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    The EU Clinical Trials Register currently displays   37504   clinical trials with a EudraCT protocol, of which   6153   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-002126-20
    Sponsor's Protocol Code Number:PID13341
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-06
    Trial 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 number2017-002126-20
    A.3Full title of the trial
    Interleukin-2 therapy of Autoimmunity in Diabetes: ITAD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aldesleukin Therapy in Type 1 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    Interleukin-2 Therapy of Autoimmunity in Diabetes
    A.4.1Sponsor's protocol code numberPID13341
    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 Oxford
    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 supportJDRF
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Office, 1st floor, Boundary Brook House Churchill Drive
    B.5.3.2Town/ cityHeadington, Oxford
    B.5.3.3Post codeOX3 7LQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00000000000
    B.5.5Fax number00000000000
    B.5.6E-mailctrg@admin.ox.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 Information not present in EudraCT
    D.2.1.1.1Trade name Proleukin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAldesleukin
    D.3.2Product code Aldesleukin
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAldesleukin
    D.3.9.1CAS number 0110942-02-4
    D.3.9.3Other descriptive nameInterleukin 2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18 x 106
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolvent for parenteral use
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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
    Type 1 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 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I 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
    To assess the effects of ultra-low dose aldesleukin on endogenous beta-cell function.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    1)To assess the efficacy of regular dosing of aldesleukin in increasing Treg levels
    2)To confrm the clinical safety and tolerability of ultra-low dose aldesleukin
    3) To assess changes in the immune system indicating benefit or potential risk for future gains/loss in beta-cell function and immune function.
    4) To assess treatment effect on glycaemic control
    5) To assess treatment effect on the immune activity and inflammatory marker CRP, as measured by frequent home dried blood spots.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have given written informed consent to participate or assent with parental consent
    2. Be aged 6-18 years
    3. Be diagnosed with T1D (at least one autoantibody positive), requiring insulin treatment
    4. Be within 6 weeks from diagnosis of T1D
    5. Have a random C-peptide > 200 pmol/l
    6. Normal full blood count
    E.4Principal exclusion criteria
    1. Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes
    2. Uncontrolled thyroid and coeliac diseases
    3. Hypersensitivity to aldesleukin or any of the excipients
    4. History of severe cardiac disease (NYHA Class III or IV)
    a. See Appendix D
    5. History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
    6. Participation in another clinical trial (CTIMP) within 4 months prior to screening
    7. Females who are pregnant, lactating or intend to get pregnant during the study
    8. Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
    9. Current use of immunosuppressive agents or steroids
    10. Active clinical infections – participants can be recruited after a minimum period of 48 h after last day of feeling unwell or last day of antibiotic/anti-viral treatment
    11. Immunisations – participants can be recruited after a minimum of 14 days following immunisation. Routine vaccinations should be avoided for the 6-month duration of treatment and for 30 days afterwards
    12. Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the participant ineligible for inclusion because of a safety concern
    13. Children with compliance problems
    E.5 End points
    E.5.1Primary end point(s)
    Differences in slopes of DBS C-peptide over the 6 month-treatment period between the active and placebo groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    DBS for c-peptide taken weekly through the treatment phase (6 months) and then monthly during the follow-up period.
    E.5.2Secondary end point(s)
    1) Change in Treg, Teff and NK56bright cell frequencies and phenotypes from baseline
    2) Safety will be assessed at each visit by:
    Physical examination, including assessment of the most commonly reported reactions to low- or high-dose aldesleukin, namely influenza-like syndrome, skin reaction, diarrhea, nausea; vital signs (temperature, weight, blood pressure, heart rate);
    abnormal laboratory parameters (liver, kidney function, full blood count); reporting of adverse events.
    3) Changes in the absolute numbers of T, B and NK cells. A whole blood 6-color BD TBNK Multitest™ assay using BD Trucount Tubes according to the manufacturers’ instructions (BD Biosciences) will be run to determine the relative and absolute concentration of lymphocyte subpopulations, including mature T, B and NK cells.
    4) Change in HbA1c and daily insulin requirements during the trial period.
    5) Change in CRP levels during the trial period
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) At baseline and then1, 2 , 3, 6 and 12 months from the beginning of treatment
    2) At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
    3) At baseline and then, 1, 2 , 3, 6 and 12 months from the beginning of treatment
    4) HbA1c: At baseline and then 3,6 and 12 months
    Insulin dose data: Baseline and then 1, 2, 3, 6 and 12 months
    5) Weekly DBS CRP collected during the 6-month treatment period, and monthly during the 6 months post-treatment period
    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 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 No
    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 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 Yes
    E.8.2.3Other No
    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 concerned5
    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 No
    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
    last patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days30
    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: 45
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    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)
    There will be no continued provision of the IMP to participants after their trial treatment has ended. This has been explicitly stated in both the protocol and the Patient Information Sheets.
    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 Thames Valley and South Midlands Offices
    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 Decision2018-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-13
    P. End of Trial
    P.End of Trial StatusOngoing
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