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    Clinical Trial Results:
    Pilot trial to determine the efficacy of secukinumab in active non-segmental vitiligo

    Summary
    EudraCT number
    		 2015-003552-48
    Trial protocol
    		 BE  
    Global end of trial date
    16 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2024
    First version publication date
    06 Jun 2024
    Other versions
    Summary report(s)
    		 Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2015/009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    22 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to investigate the capacity of a targeted anti-IL-17A treatment with secukinumab to induce repigmentation in vitiligo patients with active disease.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2016
    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
    Belgium: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    7
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 8 patients were recruited between 12-Oct-2016 and 16-Dec-2017. End of trial notification was dated 16-Dec-2017(last patient last visit) and submitted to EC and CA on 13-Feb-2018. There were 3 dropouts due to disease progression (for 2 patients) and unexpected stay abroad (for 1 patient).

    Pre-assignment
    Screening details
    		 Main inclusion criteria: 1) Moderate to extensive vitiligo (body surface area ≥ 3%) 2) Vitiligo patients with ‘active vitiligo’. 3) Vitiligo on hands and/or face 4) Fitzpatrick skin type 3-6 5) Impact score > 8/10 or DLQI (Dermatology Life Quality Index) > Patients were included correctly

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding done, all patients have received the active compound

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baseline data
    Arm description
    		 Baseline data for the study, as the study only has 1 arm
    Arm type
    		 Baseline arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Active arm
    Arm description
    		 Arm receiving the active product (only one arm in the study)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injections with secukinumab (300 mg) will be performed. The injections will be given at baseline, week 1, 2, 3, 4 and subsequent injections will be administered every 4 weeks (total of 10 injections).

    Number of subjects in period 1
    		Baseline data Active arm
    Started
    8
    8
    Completed
    8
    5
    Not completed
    0
    3
         Injection missed
    -
    1
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 8 8
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 50 (30 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 4 4
    Ethnic origin
    Units: Subjects
        Caucasian
    		 5 5
        Asian
    		 1 1
        Indian
    		 2 2
    Associated auto-immune disease
    Units: Subjects
        no
    		 6 6
        thyroid
    		 2 2
    Fitzpatrick skin type
    Units: Subjects
        III
    		 5 5
        IV
    		 1 1
        V-
    		 2 2
    Disease duration
    Units: Years
        arithmetic mean (full range (min-max))
    		 16.6 (8 to 38) -
    Percentage body affected
    Units: percentage
        arithmetic mean (full range (min-max))
    		 22.42 (7.12 to 50.77) -

    End points

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    End points reporting groups
    Reporting group title
    Baseline data
    Reporting group description
    		 Baseline data for the study, as the study only has 1 arm

    Reporting group title
    Active arm
    Reporting group description
    		 Arm receiving the active product (only one arm in the study)

    Primary: Repigmentation

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    End point title
    		 Repigmentation [1] [2]
    End point description
    The primary endpoint (repigmentation) was not reached.
    End point type
    Primary
    End point timeframe
    N/A
    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 available. The endpoint was not reached. See attachement Final Study Report
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is not reported for the baseline arm. The baseline arm for the study was added as the study only has 1 arm. See attachement Final Study Report
    End point values
    		 Active arm
    Number of subjects analysed
    8
    Units: number of patients
        depigmentation
    7
        limited repigmentation
    2
    No statistical analyses for this end point

    Primary: Improvement in Global Satisfaction

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    End point title
    		 Improvement in Global Satisfaction [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    Score using the Likert scale (5 points)
    Notes
    [3] - 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: See attachement Final Study Report
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is not reported for the baseline arm. The baseline arm for the study was added as the study only has 1 arm. See attachement Final Study Report
    End point values
    		 Active arm
    Number of subjects analysed
    8
    Units: Global Satisfaction
        arithmetic mean (standard deviation)
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Disease stability (stop of progression)

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    End point title
    		 Disease stability (stop of progression) [5]
    End point description
    The secondary endpoint (disease stability) was not reached.
    End point type
    Secondary
    End point timeframe
    N/A
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is not reported for the baseline arm. The baseline arm for the study was added as the study only has 1 arm. See attachement Final Study Report
    End point values
    		 Active arm
    Number of subjects analysed
    8
    Units: number of patients
        disease progression
    7
        disease stability
    1
    No statistical analyses for this end point

    Secondary: Improvement in Dermatology Life Quality Index

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    End point title
    		 Improvement in Dermatology Life Quality Index [6]
    End point description
    In none of the patients clear clinical efficacy was noted.
    End point type
    Secondary
    End point timeframe
    N/A
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See attachement Final Study Report
    End point values
    		 Active arm
    Number of subjects analysed
    8
    Units: DLQI
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events will be reported between the first dose administration of trial medication and the last trial related activity
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Baseline data
    Reporting group description
    		 Baseline data for the study, as the study only has 1 arm

    Reporting group title
    Active arm
    Reporting group description
    		 Arm receiving the active product (only one arm in the study)

    Serious adverse events
    		 Baseline data Active arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Baseline data Active arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events occurred during the study. See attachement Final Study Report

    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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