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    Summary
    EudraCT Number:2019-003265-17
    Sponsor's Protocol Code Number:MELD-ATG
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003265-17
    A.3Full title of the trial
    Phase II, dose ranging, efficacy study of anti-thymocyteglobulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D)
    Studio di fase II, a dose variabile, che valuta l'efficacia di globulina anti-timociti (ATG) entro 6 settimane dalla diagnosi di diabete di tipo 1 (DT1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Minimum effective dose of ATG in people recently diagnosed with type 1 diabetes
    Dose minima efficace di ATG in persone con diagnosi recente di diabete di tipo 1
    A.3.2Name or abbreviated title of the trial where available
    MELD-ATG
    MELD-ATG
    A.4.1Sponsor's protocol code numberMELD-ATG
    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 SponsorUniversitair Ziekenhuis Leuven/endocrinologie
    B.1.3.4CountryBelgium
    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 support“Innovative Medicines Initiative 2” (Call IMI2-Call1:Grant Agreement Number 115797)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSanofi
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportDexcom, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Cambridge
    B.5.2Functional name of contact pointMELD-ATG Trial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Pediatrics, Level 8, Box 116
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeBox 116
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401223762944
    B.5.6E-mailMELD-ATG@medschl.cam.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 Yes
    D.2.1.1.1Trade name THYMOGLOBULINE - 5 MG/ML POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA DA 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTHYMOGLOBULINE - 5 MG/ML POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA DA 10 ML
    D.3.2Product code [THYMOGLOBULINE]
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTHYMOGLOBULINE
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous 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 Mellitus (T1DM) at onset
    Diabete Mellito di Tipo 1 (T1DM) all'esordio
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes within 9 weeks from first insulin injection.
    Diabete di tipo 1 entro 9 settimane dalla diagnosi
    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 SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    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 determine the changes in stimulated C-peptide response over the first two hours of a mixed meal
    tolerance test (MMTT) at 12 months for 2.5mg/kg ATG arm versus the placebo.

    Conditional on finding a statistical difference between the 2.5mg/kg ATG arm and placebo, to identify the minimally effective dose (lowest dose significantly different to placebo) amongst the doses studied in the trial using change in stimulated C-peptide response over the first two hours of a MMTT at 12 months versus placebo.
    Determinare la variazione nella risposta del peptide C stimolato nelle prime due ore di un test di tolleranza con pasto misto (MMTT) a 12 mesi per il braccio ATG 2,5 mg/kg rispetto al placebo.

    A condizione che venga rilevata una differenza statisticamente significativa tra il braccio ATG 2,5 mg/kg e il placebo, individuare la dose minima efficace (la dose più bassa significativamente differente dal placebo) tra le dosi esaminate nello studio, utilizzando la variazione nella risposta del peptide C stimolato nelle prime due ore di un MMTT a 12 mesi rispetto al placebo
    E.2.2Secondary objectives of the trial
    To determine the effects of ATG treatment on:
    - MMTT-stimulated C-peptide (at baseline, 3, 6 and 12 months)
    - HbA1c and total daily insulin dose (units/kg) (at baseline, 3, 6, 12 months)
    - Fasting/stimulated dried blood spot (DBS) C-peptide measurements (monthly)
    - CGM measures over 14 days at 3, 6 and 12 months

    To determine whether ATG treatment mediates a reduction in CD4 positive T-cells but relative preservation of CD8 positive T-cells

    Descriptive analysis of the safety profile of different doses of ATG in different age groups
    • Determinare gli effetti del trattamento con ATG su:
    o Peptide C stimolato in risposta al test di tolleranza con pasto misto (MMTT) (al basale e a 3, 6 e 12 mesi)
    o HbA1c e la dose totale giornaliera di insulina (unità/kg) (al basale e a 3, 6 e 12 mesi)
    o Misurazioni dei valori del peptide C stimolato su campione di sangue secco (DBS)/a digiuno (una volta al mese)
    o Misurazioni della glicemia tramite monitoraggio continuo (CGM) in un periodo di 14 giorni a 3, 6 e 12 mesi

    • Determinare se il trattamento con ATG sia capace di mediare una riduzione dei linfociti T CD4 positivi, ma la preservazione relativa dei linfociti T CD8 positivi

    • Analisi descrittiva del profilo di sicurezza di diverse dosi di ATG in diversi gruppi di età
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has given written informed consent to participate; or have a parent or legal guardian provide written informed consent. Individual under the age of consent will be asked to assent to trial participation.
    2. Be aged =5 years to =25 years at written informed consent/assent
    3. Have been diagnosed with T1D within 3–9 weeks of planned treatment day 1
    4. Have random C-peptide levels =200 pmol/L measured at screening, as tested centrally
    5. Have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
    6. Will be =6 weeks from last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
    7. Be willing to comply with intensive diabetes management
    1. Consenso scritto del soggetto a partecipare allo studio, oppure consenso informato scritto da parte di un genitore o tutore legale. Ai soggetti sotto l'età del consenso verrà chiesto di fornire l'assenso alla partecipazione allo studio.
    2. Avere un'età da =5 a =25 anni al momento del consenso/assenso informato
    3. Aver ricevuto una diagnosi di DT1 nelle 3-9 settimane precedenti il giorno di trattamento 1 pianificato
    4. Presentare livelli casuali del peptide C =200 pmol/L misurati allo screening e testati a livello centralizzato
    5. Avere 1 o più autoanticorpi associati al diabete (GADA, IA-2A o ZnT8A) presenti allo screening e testati a livello centralizzato
    6. Essere trascorse =6 settimane dall'ultima immunizzazione con un vaccino vivo fino al giorno di trattamento 1 pianificato ed essere disposto/a a rinunciare a ricevere vaccini vivi durante lo studio, fino a 6 mesi dopo la somministrazione del trattamento
    7. Essere disposto/a ad attenersi a un piano di gestione intensiva del diabete
    E.4Principal exclusion criteria
    1. Type 2 diabetes
    2. Evidence of prior or current tuberculosis (TB) infection
    3. Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including:
    o Immunodeficient or clinically significant chronic leucopenia, neutropenia, lymphopenia or thrombocytopenia at the screening visit, according to local reference ranges
    o Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN), at screening
    o Evidence of renal dysfunction with creatinine greater than 1.5 times the ULN at screening, adjusted for the age of the patient
    o Clinically significant clotting disorder, according to local reference ranges
    4. Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
    5. Any active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any additional immunosuppression
    6. Seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection at screening
    7. Positive for SARS-CoV-2 based on local testing regimen
    8. Unwilling to use appropriate contraception if sexually active during the trial, from date of written informed consent until completion of the 12-month follow up visit
    9. Any history of malignancies
    10. Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control
    11. Active participation in another T1D treatment interventional trial in the previous 30 days prior to screening (excluding treatment with insulin)
    12. Any prior treatment with ATG, Abatacept or anti-CD3 13. Known allergy to ATG or to similar products, or hypersensitivity to rabbit proteins or to any of the excipients
    14. Any condition, complicating medical issues, or abnormal clinical laboratory results that the investigator judges may adversely affect trial conduct, cause increased risk to the participant, or compromise the trial results
    15. Pregnant and breastfeeding women
    1. Diabete di tipo 2
    2. Evidenza di infezione da tubercolosi (TBC) attuale o pregressa
    3. Emocromo completo (FBC), funzionalità renale o funzionalità epatica con anomalie clinicamente significative allo screening, inclusi:
    -Immunodeficiente o leucopenia, neutropenia, linfopenia o trombocitopenia cronica o clinicamente significativa alla visita di screening, secondo gli intervalli di riferimento locali
    -Evidenza di insufficienza epatica con aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) superiore a 3 volte il limite superiore della norma (ULN), allo screening.
    -Evidenza di disfunzione renale con creatinina superiore a 1,5 volte l'ULN allo screening aggiustato per l'età del paziente
    4. Necessità di utilizzare altri agenti immunosoppressivi o immunomodulatori, compresa l’assunzione cronica di steroidi sistemici
    5. Qualsiasi infezione cronica attiva allo screening, o qualsiasi infezione acuta o cronica attiva al basale o al giorno di trattamento, che potrebbe controindicare qualsiasi immunosoppressione aggiuntiva
    6. Sieropositività per il virus dell'immunodeficienza umana (HIV), infezione da epatite B o epatite C allo screening
    7. Positività a SARS-CoV-2 in base al test locale
    8. Rifiuto di utilizzare metodi contraccettivi adeguati se il soggetto è sessualmente attivo durante lo studio, dalla data del consenso informato scritto fino al completamento della visita di follow-up a 12 mesi
    9. Anamnesi di tumori maligni
    10. Uso attuale o continuo di farmaci non insulinici che influiscono sul controllo glicemico
    11. Partecipazione attiva a un altro studio interventistico su un trattamento per il DT1 nei 30 giorni precedenti lo screening (escluso il trattamento con insulina)
    12. Eventuale trattamento precedente con ATG, Abatacept o anticorpi Anti-CD3
    13. Allergia nota ad ATG o a prodotti simili, o ipersensibilità alle proteine di coniglio o a qualsiasi eccipiente
    14. Eventuali condizioni, problemi medici di rilievo, anomalie cliniche di laboratorio che, a giudizio dello sperimentatore, potrebbero compromettere la conduzione dello studio, comportare un maggior rischio per il partecipante o pregiudicare i risultati dello studio.
    15. Le donne incinte e che allattano
    E.5 End points
    E.5.1Primary end point(s)
    Area under the stimulated C-peptide response curve
    Area sotto la curva della risposta del C-peptide stimolato
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured in the first 2 hours of an MMTT at 12 months after treatment.
    Misurato nelle prime 2 ore di un MMTT a 12 mesi dopo il trattamento.
    E.5.2Secondary end point(s)
    4. HbA1c; 2. Measurements of the stimulated C peptide values on a blood sample dry (DBS); 5. Insulin requirement; 3. CD4-positive T cells and CD8-positive T cells; 1. Area under the stimulated C-peptide response curve
    The area under the curve of the response of the C-peptide stimulated during the
    first two hours of a mixed meal tolerance test (MMTT); 6. T1D-associated autoantibodies (GADA, IAA, IA-2A and ZnT8A); 7. CGM measurements (time in range, time above, time below)
    4. HbA1c; 2. Misurazioni dei valori del peptide C stimolato su campione di sangue secco (DBS ); 5. Fabbisogno insulinico; 3. Cellule T CD4-positive e cellule T CD8-positive; 1. Area sotto la curva della risposta del C-peptide stimolato
    L’area sotto la curva della risposta del C-peptide stimolato nel corso delle
    prime due ore di un test di tolleranza al pasto misto (MMTT); 6. Autoanticorpi associati al T1D (GADA, IAA, IA-2A e ZnT8A); 7. Misure CGM (tempo in range, tempo al di sopra, tempo al di sotto)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 12 months; At all observation times; Over 12 months; Over 12 months; At baseline, 3, 6 and 12 months; Over 12 months; Over 12 months
    Nell’arco dei 12 mesi; In tutti i tempi di osservazione; Nell’arco dei 12 mesi; Nell’arco dei 12 mesi; Al basale, 3, 6 e 12 mesi; Nell’arco dei 12 mesi; Nell’arco dei 12 mesi
    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 Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Disegno adattativo, in base al quale le dosi di trattamento saranno decise da analisi intermedie
    Adaptive design, according to which the treatment doses will be decided by intermediate analysis
    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 trial5
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Denmark
    Finland
    Germany
    Italy
    Poland
    Slovenia
    United Kingdom
    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
    The trial ends when the last patient has completed the trial. The translational endpoints will be analyzed, and the data processed for the primary analysis and reported within 6 months of the end of the trial.
    La sperimentazione si conclude quando l'ultimo paziente ha completato i controlli previsti. Gli endpoint traslazionali verranno analizzati, e i dati elaborati per l'analisi primari e riportati entro 6 mesi dalla fine della sperimentazione.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 47
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children aged 5 and over
    Minori dai 5 anni in su
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 114
    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)
    Subjects will continue standard care for type 1 diabetes during and after participation in the study
    I soggetti continueranno la cura standard per il diabete di tipo 1 durante e dopo la partecipazione allo studio
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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