Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001946-17
    Sponsor's Protocol Code Number:SGNLVA-005
    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:2021-02-01
    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 number2019-001946-17
    A.3Full title of the trial
    Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors
    Studio di fase 2 in aperto su ladiratuzumab vedotin (LV) per tumori solidi localmente avanzati o metastatici non resecabili
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of LV in Advanced Solid Tumors
    Studio di fase 2 su LV per tumori solidi avanzati
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 Study of LV in Advanced Solid Tumors
    Studio di fase 2 su LV per tumori solidi avanzati
    A.4.1Sponsor's protocol code numberSGNLVA-005
    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 SponsorSEATTLE GENETICS, INC.
    B.1.3.4CountryUnited States
    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 supportSeattle Genetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeattle Genetics, Inc.
    B.5.2Functional name of contact pointSeagen Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address21823 30th Drive SE
    B.5.3.2Town/ cityBothell
    B.5.3.3Post codeWA 98021
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018663337436
    B.5.5Fax number000000000
    B.5.6E-mailEU-Requlatory@seaqen.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 nameLadiratuzumab vedotin
    D.3.2Product code [SGN-LIV1A ]
    D.3.4Pharmaceutical form Powder for solution for 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 INNLadiratuzumab vedotin
    D.3.9.1CAS number 1629760-29-7
    D.3.9.2Current sponsor codeSGN-LIV1A
    D.3.9.3Other descriptive namevcMMAE-hLIV22 hLIV22-vcMMAE
    D.3.9.4EV Substance CodeSUB188156
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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.IMP: 2
    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 nameLadiratuzumab vedotin
    D.3.2Product code [SGN-LIV1A]
    D.3.4Pharmaceutical form Powder for solution for 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 INNLadiratuzumab vedotin
    D.3.9.1CAS number 1629760-29-7
    D.3.9.2Current sponsor codeSGN-LIV1A
    D.3.9.3Other descriptive namevcMMAE-hLIV22 hLIV22-vcMMAE
    D.3.9.4EV Substance CodeSUB188156
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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.IMP: 3
    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 nameLadiratuzumab vedotin
    D.3.2Product code [SGN-LIV1A]
    D.3.4Pharmaceutical form Powder for solution for 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 INNLadiratuzumab vedotin
    D.3.9.1CAS number 1629760-29-7
    D.3.9.2Current sponsor codeSGN-LIV1A
    D.3.9.3Other descriptive namevcMMAE-hLIV22 hLIV22-vcMMAE
    D.3.9.4EV Substance CodeSUB188156
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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
    Multiple Solid Tumors
    Multipli Tumori Solidi
    E.1.1.1Medical condition in easily understood language
    Multiple Solid Tumors
    Multipli Tumori Solidi
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate antitumor activity of LV as measured by investigator-determined confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    Valutare l'attività antitumorale di LV misurata in base al tasso di risposta obiettiva (ORR) confermato dallo sperimentatore utilizzando i Criteri di valutazione della risposta nei tumori solidi, versione 1.1 (RECIST v1.1)
    E.2.2Secondary objectives of the trial
    -Evaluate the safety and tolerability of LV as measured by type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
    -Evaluate stability and control of disease as measured by disease control rate (DCR)
    -Evaluate durability of response as measured by duration of response (DOR)
    -Assess progression-free survival (PFS)
    -Assess survival as measured by overall survival (OS)
    -Assess pharmacokinetics (PK) and immunogenicity of LV
    ¿ Valutare la sicurezza e la tollerabilità di LV misurate in base a tipo, incidenza, severità, serietà e correlazione degli eventi avversi (EA)
    ¿ Valutare la stabilità e il controllo della malattia misurati in base al tasso di controllo della malattia (DCR)
    ¿ Valutare il mantenimento nel tempo della risposta misurata come durata della risposta (DOR)
    ¿ Valutare la sopravvivenza libera da progressione (PFS)
    ¿ Valutare la sopravvivenza misurata come sopravvivenza complessiva (OS)
    ¿ Valutare la farmacocinetica (PK) e l'immunogenicità di LV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Cohorts of Part A and Part B
    •Measurable disease according to RECIST v1.1 as assessed by the investigator
    •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1

    Cohort 1: SCLC
    •Must have extensive stage disease
    •No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
    •May have received prior anti-PD(L)1 therapy

    Cohort 2: NSCLC-squamous
    •Must have unresectable locally advanced or metastatic disease
    •Must have disease progression during or following systemic therapy
    a. Participants must have progressed during or after a platinum based combination therapy administered for the treatment of metastatic disease
    b. Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease.
    •No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
    •Must have received prior anti-PD(L)1 therapy, unless contraindicated

    Cohort 3: NSCLC-nonsquamous
    •Must have unresectable locally advanced or metastatic disease
    •Must have disease progression during or following systemic therapy
    a. Participants must have progressed during or after a platinumbased combination therapy administered for the treatment of metastatic disease
    b. Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease.
    •Must have had prior platinum-based chemotherapy
    •No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
    •Must have received prior anti-PD(L)1 therapy, unless contraindicated
    •Cohort 4: HNSCC
    •Must have unresectable locally recurrent or metastatic disease
    •Must have disease progression during or following prior line of systemic therapy
    a. Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; or
    b. Recurrence/progression within 6 months of last dose of
    platinum therapy given as part of a multimodal therapy in the curative setting
    •No more than 1 line of cytotoxic chemotherapy for their advanced disease
    •May have received prior anti-PD(L)1 therapy, unless contraindicated

    Cohort 5: esophageal-squamous
    •Must have unresectable locally advanced or metastatic disease
    •Must have disease progression during or following systemic therapy
    •Must have had prior platinum-based chemotherapy
    •No more than 1 line of cytotoxic chemotherapy for their advanced disease

    Cohort 6: gastric and GEJ adenocarcinoma
    •Must have unresectable locally advanced or metastatic disease
    •Must have received prior platinum-based therapy
    •Must have disease progression during or following systemic therapy
    •Participants with known human epidermal growth factor receptor 2(HER2) overexpression must have received prior HER2-targeted therapy
    •No more than 1 line of prior cytotoxic chemotherapy for their advanced disease
    Tutte le coorti della Parte A e della parte B
    • Malattia misurabile secondo RECIST v1.1 valutata dallo sperimentatore
    • Performance status secondo l'ECOG (Eastern Cooperative Oncology Group) di 0 o 1

    Coorte 1: SCLC
    • Deve avere una malattia allo stadio avanzato
    • Non più di 1 linea precedente di chemioterapia citotossica per la malattia allo stadio avanzato
    • Potrebbe aver ricevuto una precedente terapia anti-PD-L1

    Coorte 2: NSCLC squamoso
    • Deve avere una malattia localmente avanzata o metastatica non resecabile
    • Deve avere una progressione della malattia durante o dopo la terapia sistemica
    a. I partecipanti devono aver progredito durante o dopo una terapia di combinazione a base di platino somministrata per il trattamento della malattia metastatica
    b. I partecipanti devono aver progredito entro 6 mesi dall'ultima dose di adiuvante a base di platino, neoadiuvante o chemioterapia definitiva o regime di chemioradioterapia concomitante per la malattia allo stadio iniziale o localmente avanzato
    • Non più di 1 linea precedente di chemioterapia citotossica per la loro malattia avanzata
    • Deve aver ricevuto una precedente terapia anti-PD-L1, a meno che non era controindicata

    Coorte 3: NSCLC non squamoso
    • Deve avere una malattia localmente avanzata o metastatica non resecabile
    • Deve avere una progressione della malattia durante o dopo la terapia sistemica
    a. I partecipanti devono aver progredito durante o dopo una terapia di combinazione a base di platino somministrata per il trattamento della malattia metastatica
    b. I partecipanti devono aver progredito entro 6 mesi dall'ultima dose di adiuvante a base di platino, neoadiuvante o chemioterapia definitiva o regime di chemioradioterapia concomitante per la malattia allo stadio iniziale o localmente avanzato
    • Deve aver ricevuto una precedente chemioterapia a base di platino
    • Non più di 1 linea precedente di chemioterapia citotossica per la loro malattia avanzata
    • Deve aver ricevuto una precedente terapia anti-PD-L1, a meno che non era controindicata

    • Coorte 4: HNSCC
    • Deve avere una malattia localmente ricorrente o metastatica non resecabile
    • Deve avere una progressione della malattia durante o dopo la precedente linea di terapia sistemica
    a. Progressione della malattia dopo il trattamento con un regime contenente platino per la malattia ricorrente/metastatica; o
    b. Ricorrenza/progressione entro 6 mesi dall'ultima dose di terapia con platino somministrata come parte di una terapia multimodale in ambiente curativo
    • Non più di 1 linea di chemioterapia citotossica per la loro malattia avanzata
    • Può aver ricevuto una precedente terapia anti-PD-L1, a meno che non era controindicata

    Coorte 5: esofageo squamoso
    • Deve avere una malattia localmente avanzata o metastatica non resecabile
    • Deve avere una progressione della malattia durante o dopo la terapia sistemica
    • Deve aver ricevuto una precedente chemioterapia a base di platino
    • Non più di 1 linea di chemioterapia citotossica per la loro malattia avanzata

    Coorte 6: adenocarcinoma gastrico e della GEJ
    • Deve avere una malattia localmente avanzata o metastatica non resecabile
    • Deve aver ricevuto una precedente terapia a base di platino
    • Deve avere una progressione della malattia durante o dopo la terapia sistemica
    • I partecipanti con sovraespressione nota del recettore 2 (HER2) del fattore di crescita epidermica umana devono aver ricevuto una terapia precedente con target HER2
    • Non più di 1 linea precedente di chemioterapia citotossica per la loro malattia avanzata
    E.4Principal exclusion criteria
    All Cohorts of Part A and Part B
    •Active concurrent malignancy or a previous malignancy within the past 3 years
    •Known active central nervous system lesions
    •Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
    •Ongoing sensory or motor neuropathy of Grade =2
    •Has received prior radiotherapy within 2 weeks of start of study treatment
    Tutte le coorti della Parte A e della parte B
    • Malignità concomitante attiva o malignità precedente negli ultimi 3 anni
    • Lesioni del sistema nervoso centrale attive note
    • Eventuali tossicità clinicamente significative in corso associate al trattamento precedente (grado 2 o superiore)
    • Neuropatia sensoria o motoria in corso di grado > = 2
    • Ha ricevuto una precedente radioterapia entro 2 settimane dall'inizio del trattamento in studio
    E.5 End points
    E.5.1Primary end point(s)
    -Evaluate antitumor activity of LV
    -Valutare l'attività antitumorale di LV
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Investigator-determined confirmed ORR as measured by RECIST v1.1
    ORR confermato determinato dallo sperimentatore, misurato da RECIST v1.1
    E.5.2Secondary end point(s)
    -Evaluate the safety and tolerability of LV
    -Evaluate stability and control of disease
    -Evaluate durability of response in subjects who respond to LV
    -Evaluate PFS of subjects treated with LV
    -Evaluate survival of subjects treated with LV
    -Assess PK of LV
    -Assess immunogenicity of LV
    -Assess biomarkers of biological activity and resistance and predictive
    biomarkers of response
    -Valutare la sicurezza e la tollerabilità di LV.
    -Valutare la stabilità e il controllo della malattia
    -Valutare la durabilità della risposta nei soggetti che rispondono a LV
    -Valutare la PFS in soggetti trattati con LV
    -Valutare la sopravvivenza dei soggetti trattati con LV
    -Valutare PK di LV
    -Valutare l'immunogenicità di LV
    -Valutare i biomarcatori di attività biologica, resistenza e predittivi di risposta
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Type, incidence, severity, seriousness, and relatedness of AEs
    -Investigator-determined DCR as measured by RECIST v1.1
    -Investigator-determined DOR as measured by RECIST v1.1
    -Investigator-determined PFS as measured by RECIST v1.1
    -OS
    -Selected PK parameters for LV, total antibody, and MMAE
    -Incidence of ATAs to LV
    -Relationship between biomarkers in blood and tumor tissue to efficacy,
    safety, or other biomarker endpoints following treatment with LV
    -Tipo, incidenza, serietà, severità e correlazione degli eventi avversi (EA)
    -DCR determinato dallo sperimentatore, misurato da RECIST v1.1
    -DOR determinato dallo sperimentatore, misurato da RECIST v1.1
    -PFS determinata dallo sperimentatore, misurata da RECIST v1.1
    -Sopravvivenza complessiva (OS, Overall Survival)
    -Parametri PK selezionati per LV, anticorpo totale e MMAE
    -Incidenza di ATAs a LV
    -Relazione tra biomarcatori nel sangue e nel tessuto tumorale per l'efficacia, la sicurezza o altri endpoint di biomarcatori dopo il trattamento con LV
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Korea, Republic of
    Taiwan
    United States
    Italy
    Spain
    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
    Last patient, Last Visit
    Ultimo paziente, Ultima visita
    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 months4
    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: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 264
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 23:11:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA