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    Clinical Trial Results:
    A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis (AD).

    Summary
    EudraCT number
    		 2021-000404-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2022
    First version publication date
    27 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0133-1181
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03826901
    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 Specialist, LEO Pharma A/S, 0045 4494 5888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, 0045 4494 5888, 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
    29 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1: adolescents and adults (12 years and above) - To evaluate safety of twice daily applications of delgocitinib cream in the treatment of adults and adolescents with moderate to severe AD. Part 2: children (2-11 years) - To evaluate safety of twice daily applications of delgocitinib cream in the treatment of children with moderate to severe AD under maximal usage conditions.
    Protection of trial subjects
    Part 1 and Part 2 of the trial were separated by a safety evaluation. The purpose of the safety evaluation was to minimise the potential risks in children. Exposure of children (age 2 to 11 years) to delgocitinib cream was not initiated before the safety data from Part 1 were evaluated by a safety committee. In Part 2 of the trial, an independent data monitoring committee assessed safety for children (age 2 to 11 years) during conduct. This clinical trial was conducted in compliance with the Declaration of Helsinki as adopted by the 18th World Medical Association General Assembly (1964) and subsequent amendments. All subjects received written and verbal information concerning the clinical trial. Subjects were asked to consent that their personal data were recorded, collected, processed and could be transferred to EU and non-EU countries in accordance with any national legislation regulating privacy and data protection. If medically necessary (i.e. to control intolerable AD symptoms), rescue treatment for AD could be provided to subjects at the discretion of the investigator.
    Background therapy
    		 Subjects could use an emollient throughout the trial as needed from screening (Visit 1) and throughout the treatment period (to Visit 8). The emollient was to preferably be an additive-free, basic bland emollient.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2019
    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
    United States: 31
    Country: Number of subjects enrolled
    Canada: 15
    Worldwide total number of subjects
    46
    EEA total number of subjects
    0
    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)
    20
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    13
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Trial start date: 20-Feb-2019; Trial completion date: 29-Oct-2021. The trial was conducted in 2 countries: the United States and Canada.

    Pre-assignment
    Screening details
    		 At screening (Visit 1), the subjects’ eligibility to enter the trial was checked. The screening period had a minimum duration of 1 week and a maximal duration of 4 weeks.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Children (2-11 years)
    Arm description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.
    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
    20 mg/g twice daily topical application for 8 weeks. The applications were to be performed preferably 12 hours apart, and minimum 8 hours apart.

    Arm title
    		 Adolescents (12-17 years)
    Arm description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.
    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
    20 mg/g twice daily topical application for 8 weeks. The applications were to be performed preferably 12 hours apart, and minimum 8 hours apart.

    Arm title
    		 Adults (>=18 years)
    Arm description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.
    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
    20 mg/g twice daily topical application for 8 weeks. The applications were to be performed preferably 12 hours apart, and minimum 8 hours apart.

    Number of subjects in period 1
    		Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Started
    20
    12
    14
    Completed
    20
    12
    12
    Not completed
    0
    0
    2
         Adverse event, non-fatal
    -
    -
    1
         Lack of efficacy
    -
    -
    1
    Period 2
    Period 2 title
    Safety follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Children (2-11 years)
    Arm description
    		 All subjects attended a safety follow-up visit approximately 2 weeks after the last IMP application. This visit marked the end of trial participation.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Adolescents (12-17 years)
    Arm description
    		 All subjects attended a safety follow-up visit approximately 2 weeks after the last IMP application. This visit marked the end of trial participation.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Adults (>=18 years)
    Arm description
    		 All subjects attended a safety follow-up visit approximately 2 weeks after the last IMP application. This visit marked the end of trial participation.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Started
    20
    12
    12
    Completed
    20
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Children (2-11 years)
    Reporting group description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.

    Reporting group title
    Adults (>=18 years)
    Reporting group description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.

    Reporting group values
    		 Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years) Total
    Number of subjects
    		 20 12 14 46
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 20 0 0 20
        Adolescents (12-17 years)
    		 0 12 0 12
        Adults (18-64 years)
    		 0 0 13 13
        From 65-84 years
    		 0 0 1 1
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.2 ± 3.3 14.8 ± 1.9 37.7 ± 18.0 -
    Gender categorical
    Units: Subjects
        Female
    		 7 8 6 21
        Male
    		 13 4 8 25
    Race
    Units: Subjects
        White
    		 8 7 12 27
        Black or African American
    		 7 2 0 9
        Asian
    		 3 2 2 7
        Native Hawaiian or other Pacific islander
    		 0 0 0 0
        American Indian or Alaska native
    		 0 1 0 1
        Other
    		 2 0 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 0 2 5
        Not Hispanic or Latino
    		 17 12 12 41
    vIGA-AD
    The validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) is an instrument used in clinical trials to assess the subject’s global disease severity and is based on a 5 point scale ranging from 0 (clear) to 4 (severe).
    Units: Subjects
        0- Clear
    		 0 0 0 0
        1 - Almost clear
    		 0 0 0 0
        2 - Mild
    		 0 0 0 0
        3 - Moderate
    		 10 7 12 29
        4- Severe
    		 10 5 2 17
    EASI Total
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.
    Units: Score
        arithmetic mean (standard deviation)
    		 27.2 ± 9.9 20.1 ± 7.4 19.9 ± 7.4 -
    BSA
    Total body surface area (BSA) affected by atopic dermatitis.
    Units: Percentage
        arithmetic mean (standard deviation)
    		 46.0 ± 13.1 31.8 ± 6.3 33.6 ± 5.8 -

    End points

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    End points reporting groups
    Reporting group title
    Children (2-11 years)
    Reporting group description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.

    Reporting group title
    Adults (>=18 years)
    Reporting group description
    		 At baseline (Visit 2), subjects were enrolled if eligible. The first application of investigational medicinal product (IMP) occurred at the trial site on Visit 2 after subject eligibility confirmation, baseline assessments, pre-dose PK blood draw, and IMP instructions were carried out. All IMP applications were performed by the subject/ subject’s caregiver. Subjects returned to the trial site for the scheduled visits. However, Visits 3, 4, and 7 could be conducted remotely, if preferred. The last IMP application occurred before the subjects attended Visit 8.
    Reporting group title
    Children (2-11 years)
    Reporting group description
    		 All subjects attended a safety follow-up visit approximately 2 weeks after the last IMP application. This visit marked the end of trial participation.

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 All subjects attended a safety follow-up visit approximately 2 weeks after the last IMP application. This visit marked the end of trial participation.

    Reporting group title
    Adults (>=18 years)
    Reporting group description
    		 All subjects attended a safety follow-up visit approximately 2 weeks after the last IMP application. This visit marked the end of trial participation.

    Primary: number of AEs

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    End point title
    		 number of AEs [1]
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to Week 8
    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 data for the primary endpoint were summarised descriptively, and no comparative analyses were made.
    End point values
    		 Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Number of subjects analysed
    20
    12
    14
    Units: AEs
    23
    5
    9
    No statistical analyses for this end point

    Primary: number of subjects with AEs

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    End point title
    		 number of subjects with AEs [2]
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to Week 8
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The data for the primary endpoint were summarised descriptively, and no comparative analyses were made.
    End point values
    		 Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Number of subjects analysed
    20
    12
    14
    Units: subjects
    9
    3
    5
    No statistical analyses for this end point

    Secondary: Cmax at Day 8

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    End point title
    		 Cmax at Day 8
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Number of subjects analysed
    16
    10
    13
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    3.26 ± 369.32
    0.70 ± 216.42
    1.20 ± 188.27
    No statistical analyses for this end point

    Secondary: AUC at Day 8

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    End point title
    		 AUC at Day 8
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Number of subjects analysed
    16
    8
    13
    Units: h*ng/mL
        geometric mean (geometric coefficient of variation)
    23.30 ± 313.27
    5.93 ± 289.39
    8.39 ± 231.48
    No statistical analyses for this end point

    Secondary: tmax at Day 8

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    End point title
    		 tmax at Day 8
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Children (2-11 years) Adolescents (12-17 years) Adults (>=18 years)
    Number of subjects analysed
    16
    10
    13
    Units: hours
        geometric mean (geometric coefficient of variation)
    2.59 ± 126.17
    3.44 ± 137.61
    1.88 ± 103.56
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to Week 8
    Adverse event reporting additional description
    The analysis was based on safety analysis set
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Adults (>=18 years)
    Reporting group description
    		 -

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 -

    Reporting group title
    Children (2-11 years)
    Reporting group description
    		 -

    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 Adults (>=18 years) Adolescents (12-17 years) Children (2-11 years) All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
    0 / 46 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adults (>=18 years) Adolescents (12-17 years) Children (2-11 years) All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 14 (35.71%)
    3 / 12 (25.00%)
    9 / 20 (45.00%)
    17 / 46 (36.96%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    1
    1
    0
    2
    Presyncope
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    1
    1
    0
    2
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Face oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    2 / 46 (4.35%)
         occurrences all number
    1
    0
    2
    3
    Vomiting
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Nasal congestion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    3 / 20 (15.00%)
    4 / 46 (8.70%)
         occurrences all number
    1
    0
    3
    4
    Drug eruption
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    2 / 20 (10.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    2
    Pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    2
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Folliculitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Periorbital cellulitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2019
    The main reason for the amendment was to address comments to other protocols under this IND received from the US Food and Drug Administration (FDA). Miscellaneous other changes/updates were also implemented.
    10 Sep 2020
    The main reason for the amendment was to add an independent data monitoring for Part 2 based on regulatory advice received from Paediatric Committee (PDCO) of the European Medicines Agency (EMA). Furthermore, the dose strength in Part 2 was defined as 20 mg/g based on the results of the LP0133-1275 dose-ranging trial, and the evaluation by the safety committee from Part 1.
    25 Feb 2021
    The main reason for the amendment was to address comments to the protocol received from the US Food and Drug Administration. Furthermore, to follow authorities’ restrictions related to the COVID-19 pandemic, guidance was provided on how to proceed in case the subjects were not able to come to the site for the visits.

    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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