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    Clinical Trial Results:
    A double-blind, randomized, placebo-controlled phase II pilot trial investigating efficacy, safety and feasibility of 11β-hydroxysteroid dehydrogenase type 1 inhibition by AZD4017 to improve skin function and wound healing in patients with type 2 diabetes

    Summary
    EudraCT number
    		 2017-001351-31
    Trial protocol
    		 GB  
    Global end of trial date
    12 May 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Nov 2020
    First version publication date
    29 Aug 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Update required to amend the end point table heading to ‘24 hour 11β-HSD1 activity % conversion/24 hours’. Please see attached file note detailing the change
    Summary report(s)
    		 GC-SHealD supplementary figures

    Trial information

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    Trial identification
    Sponsor protocol code
    ED17/93260
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Worsley Building, Leeds, United Kingdom, LS2 9JT
    Public contact
    Ana Tiganescu, University of Leeds, 0113 3438336, a.tiganescu@leeds.ac.uk
    Scientific contact
    Ana Tiganescu, University of Leeds, 0113 3438336, a.tiganescu@leeds.ac.uk
    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
    12 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We will determine if the treatment is able to achieve it's intended effect (decrease target enzyme activity) in skin of patients with type 2 diabetes
    Protection of trial subjects
    The Trial was was monitored multiple times by the Sponsor over it's life cycle, and was conducted in accordance with GCP. The Chief Investigator retained overall responsibility for the informed consent of participants at their site and must ensure that any person delegated responsibility to participate in the informed consent process is duly authorised, trained and competent to participate according to the ethically approved protocol,principles of Good Clinical Practice (GCP) and Declaration of Helsinki 1996.
    Background therapy
    		 Chronic, non-healing wounds e.g. diabetic foot ulcers (DFU) are a common worldwide health problem that have substantial medical and socioeconomic importance and represent a major unmet clinical need [1]. In Europe, 1-1.5% of the population has a problem wound at any one time. The average cost per episode is 6,650€ for leg ulcers and 10,000€ for foot ulcers, accounting for 2-4% of the healthcare budget and likely to escalate with an increasingly elderly and diabetic population [2]. In the Leeds/Bradford region the overall prevalence of wounds is 2.8-3.6 people per 1000 population [3], up to 50% of which are chronically inflamed, non-healing wounds. Costs for wound care in the UK are estimated at £2.03-3.8 million per 100,000 population [4] and diabetes currently accounts for approximately 10% of the total health resource expenditure and is projected to account for around 17% in 2035/2036 [5].
    Evidence for comparator
    		 The profound atrophogenic effects of glucocorticoids (GC) on human skin structure and function are well documented, causing decreased collagen content, increased transepidermal water loss (TEWL), dermal and epidermal thinning, telangiectasia, impaired wound healing (WH) and increased infection risk [6-13]. Keratinocytes, melanocytes, fibroblasts and sebocytes play significant roles as GC targets in these processes [11, 14]. These effects arise from GC excess including systemic [7, 8] and topical [10] GC therapy, Cushing’s disease [6] and psychological stress [13, 15-17].
    Actual start date of recruitment
    03 Jul 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
    United Kingdom: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants will be identified using medical records from the Diabetes Clinic at St. James’s University Hospital by the Chief Investigator or an authorized member of the direct care team. Potentially eligible participants will be selected using a computerized search and review of medical records.

    Pre-assignment
    Screening details
    		 Assenting patients will then be invited to attend a screening visit where they will be formally assessed for eligibility and asked to provide written, informed consent.The original Informed Consent Form will be filed in the Trial Master File (TMF), with one copy given to the patient and one filed in the hospital notes.

    Period 1
    Period 1 title
    Main Trial Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Treatment groups will be allocated on a fully randomised basis. A randomization schedule will be generated by the dedicated trials pharmacy representative who has signed/dated the staff delegation log and is not otherwise associated with this study. Patients will be randomised in a 1:1 treatment allocation ratio to either AZD4017 or placebo. The randomization schedule will be stored in a password protected file accessible only to the dedicated trials pharmacy

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD4017
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD4017
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The AZD4017 tablets and matching placebo will be supplied to the dedicated trial pharmacy by Almac in bottles of 32, 200mg tablets with a unique kit number (sufficient for 8 days per bottle); 4 bottles will be dispensed at Visit 1 and 1 bottle will be dispensed at Visit 4

    Arm title
    		 Placebo to match AZD4017
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match AZD4017
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The AZD4017 tablets and matching placebo will be supplied to the dedicated trial pharmacy by Almac in bottles of 32, 200mg tablets with a unique kit number (sufficient for 8 days per bottle); 4 bottles will be dispensed at Visit 1 and 1 bottle will be dispensed at Visit 4 (sufficient for 5 days overage per participant).

    Number of subjects in period 1
    		AZD4017 Placebo to match AZD4017
    Started
    14
    14
    Completed
    14
    13
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Trial Period
    Reporting group description
    		 -

    Reporting group values
    		 Main Trial Period Total
    Number of subjects
    		 28 28
    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 (standard deviation)
    		 60.21 ( 13.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    AZD4017
    Reporting group description
    		 -

    Reporting group title
    Placebo to match AZD4017
    Reporting group description
    		 -

    Primary: 24hr 11bHSD1 activity radioassay (% conv per 24 hrs ): Day 28

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    End point title
    		 24hr 11bHSD1 activity radioassay (% conv per 24 hrs ): Day 28 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Measured at Day 28 of treatment.
    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 see Figure 1 of the attached document for full details of Primary Endpoint analysis performed
    End point values
    		 AZD4017 Placebo to match AZD4017
    Number of subjects analysed
    14
    13
    Units: % conv/hr
        arithmetic mean (standard deviation)
    12.58 ( 5.64 )
    12.38 ( 4.51 )
    Attachments
    		 End Point Figures
    File note explaining change in heading
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Any reported AE will record the following information directly into the CRF at Visits 2, 3, 4, 5 and 6 • Type of AE defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 preferred term • Date of onset • Severity
    Adverse event reporting additional description
    Any reported AE will record the following information directly into the CRF at Visits 2, 3, 4, 5 and 6 • Type of AE defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 preferred term • Date of onset • Severity (defined by CTCAE v5.0) • Relation to study intervention • Date of Resolution
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Frequency threshold for reporting non-serious adverse events: 5%
    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: One Adverse Event was reported on the trial. Please see Figure 2 of the attached document for full details.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Oct 2018
    Protocol was amended to v2.0, to include an extra TEWL measurement at visits 2, 3 and 5.

    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
    For support, Contact us.
    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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