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    Clinical Trial Results:
    An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

    Summary
    EudraCT number
    		 2017-003757-41
    Trial protocol
    		 GB   AT   NL   DE   FR  
    Global end of trial date
    17 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2020
    First version publication date
    17 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCP-020-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03389308
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 131 384
    Sponsors
    Sponsor organisation name
    Castle Creek Pharmaceuticals, LLC
    Sponsor organisation address
    233 Mt. Airy Road, Basking Ridge, United States, 07920
    Public contact
    Dr. Mary Spellman, Castle Creek Pharmaceuticals, LLC, +001 8622860400, mspellman@castlecreekpharma.com
    Scientific contact
    Dr. Mary Spellman, Castle Creek Pharmaceuticals, LLC, +001 8622860400, mspellman@castlecreekpharma.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
    08 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the long-term safety and tolerability of Diacerein 1% Ointment in subjects with EBS that were previously enrolled in studies CCP-020-301 or CCP-020-101.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements, and the Castle Creek Policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 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
    Netherlands: 3
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    United States: 22
    Worldwide total number of subjects
    51
    EEA total number of subjects
    22
    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)
    33
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects with EBS that were previously enrolled in studies CCP-020-301 or CCP-020-101 were recruited.

    Pre-assignment
    Screening details
    		 At baseline, EBS subjects who participated in the CCP-020-301 double-blind safety and efficacy study or participated in the CCP-020-101 pharmacokinetic study (feeder studies) and who met all of the inclusion/exclusion criteria were eligible to enroll and complete up to 2 treatment cycles of diacerein 1% ointment in this study.

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

    Arms
    Arm title
    		 Open Label
    Arm description
    		 Each treatment cycle consisted of 8 weeks on treatment (once-daily, at-home study drug applications) followed by 8 weeks off treatment (only Investigator-approved, bland, non-medicated emollient/moisturizer, routine cleansing products, and sunscreens were allowed off treatment), with a maximum of 2 treatment cycles allowed for up to 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diacerein
    Investigational medicinal product code
    CCP-020
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    During the treatment period of each cycle, subjects/caregivers applied a thin layer of the assigned study drug, sufficient to cover the subject’s EBS lesions and approximately ¾ inch (2 cm) of surrounding uninvolved skin, and gently rubbed in the study drug. Subjects/caregivers applied the assigned study drug to all EBS lesions, including any new EBS lesions that developed (up to 30% BSA), once daily, every evening until the lesions resolved, for 8 weeks.

    Number of subjects in period 1
    		Open Label
    Started
    51
    Completed
    39
    Not completed
    12
         Consent withdrawn by subject
    5
         Adverse event, non-fatal
    2
         Sponsor request
    2
         Lost to follow-up
    3

    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
    		 51 51
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 33 33
        Adolescents (12-17 years)
    		 7 7
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Open Label
    Reporting group description
    		 Each treatment cycle consisted of 8 weeks on treatment (once-daily, at-home study drug applications) followed by 8 weeks off treatment (only Investigator-approved, bland, non-medicated emollient/moisturizer, routine cleansing products, and sunscreens were allowed off treatment), with a maximum of 2 treatment cycles allowed for up to 52 weeks.

    Primary: Treatment-Emergent Adverse Events

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    End point title
    		 Treatment-Emergent Adverse Events [1]
    End point description
    Number and percentage of participants with any treatment-emergent adverse event
    End point type
    Primary
    End point timeframe
    Up to 52 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: The primary objective of this safety study was to describe treatment-emergent adverse events.
    End point values
    		 Open Label
    Number of subjects analysed
    51
    Units: Count of Participants
        Treatment-Emergent Adverse Events
    40
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    All study participants
    Reporting group description
    		 Safety population

    Serious adverse events
    		 All study participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All study participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 51 (41.18%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 51 (13.73%)
         occurrences all number
    10
    Skin infection
         subjects affected / exposed
    5 / 51 (9.80%)
         occurrences all number
    9
    Ear infection
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Gastroenteritis viral
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3

    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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