason for screening failure was failure to meet eligibility criteria (11.8%). The eligibility criterion most frequently not met was exclusion criterion 21 (positive HBsAg, HBsAb, HBcAb, or antiHCV serology at screening [3.3%].

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Assessor, Subject
    Blinding implementation details
    This was a double-blind study in which it was not possible to differentiate between the IMPs solely by sensory evaluation. Neither the participant nor any of the investigators or LEO Pharma staff involved in the treatment or clinical evaluation and monitoring of the participants were aware of the treatment received. The packaging and labelling of the IMPs contained no evidence of their identity.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Delgocitinib cream 1 mg/g
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib cream
    Investigational medicinal product code
    Other name
    LEO 124249 cream
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied twice daily for 16 weeks.

    Arm title
    		 Delgocitinib cream 3 mg/g
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib cream
    Investigational medicinal product code
    Other name
    LEO 124249 cream
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied twice daily for 16 weeks.

    Arm title
    		 Delgocitinib cream 8 mg/g
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib cream
    Investigational medicinal product code
    Other name
    LEO 124249 cream
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied twice daily for 16 weeks.

    Arm title
    		 Delgocitinib cream 20 mg/g
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib cream
    Investigational medicinal product code
    Other name
    LEO 124249 cream
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Applied twice daily for 16 weeks.

    Arm title
    		 Delgocitinib cream vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Delgocitinib cream vehicle
    Investigational medicinal product code
    Other name
    LEO 124249 cream
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Participants applied the investigational medicinal product (delgocitinib cream 1, 3, 8, or 20 mg/g or delgocitinib cream vehicle) as a twice daily cutaneous application for 16 weeks. The applications were performed approximately 12 hours apart.

    Number of subjects in period 1
    		Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Started
    52
    51
    52
    53
    50
    Completed
    40
    38
    44
    46
    36
    Not completed
    12
    13
    8
    7
    14
         Consent withdrawn by subject
    4
    4
    3
    5
    5
         Adverse event, non-fatal
    6
    6
    -
    1
    3
         Lost to follow-up
    1
    -
    -
    1
    1
         Other personal reasons
    -
    -
    1
    -
    1
         Lack of efficacy
    1
    3
    4
    -
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Delgocitinib cream 1 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 3 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 8 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 20 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream vehicle
    Reporting group description
    		 -

    Reporting group values
    		 Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle Total
    Number of subjects
    		 52 51 52 53 50 258
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 48 45 46 50 44 233
        From 65-84 years
    		 4 6 6 3 6 25
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.3 ( 13.6 ) 46.1 ( 14.6 ) 47.9 ( 12.9 ) 43.9 ( 15.1 ) 47.8 ( 16.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 28 32 34 27 158
        Male
    		 15 23 20 19 23 100
    Baseline IGA-CHE score
    Units: Subjects
        0 - Clear
    		 0 0 0 0 0 0
        1 - Almost clear
    		 0 0 0 0 0 0
        2 - Mild
    		 13 13 11 12 12 61
        3 - Moderate
    		 29 29 29 31 27 145
        4 - Severe
    		 10 9 12 10 11 52
    Baseline HECSI score
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 59.0 ( 48.0 ) 52.4 ( 35.9 ) 49.5 ( 29.3 ) 65.7 ( 58.3 ) 52.7 ( 34.9 ) -

    End points

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    End points reporting groups
    Reporting group title
    Delgocitinib cream 1 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 3 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 8 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 20 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream vehicle
    Reporting group description
    		 -

    Primary: Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement (IGA-CHE treatment success) from baseline to Week 16.

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    End point title
    		 Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement (IGA-CHE treatment success) from baseline to Week 16.
    End point description
    IGA-CHE is an instrument used in clinical trials to rate the severity of participant's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Primary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    52
    51
    52
    53
    50
    Units: Participants reaching IGA-CHE success
    11
    4
    19
    20
    4
    Statistical analysis title
    		 Delgocitinib cream 1 mg/g vs. vehicle cream
    Statistical analysis description
    The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 1 mg/g
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    13.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 26.24
    Notes
    [1] - The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
    Statistical analysis title
    		 Delgocitinib cream 3 mg/g vs. vehicle cream
    Statistical analysis description
    The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 3 mg/g
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.44
         upper limit
    		 10.39
    Notes
    [2] - The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
    Statistical analysis title
    		 Delgocitinib cream 8 mg/g vs. vehicle cream
    Statistical analysis description
    The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 8 mg/g
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    28.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.8
         upper limit
    		 42.64
    Notes
    [3] - The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
    Statistical analysis title
    		 Delgocitinib cream 20 mg/g vs. vehicle cream
    Statistical analysis description
    The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 20 mg/g
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    29.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.56
         upper limit
    		 44.67
    Notes
    [4] - The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
    Statistical analysis title
    		 Dose-response analysis
    Statistical analysis description
    The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.
    Comparison groups
    Delgocitinib cream 1 mg/g v Delgocitinib cream 3 mg/g v Delgocitinib cream 8 mg/g v Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Multiple contrast test
    Confidence interval
    Notes
    [5] - P-values were adjusted for multiple comparisons. Models with an adjusted p-value <0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.

    Secondary: Change in Hand Eczema Severity Index (HECSI) from baseline to Week 16.

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    End point title
    		 Change in Hand Eczema Severity Index (HECSI) from baseline to Week 16.
    End point description
    HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The highest possible HECSI score is 360.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    52
    51
    52
    53
    50
    Units: Change in HECSI from baseline to Week 16
        least squares mean (standard error)
    -39.81 ( 3.71 )
    -35.93 ( 3.77 )
    -46.69 ( 3.63 )
    -41.99 ( 3.59 )
    -26.40 ( 3.80 )
    Statistical analysis title
    		 Delgocitinib cream 1 mg/g vs. vehicle cream
    Statistical analysis description
    Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows: Change from baseline in HECSI = treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE. The primary comparison between each active delgocitinib dose and vehicle was at Week 16.
    Comparison groups
    Delgocitinib cream 1 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -13.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.82
         upper limit
    		 -4.01
    Notes
    [6] - The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Delgocitinib cream 3 mg/g vs. vehicle cream
    Statistical analysis description
    Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows: Change from baseline in HECSI = treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE. The primary comparison between each active delgocitinib dose and vehicle was at Week 16.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 3 mg/g
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [7]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -9.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.04
         upper limit
    		 -0.02
    Notes
    [7] - The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Delgocitinib cream 8 mg/g vs. vehicle cream
    Statistical analysis description
    Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows: Change from baseline in HECSI = treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE. The primary comparison between each active delgocitinib dose and vehicle was at Week 16.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 8 mg/g
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (net)
    Point estimate
    -20.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.56
         upper limit
    		 -11.02
    Notes
    [8] - The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Delgocitinib cream 20 mg/g vs. vehicle cream
    Statistical analysis description
    Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows: Change from baseline in HECSI = treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE. The primary comparison between each active delgocitinib dose and vehicle was at Week 16.
    Comparison groups
    Delgocitinib cream vehicle v Delgocitinib cream 20 mg/g
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [9]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -15.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.82
         upper limit
    		 -6.36
    Notes
    [9] - The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Dose-response analysis
    Statistical analysis description
    The secondary endpoint "Change from baseline to Week 16 in HECSI score" was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.
    Comparison groups
    Delgocitinib cream 1 mg/g v Delgocitinib cream 3 mg/g v Delgocitinib cream 8 mg/g v Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Multiple contrast test
    Confidence interval
    Notes
    [10] - P-values were adj. for multiple comparisons. Models with an adj. p-value <0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.

    Secondary: Time to IGA-CHE treatment success.

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    End point title
    		 Time to IGA-CHE treatment success.
    End point description
    Time to IGA-CHE treatment success response is defined as the time from baseline to first assessment of an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement. The median time to achieve success in IGA-CHE was not estimable in all groups, as fewer participants (less than 50 percent) reached success in IGA-CHE in delgocitinib cream 1 mg/g, delgocitinib cream 3 mg/g, and delgocitinib cream vehicle. Therefore, values are only reported for delgocitinib cream 8 mg/g and delgocitinib cream 20 mg/g.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    52 [11]
    51 [12]
    52
    53
    50 [13]
    Units: Median time to achieve treatment success
        number (not applicable)
    9999
    9999
    82
    98
    9999
    Notes
    [11] - 9999=number NA. IGA-CHE TS was reached in <50% of participants, therefore median time not estimable
    [12] - 9999=number NA. IGA-CHE TS was reached in <50% of participants, therefore median time not estimable
    [13] - 9999=number NA. IGA-CHE TS was reached in <50% of participants, therefore median time not estimable
    Statistical analysis title
    		 Delgocitinib cream 1 mg/g vs. vehicle cream
    Statistical analysis description
    Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
    Comparison groups
    Delgocitinib cream 1 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 < 0.05 [15]
    Method
    		 Logrank
    Confidence interval
    Notes
    [14] - Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
    [15] - IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable. The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Delgocitinib cream 3 mg/g vs. vehicle cream
    Statistical analysis description
    Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
    Comparison groups
    Delgocitinib cream 3 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 > 0.1 [17]
    Method
    		 Logrank
    Confidence interval
    Notes
    [16] - Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
    [17] - IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable. The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Delgocitinib cream 8 mg/g vs. vehicle cream
    Statistical analysis description
    Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
    Comparison groups
    Delgocitinib cream 8 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    P-value
    		 < 0.0001 [19]
    Method
    		 Logrank
    Confidence interval
    Notes
    [18] - Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
    [19] - The statistical test was not controlled for multiplicity.
    Statistical analysis title
    		 Delgocitinib cream 20 mg/g vs. vehicle cream
    Statistical analysis description
    Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 < 0.01 [21]
    Method
    		 Logrank
    Confidence interval
    Notes
    [20] - Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
    [21] - The statistical test was not controlled for multiplicity.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
    Adverse event reporting additional description
    At all visits/phone call, the participants were asked a non-leading question by the investigator about AEs, for example: “How have you felt since I saw you last?” No specific symptoms were to be asked for.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Delgocitinib cream 1 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 3 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 8 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream 20 mg/g
    Reporting group description
    		 -

    Reporting group title
    Delgocitinib cream vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness postural
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pemphigoid
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Delgocitinib cream 1 mg/g Delgocitinib cream 3 mg/g Delgocitinib cream 8 mg/g Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 52 (38.46%)
    25 / 51 (49.02%)
    25 / 52 (48.08%)
    26 / 53 (49.06%)
    24 / 50 (48.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    6 / 52 (11.54%)
    4 / 53 (7.55%)
    2 / 50 (4.00%)
         occurrences all number
    2
    4
    7
    5
    2
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    5 / 52 (9.62%)
    4 / 51 (7.84%)
    3 / 52 (5.77%)
    6 / 53 (11.32%)
    8 / 50 (16.00%)
         occurrences all number
    5
    5
    7
    7
    9
    Pruritus
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 51 (3.92%)
    1 / 52 (1.92%)
    3 / 53 (5.66%)
    1 / 50 (2.00%)
         occurrences all number
    3
    2
    1
    3
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    2 / 52 (3.85%)
    3 / 53 (5.66%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    2
    3
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 52 (17.31%)
    15 / 51 (29.41%)
    15 / 52 (28.85%)
    14 / 53 (26.42%)
    20 / 50 (40.00%)
         occurrences all number
    11
    22
    16
    20
    20
    Influenza
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    4 / 53 (7.55%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    0
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2018
    The main reason for the amendment was to add an exclusion criterion to ensure that participants who previously participated in a clinical trial with delgocitinib were not allowed to participate in this trial. The amendment was approved prior to first participant first visit.
    07 Dec 2018
    The main reason for the amendment was to address comments to the protocol received from the U.S. Food and Drug Administration (FDA). Exclusion criterion 1 was revised to ensure exclusion of participants with a diagnosis of tinea manuum. The participant’s Global Assessment of disease severity (PaGa) scale was updated. The Patient Global Impression of Change (PGI-C) questionnaire was added as a PRO to support the planned psychometric properties analyses. A tuberculosis test was added to further safeguard participants in risk of (re)activation of latent tuberculosis. Participant assessment of local tolerability (stinging/burning) was added as an active safety assessment. Miscellaneous other changes/updates have also been implemented.

    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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