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    Summary
    EudraCT Number:2017-001351-31
    Sponsor's Protocol Code Number:ED17/93260
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-001351-31
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety, rationale and effect of a new treatment to improve skin function and wound healing in patients with type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    GC-SHealD (Glucocorticoids and Skin Healing in Diabetes) v1.1
    A.4.1Sponsor's protocol code numberED17/93260
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMRC Confidence in Concept Scheme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leeds
    B.5.2Functional name of contact pointAna Tiganescu
    B.5.3 Address:
    B.5.3.1Street Address8.13 Wellcome Trust Brenner Building, St James's University Hospital, Beckett Street
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS9 7TF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01133438336
    B.5.6E-maila.tiganescu@leeds.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD4017
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameAZD4017
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary objectives of the trial
    1) Compare the ability of the new treatment to decrease target enzyme activity in skin and at the whole body level

    2) Obtain data on the ability of the treatment to reach the skin

    3) Asses treatment safety in patient with type 2 diabetes

    4) Determine effects of the new treatment on measures of skin function including the role of skin as a barrier against water loss, the ability of skin to retain water (hydration), the ability of nerves in the skin to work correctly, effects on skin thickness and wound healing. We will also examine the underlying causes of these effects by analyzing the levels of all genes in skin.

    5) Obtain data on the number of participants that are able to take part, how many participants are recruited and how long it takes to complete recruitment, how many participants that are able to take part agree to taking part, how participants are allocated the treatment or placebo, the ability of participants to take the treatment as instructed, the number of participant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Able and willing to provide informed consent
    2) Clinical diagnosis of T2DM with HbA1c below or equal to 11% (below or equal to 97 mmol/mol) at screening while taking standard therapy at a stable dose for ≥10 weeks
    E.4Principal exclusion criteria
    1) Women of child-bearing potential (WOCBP). Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >/= 12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level >35 mIU/mL].

    Additionally, male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized or agree, along with their partner, to use a highly effective method of birth control (as defined below) from the time of screening until 3 weeks after final dose of study drug (5 drug elimination half-lives plus 2 weeks). Male study participants must also not donate sperm from the time of screening until 3 weeks after final dose of study drug (5 drug elimination half-lives plus 2 weeks).

    Highly effective methods of contraception are defined as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (either oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (either oral [such as Cerazette™], injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
    2) Active leg/foot ulceration
    3) Acute electrocardiogram (ECG) anomalies deemed to be clinically relevant by the CI
    4) Systemic hypertension (BP >150/90) on 3 successive measurements at the screening visit (patients with controlled hypertension can be included in the trial)
    5) Any endocrine disorder (other than T2DM), including type 1 or secondary diabetes, except treated hypothyroidism with normal thyroid function tests for at least 3 months
    6) Suspicion of or known Gilbert's disease
    7) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or alkaline phosphatase (ALP) > 1.5x upper limit of normal (ULN)
    8) Bilirubin (total) > 1.5x ULN
    9) An eGFR calculated by the Modification of Diet in Renal Disease equation of <45 ml/min/m2
    10) Creatine kinase (CK) >2 x ULN
    11) Participant is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence on questioning or clinical history
    12) Receiving any topical, systemic (including vaginal/rectal) or inhaled GC treatment at the time of or within 3 months prior to the screening visit
    13) Taking any anticoagulant medication (blood thinning e.g. warfarin)
    14) Taking probenicid or similar (for gout) at the time of inquiry
    15) Any medical/surgical procedure (excluding skin biopsies) or trauma during IMP administration or within one week following the last administration of the IMP as judged by the CI
    16) Involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    17) Participated in any other clinical study within 1 calendar month prior to the screening visit (except registry-only participation)
    18) Deemed otherwise inappropriate to participate by the trial team
    E.5 End points
    E.5.1Primary end point(s)
    24 hour 11β-HSD1 activity in skin (efficacy)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline Visit 1 (day 0) and Visit 4 (day 28).
    E.5.2Secondary end point(s)
    Additional AZD4017 efficacy variables (24 hour urinary cortisol to cortisone metabolite ratio for systemic 11β-HSD1 activity and AZD4017 detection in skin and plasma).

    Safety measures (adverse event reporting, body mass index, waist-hip ratio, blood pressure, blood HbA1c, blood lipids, full blood count, liver function, estimated glomerular filtration rate, kidney function, adrenal function, thyroid function and number of patients discontinuing study therapy due to safety).

    Skin function measures (sudomotor function and skin hydration, epidermal barrier function, recovery and integrity, skin thickness, wound healing and RNA-seq gene expression profiling).

    Other measures (24 hour urinary free cortisol for systemic cortisol exposure evaluation).

    Feasibility (eligibility, recruitment rate, consent rate, assessment of randomization, adherence rate, retention rate, completeness of outcome measure reporting and overall protocol assessment).
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hour urinary cortisol to cortisone metabolite ratio (days 0 and 35), AZD4017 detection in skin and plasma (day 28), adverse event reporting (days 2, 7, 28, 30 and 35), body mass index, waist-hip ratio and blood pressure (days, 0 and 35) safety blood tests (days 0, 7, 28 and 35), number of patients discontinuing study therapy due to safety (end of trial), sudomotor function and skin hydration (days 0 and 35), epidermal water loss (days 0, 2, 7, 28, 30 and 35), integrity (days 0 and 28, 3 hour, 2 day and 7 day), skin thickness (days 0 and 35), wound healing (days 0 and 28, 2 day and 7 day), RNA-seq gene expression profiling (days 0 and 28), 24 hour urinary free cortisol (days 0 and 35) and feasibility (end of trial).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Entry of the last participant’s last data item.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Routine care will be available throughout the trial period and will continue after a subject has ended his/her participation in the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-12
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