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    Clinical Trial Results:
    A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of a twice-daily treatment with delgocitinib cream 20 mg/g as needed for up to 36 weeks in adult subjects with chronic hand eczema (DELTA 3)

    Summary
    EudraCT number
    		 2020-002962-15
    Trial protocol
    		 NL   DE   DK   FR   ES   BE   PL   IT  
    Global end of trial date
    18 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Sep 2024
    First version publication date
    29 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0133-1403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04949841
    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, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure, LEO Pharma A/S, 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
    30 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and International Council for Harmonization (ICH) Good Clinical Practice (GCP) (2016), including archiving of essential documents.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    23 Aug 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: 162
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    Poland: 180
    Country: Number of subjects enrolled
    Spain: 58
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Denmark: 20
    Country: Number of subjects enrolled
    France: 68
    Country: Number of subjects enrolled
    Germany: 215
    Country: Number of subjects enrolled
    Italy: 40
    Worldwide total number of subjects
    801
    EEA total number of subjects
    616
    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)
    735
    From 65 to 84 years
    65
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who completed one of the two phase 3 trials with delgocitinib cream 20 mg/g or cream vehicle (parent trials – Trial 1401 [2020-002960-30] or Trial 1402 [2020-002961-32]) could participate.

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

    Arms
    Arm title
    		 As-needed treatment with delgocitinib
    Arm description
    		 Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. Delgocitinib: Delgocitinib cream 20 mg/g
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Delgocitinib cream 20 mg/g twice daily as needed

    Number of subjects in period 1
    		As-needed treatment with delgocitinib
    Started
    801
    Completed
    664
    Not completed
    137
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    52
         Adverse event, non-fatal
    7
         Pregnancy
    4
         Various reasons
    9
         Lost to follow-up
    9
         Lack of efficacy
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 801 801
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.0 ( 14.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 512 512
        Male
    		 289 289
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 21 21
        Not Hispanic or Latino
    		 752 752
        Unknown or Not Reported
    		 28 28

    End points

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    End points reporting groups
    Reporting group title
    As-needed treatment with delgocitinib
    Reporting group description
    		 Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. Delgocitinib: Delgocitinib cream 20 mg/g

    Primary: Number of treatment-emergent AEs from baseline up to Week 38

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    End point title
    		 Number of treatment-emergent AEs from baseline up to Week 38 [1]
    End point description
    An AE will be considered treatment emergent if it started after the baseline visit.
    End point type
    Primary
    End point timeframe
    From baseline to Week 38
    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: No statistical analyses have been specified for the primary end point as the endpoint investigated safety.
    End point values
    		 As-needed treatment with delgocitinib
    Number of subjects analysed
    801
    Units: events
    1238
    No statistical analyses for this end point

    Secondary: Number of participants with IGA-CHE score at each scheduled visit

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    End point title
    		 Number of participants with IGA-CHE score at each scheduled visit
    End point description
    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 chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    From baseline up to Week 36
    End point values
    		 As-needed treatment with delgocitinib
    Number of subjects analysed
    801
    Units: Number
        At baseline: 0-Clear
    77
        At baseline: 1-Almost clear
    83
        At baseline: 2-Mild
    345
        At baseline: 3-Moderate
    243
        At baseline: 4-Severe
    53
        Week 4: 0-Clear
    58
        Week 4: 1-Almost clear
    76
        Week 4: 2-Mild
    436
        Week 4: 3-Moderate
    189
        Week 4: 4-Severe
    28
        Week 8: 0-Clear
    73
        Week 8: 1- Almost clear
    82
        Week 8: 2-Mild
    413
        Week 8: 3- Moderate
    167
        Week 8: 4- Severe
    25
        Week 12: 0- Clear
    79
        Week 12: 1-Almost Clear
    76
        Week 12: 2-Mild
    414
        Week 12: 3- Moderate
    152
        Week 12: 4- Severe
    18
        Week 16: 0- Clear
    79
        Week 16: 1- Almost clear
    77
        Week 16: 2- Mild
    407
        Week 16: 3- Moderate
    147
        Week 16: 4- Severe
    13
        Week 20: 0- Clear
    72
        Week 20: 1- Almost clear
    90
        Week 20: 2- Mild
    401
        Week 20: 3- Moderate
    123
        Week 20: 4- Severe
    19
        Week 24: 0- Clear
    65
        Week 24: 1- Almost clear
    67
        Week 24: 2- Mild
    415
        Week 24: 3- Moderate
    118
        Week 24: 4- Severe
    15
        Week 28: 0- Clear
    68
        Week 28: 1- Almost clear
    79
        Week 28: 2- Mild
    408
        Week 28: 3- Moderate
    109
        Week 28: 4- Severe
    8
        Week 32: 0- Clear
    71
        Week 32: 1- Almost clear
    67
        Week 32: 2- Mild
    395
        Week 32: 3- Moderate
    118
        Week 32: 4- Severe
    12
        Week 36: 0- Clear
    115
        Week 36: 1- Almost clear
    124
        Week 36: 2- Mild
    300
        Week 36: 3- Moderate
    111
        Week 36: 4- Severe
    13
    No statistical analyses for this end point

    Secondary: Number of participants with IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit

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    End point title
    		 Number of participants with IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit
    End point description
    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 chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    From baseline up to Week 36
    End point values
    		 As-needed treatment with delgocitinib
    Number of subjects analysed
    801
    Units: participants
        Baseline
    160
        Week 4
    134
        Week 8
    155
        Week 12
    155
        Week 16
    156
        Week 20
    162
        Week 24
    132
        Week 28
    147
        Week 32
    138
        Week 36
    239
    No statistical analyses for this end point

    Secondary: HECSI score at each scheduled visit

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    End point title
    		 HECSI score at each scheduled visit
    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).
    End point type
    Secondary
    End point timeframe
    From baseline up to Week 36
    End point values
    		 As-needed treatment with delgocitinib
    Number of subjects analysed
    801
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    30.8 ( 36.5 )
        Week 4
    24.3 ( 27.2 )
        Week 8
    21.4 ( 25.3 )
        Week 12
    20.2 ( 23.9 )
        Week 16
    17.9 ( 21.1 )
        Week 20
    17.8 ( 22.5 )
        Week 24
    17.7 ( 19.6 )
        Week 28
    16.6 ( 19.0 )
        Week 32
    16.9 ( 20.0 )
        Week 36
    15.4 ( 20.6 )
    No statistical analyses for this end point

    Secondary: Number of participants with HECSI-75 at each scheduled visit

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    End point title
    		 Number of participants with HECSI-75 at each scheduled visit
    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). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 36
    End point values
    		 As-needed treatment with delgocitinib
    Number of subjects analysed
    801
    Units: participants
        At baseline
    347
        Week 4
    391
        Week 8
    415
        Week 12
    411
        Week 16
    432
        Week 20
    438
        Week 24
    409
        Week 28
    414
        Week 32
    411
        Week 36
    452
    No statistical analyses for this end point

    Secondary: Number of participants with HECSI-90 at each scheduled visit

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    End point title
    		 Number of participants with HECSI-90 at each scheduled visit
    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). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 36
    End point values
    		 As-needed treatment with delgocitinib
    Number of subjects analysed
    801
    Units: participants
        At baseline
    207
        Week 4
    195
        Week 8
    224
        Week 12
    222
        Week 16
    229
        Week 20
    239
        Week 24
    204
        Week 28
    236
        Week 32
    220
        Week 36
    291
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to week 36
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    As-needed treatment with delgocitinib
    Reporting group description
    		 As-needed treatment with delgocitinib cream 20 mg/g (N=801)

    Serious adverse events
    		 As-needed treatment with delgocitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 801 (3.37%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lipofibroma
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pyogenic granuloma
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Adnexal torsion
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal incarcerated hernia
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Hand dermatitis
         subjects affected / exposed
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paranasal sinus abscess
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis aspergillus
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 As-needed treatment with delgocitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    329 / 801 (41.07%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 801 (2.75%)
         occurrences all number
    27
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    17 / 801 (2.12%)
         occurrences all number
    21
    Hand dermatitis
         subjects affected / exposed
    30 / 801 (3.75%)
         occurrences all number
    34
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    19 / 801 (2.37%)
         occurrences all number
    20
    Infections and infestations
    COVID-19
         subjects affected / exposed
    134 / 801 (16.73%)
         occurrences all number
    138
    Influenza
         subjects affected / exposed
    28 / 801 (3.50%)
         occurrences all number
    28
    Nasopharyngitis
         subjects affected / exposed
    128 / 801 (15.98%)
         occurrences all number
    161
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 801 (4.00%)
         occurrences all number
    36

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2021
    This amendment was written to comply with requests from health authorities, to accommodate for the conduct of the trial in Russia, to add photography of hands at certain visits, and to proceed with administrative and editorial changes.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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