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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-006629-23
    Sponsor's Protocol Code Number:61186372GIC2002
    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:2022-07-13
    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 number2021-006629-23
    A.3Full title of the trial
    A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer
    Uno Studio in aperto di fase 1b/2, di amivantamab in monoterapia e in aggiunta alla chemioterapia standard di cura in partecipanti con tumore del colon-retto avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer
    Uno Studio in aperto di fase 1b/2, di amivantamab in monoterapia e in aggiunta alla chemioterapia standard di cura in partecipanti con tumore del colon-retto avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    61186372GIC2002
    61186372GIC2002
    A.4.1Sponsor's protocol code number61186372GIC2002
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    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 supportJanssen Cilag SpA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameAmivantamab
    D.3.2Product code [JNJ-61186372]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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.3.8INN - Proposed INNAmivantamab
    D.3.9.1CAS number 2171511-58-1
    D.3.9.2Current sponsor codeJNJ-61186372
    D.3.9.3Other descriptive nameD.3.6.2.1 - valore: 350-2,100 (>=80 kg) D.3.6.2.2 - unità: mg milligram(s) D.3.10.2.1.1 - valore concentrazione: 50
    D.3.9.4EV Substance CodeSUB193051
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.3.11.9Recombinant medicinal product Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or Metastatic Colorectal Cancer
    Tumore del colon-retto avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Advanced or Metastatic Colorectal Cancer
    Tumore del colon-retto avanzato o metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 anti-tumor activity of amivantamab as a monotherapy and characterize the safety of amivantamab when added to SoC Chemotherapy in participants with mCRC (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b).
    L’obiettivo primario è valutare l’attività antitumorale di amivantamab in monoterapia e caratterizzare la sicurezza di amivantamab quando aggiunto alla chemioterapia SoC nei partecipanti con mCRC (coorti di Ph2) e valutare la dose di combinazione raccomandata di fase 2 (Recommended Phase 2 Combination Dose, RP2CD) di amivantamab quando aggiunto alla chemioterapia SoC (Ph1b).
    E.2.2Secondary objectives of the trial
    To characterize the safety of amivantamab as a monotherapy and to assess the anti-tumor activity of amivantamab when added to SoC chemotherapy in participants with mCRC.
    Gli obiettivi secondari principali sono caratterizzare la sicurezza di amivantamab in monoterapia e valutare l’attività antitumorale di amivantamab quando aggiunto alla chemioterapia SoC nei partecipanti con mCRC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
    2. Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum.
    3. Participant must have previously been characterized as wild-type KRAS, NRAS, BRAF by local testing.
    4. For Ph1b-D and Ph1b-E: Participant must have evaluable disease.
    For Ph 2: Participant must have measurable disease according to RECIST v1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed =7 days after the biopsy.
    5. Participant must have ECOG PS 0 or 1.
    6. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony stimulating factor (G-CSF) within 7 days prior to the date of the laboratory test.
    7. Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsies.
    8. Human immunodeficiency virus (HIV)-positive participants are eligible if they meet the criteria
    9. A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
    10. A female participant must be either not of childbearing potential, or of childbearing potential and practicing at least 1 highly effective method of contraception.
    11. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility.
    12. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. If partner is a female of childbearing potential, the male participant must use condoms, and the partner must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom, but the partner is not required to use contraception.
    13. A male participant must agree not to donate sperm for the purposes of reproduction during the study and for 6 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anti-cancer treatments may impair fertility.
    14. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    15. Participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
    1. Il partecipante deve avere =18 anni di età (o l’età legale del consenso nella giurisdizione in cui si svolge lo studio).
    2. Il partecipante deve aver precedentemente ricevuto una diagnosi di adenocarcinoma istologicamente o citologicamente confermato, non resecabile o metastatico, del colon o del retto.
    3. Il partecipante deve essere stato precedentemente caratterizzato come KRAS, NRAS, BRAF wild-type mediante test a livello locale
    4. Per Ph1b-D e Ph1b-E: il partecipante deve presentare malattia valutabile.
    Per Ph 2: il partecipante deve presentare malattia misurabile secondo i criteri RECIST (Response Evaluation Criteria In Solid Tumors [criteri di valutazione della risposta nei tumori solidi]) v1.1. Se è presente una sola lesione misurabile, può essere utilizzata per la biopsia di screening a condizione che vengano eseguite scansioni di valutazione del tumore al basale =7 giorni dopo la biopsia.
    5, Il partecipante deve avere un PS (Performance Status [stato di validità]) secondo i criteri dell’ECOG (Eastern Cooperative Oncology Group [Gruppo cooperativo orientale di oncologia]) pari a 0 o 1.
    6. Il partecipante deve presentare un’adeguata funzionalità d’organo e del midollo osseo, come specificato di seguito, in assenza di un’anamnesi di trasfusione di globuli rossi, trasfusione piastrinica o uso di fattore stimolante le colonie di granulociti (Granulocyte Colony-Stimulating Factor, G-CSF) entro i 7 giorni precedenti la data del test di laboratorio.
    7. Il partecipante deve presentare una lesione tumorale adatta alla biopsia e acconsentire alla biopsia di screening obbligatoria definita dal protocollo.
    8. I partecipanti positivi al virus dell’immunodeficienza umana (Human Immunodeficiency Virus, HIV) sono idonei se soddisfano tutti i requisiti.
    9. Una partecipante di sesso femminile potenzialmente fertile deve presentare un test di gravidanza sul siero negativo allo screening ed entro 72 ore dalla prima dose del trattamento dello studio, nonché acconsentire a sottoporsi a ulteriori test di gravidanza sul siero o sulle urine nel corso dello studio.
    10. Una partecipante donna deve essere non in età fertile o in età fertile e fase uso di almeno 1 metodo contraccettivo altamente efficace.
    11. La partecipante di sesso femminile deve acconsentire a non donare ovuli (ovociti) o a congelarli per utilizzo futuro per finalità di riproduzione assistita durante lo studio e per un periodo di 6 mesi dopo aver ricevuto l’ultima dose del trattamento dello studio. Le partecipanti di sesso femminile devono prendere in considerazione la conservazione degli ovuli prima del trattamento dello studio, in quanto i trattamenti antitumorali possono compromettere la fertilità.
    12. Un partecipante di sesso maschile deve utilizzare un preservativo durante qualsiasi attività che consenta il passaggio di eiaculato a un’altra persona per la durata dello studio e per 6 mesi dopo aver ricevuto l’ultima dose del trattamento dello studio.Se la partner è una donna in età fertile, il partecipante di sesso maschile deve utilizzare il preservativo e la partner deve adottare anche un metodo contraccettivo altamente efficace. Un partecipante di sesso maschile che sia vasectomizzato deve comunque usare un preservativo, ma la partner non è tenuta a usare metodi contraccettivi.
    13. I partecipanti di sesso maschile devono acconsentire a non donare lo sperma per finalità riproduttive durante lo studio e per 6 mesi dopo aver ricevuto l’ultima dose del trattamento dello studio. I partecipanti di sesso maschile devono considerare la conservazione dello sperma prima del trattamento dello studio, in quanto i trattamenti antitumorali possono compromettere la fertilità.
    14. Il partecipante deve firmare un Modulo di consenso informato che indichi che il partecipante comprende l’obiettivo dello studio e le procedure da questo previste ed è disposto a parteciparvi.
    Per un elenco completo dei criteri di inclusione si prega di fare riferimenot alla sezione 5.1 del Protocollo
    E.4Principal exclusion criteria
    1. Participant with known ERBB2/HER2 amplification based on the local testing results
    2. Participant with identified mutation in KRAS, NRAS, BRAF, or EGFR ectodomain, or ERBB2/HER2 amplification by central ctDNA testing at screening
    3. Participant has an uncontrolled illness
    4. Participant with symptomatic brain metastasis
    5. History or known presence of leptomeningeal disease
    6. Participant has a history of (non-infectious) ILD/pneumonitis/pulmonary fibrosis, or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening.
    7. Participant has a history of clinically significant cardiovascular disease.
    8. Participant has known allergies, hypersensitivity, or intolerance to excipients of:
    a. amivantamab (refer to the IB, all participants)
    b. 5-FU or leucovorin (Participants in Ph1b-D, Ph1b-E, and Ph2 Cohorts D and E)
    c. Oxaliplatin (Participants in Ph1b-D and Ph2 Cohort D)
    d. Irinotecan (Participants in Ph1b-E and Ph2 Cohort E)
    9. Participant has at screening:
    a. Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Exception: Participants with a prior history of HBV demonstrated by positive hepatitis B core antibody (HBcAb) are eligible if they have at screening 1) a negative HBsAg and 2) an HBV DNA (viral load) below the lower limit of quantification, per local testing. Participants with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
    b. Positive hepatitis C antibody (anti-HCV [hepatitis C virus])
    c. Other clinically active infectious or non-infectious liver disease
    10. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    11. Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study drug. Participants must not have received any anti-EGFR treatment within 28 days of the first dose of study drug.
    12. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or postradiation skin changes [any grade], Grade =2 peripheral neuropathy, and Grade =2 hypothyroidism stable on hormone replacement).
    13. Participant has, or will have, any of the following:
    a. An invasive operative procedure with entry into a body cavity, within 4 weeks or without complete recovery before the first administration of study treatment. Thoracentesis, if needed, and percutaneous biopsy for baseline tumor tissue sample may be done less than 4 weeks prior to the first administration of study treatment, as long as the participant has adequately recovered from the procedure prior to the first dose of study treatment in the clinical judgement of the investigator
    b. Significant traumatic injury within 3 weeks before the start of the first administration of study treatment (all wounds must be fully healed prior to Day 1)
    c. Expected major surgery while the investigational agent is being administered or within 6 months after the last dose of study treatment
    14. Participant has received an investigational drug (including investigational vaccines, but not including anti-cancer therapy) or used an invasive investigational medical device within 6 weeks before the planned first dose of study treatment.
    1. Partecipante con amplificazione nota di ERBB2/HER2 in base ai risultati dei test locali.
    2. Partecipante con mutazione identificata di KRAS, NRAS, BRAF o ectodominio di EGFR o amplificazione di ERBB2/HER2 al test del ctDNA (Circulating tumor DNA [DNA tumorale circolante]) a livello centrale allo screening.
    3. Il partecipante presenta una malattia non controllata.
    4. Il partecipante presenta metastasi cerebrali sintomatiche.
    5. Anamnesi o presenza nota di malattia leptomeningea.
    6. Il partecipante presenta un’anamnesi di ILD (Interstitial Lung Disease [malattia polmonare interstiziale])/polmonite/fibrosi polmonare (non infettiva) o ha ILD/polmonite/fibrosi polmonare in corso, oppure non è possibile escludere ILD/polmonite/fibrosi polmonare sospetta mediante diagnostica per immagini allo screening.
    7. Il partecipante presenta un’anamnesi di malattia cardiovascolare clinicamente significativa.
    8. Il partecipante ha allergie note, ipersensibilità o intolleranza agli eccipienti di:
    a. amivantamab (consultare il Dossier per lo sperimentatore, tutti i partecipanti)
    b. 5-FU o leucovorina (Partecipanti nelle Coorti D ed E in Ph1b-D, Ph1b-E e Ph2)
    c. Oxaliplatino (Partecipanti nella Coorte D in Ph1b-D e Ph2)
    d. Irinotecan (Partecipanti nella Coorte E in Ph1b-E e Ph2)
    9. Il partecipante presenta positività allo screening per:
    a. Antigene di superficie dell’epatite B (virus dell’epatite B [Hepatitis B Virus, HBV]) (HB surface antigen, HBsAg)
    Eccezioni: i partecipanti con anamnesi pregressa di infezione da HBV dimostrata tramite positività per gli anticorpi anti-core dell’epatite B (Hepatitis B core Antibody, HBcAb) sono considerati idonei se, allo screening, presentano 1) HBsAg negativo e 2) DNA dell’HBV (carica virale) al di sotto del limite inferiore di quantificazione secondo i test locali. I partecipanti con HBsAg positivo dovuto a recente vaccinazione sono idonei se i livelli di DNA dell’HBV (carica virale) sono al di sotto del limite inferiore di quantificazione secondo i test locali.
    b. Positività agli anticorpi anti-epatite C (virus dell’epatite C [Hepatitis C Virus, HBC])
    Eccezioni: i partecipanti con anamnesi pregressa di infezione da HCV che hanno completato il trattamento antivirale con successiva documentazione di livelli di RNA dell’HCV al di sotto del limite inferiore di quantificazione secondo i test locali sono considerati idonei.
    c. Altra malattia epatica infettiva o non infettiva clinicamente attiva
    10. Qualsiasi condizione per cui, a giudizio dello sperimentatore, la partecipazione non sarebbe nel miglior interesse del partecipante (ad es. comprometterne il benessere) o che potrebbe prevenire, limitare o confondere le valutazioni specificate dal protocollo.
    11. Il partecipante ha ricevuto una precedente chemioterapia, terapia antitumorale mirata, immunoterapia o trattamento con un agente antitumorale sperimentale entro 2 settimane o 4 emivite, a seconda di quale periodo sia più lungo, prima della prima somministrazione del farmaco dello studio. I partecipanti non devono aver ricevuto alcun trattamento anti-EGFR entro 28 giorni dalla prima dose del farmaco dello studio. Per gli agenti con emivite lunghe, il tempo massimo necessario dall’ultima dose è di 28 giorni.
    12. Le tossicità delle precedenti terapie antitumorali devono essere state risolte ai livelli basali o al Grado 1 o inferiore prima della prima dose di trattamento dello studio (ad eccezione dell’alopecia o alterazioni della pelle post-radiazioni [qualsiasi grado], della neuropatia periferica di grado =2 e dell’ipotiroidismo di grado =2 stabile per sostituzione ormonale).

    Per un elenco completo dei criteri di esclusione si prega di fare riferimento alla sezione 5.2 del Protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR)
    Tasso di risposta obiettiva (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks (±1 week) for the first 30 months, then every 12 weeks (±1 week) until disease progression during the treatment period
    Dopo 8 settimane (±1 settimana) per i primi 30 mesi, poi ogni 12 settimane (±1 settimana) fino alla progressione della malattia durante il periodo di trattamento
    E.5.2Secondary end point(s)
    Duration of response (DoR), clinical benefit rate (CBR), and progression free survival (PFS) as determined by investigator, according to the Response Criteria in Solid Tumors (RECIST) Version 1.1
    Durata della risposta (DoR), tasso di beneficio clinico (CBR) e sopravvivenza libera da progressione (PFS) come determinato dallo sperimentatore, secondo i Criteri di risposta nei tumori solidi (RECIST) Versione 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 8 weeks (±1 week) for the first 30 months, then every 12 weeks (±1 week) until disease progression during the treatment period
    Dopo 8 settimane (±1 settimana) per i primi 30 mesi, poi ogni 12 settimane (±1 settimana) fino alla progressione della malattia durante il periodo di trattamento
    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 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
    Tolerability, Biomarker evaluation, Immunogenicity assessments,
    Quality of life
    Tollerabilità, valutazione dei biomarcatori, valutazioni dell'immunogenicità, Qualità della vita
    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
    phase 1b – dose confirmation/phase 2
    fase 1b – conferma della dose/fase 2
    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 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 Yes
    E.8.1.7.1Other trial design description
    In aperto
    Open
    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 trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Canada
    China
    Korea, Republic of
    Malaysia
    Taiwan
    United States
    France
    Spain
    Germany
    Italy
    Belgium
    United Kingdom
    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
    The end of study is considered as the last scheduled study assessment shown in the Schedule of Activities for the last participant in the study
    La fine dello studio è considerata come l'ultima valutazione programmata dello studio indicato nel Programma delle attività per l'ultimo partecipante allo studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 225
    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)
    Standard of care
    Standard of care
    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 Decision2022-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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