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    Clinical Trial Results:
    A phase 3 clinical trial to evaluate efficacy and safety of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adolescents 12-17 years of age with moderate to severe chronic hand eczema

    Summary
    EudraCT number
    		 2021-006340-27
    Trial protocol
    		 FR   ES   BE   PL  
    Global end of trial date
    17 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2025
    First version publication date
    03 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0133-1426
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05355818
    WHO universal trial number (UTN)
    		 U1111-1284-2122
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002329-PIP02-20
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adolescents with moderate to severe CHE.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH GCP (2016), including archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 16
    Worldwide total number of subjects
    98
    EEA total number of subjects
    70
    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)
    98
    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
    		 This trial was conducted at sites in 7 countries (Australia, Belgium, Canada, Spain, France, United Kingdom, and Poland).

    Pre-assignment
    Screening details
    		 101 participants were screened; 3 were excluded prior to randomization. Participants were randomized 3:1 to treatment with delgocitinib cream 20 mg/g or cream vehicle.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Delgocitinib Cream 20 mg/g
    Arm description
    		 Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Twice-daily delgocitinib cream 20 mg/g for 16 weeks. Applied topically.

    Arm title
    		 Cream vehicle
    Arm description
    		 Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Cream vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Twice-daily cream vehicle for 16 weeks. Applied topically.

    Number of subjects in period 1
    		Delgocitinib Cream 20 mg/g Cream vehicle
    Started
    74
    24
    Completed
    71
    21
    Not completed
    3
    3
         Adverse event, non-fatal
    1
    1
         Lost to follow-up
    -
    1
         Lack of efficacy
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Delgocitinib Cream 20 mg/g
    Reporting group description
    		 Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.

    Reporting group title
    Cream vehicle
    Reporting group description
    		 Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

    Reporting group values
    		 Delgocitinib Cream 20 mg/g Cream vehicle Total
    Number of subjects
    		 74 24 98
    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)
    		 0 0 0
        Adolescents (12-17 years)
    		 74 24 98
        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)
    		 14.6 ( 1.7 ) 14.7 ( 1.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 12 58
        Male
    		 28 12 40
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 8 0 8
        Not Hispanic or Latino
    		 62 21 83
        Not reported
    		 4 3 7
    Race
    Units: Subjects
        White
    		 69 20 89
        Black or African American
    		 2 0 2
        Asian
    		 1 2 3
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Not reported
    		 2 2 4
    IGA-CHE score
    The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    Units: Subjects
        Clear
    		 0 0 0
        Almost clear
    		 0 0 0
        Mild
    		 0 0 0
        Moderate
    		 56 18 74
        Severe
    		 18 6 24
    HECSI score
    The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 70.9 ( 37.8 ) 76.2 ( 39.7 ) -
    HESD itch score (weekly average)
    The Hand Eczema Symptom Diary (HESD) itch score is one component of the HESD eDiary. In the HESD eDiary, participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. Data is missing for 1 participant in the delgocitinib cream group.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 5.56 ( 2.59 ) 5.91 ( 3.01 ) -
    HESD pain score (weekly average)
    The Hand Eczema Symptom Diary (HESD) pain score is one component of the HESD eDiary. In the HESD eDiary, participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. Data is missing for 1 participant in the delgocitinib cream group.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 5.20 ( 2.75 ) 5.65 ( 3.49 ) -
    HESD score (weekly average)
    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. Data is missing for 1 participant in the delgocitinib cream group.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 5.63 ( 2.26 ) 5.75 ( 3.00 ) -
    CDLQI score
    The Children's Dermatology Life Quality Index (CDLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30).
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 8.5 ( 5.5 ) 9.6 ( 6.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Delgocitinib Cream 20 mg/g
    Reporting group description
    		 Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.

    Reporting group title
    Cream vehicle
    Reporting group description
    		 Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

    Primary: IGA-CHE treatment success at Week 16

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    End point title
    		 IGA-CHE treatment success at Week 16 [1]
    End point description
    The Investigator’s Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject’s CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
    End point type
    Primary
    End point timeframe
    Week 16
    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: The statistical analysis used was the Bayesian method with neither a p-value nor a confidence interval to report.
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    74
    24
    Units: count of participants
    47
    7
    No statistical analyses for this end point

    Secondary: HECSI-90 at Week 16

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    End point title
    		 HECSI-90 at Week 16
    End point description
    The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. The statistical analysis used was the Bayesian method with neither a p-value nor a confidence interval to report.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    74
    24
    Units: count of participants
    53
    9
    No statistical analyses for this end point

    Secondary: Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16

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    End point title
    		 Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16
    End point description
    The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points. The statistical analysis used was the Bayesian method with neither a p-value nor a confidence interval to report.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    54
    19
    Units: count of participants
    35
    7
    No statistical analyses for this end point

    Secondary: Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16

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    End point title
    		 Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16
    End point description
    The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points. The statistical analysis used was the Bayesian method with neither a p-value nor a confidence interval to report.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    49
    15
    Units: count of participants
    31
    5
    No statistical analyses for this end point

    Secondary: Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16

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    End point title
    		 Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16
    End point description
    The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points. The statistical analysis used was the Bayesian method with neither a p-value nor a confidence interval to report.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    54
    16
    Units: count of participants
    30
    5
    No statistical analyses for this end point

    Secondary: IGA-CHE treatment success at Weeks 2, 4, 8, and 12

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    End point title
    		 IGA-CHE treatment success at Weeks 2, 4, 8, and 12
    End point description
    The Investigator’s Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject’s CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
    End point type
    Secondary
    End point timeframe
    Week 2, week 4, week 8, and week 12
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    74
    24
    Units: count of participants
        Week 2
    16
    1
        Week 4
    28
    4
        Week 8
    36
    9
        Week 12
    43
    6
    Statistical analysis title
    		 Statistical analysis - week 2
    Statistical analysis description
    The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.
    Comparison groups
    Cream vehicle v Delgocitinib Cream 20 mg/g
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0054
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    17.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.16
         upper limit
    		 29.78
    Statistical analysis title
    		 Statistical analysis - week 4
    Statistical analysis description
    The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.
    Comparison groups
    Delgocitinib Cream 20 mg/g v Cream vehicle
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0248
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    21.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.69
         upper limit
    		 39.72
    Statistical analysis title
    		 Statistical analysis - week 8
    Statistical analysis description
    The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.
    Comparison groups
    Delgocitinib Cream 20 mg/g v Cream vehicle
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.332
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 33.46
    Statistical analysis title
    		 Statistical analysis - week 12
    Statistical analysis description
    The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.
    Comparison groups
    Delgocitinib Cream 20 mg/g v Cream vehicle
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    33.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.51
         upper limit
    		 53.52

    Secondary: Change in CDLQI score from baseline to Week 16

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    End point title
    		 Change in CDLQI score from baseline to Week 16
    End point description
    The Children's Dermatology Life Quality Index (DDLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    74
    24
    Units: score on a scale
        least squares mean (standard error)
    -5.57 ( 0.44 )
    -2.92 ( 0.78 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).
    Comparison groups
    Delgocitinib Cream 20 mg/g v Cream vehicle
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0038
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.42
         upper limit
    		 -0.88

    Secondary: Number of treatment emergent AEs from baseline up to Week 18

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    End point title
    		 Number of treatment emergent AEs from baseline up to Week 18
    End point description
    An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Number of subjects analysed
    74
    24
    Units: events
    77
    19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Delgocitinib Cream 20 mg/g
    Reporting group description
    		 Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.

    Reporting group title
    Cream vehicle
    Reporting group description
    		 Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

    Serious adverse events
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Delgocitinib Cream 20 mg/g Cream vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 74 (22.97%)
    4 / 24 (16.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 24 (4.17%)
         occurrences all number
    4
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 74 (13.51%)
    4 / 24 (16.67%)
         occurrences all number
    12
    4
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 74 (6.76%)
    0 / 24 (0.00%)
         occurrences all number
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2023
    This amendment was mainly written to change the statistical methodology. Minor clarifications and editorial changes have been made throughout the document.

    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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    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
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