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    Clinical Trial Results:
    A phase 2a, randomised, double-blind, placebo-controlled, multi-site, proof of concept trial to evaluate the efficacy and safety of LEO 138559 in adult subjects with moderate to severe atopic dermatitis (AD).

    Summary
    EudraCT number
    		 2020-005541-16
    Trial protocol
    		 DE  
    Global end of trial date
    26 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2023
    First version publication date
    18 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0145-1376
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    11 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of LEO 138559 with placebo in subjects with moderate to severe AD.
    Protection of trial subjects
    This clinical trial was conducted to conform to the principles of the Declaration of Helsinki, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, in compliance with the approved protocol, and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 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
    Poland: 35
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    58
    EEA total number of subjects
    44
    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)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 58 participants from 19 sites in 4 countries (Canada, Germany, Poland, and the United States of America) were randomized in this trial. The first participant was screened on 14-Jul-2021 and the last participant completed the trial on 26-Sep-2022.

    Pre-assignment
    Screening details
    		 76 participants were screened in this trial. Of these, 18 participants (23.7%) were excluded prior to randomization. The main reason for exclusion prior to randomization was eligibility criteria not met (17.1%).

    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
    Blinding implementation details
    This was a double-blinded trial in which LEO 138559 and placebo were visually distinct from each other and not matched for viscosity. IMP was administered by an unblinded trial staff member who was not involved in the trial assessments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEO 138559
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 138559
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LEO 138559 was given every 2 weeks (Q2W) as 3 SC injections (each 1.0 mL) until Week 14. In addition to the Q2W dosing schedule, an additional dose was given at Week 1.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A dose of 3 SC injections (each 1.0 mL) was given Q2W until Week 14. In addition to the Q2W dosing schedule, an additional dose was given at Week 1.

    Number of subjects in period 1
    		LEO 138559 Placebo
    Started
    29
    29
    Completed
    22
    16
    Not completed
    7
    13
         Consent withdrawn by subject
    4
    10
         Adverse event, non-fatal
    2
    2
         Multiple reasons
    1
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEO 138559
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 LEO 138559 Placebo Total
    Number of subjects
    		 29 29 58
    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)
    		 0 0 0
        Adults (18-64 years)
    		 29 29 58
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 12.1 ) 32.8 ( 10.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 16 33
        Male
    		 12 13 25
    Baseline disease severity
    Units: Subjects
        Baseline EASI score <21
    		 14 13 27
        Baseline EASI score ≥21
    		 15 16 31
    vIGA-AD
    Units: Subjects
        Moderate
    		 17 20 37
        Severe
    		 12 9 21
    EASI
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 26.93 ( 11.77 ) 26.12 ( 9.80 ) -
    BSA
    Units: Percentage
        arithmetic mean (standard deviation)
    		 40.2 ( 21.4 ) 38.6 ( 18.5 ) -
    Worst daily pruritus NRS (weekly average)
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 7.57 ( 1.63 ) 7.53 ( 1.56 ) -
    POEM
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 22.4 ( 4.7 ) 19.2 ( 5.4 ) -
    DLQI
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 17.1 ( 7.7 ) 14.0 ( 6.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    LEO 138559
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in EASI Score From Baseline to Week 16

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    End point title
    		 Change in EASI Score 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 and/or severe condition.
    End point type
    Primary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 LEO 138559 Placebo
    Number of subjects analysed
    29
    29
    Units: Score on a scale
        arithmetic mean (standard error)
    -15.3 ( 2.64 )
    -3.5 ( 2.91 )
    Statistical analysis title
    		 LEO 138559 vs Placebo
    Comparison groups
    Placebo v LEO 138559
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.003 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    -11.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.6
         upper limit
    		 -4.1
    Notes
    [1] - Two-sided hypotheses were tested based on the pre-specified primary analysis for the primary estimand. The primary estimand used a hypothetical strategy evaluating the treatment difference as if all subjects adhered to the treatment regimen, i.e. they did not discontinue IMP permanently, did not initiate rescue treatment, or did not have more than one missed treatment dose related to COVID-19.
    [2] - The type I error rate of the two-sided hypothesis test was controlled at the 5% significance level. ANCOVA model: Change in EASI = Treatment + Region + Baseline EASI. Missing values and data 'treated as missing' were imputed using MI assuming MAR.

    Secondary: Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Participant

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    End point title
    		 Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Participant
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 LEO 138559 Placebo
    Number of subjects analysed
    29
    29
    Units: Number of adverse events
    40
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    LEO 138559
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 LEO 138559 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LEO 138559 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 29 (72.41%)
    14 / 29 (48.28%)
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Syncope
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    3
    Inflammation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Injection site reaction
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Oral pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    4 / 29 (13.79%)
    4 / 29 (13.79%)
         occurrences all number
    5
    4
    Eczema
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    4
    0
    Bursitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 29 (20.69%)
    2 / 29 (6.90%)
         occurrences all number
    6
    2
    Conjunctivitis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Coronavirus infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Eczema herpeticum
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
         occurrences all number
    3
    3
    Rhinitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 29 (17.24%)
         occurrences all number
    1
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2021
    The purpose of this protocol amendment was to allow for the clarification and addition of eligibility criteria and the inclusion of additional safety assessments.
    31 Jan 2022
    The main purpose for this protocol amendment was to change the event of a positive SARS CoV-2 test (COVID-19) from leading to permanent discontinuation of IMP to leading to a possible temporary discontinuation of IMP.

    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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