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    Clinical Trial Results:
    Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12 weeks on eyebrow alopecia areata. Exploratory Phase 2a

    Summary
    EudraCT number
    		 2017-002720-24
    Trial protocol
    		 DK  
    Global end of trial date
    16 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2019
    First version publication date
    03 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EXP-1377
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03325296
    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, +45 44945888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, 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
    26 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of twice daily topical LEO 124249 ointment 30 mg/g compared with LEO 124249 ointment vehicle on hair growth in subjects with alopecia areata on eyebrows.
    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
    07 Nov 2017
    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
    Denmark: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were recruited in Denmark, at 2 sites, between 7-Nov-2017 and 22-Mar-2018.

    Pre-assignment
    Screening details
    		 Main inclusion criteria: clinical unequivocal diagnosis of alopecia areata (AA), maximal duration of current disease episode of 3 years and no ongoing eyebrow hair growth at study start Main exclusion criteria: diffuse type AA, subjects with skin condition(s) or use of treatments which could put subject at risk or interfere with trial assessments

    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
    		 Investigator, Subject
    Blinding implementation details
    The packaging and labelling of the 2 investigational medical products contained no evidence of their identity. There is a slight colour difference between the products. However, the difference is only discernible on close inspection with both products compared side by side. Neither the subject nor the investigator were allowed to see the 2 products at the same time. Subjects from the same household were not allowed to participate.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEO 124249 ointment 30 mg/g
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 124249 ointment 30 mg/g
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Twice daily topical application on both eyebrows for 12 weeks

    Arm title
    		 LEO 124249 ointment vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    LEO 124249 ointment vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Twice daily topical application on both eybrows for 12 weeks

    Number of subjects in period 1
    		LEO 124249 ointment 30 mg/g LEO 124249 ointment vehicle
    Started
    9
    4
    Completed
    8
    3
    Not completed
    1
    1
         Trial ended prematurely
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEO 124249 ointment 30 mg/g
    Reporting group description
    		 -

    Reporting group title
    LEO 124249 ointment vehicle
    Reporting group description
    		 -

    Reporting group values
    		 LEO 124249 ointment 30 mg/g LEO 124249 ointment vehicle Total
    Number of subjects
    		 9 4 13
    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)
    		 9 4 13
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ( 12.2 ) 45.0 ( 11.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 3 7
        Male
    		 5 1 6
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set includes all randomised subjects. The safety analysis set includes the randomised subjects who received at least 1 application of the investigational medicinal product. This set is identical to the full analysis set.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    13
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    13
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.5 ( 11.6 )
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    LEO 124249 ointment 30 mg/g
    Reporting group description
    		 -

    Reporting group title
    LEO 124249 ointment vehicle
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set includes all randomised subjects. The safety analysis set includes the randomised subjects who received at least 1 application of the investigational medicinal product. This set is identical to the full analysis set.

    Primary: Change from baseline to Week 12 of investigator evaluated overall area score of eyebrow hair growth

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    End point title
    		 Change from baseline to Week 12 of investigator evaluated overall area score of eyebrow hair growth [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to Week 12
    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 analysis is provided due to lack of efficacy, as demonstrated by an unplanned blinded futility analysis.
    End point values
    		 LEO 124249 ointment 30 mg/g LEO 124249 ointment vehicle
    Number of subjects analysed
    9
    4
    Units: area score
        arithmetic mean (standard deviation)
    0.0 ( 0.5 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Treatment-emergent adverse events

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    End point title
    		 Treatment-emergent adverse events
    End point description
    The treatment-emergent adverse events include adverse events relating to local tolerability.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 16
    End point values
    		 LEO 124249 ointment 30 mg/g LEO 124249 ointment vehicle
    Number of subjects analysed
    9
    4
    Units: number of events
    7
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From subject signing inform consent form to Week 16
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    LEO 124249 ointment 30 mg/g
    Reporting group description
    		 -

    Reporting group title
    LEO 124249 ointment vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 LEO 124249 ointment 30 mg/g LEO 124249 ointment vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Pilonidal cyst
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LEO 124249 ointment 30 mg/g LEO 124249 ointment vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
    2 / 4 (50.00%)
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 4 (25.00%)
         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
    07 Feb 2018
    The main reason for this amendment was to revise 2 of the inclusion criteria to reduce the number of screening failures and to aid recruitment into the trial.
    28 Mar 2018
    The main reason for this amendment was to revise 1 of the exclusion criteria to align with the first amendment. The factor 'site' was added to the statistical analysis model. In addition, informed consent date and demographics were added to the data that must be collected for screening failures.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 May 2018
    An unplanned futility analysis was conducted and on the basis of this analysis the trial was terminated prior to completion. For this reason, the trial was reported as an abbreviated report in accordance with ICH E3. Results for 2 secondary efficacy endpoints were therefore neither analysed nor reported.
    -

    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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