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    Summary
    EudraCT Number:2020-001317-20
    Sponsor's Protocol Code Number:IMCY-T1D-003
    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:2021-06-14
    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 number2020-001317-20
    A.3Full title of the trial
    A Phase Ib/IIa, randomized, double-blind placebo-controlled, multicenter adaptive design clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect on the preservation of beta-cell function in young adult and adolescent patients with a recent onset Type 1 diabetes
    Studio clinico multicentrico di fase Ib/IIa con disegno adattivo, randomizzato, in doppio cieco, controllato con placebo, inteso a valutare l’impronta immunitaria del trattamento con ImotopeTM IMCY- 0098 e i suoi effetti sulla preservazione della funzione delle cellule beta in giovani adulti e adolescenti con insorgenza recente di diabete di tipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMCY-0098 Proof of ACtion in Type 1 Diabetes - IMPACT Study
    Dimostrazione di attività di IMCY-0098 nel diabete di tipo 1 (IMCY-0098 Proof of ACtion in Type 1 Diabetes) - Studio IMPACT
    A.3.2Name or abbreviated title of the trial where available
    IMPACT
    IMPACT
    A.4.1Sponsor's protocol code numberIMCY-T1D-003
    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 SponsorImcyse SA
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImcyse SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImcyse SA
    B.5.2Functional name of contact pointJean Van Ramperlbergh
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de l'Hospital, 1 / GIGA B34
    B.5.3.2Town/ cityLiege
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical@imcyse.com
    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 nameIMCY-0098
    D.3.2Product code [IMCY-0098]
    D.3.4Pharmaceutical form Powder for suspension for injection
    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.3.9.2Current sponsor codeIMCY-0098
    D.3.9.4EV Substance CodeSUB188922
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number450 to 1350
    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 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 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 placeboPowder for suspension 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
    Diabete di tipo 1
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes
    Diabete di tipo 1
    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 21.1
    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
    To determine the difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups at 48 weeks for the best dose/regimen of IMCY-0098 defined in the first step.
    Determinare la differenza nel peptide C misurato a digiuno su gocce di sangue secco (DBS) tra il gruppo di trattamento e il gruppo placebo a 48 settimane, per la dose/posologia ottimale di IMCY-0098 secondo quanto stabilito nella prima fase.
    E.2.2Secondary objectives of the trial
    (1) To determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) at baseline and after 12, 24 and 48 weeks for the best dose/regimen of IMCY-0098 defined in the first step versus placebo.
    (2) To determine the changes in DBS C-peptide measurements at each visit comparing each dose/regimen with placebo.
    (3) To determine the effects of the best dose/regimen of IMCY-0098 on HbA1c, hypoglycaemic events, Diabetes Ketoacidosis episodes, daily total insulin dose and CGM measures
    (4)To evaluate the impact of IMCY-0098 on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time
    (5)To evaluate the safety features of IMCY-0098 at all doses/regimens in adult and adolescents (12-17 y.o.a).
    (1) Determinare la variazione nella risposta del peptide C stimolato durante le prime due ore di un test di tolleranza del pasto misto (MMTT), al basale e dopo 12, 24 e 48 settimane per la dose/posologia ottimale di IMCY-0098 secondo quanto stabilito nella prima fase e in relazione al gruppo placebo.
    (2) Determinare a ciascuna visita le variazioni del peptide C misurato nelle DBS, per ogni dose/posologia rispetto al placebo.
    (3) Determinare gli effetti della dose/posologia ottimale di IMCY-0098 su HbA1c, eventi ipoglicemici, episodi di chetoacidosi diabetica (CAD), dose totale di insulina e misurazioni del monitoraggio continuo del glucosio (CGM)
    (4) Valutare l’effetto di IMCY-0098 su anticorpi anti GAD65, IA 2, ZnT8 e insulina nel corso del tempo
    (5) Valutare le caratteristiche di sicurezza di IMCY-0098 per tutte le dosi/posologie negli adulti e negli adolescenti (età compresa tra 12 e 17 anni).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1)Have given written informed consent for adult participants and adolescent participant's parent(s). Have given written informed assent for adolescent participants.
    (2)Age at screening:
    - Step 1 will include participants aged greater than or equal to 18 years and < 45 years at the time of consent
    - Step 2 will include participants aged greater than or equal to 12 years and <45 years at the time of assent/consent.
    (3)Must have a diagnosis of T1D of within maximum 9 weeks duration at screening (date of the first insulin injection)(4)Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8)
    (5)Must have random C-peptide levels greater than or equal to 200 pmol/L measured at screening
    (6)Must be HLA DR4 positive
    (7)Must be willing to comply with intensive diabetes management
    (8)Be treated with insulin therapy in accordance with local standard of care
    (9)Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment.
    This includes:
    - Barrier contraception (condom and spermicide) or
    - True abstinence (where this is in accordance with the participants preferred and usual lifestyle)
    (10)All females must have a negative serum pregnancy test at screening. Women sexually active and of childbearing potential must agree to use a highly effective contraception method from screening up to 90 days after last treatment with the investigational product
    (1) Consenso informato scritto dei partecipanti adulti o dei genitori dei partecipanti adolescenti. Assenso scritto per i partecipanti adolescenti.
    (2) Età al momento dello screening:
    a. La fase 1 includerà partecipanti di età maggiore o uguale a 18 anni e <45 anni al momento del consenso
    b. La fase 2 includerà partecipanti di età maggiore o uguale a 12 anni e <45 anni al momento dell’assenso/ consenso.
    (3) Diagnosi di T1D effettuata non più di 9 settimane prima dello screening (data della prima iniezione di insulina)
    (4) Presenza di almeno uno o più autoanticorpi associati al diabete al momento dello screening (GAD65, IA-2 o ZnT8)
    (5) Livelli random di peptide C maggiore o uguale a 200 pmol/l misurati allo screening
    (6) Positività HLA DR4
    (7) Disponibilità ad aderire ad una gestione intensiva del diabete
    (8) In trattamento con terapia insulinica conformemente a quanto previsto dai protocolli di cura locali
    (9) I pazienti fertili di sesso maschile devono accettare di utilizzare un metodo contraccettivo adeguato fino a 90 giorni dall’ultimo trattamento con il farmaco sperimentale. Con ciò si intende:
    - metodo di barriera (preservativo e spermicida) oppure
    - astinenza totale (quando in accordo allo stile di vita prescelto e abituale del partecipante)
    (10) Le pazienti di sesso femminile dovranno avere un risultato negativo al test di gravidanza effettuato al momento dello screening sul siero. Le donne sessualmente attive e in età fertile devono accettare di usare un metodo contraccettivo altamente efficace dal momento dello screening fino a 90 giorni dall’ultimo trattamento con il farmaco sperimentale.
    E.4Principal exclusion criteria
    (1)Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including
    a.Be immunodeficient or have clinically significant chronic lymphopenia:
    Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)
    b.Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
    c.Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal. Patients with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is less than or equal to 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis.
    (2)Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry
    (3)Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but is not limited to: oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
    (4)Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration
    (5)Require the use of immunosuppressive agents including chronic use of systemic steroids
    (6)Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
    (7)Presence of any uncontrolled disease (including uncontrolled autoimmune disease) or abnormal clinical laboratory results that may interfere with study conduct as judged by the investigator
    (8)History of, or current malignancy (except excised basal cell skin cancer)
    (9)Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within the 7 days prior to screening visit
    (10)Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days
    (11)Known hypersensitivity to any component of the drug product
    (12)CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study.
    (1) Anomalie clinicamente significative dell’emocromo (FBC), della funzione renale o epatica al momento dello screening, tra cui
    a. Immunodeficienza o linfopenia cronica clinicamente significativa: Leucopenia (<3000 leucociti/µl), neutropenia (<1500 neutrofili/µl), linfopenia (<800 linfociti/µl) o trombocitopenia (<100.000 piastrine/µl)
    b. Segni di insufficienza renale con valori di creatinina che superano di oltre 1,5 volte il limite superiore per i valori normali
    c. Evidenza di insufficienza epatica con valori di aspartato aminotransferasi (AST) o alanina transaminasi (ALT) che superano di oltre 3 volte i limiti superiori per i valori normali. Pazienti aventi valori elevati di bilirubina non coniugata (sindrome di Gilbert) sono eleggibili nel caso in cui la bilirubina sia minore o uguale a 3 volte i limiti di normalità superiori e gli enzimi e la funzione epatica siano invece normali (AST/ALT/Fosfatasi alcalina entro i limiti superiori di normalità), e non ci sia alcuna evidenza di emolisi.
    (2) Segni o sintomi di infezione attiva grave che necessiti di somministrazione endovenosa di antibiotici e/o di ricovero ospedaliero al momento dell’arruolamento
    (3) Vaccino vivo attenuato di qualsiasi tipo nei 3 mesi antecedenti alla prima somministrazione programmata del farmaco sperimentale (che include, ma non è limitato a: vaccino contro la poliomielite, vaccino contro morbillo/parotite/rosolia, vaccino contro la febbre gialla, vaccino contro l’encefalite giapponese, vaccino contro il dengue, vaccino contro il rotavirus, vaccino contro la varicella, vaccino vivo attenuato anti-herpes zoster, vaccino BCG contro il bacillo di Calmette-Guérin, vaccino orale contro la febbre tifoide)
    (4) Gravidanza o allattamento in corso o gravidanza prevista fino ad almeno 24 settimane dall’ultima somministrazione di farmaco sperimentale
    (5) Necessità di fare uso di agenti immunodepressivi, inclusa l’assunzione cronica di steroidi sistemici. I corticosteroidi topici o intranasali sono concessi
    (6) Evidenza di infezione in corso o pregressa di virus dell’immunodeficienza umana (HIV), di infezione da epatite B o epatite C
    (7) Presenza di qualsiasi patologia non controllata (incluse malattie autoimmuni non controllate) oppure risultati clinici di laboratorio anomali che si ritiene possano interferire con la conduzione dello studio secondo l’opinione dello sperimentatore
    (8) Tumori in corso o pregressi (a eccezione di epitelioma basocellulare escisso)
    (9) Uso, in corso o nei 7 giorni prima della visita di screening, di farmaci diversi dall’insulina, suscettibili di avere un impatto sul controllo glicemico
    (10) Partecipazione attiva a un altro studio sul trattamento del T1D o altro studio sperimentale interventistico negli ultimi 30 giorni
    (11) Nota ipersensibilità a qualsiasi componente del farmaco
    (12) Personale dipendente della CRO o dello sponsor o sotto la diretta supervisione dello sperimentatore e/o direttamente coinvolto nello studio
    E.5 End points
    E.5.1Primary end point(s)
    The DBS C-peptide measurements
    Misurazioni del peptide C in DBS a 48 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    (1) The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at 12, 24 and 48 weeks in the IMCY-0098 groups compared to placebo
    (2) The DBS C-peptide responses at each visit
    (3)
    3.1.Change in HbA1c, from baseline to 24 and 48 weeks
    3.2.Number of treatment-emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA)
    3.3.Number of treatment-emergent episodes of diabetic ketoacidosis (DKA)
    3.4.Change in insulin requirements, baseline to 24 and 48 weeks as the daily total dose (three days average) in units per kg body weight (BW)
    3.5.Continuous glucose monitoring (CGM) time in range (70-180 mg/dL, 3.9-10.0 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range (<70 mg/dL, < 3.9 mmol/L) during 10 days at 12, 24 and 48 weeks compared to the reference period (first 10 days after randomization)
    (4) Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 24 and 48 weeks
    (5)
    5.1 Occurrence, intensity and relationship of any listed injection site and systemic AEs during a 7-day follow-up period (i.e., day of study product administration and 6 subsequent days) after each IMCY-0098 or placebo
    dose
    5.2 Occurrence, intensity and relationship of any unlisted injection site and AEs throughout the study period
    5.3 Occurrence and relationship of all SAEs throughout the study period
    5.4 Occurrence and relationship of any abnormality in physical examination, vital signs, 12-lead ECG
    5.5 Measure of CD4+/CD8+ lymphocytes ratio.
    1) L’area sotto la curva della risposta del peptide C stimolato nel corso delle prime due ore di un test di tolleranza del pasto misto (MMTT) a 12, 24 e 48 settimane nel gruppo trattato con IMCY-0098 rispetto al gruppo placebo
    2) Le risposte del peptide C nelle DBS a ogni visita
    3)
    3.1 Variazioni dei valori HbA1c dal basale alle settimane 24 e 48
    3.2 Numero di episodi ipoglicemici acuti ascrivibili al trattamento. Secondo la American Diabetes Association (ADA), una ipoglicemia grave è indice di un deterioramento cognitivo importante che richiede assistenza esterna ai fini del recupero
    3.3 Numero di episodi di CAD ascrivibili al trattamento
    3.4 Variazioni dei requisiti di insulina dal basale alle settimane 24 e 48, in termini di dose giornaliera complessiva (media su tre giorni) espressa in unità per chilogrammo di peso corporeo (BW)
    3.5 Tempo durante il quale il monitoraggio continuo del glucosio (CGM) rientra nell’intervallo previsto (70-180 mg/dl, 3,9-10,0 mmol/l), tempo in cui i valori sono superiori a quelli previsti (>180 mg/dl, >10,0 mmol/l), tempo in cui i valori sono inferiori a quelli previsti (<70 mg/dl, <3,9 mmol/l) durante un periodo di 10 giorni misurato alle settimane 12, 24 e 48 in relazione al periodo di riferimento (i primi 10 giorni dopo la randomizzazione)
    4) Variazioni degli autoanticorpi associati al T1D (GADA, IAA, IA-2A e ZnT8A) dal basale alle settimane 24 e 48
    5)
    5.1 Insorgenza, intensità e correlazione di eventuali AE (eventi avversi) attesi, sistemici e relativi ai siti di iniezione, durante un periodo di follow-up di 7 giorni (ossia, il giorno della somministrazione del farmaco oggetto dello studio e i 6 giorni successivi) dopo ogni dose di IMCY-0098 o placebo
    5.2 Insorgenza, intensità e correlazione di eventuali AE inattesi, sistemici e relativi a siti di iniezione, per tutta la durata dello studio
    5.3 Insorgenza e correlazione di tutti i SAE (eventi avversi gravi) per tutta la durata dello studio
    5.4 Insorgenza e correlazione di eventuali anomalie riscontrate durante l’esame obiettivo, nei parametri vitali, nei valori dell’ECG a 12 derivazioni
    5.5 Misura del rapporto di linfociti CD4+/CD8+
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) MMTT: D0, w12, w24, w48
    2) The DBS C-peptide: at each visit
    3)- HbA1c: D0, w12, w24, w48
    3.1 # of treatment-emergent severe hypoglycaemic episodes: throughoutthe study period
    3.2 # of treatment-emergent episodes of diabetic ketoacidosis (DKA):throughout the study period
    3.3 Change in insulin requirements: D0, w24, w48
    3.4 CGM: D0, w12, w24, w48
    4) GADA, IAA, IA-2A and ZnT8A: D0, w24, w48
    5)
    5.1 any listed injection site and systemic AEs: after each IMP administration (7days)
    5.2 any unlisted injection site and AEs: throughout the study period
    5.3 SAEs: throughout the study period
    5.4
    - Physical examination: screening (D0), w6, w12, w24, w48
    - vital signs: each visit
    - 12-lead ECG: screening, w12, w48
    5.5 Measure of CD4+/CD8+ lymphocytes ratio: at each visit
    1)MMTT :12, 24 e 48 settimane
    2) Le risposte del peptide C nelle DBS: ogni visita
    3)
    3.1 HbA1c : D0, settimane 12, 24,48
    3.2 Numero di episodi ipoglicemici acuti ascrivibili al trattamento: tutta la durata dello studio
    3.3 Numero di episodi di CAD ascrivibili al trattamento tutta la durata dello studio
    3.4 Variazioni dei requisiti di insulina: D0, settimane 24,48
    3.5 CGM: D0,settimane 12, 24,48
    4)GADA, IAA, IA-2A e ZnT8A: dD0, settimane 24,48
    5)
    5.1 AE attesi: periodo di follow-up di 7 giorni dopo ogni dose di IMCY-0098 o placebo
    5.2 AE inattesi:per tutta la durata dello studio
    5.3 SAE:per tutta la durata dello studio
    5.4
    -esame obiettivo: D0, settimane 6,12,24,28
    -parametri vitali: tutte le visite
    -ECG: screening, settimane 12,48
    5.5 CD4+/CD8+:tutte le visite
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib/IIa phase
    Fase Ib/IIa
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    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
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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)
    none
    nessuno
    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 INNODIA
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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