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    Clinical Trial Results:
    A phase 2 trial to evaluate the efficacy and safety of orally administered LEO 152020 tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis

    Summary
    EudraCT number
    		 2020-004561-39
    Trial protocol
    		 DE   CZ   PL   ES  
    Global end of trial date
    26 Jul 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    20 Jun 2024
    First version publication date
    05 May 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    correction of data set

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0190-1488
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05117060
    WHO universal trial number (UTN)
    		 U1111-1281-1895
    Sponsors
    Sponsor organisation name
    JW Pharmaceutical
    Sponsor organisation address
    JW Gwacheon Tower, 38, Gwacheon-daero 7-gil, Gwacheon-si, Gyeonggi-do, Korea, Republic of, 13840
    Public contact
    Soojin Park, JW Pharmaceutical , +82 -1588-2675, park.soojin@jwhealthcare.com
    Scientific contact
    Soojin Park, JW Pharmaceutical , +82 -1588-2675, park.soojin@jwhealthcare.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
    31 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the exposure response relationship of LEO 152020 and evaluate efficacy of LEO 152020 compared with placebo for up to 16 weeks of treatment in subjects with moderate to severe AD
    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
    		 Not applicable.
    Actual start date of recruitment
    13 Dec 2021
    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: 25
    Country: Number of subjects enrolled
    Czechia: 28
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Poland: 48
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    Japan: 36
    Worldwide total number of subjects
    216
    EEA total number of subjects
    107
    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)
    208
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was conducted at 45 sites that screened subjects in 8 countries (Australia, Canada, Czech Republic (Czechia), Germany, Japan, Poland, Spain and the United States).

    Pre-assignment
    Screening details
    		 285 subjects were screened and 216 were randomized in a 4:3:3:4 ratio into the 4 treatment groups.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEO 152020 - Dosing Regimen 1 (higher dose)
    Arm description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 152020 film-coated tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Self-administration of tablets daily. Film-coated tablet.

    Arm title
    		 LEO 152020 - Dosing Regimen 2 (middle dose)
    Arm description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 152020 film-coated tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Self-administration of tablets daily. Film-coated tablet

    Investigational medicinal product name
    LEO 152020 placebo film-coated tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Self-administration of tablets daily. Film-coated placebo tablet

    Arm title
    		 LEO 152020 - Dosing Regimen 3 (lower dose)
    Arm description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 152020 film-coated tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Self-administration of tablets daily. Film-coated tablet

    Investigational medicinal product name
    LEO 152020 placebo film-coated tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Self-administration of tablets daily. Film-coated placebo tablet

    Arm title
    		 LEO 152020 - placebo
    Arm description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.
    Arm type
    		 Placebo

    Investigational medicinal product name
    LEO 152020 placebo film-coated tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Self-administration of tablets daily. Film-coated placebo tablet

    Number of subjects in period 1
    		LEO 152020 - Dosing Regimen 1 (higher dose) LEO 152020 - Dosing Regimen 2 (middle dose) LEO 152020 - Dosing Regimen 3 (lower dose) LEO 152020 - placebo
    Started
    61
    45
    49
    61
    Completed
    44
    29
    33
    46
    Not completed
    17
    16
    16
    15
         Consent withdrawn by subject
    8
    5
    5
    6
         Adverse event, non-fatal
    3
    5
    6
    1
         Other
    2
    1
    3
    1
         Lost to follow-up
    -
    -
    -
    1
         Lack of efficacy
    4
    5
    2
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEO 152020 - Dosing Regimen 1 (higher dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Dosing Regimen 2 (middle dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Dosing Regimen 3 (lower dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - placebo
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.

    Reporting group values
    		 LEO 152020 - Dosing Regimen 1 (higher dose) LEO 152020 - Dosing Regimen 2 (middle dose) LEO 152020 - Dosing Regimen 3 (lower dose) LEO 152020 - placebo Total
    Number of subjects
    		 61 45 49 61 216
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 59 42 48 59 208
        From 65-84 years
    		 2 3 1 2 8
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.2 ( 13.3 ) 35.2 ( 15.0 ) 35.2 ( 13.5 ) 33.4 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 21 30 35 118
        Male
    		 29 24 19 26 98

    End points

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    End points reporting groups
    Reporting group title
    LEO 152020 - Dosing Regimen 1 (higher dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Dosing Regimen 2 (middle dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Dosing Regimen 3 (lower dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - placebo
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.

    Primary: Change in EASI From Baseline to Week 16

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    End point title
    		 Change in EASI From Baseline to Week 16
    End point description
    The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive or severe condition.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 LEO 152020 - Dosing Regimen 1 (higher dose) LEO 152020 - Dosing Regimen 2 (middle dose) LEO 152020 - Dosing Regimen 3 (lower dose) LEO 152020 - placebo
    Number of subjects analysed
    61
    45
    49
    61
    Units: score on a scale
        arithmetic mean (confidence interval 95%)
    -9.99 (-12.85 to -7.13)
    -8.83 (-12.63 to -5.04)
    -8.87 (-12.47 to -5.28)
    -9.11 (-11.88 to -6.35)
    Statistical analysis title
    		 Change in EASI from baseline to Week 16
    Comparison groups
    LEO 152020 - Dosing Regimen 1 (higher dose) v LEO 152020 - placebo
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.663
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.85
         upper limit
    		 3.1
    Notes
    [1] - The mixed model was fitted to the entire dataset of 216 subjects, but only 122 of the subjects were in the two treatment groups compared.
    Statistical analysis title
    		 Change in EASI from baseline to Week 16
    Comparison groups
    LEO 152020 - Dosing Regimen 2 (middle dose) v LEO 152020 - placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.907
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.42
         upper limit
    		 4.97
    Notes
    [2] - The mixed model was fitted to the entire dataset of 216 subjects, but only 106 of the subjects were in the two treatment groups compared.
    Statistical analysis title
    		 Change in EASI from baseline to Week 16
    Comparison groups
    LEO 152020 - placebo v LEO 152020 - Dosing Regimen 3 (lower dose)
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.917
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.29
         upper limit
    		 4.77
    Notes
    [3] - The mixed model was fitted to the entire dataset of 216 subjects, but only 110 of the subjects were in the two treatment groups compared.

    Secondary: Number of adverse events from baseline to week 16+3 days per subject

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    End point title
    		 Number of adverse events from baseline to week 16+3 days per subject
    End point description
    Only treatment-emergent adverse events will be reported for this outcome measure. An adverse event will be considered treatment emergent if occurring after the first dose of treatment (Week 0) and up until 3 days after the last dose of treatment (Week 16+3 days for a participant completing the 16-week treatment period).
    End point type
    Secondary
    End point timeframe
    Week 0 to week 16+3 days
    End point values
    		 LEO 152020 - Dosing Regimen 1 (higher dose) LEO 152020 - Dosing Regimen 2 (middle dose) LEO 152020 - Dosing Regimen 3 (lower dose) LEO 152020 - placebo
    Number of subjects analysed
    44
    31
    33
    38
    Units: events
    109
    67
    80
    75
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 weeks + 3 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    LEO 152020 - Dosing Regimen 1 (higher dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Dosing Regimen 3 (lower dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Placebo
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally.

    Reporting group title
    LEO 152020 - Dosing Regimen 2 (middle dose)
    Reporting group description
    		 Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally.

    Serious adverse events
    		 LEO 152020 - Dosing Regimen 1 (higher dose) LEO 152020 - Dosing Regimen 3 (lower dose) LEO 152020 - Placebo LEO 152020 - Dosing Regimen 2 (middle dose)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 49 (2.04%)
    0 / 61 (0.00%)
    2 / 45 (4.44%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 49 (2.04%)
    0 / 61 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Eczema herpeticum
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 49 (0.00%)
    0 / 61 (0.00%)
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LEO 152020 - Dosing Regimen 1 (higher dose) LEO 152020 - Dosing Regimen 3 (lower dose) LEO 152020 - Placebo LEO 152020 - Dosing Regimen 2 (middle dose)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 61 (47.54%)
    23 / 49 (46.94%)
    24 / 61 (39.34%)
    24 / 45 (53.33%)
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 61 (1.64%)
    6 / 49 (12.24%)
    1 / 61 (1.64%)
    3 / 45 (6.67%)
         occurrences all number
    2
    10
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 49 (4.08%)
    1 / 61 (1.64%)
    4 / 45 (8.89%)
         occurrences all number
    2
    2
    6
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 49 (0.00%)
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    5
    0
    0
    1
    Nausea
         subjects affected / exposed
    8 / 61 (13.11%)
    5 / 49 (10.20%)
    1 / 61 (1.64%)
    2 / 45 (4.44%)
         occurrences all number
    10
    5
    1
    2
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    10 / 61 (16.39%)
    7 / 49 (14.29%)
    13 / 61 (21.31%)
    11 / 45 (24.44%)
         occurrences all number
    14
    8
    14
    15
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 61 (9.84%)
    2 / 49 (4.08%)
    1 / 61 (1.64%)
    6 / 45 (13.33%)
         occurrences all number
    6
    2
    1
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 61 (9.84%)
    3 / 49 (6.12%)
    3 / 61 (4.92%)
    4 / 45 (8.89%)
         occurrences all number
    6
    3
    3
    6
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 61 (4.92%)
    2 / 49 (4.08%)
    7 / 61 (11.48%)
    3 / 45 (6.67%)
         occurrences all number
    3
    3
    7
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Oct 2021
    The main purpose of the protocol amendment was to: • Allow data collection after the occurrence of intercurrent events (initiation of rescue treatment and permanent discontinuation of investigational medicinal product [IMP]) and incorporate the data when applying the treatment policy strategy to handle these events. The collection of data described is in line with ICH E9 (R1) addendum. Consequently, sections related to rescue treatment, permanent discontinuation of IMP / withdrawal from trial, estimand strategy, and statistical analysis methods were revised. • Include subjects with mild and moderate renal impairment in the trial. • Increase monitoring to safeguard subject safety and well-being. • Update of the contraception requirements for men and women.

    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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