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    Summary
    EudraCT Number:2021-002570-54
    Sponsor's Protocol Code Number:D8231C00001
    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:2022-01-14
    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 number2021-002570-54
    A.3Full title of the trial
    A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination with Anti-cancer Agents in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma or classical Hodgkin Lymphoma
    Studio modulare di fase II, in aperto, multicentrico per valutare l’efficacia e la sicurezza di AZD4573 in monoterapia o in combinazione con agenti antitumorali in pazienti con linfoma a cellule T periferico o linfoma di Hodgkin classico recidivante/refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AZD4573 as Monotherapy or in Combination with Anti-cancer Agents in Patients with r/r PTCL or r/r cHL
    AZD4573 in monoterapia o in combinazione con agenti antitumorali in pazienti con PTCL r/r o cHL r/r
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberD8231C00001
    A.5.4Other Identifiers
    Name:IND numberNumber:156169
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concorde Pike
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE, 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018772409479
    B.5.5Fax number000000
    B.5.6E-mailInformation.Center@astrazeneca.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 nameAZD4573
    D.3.2Product code [AZD4573]
    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 INNAZD4573
    D.3.9.1CAS number 2057509-72-3
    D.3.9.2Current sponsor codeAZD4573
    D.3.9.3Other descriptive nameAZ13810325
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Relapsed/refractory Peripheral T-cell Lymphoma
    - Relapsed/refractory Classical Hodgkins Lymphoma
    - Linfoma a cellule T periferico recidivante/refrattario
    - Linfoma di Hodgkin classico recidivante/refrattario
    E.1.1.1Medical condition in easily understood language
    Cancer (lymphoma)
    Cancro (linfoma)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10034625
    E.1.2Term Peripheral T-cell lymphoma unspecified recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10034626
    E.1.2Term Peripheral T-cell lymphoma unspecified refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10020245
    E.1.2Term Hodgkin's disease nodular sclerosis recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10020246
    E.1.2Term Hodgkin's disease nodular sclerosis refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020233
    E.1.2Term Hodgkin's disease mixed cellularity recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020234
    E.1.2Term Hodgkin's disease mixed cellularity refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020216
    E.1.2Term Hodgkin's disease lymphocyte depletion type refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020215
    E.1.2Term Hodgkin's disease lymphocyte depletion type recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020227
    E.1.2Term Hodgkin's disease lymphocyte predominance type recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020228
    E.1.2Term Hodgkin's disease lymphocyte predominance type refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Module 1 :
    To assess the efficacy of AZD4573 by evaluation of objective response rate.
    Modulo 1:
    Valutare l’efficacia di AZD4573 mediante la valutazione del tasso di risposta obiettivo
    E.2.2Secondary objectives of the trial
    Module 1:
    - To assess efficacy of AZD4573 by evaluation of tumour response and OS.
    - To assess the safety and tolerability of AZD4573.
    - To assess the plasma PK of AZD4573.
    Modulo 1:
    - Valutare l’efficacia di AZD4573 mediante la valutazione della risposta al tumore e del OS.
    - Valutare la sicurezza e la tollerabilità di AZD4573.
    - Valutare la farmacocinetica (PK) plasmatica/sierica di AZD4573
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be at least 18 years of age inclusive at the time of signing the informed consent.
    - Participants who are diagnosed with one of the following, as defined by the World Health Organisation:
    • Peripheral T-cell Lymphoma
    • Classical Hodgkin Lymphoma
    - Eastern Cooperative Oncology Group performance status of <= 2.
    - Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:
    • Recurrence of disease after response to prior line(s) of therapy, or
    • Progressive disease after completion of or on the treatment regimen preceding entry into the study, or
    • Disease which did not achieve an objective response (CR or PR).
    -Prior lines of therapy:
    PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.
    • Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received BV as part of prior therapy.
    • NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.
    - cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.
    - Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano criteria [Cheson et al 2014]).
    - Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.
    - Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.
    - Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.
    - Adequate haematologic function at screening.
    - PTCL Only: All participants with PTCL must be willing and able to provide mandatory baseline bone marrow aspirate and/or biopsy no older than 3 months, and agree to undergo post-treatment bone marrow biopsy when required to confirm response.
    - Il partecipante deve avere almeno 18 anni di età al momento della firma del consenso informato.
    - Partecipanti a cui è stata diagnosticata una delle seguenti condizioni, come definito dall'Organizzazione mondiale della sanità:
    • Linfoma a cellule T periferico
    • Linfoma di Hodgkin classico
    - Performance status dell'Eastern Cooperative Oncology Group di <= 2.
    - Deve aver ricevuto almeno 1 linea di terapia precedente per il trattamento della malattia in corso e avere una malattia attiva recidivante o refrattaria documentata che richiede un trattamento, definita come:
    • Recidiva della malattia dopo la risposta alla(e) precedente(i) linea(e) di terapia(e), o
    • Malattia progressiva dopo il completamento o durante il regime di trattamento prima dell'ingresso nello studio, o
    • Malattia che non ha ottenuto una risposta obiettiva (CR o PR).
    - Linee terapeutiche precedenti:
    PTCL: i partecipanti devono aver fallito almeno 1 terapia precedente per il trattamento del PTCL.
    • Non NK-PTCL (Coorte 1): la terapia precedente deve aver incluso un agente alchilante e/o antraciclina. Inoltre, i partecipanti ALCL devono aver ricevuto BV come parte della terapia precedente.
    • NKTCL (Coorte 2): il trattamento precedente deve aver incluso un agente al platino e/o asparaginasi.
    - cHL (Coorte 3): i partecipanti devono aver fallito almeno 2 terapie precedenti per il trattamento del cHL (inclusi BV e anti-PD1), tranne quando non possono ricevere BV o anti-PD1 a causa di neuropatia o malattia autoimmune.
    - Presenza di almeno 1 lesione radiograficamente misurabile, con linfoma FDG-avid > 1,5 cm (secondo i criteri di Lugano [Cheson et al 2014]).
    - Livello di acido urico < ULN allo screening. Se allo screening è presente iperuricemia, deve essere somministrata una terapia SoC (inclusi liquidi EV e rasburicase o allopurinolo) per ridurre i livelli di acido urico a < ULN prima dell'inizio dell'intervento in studio.
    - Disponibilità e capacità di partecipare a tutte le valutazioni e procedure richieste in questo protocollo di studio, inclusa la somministrazione endovenosa del farmaco in studio e il ricover, se necessario, per almeno 24 ore durante la somministrazione del farmaco in studio.
    - La disponibilità di tessuto tumorale fresco o tessuto tumorale d'archivio deve essere confermata allo screening.
    - Adeguata funzione ematologica allo screening.
    - Solo PTCL: tutti i partecipanti con PTCL devono essere disposti e in grado di fornire obbligatoriamente un aspirato e/o una biopsia del midollo osseo non più vecchio di 3 mesi e devono accettare di sottoporsi a biopsia midollare post-trattamento quando richiesto per confermare la risposta.
    E.4Principal exclusion criteria
    - PTCL only: Presence of bulky disease (defined as largest lymphoma lesion >= 10 cm) or a LDH value > 3 x ULN.
    - PTCL only: Diagnosis of any of the following:
    • Lymphoblastic/precursor T-cell lymphoma or leukaemia
    • T-cell prolymphocytic leukaemia
    • T-cell large granular lymphocytic leukaemia
    • Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).
    - With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
    - Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.
    - History of prior non-haematological malignancy except for the following:
    • Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.
    • Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
    • Adequately treated carcinoma in situ without current evidence of disease.
    - As judged by the investigator, any evidence of:
    • Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]).
    • Current unstable or uncompensated respiratory or cardiac conditions.
    • Uncontrolled hypertension.
    • Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
    • IV anti-infective treatment within 1 week before first dose of study drug.
    - Known history of infection with HIV.
    - Serologic status reflecting active hepatitis B or C infection:
    • Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B PCR-positive will be excluded.
    • Participants who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCRpositive will be excluded.
    - Any of the following cardiac criteria:
    • Resting QT interval corrected using Fridericia's formula (QTcF) >= 470 msec obtained from a single ECG.
    • Any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
    - Documented confirmation and ongoing treatment of adrenal gland insufficiency or pancreatitis.
    - Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose:
    • Coronary artery bypass graft
    • Angioplasty
    • Vascular stent
    • Myocardial infarction
    • Angina pectoris
    • CHF (New York Heart Association Class >= 2)
    • Ventricular arrhythmias requiring continuous therapy
    • Atrial fibrillation, which is judged as uncontrolled by the treating physician
    • Haemorrhagic or thrombotic stroke, including transient ischemic attacks or any other CNS bleeding.
    - Solo PTCL: presenza di malattia bulky (definita come lesione di linfoma più grande >= 10 cm) o un valore di LDH > 3 x ULN.
    - Solo PTCL: diagnosi di uno dei seguenti:
    • Linfoma linfoblastico/precursore a cellule T o leucemia
    • Leucemia prolinfocitica a cellule T
    • Leucemia linfocitica granulare a grandi cellule T
    • Linfoma cutaneo a cellule T (es., ALCL di tipo cutaneo primitivo, micosi fungoide/sindrome di Sezary).
    - Ad eccezione dell'alopecia e della neuropatia, presenza di qualsiasi tossicità non ematologica non risolta da precedente terapia superiore al Grado 1 CTCAE al momento dell'inizio del trattamento in studio.
    - Presenza o anamnesi di linfoma del SNC, malattia leptomeningea o compressione del midollo spinale.
    - Anamnesi di precedenti neoplasie non ematologiche ad eccezione dei seguenti:
    • Malignità trattata con intento curativo e senza evidenza di malattia attiva presente da più di 1 anno prima dello screening e ritenuta a basso rischio di recidiva dal medico curante.
    • Melanoma lentigo maligna adeguatamente trattato senza evidenza attuale di malattia o cancro della pelle non melanomatoso adeguatamente controllato.
    • Carcinoma in situ adeguatamente trattato senza evidenza attuale di malattia.
    - A giudizio dell'investigatore, qualsiasi prova di:
    • Malattia sistemica grave o non controllata (ad es. insufficienza epatica grave, malattia polmonare interstiziale [bilaterale, diffusa, parenchimale]).
    • Attuali condizioni respiratorie o cardiache instabili o non compensate.
    • Ipertensione non controllata.
    • Infezioni sistemiche micotiche, batteriche, virali o di altro tipo non controllate (definite con la presenza di segni/sintomi in corso correlati all'infezione e senza miglioramento, nonostante gli antibiotici appropriati o altri trattamenti).
    • Trattamento antinfettivo per via endovenosa entro 1 settimana prima della prima dose del farmaco in studio.
    - Storia nota di infezione da HIV.
    - Stato sierologico che riflette l'infezione attiva da epatite B o C:
    • I partecipanti che sono positivi agli anticorpi di base dell'epatite B (anti-HBc) e che sono negativi all'antigene di superficie dovranno avere un risultato PCR negativo prima dell'arruolamento. Saranno esclusi coloro che sono positivi all'antigene di superficie dell'epatite B o positivi alla PCR dell'epatite B.
    • I partecipanti che sono positivi agli anticorpi dell'epatite C dovranno avere un risultato PCR negativo prima dell'arruolamento. Saranno esclusi coloro che risultano positivi alla PCR per l'epatite C.
    - Uno dei seguenti criteri cardiaci:
    • Intervallo QT a riposo corretto con la formula di Fridericia (QTcF) >= 470 msec ottenuto da un singolo ECG.
    • Qualsiasi anomalia clinicamente importante del ritmo (ad eccezione dei partecipanti con un pacemaker in sede), della conduzione o della morfologia dell'ECG a riposo (ad es. blocco di branca sinistro completo, blocco cardiaco di terzo grado).
    • Qualsiasi fattore che aumenta il rischio di prolungamento dell'intervallo QTc o il rischio di eventi aritmici come insufficienza cardiaca, sindrome congenita del QT lungo, storia familiare di sindrome del QT lungo o morte improvvisa inspiegabile al di sotto dei 40 anni.
    - Conferma documentata e trattamento in corso dell'insufficienza della ghiandola surrenale o della pancreatite.
    - Ha subito una delle seguenti procedure o ha manifestato una delle seguenti condizioni entro 6 mesi prima della prima dose:
    • Innesto di bypass coronarico
    • Angioplastica
    • Stent vascolare
    • Infarto miocardico
    • Angina pectoris
    • CHF (New York Heart Association Class >= 2)
    • Aritmie ventricolari che richiedono una terapia continua
    • Fibrillazione atriale, giudicata non controllata dal medico curante
    • Ictus emorragico o trombotico, inclusi attacchi ischemici transitori o qualsiasi altra emoraggia del SNC.
    E.5 End points
    E.5.1Primary end point(s)
    ORR, defined as the proportion of participants who have a tumour response (CR and PR) based on Lugano response criteria for malignant lymphoma.
    ORR, definito come la proporzione di partecipanti che hanno una risposta tumorale (CR e PR) basata sui criteri di risposta di Lugano per il linfoma maligno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Screening (Day -30 to Day -1) until disease progression or survival until death (approximately 6 months)
    Dallo Screening (Giorno -30 a Giorno -1) fino alla progressione della malattia o alla sopravvivenza fino alla morte (circa 6 mesi)
    E.5.2Secondary end point(s)
    - Endpoints based on Lugano response criteria for malignant lymphoma: CR rate, DoR, PFS.
    - OS
    - Plasma concentrations and derived PK parameters for AZD4573
    - Endpoint basati sui criteri di risposta di Lugano per il linfoma maligno: Tasso di CR, DoR, PFS.
    - OS
    - Concentrazioni plasmatiche e parametri PK derivati per AZD4573
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Screening (Day -30 to Day -1) until disease progression or survival until death (approximately 6 months)
    Dallo Screening (Giorno -30 a Giorno -1) fino alla progressione della malattia o alla sopravvivenza fino alla morte (circa 6 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 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) 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
    Modulare
    Modular
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    France
    Hong Kong
    Italy
    Korea, Republic of
    Singapore
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    With consent of participant's legally authorised representative
    Con il consenso del rappresentante legalmente autorizzato dal partecipante
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 90
    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 Decision2022-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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