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    Clinical Trial Results:
    Anti-IL-17, a possible new treatment for contact dermatitis?

    Summary
    EudraCT number
    		 2015-004494-33
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    Summary report(s)
    		 manuscript II
    manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    2015-004494-33
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen Denmark
    Sponsor organisation address
    Gentofte Hospitalsvej 15, 2900 Hellerup, Hellerup, Denmark, 2900
    Public contact
    Dept of dermato-allergology, Herlev and Gentofte Hospital, tanja.todberg@regionh.dk
    Scientific contact
    Dept of dermato-allergology, Herlev and Gentofte Hospital, +45 27366340, tanja.todberg@regionh.dk
    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
    13 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate secukinumab treatment in patients with known allergic contact dermatitis. The study which is an interventional type will consist of two parts both performed at Department of Dermato-allergology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. Study 1 Study 1 will include 10 patients with known allergy to nickel, but with no to low grade of eczema at inclusion. 1.Reduction in clinical patch test score for dermatitis after secukinumab treatment compared to patch test score before secukinumab treatment in patients challenged with nickel.
    Protection of trial subjects
    GCP, Copenhagen
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jan 2016
    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
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Herlev and Gentofte Hospital

    Pre-assignment
    Screening details
    		 - known contact allergy -age + 18 -no other skin diseases

    Period 1
    Period 1 title
    IL-17 ACD (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IL-17
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    secukimumab in approved dosis.

    Number of subjects in period 1
    		IL-17
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IL-17 ACD
    Reporting group description
    		 -

    Reporting group values
    		 IL-17 ACD Total
    Number of subjects
    		 15 15
    Age categorical
    Age 18-79
    Units: Subjects
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8
    Subject analysis sets

    Subject analysis set title
    IL17
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    to test effekt of il-17 on ACD

    Subject analysis sets values
    		 IL17
    Number of subjects
    15
    Age categorical
    Age 18-79
    Units: Subjects
        Adults (18-64 years)
    14
        From 65-84 years
    1
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    IL-17
    Reporting group description
    		 -

    Subject analysis set title
    IL17
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    to test effekt of il-17 on ACD

    Primary: IL17

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    End point title
    		 IL17 [1]
    End point description
    End point type
    Primary
    End point timeframe
    1.Reduction in clinical patch test score for dermatitis after secukinumab treatment compared to patch test score before secukinumab treatment in patients challenged with nickel (21 days) 2. The effect of IL-17 in patients with severe ACD (16 weeks)
    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: Please not this is a single arm study, thus a statistical analysis is not mandatory
    End point values
    		 IL-17
    Number of subjects analysed
    15 [2]
    Units: 1.1
        il-17
    15
    Attachments
    		 article_1
    article_2
    Notes
    [2] - Subjects: 15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    + 4 weeks after last dosis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    IL-17
    Reporting group description
    		 A flare-up of eczema was seen in one case, so prednisolone was administered to this patient in week 12. This patient and one other patient applied strong topical corticosteroid due to a lack of improvement in their eczema from week 2 in one case and from week 8 in the other. There were no severe adverse events. One patient experienced vertigo, and one patient had a debut of psoriasis during the trial.

    Serious adverse events
    		 IL-17
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 IL-17
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    General disorders and administration site conditions
    Dermatitis
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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