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    Summary
    EudraCT Number:2015-003934-28
    Sponsor's Protocol Code Number:SPON1455-15
    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:2015-12-04
    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 number2015-003934-28
    A.3Full title of the trial
    Enhanced Epidermal Antigen Specific Immunotherapy trial -1 (EE-ASI-1): A Phase 1a study of gold nanoparticles administered intradermally by microneedles to deliver immunotherapy with a proinsulin derived peptide in Type 1 diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EE-ASI 1
    A.3.2Name or abbreviated title of the trial where available
    EE-ASI-1
    A.4.1Sponsor's protocol code numberSPON1455-15
    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 SponsorCardiff University
    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 supportEuropean Commission
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiff University
    B.5.2Functional name of contact pointProfessor Colin Dayan
    B.5.3 Address:
    B.5.3.1Street AddressDiabetes Research, Cardiff University, C2 Link,
    B.5.3.2Town/ cityHeath Park, Cardiff
    B.5.3.3Post codeCF14 4XN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02920742182
    B.5.5Fax number029 20 744671
    B.5.6E-maildayancm@cardiff.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 nameC19-A3 GNP intradermal micro-injectable solution of human C19-A3 pro-insulin peptide coupled to gold
    D.3.2Product code C19-A3 GNP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman C19-A3 proinsulin peptide coupled to gold nanoparticles (GNPs)
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeSPON1455-15
    D.3.9.3Other descriptive nameC19-A3 GNP
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10μg of peptide
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes
    E.1.1.1Medical condition in easily understood language
    Insulin dependent diabetes (juvenile onset diabetes)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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
    The primary objective of the study is to examine the risk of C19-A3 GNP administration in terms of general safety and induction of hypersensitivity.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    •To study the feasibility of delivering C19-A3 GNP via microneedles to humans.
    •To study the size and nature of immune responses to C19-A3 GNP generated in blood and the draining (axillary) lymph node.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Clinical diagnosis of type 1 diabetes for > 3 months (dated from the first insulin injection).
    2.Commenced on insulin treatment within 1 month of diagnosis after diagnosis.
    3.Age 16 to 40 years
    4.2 hour post-meal UCPCR > 0.53 nmol/mmol on at least one occasion (maximum 3 tests on different days)
    5.Possession of 0401 allele at the HLA-DRB1 gene locus

    If female, must be (as documented in patient notes):
    a.surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrolment), or
    b.using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrolment, or
    c.have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or
    d.be using 1 barrier method with the use of a spermicide(e.g., condom, diaphragm or cap)
    e.have placement of a intra-uterine device
    6.If male, must be:
    a.using a barrier method of contraception (condom) with the use of a spermicide. or
    b. have a sexual partner using one of the methods in point 7 above or
    c.have a non-reversed vasectomy (with confirmed azoospermia),
    7.Written and witnessed informed consent to participate.
    E.4Principal exclusion criteria
    1.HbA1c > 86mmol/L (10%).
    2.Females who are pregnant, breast-feeding or not using adequate forms of contraception.
    3.Previous diagnosis of renal disease including glomerulonephritis or nephropathy.
    4.Raised serum creatinine or abnormal urine albumin/creatinine ratio (ACR). If the initial ACR is raised, this should be repeated on two further occasions as first morning samples. The subject can be included if both of these samples are negative (within the reference range).
    5.Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to receiving the IMP and any monoclonal antibody therapy given for any indication. Note that previous exposure to proinsulin peptide C19-A3 in a clinical trial is not an exclusion criterion.
    6.Use of any hypoglycaemia agents other than insulin, for more than 6 weeks, at any time prior to trial entry.
    7.Use of inhaled insulin.
    8.Known alcohol abuse, drug abuse, HIV or hepatitis.
    9.Any other medical condition which, in the opinion of investigators, could affect the safety of the subject’s participation or outcomes of the study, including immunocompromised states and autoimmune conditionsor outcomes of the study, including immunocompromised states and autoimmune conditions.
    10.Subjects should not have had immunisations (flu and others) for 1 month prior to trial entry and should not receive any during their time in the trial
    11.Recent subject’s involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the subjects or the results of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the trial is the safety (adverse event) profile of this investigational agent.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The following time points are set for evaluation of adverse event profiles, but pharmacovigilance data will be collected at times points in between if events arise:
    2hours
    4 weeks
    8 weeks
    14 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints and timepoints:
    •T cell responses to GNP C19-A3 as determined by changes from baseline of interferon gamma and IL-10 ELISPOT responses to this peptide in blood following treatment at weeks 0, 8 and 14.
    •T cell responses to GNP C19-A3 as determined by changes from baseline of interferon gamma and IL-10 ELISPOT responses to this peptide in draining axillary lymph node before and after the first and last treatment administration.
    •Changes in additional immunological biomarkers (e.g. flow cytoemtry profiles, T reg assays, beta cell and T cell cell free DNA markers) from baseline at week 0, 8 and 14.
    •Effects on residual c-peptide secretion at week 12 as compared to baseline as assessed by a mixed meal tolerance test and a stimulated urine c-peptide test.
    •Effects on glycaemic control assessed by blood sugar profiles and HbA1c at week 14 as compared to baseline
    •Questionnaires on quality of life and diabetes self-management at baseline and week 14.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See point 23.2
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 8
    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)
    The trial intervention treatment will not be available to patients after the study has finished. This is an early phase study, with a small number of participants and is looking primarily at safety rather than treatment benefits. The treatment is not marketed or available outside of this study. Following treatment, care will be as normal in their local diabetes service.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Haematology Cancer Trials Unit
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-30
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