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    Clinical Trial Results:
    Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria

    Summary
    EudraCT number
    		 2020-004961-38
    Trial protocol
    		 DE  
    Global end of trial date
    11 Jul 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Apr 2024
    First version publication date
    27 Jul 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of data

    Trial information

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    Trial identification
    Sponsor protocol code
    EXP-2177
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04853992
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark,
    Public contact
    Clinical Disclosure, LEO Pharma A/S, +45 4494 5888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure, LEO Pharma A/S, +45 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
    10 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the efficacy of LEO 152020 compared with placebo in patients with cholinergic urticaria.
    Protection of trial subjects
    This clinical trial was conducted to conform to the principles of the Declaration of Helsinki as adopted by the 18th World Medical Association General Assembly, 1964, and the amendment from Somerset West, South Africa, October 1996. 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 other countries in accordance with any national legislation regulating privacy and data protection.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 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
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total number of 29 subjects were screened and thereof, 20 subjects in 4 trial sites were randomly assigned stratified by site to one of the two treatment sequences with a ratio of 1:1.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Active
    Arm description
    		 This is a cross over study with two treatment periods. All participants received Active, either in the first or second treatment period and Placebo in the other period. There were 20 participants that started the trial. 11 were randomised to the sequence Placebo-Active. 1 was withdrawn after completing treatment with Active as they met an exclusion criteria before the start of the second (Placebo) treatment. 9 were randomised to the sequence Active-Placebo. 1 withdrew due to an AE (COVID-19) during the first (Placebo) treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 152020
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Twice a day for 7 days

    Arm title
    		 Placebo
    Arm description
    		 This is a cross over study with two treatment periods. All participants received Placebo, either in the first or second treatment period and Active in the other period. There were 20 participants that started the trial. 11 were randomised to the sequence Placebo-Active. 1 was withdrawn after completing treatment with Active as they met an exclusion criteria before the start of the second (Placebo) treatment. 9 were randomised to the sequence Active-Placebo. 1 withdrew due to an AE (COVID-19) during the first (Placebo) treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Twice a day for 7 days

    Number of subjects in period 1
    		Active Placebo
    Started
    20
    20
    Completed
    18
    18
    Not completed
    2
    2
         Adverse event, non-fatal
    1
    1
         Met exclusion criteria for second treatment phase
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 25 (20 to 56) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 This is a cross over study with two treatment periods. All participants received Active, either in the first or second treatment period and Placebo in the other period. There were 20 participants that started the trial. 11 were randomised to the sequence Placebo-Active. 1 was withdrawn after completing treatment with Active as they met an exclusion criteria before the start of the second (Placebo) treatment. 9 were randomised to the sequence Active-Placebo. 1 withdrew due to an AE (COVID-19) during the first (Placebo) treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 This is a cross over study with two treatment periods. All participants received Placebo, either in the first or second treatment period and Active in the other period. There were 20 participants that started the trial. 11 were randomised to the sequence Placebo-Active. 1 was withdrawn after completing treatment with Active as they met an exclusion criteria before the start of the second (Placebo) treatment. 9 were randomised to the sequence Active-Placebo. 1 withdrew due to an AE (COVID-19) during the first (Placebo) treatment period.

    Primary: Change from baseline in post-provocation Urticaria Activity Score (UASprovo).

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    End point title
    		 Change from baseline in post-provocation Urticaria Activity Score (UASprovo).
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to day 7
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    18
    Units: scores on a scale
        least squares mean (standard deviation)
    -1.1 ( 2.1 )
    -0.5 ( 1.7 )
    Statistical analysis title
    		 Active vs Placebo
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.277
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 0.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [1] - The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate. This is a cross over study.

    Secondary: Number of Treatment Emergent Adverse Events

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    End point title
    		 Number of Treatment Emergent Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    From treatment period start to 3 days after treatment end
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    19
    Units: AEs
    9
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first trial related activity to the end of trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Active
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (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
    		 Placebo Active
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 19 (31.58%)
    9 / 19 (47.37%)
    Investigations
    Blood immunoglobulin E increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 19 (15.79%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2021
    Due to recommendations from BfArM including clarification of standard doses of antihistamines, contraception and pregnancy testing, additional ECG measurements, and benefit/risk assessment.
    16 Apr 2021
    To clarify some inconsistencies and the intent of the original protocol e.g. definition of the screening period, visits after early termination, description of CholUAS7.
    15 Jun 2021
    Exclusion criterion 18 was changed to allow patients to continue topical use of antihistamines if necessary to treat concomitant allergies.
    09 Mar 2022
    Due to a change of location and the new foundation of the Institute of Allergy Research of the Charité (Institute of Allergology IFA).
    08 Apr 2022
    With the introduction of COVID-19 vaccines, COVID-19 may now be considered more like other influenza-like diseases – and COVID-19 (confirmed by a positive SARS-CoV-2 test result) is no longer deemed a major health risk as disease symptoms are commonly only mild and patients rapidly recover from COVID-19. This amendment was intended to take account for the changed status of the COVID-19 pandemic.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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