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    Summary
    EudraCT Number:2020-004175-41
    Sponsor's Protocol Code Number:NIT-109
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2020-004175-41
    A.3Full title of the trial
    A Multicenter, Open-label, Phase 2 Study of NT-I7 in Combination with Nivolumab in Subjects with Relapsed/Refractory Gastric or Gastro-esophageal Junction or Esophageal Adenocarcinoma who Progressed on or Intolerant to 2 or more Prior Lines of Systemic Therapy
    Studio di fase 2 multicentrico, in aperto, su NT-I7 in combinazione con nivolumab in soggetti con adenocarcinoma avanzato o metastatico gastrico o della giunzione gastro-esofagea o esofageo recidivante/refrattario che hanno mostrato progressione o intolleranza a 2 o più linee precedenti di terapia sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-label, Phase 2 Study of NT-I7 in Combination with Nivolumab in Subjects with Stomach, Esophageal Cancers who Progressed on or Were Not Responsive to 2 or More Previous Therapies
    Studio di fase 2 multicentrico, in aperto, su NT-I7 in combinazione con nivolumab in soggetti con cancro metastatico dello stomaco, esofageo che hanno mostrato progressione o non responsività a 2 o più linee precedenti di terapia
    A.3.2Name or abbreviated title of the trial where available
    NT-I7 in Combination with Nivolumab in Advanced Gastric, GEJ, or EAC
    NT-I7 in combinazione con nivolumab in GGE o ACE gastrico avanzato
    A.4.1Sponsor's protocol code numberNIT-109
    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 SponsorNeoImmuneTech, 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 supportNeoImmuneTech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeoImmuneTech, Inc.
    B.5.2Functional name of contact pointClinical Division
    B.5.3 Address:
    B.5.3.1Street Address2400 Research Blvd. Suite 250
    B.5.3.2Town/ cityRockville
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.6E-mailNIT109@neoimmunetech.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 nameNT-I7
    D.3.2Product code [NT-I7]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEfineptakin alfa
    D.3.9.2Current sponsor codeNT-I7
    D.3.9.4EV Substance CodeSUB213575
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameNivolumab
    D.3.2Product code [BMS-936558]
    D.3.4Pharmaceutical form 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 INNNivolumab
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC) progressed on or intolerant to 2 or more prior lines of systemic therapy
    Adenocarcinoma gastrico o della giunzione gastro-esofagea (GGE) o esofageo (ACE) avanzato o metastatico che ha mostrato progressione o intolleranza a 2 o più linee precedenti di terapia sistemica
    E.1.1.1Medical condition in easily understood language
    Cancer in the stomach and/or esophagus, called gastric, gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC).
    Tumore allo stomaco e/o all’esofago, chiamato adenocarcinoma gastrico, della giunzione gastro-esofagea (GGE) o adenocarcinoma esofageo (EAC).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10058526
    E.1.2Term Oesophageal adenocarcinoma metastatic
    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 10063916
    E.1.2Term Metastatic gastric cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10030145
    E.1.2Term Oesophageal adenocarcinoma stage IV
    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
    To make a preliminary assessment of the antitumor activity and long-term survival of NT-I7 in combination with nivolumab in subjects with advanced or metastatic gastric or GEJ or EAC after 2 or more prior lines of systemic therapy, based on:
    o Objective response rate (ORR) per Investigators’ assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    o Overall survival (OS)
    Effettuare una valutazione preliminare dell’attività antitumorale e della sopravvivenza a lungo termine di NT-I7 in combinazione con nivolumab in soggetti con adenocarcinoma gastrico o GGE o ACE avanzato o metastatico dopo 2 o più linee precedenti di terapia sistemica, in base a:
    o Tasso di risposta obiettiva (ORR) secondo la valutazione degli sperimentatori mediante i Criteri di valutazione della risposta nei tumori solidi (RECIST) versione 1.1
    o Sopravvivenza complessiva (OS)
    E.2.2Secondary objectives of the trial
    To make further assessment of the antitumor activity of NT-I7 in combination with nivolumab in the treated subjects, based on Duration of Response (DoR), Disease Control Rate (DCR), and Progression-Free Survival (PFS);
    To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab.
    • Effettuare ulteriori valutazioni dell’attività antitumorale di NT-I7 in combinazione con nivolumab nei soggetti trattati, in base alla durata della risposta (DoR), al tasso di controllo della malattia (DCR) e alla sopravvivenza libera da progressione (PFS)
    • Valutare l’immunogenicità di NT-I7 somministrato in combinazione con nivolumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria
    1. Have histologically or cytologically confirmed locally locally advanced or metastatic carcinoma of gastric or GEJ or EAC who progressed on or intolerant to 2 or more prior lines of chemotherapy and/or targeted therapy in the advanced/metastatic setting. Subjects with HER2-overexpresing tumor who progressed on trastuzumab-based therapy and at least 1 other line of therapy are also eligible.
    Note: GEJ adenocarcinomas are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia, as described in the Siewert classification system (Siewert et al, 2000)
    2. Have at least one measurable lesion according to RECIST 1.1.
    3. Subjects enrolling in the dose escalation phase must have biopsiable disease. Subjects must agree to provide a) pre- treatment tumor tissue sample and b) on-treatment tumor biopsy.
    4. Subjects enrolled in the Phase 2 must agree to provide tumor tissue sample prior to the start of treatment.
    5. PD-L1 expression status must be determined by the study-designated central lab prior to randomization (CPS <5 versus CPS = 5) for subjects enrolled in Phase 2.
    6. Female subjects are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; if a female subject is of childbearing potential, she must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 5 months after the last dose of study treatment.
    7. Non-sterile male subjects who are sexually active with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 3 months after the last dose of study treatment.
    Criteri di inclusione principali:
    1. Conferma istologica o citologica di carcinoma gastrico o GGE o ACE localmente avanzato o metastatico, con progressione durante o intolleranza a 2 o più linee precedenti di chemioterapia e/o terapia mirata nel contesto avanzato/metastatico. Sono idonei anche i soggetti con tumore sovraesprimente il recettore 2 per il fattore di crescita epidermico umano (HER2) che hanno mostrato progressione durante una terapia a base di trastuzumab e almeno 1 altra linea di terapia.
    Nota: gli adenocarcinomi GGE sono definiti come tumori il cui centro è situato entro 5 cm prossimali e distali rispetto al cardias anatomico, come descritto nel sistema di classificazione di Siewert (Siewert et al., 2000).
    2. Presenza di almeno una lesione misurabile secondo i criteri RECIST 1.1.
    3. I soggetti che si arruolano nella fase di intensificazione della dose devono presentare malattia bioptabile. I soggetti devono acconsentire a fornire a) un campione di tessuto tumorale pre-trattamento e b) una biopsia tumorale durante il trattamento.
    4. I soggetti arruolati nella Fase 2 devono acconsentire a fornire a) un campione di tessuto tumorale prima dell’inizio del trattamento.
    5. Lo stato di espressione di PD-L1 deve essere determinato dal laboratorio centrale designato dallo studio prima della randomizzazione (CPS <5 rispetto a CPS =5) per i soggetti arruolati nella Fase 2.
    6. Soggetti di sesso femminile che sono in post-menopausa da almeno 1 anno o chirurgicamente sterili da almeno 6 settimane; se un soggetto di sesso femminile è in età fertile, deve accettare di praticare l’astinenza (astenersi dai rapporti eterosessuali) o seguire le istruzioni per un metodo contraccettivo altamente efficace per la durata del trattamento dello studio e per 5 mesi dopo l’ultima dose del trattamento dello studio.
    7. I soggetti di sesso maschile non sterili che sono sessualmente attivi con compagne in età fertile devono accettare di praticare l’astinenza (astenersi dai rapporti eterosessuali) o seguire le istruzioni per un metodo contraccettivo altamente efficace per la durata del trattamento dello studio e per 3 mesi dopo l’ultima dose del trattamento dello studio.
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    1. Pregnant, or breastfeeding or expecting to conceive or father children within the study duration from screening through 5 months (for female subjects) or 3 months (for male subjects) after the last dose of study treatment.
    2. Receiving any investigational therapy or any approved therapy for investigational use within 4 weeks or 5 half-lives, whichever is longer, prior to first dose of study treatment.
    3. Has previously received checkpoint inhibitor (CPI) treatment for gastric cancer or GEJ or EAC.
    4. Has received prior radiotherapy within 2 weeks of start of study treatment.
    5. Has received treatment with complementary medications (ex, herbal supplements, or traditional Chinese medications) to treat the disease under study within 2 weeks prior to the first dose of study treatment.
    6. Subjects are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
    7. History of severe hypersensitivity reactions to monoclonal antibodies (mAbs) or intravenous immunoglobulin preparation.
    8. Clinically significant cardiac disease.
    9. Has a history of allergy or intolerance (unacceptable AEs) to study drug components or polysorbate-80-containing infusions.
    Note: Polysorbate 80 is a buffer used to make NT-I7.
    10. Has received a live vaccine within 4 weeks prior to the first dose of study drug. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
    11. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
    Criteri di esclusione principali:
    1. Gravidanza, allattamento o previsione di concepire o procreare entro la durata dello studio, dallo screening fino a 5 mesi (per i soggetti di sesso femminile) o 3 mesi (per i soggetti di sesso maschile) dopo l’ultima dose del trattamento dello studio.
    2. Assunzione di qualsiasi terapia sperimentale o qualsiasi terapia approvata per uso sperimentale entro 4 settimane o 5 emivite, a seconda di quale sia il periodo più lungo, prima della prima dose del trattamento dello studio.
    3. Precedente trattamento con un inibitore del checkpoint (CPI) per tumore gastrico o GGE o ACE.
    4. Precedente radioterapia entro 2 settimane dall’inizio del trattamento dello studio.
    5. Precedente trattamento con farmaci complementari (es. integratori a base di erbe o farmaci tradizionali cinesi) per trattare la malattia oggetto di studio nelle 2 settimane precedenti la prima dose del trattamento dello studio.
    6. I soggetti sono idonei se le metastasi del SNC sono asintomatiche e non richiedono un trattamento immediato o sono state trattate e le condizioni neurologiche dei soggetti sono tornate al basale (fatta eccezione per segni o sintomi residui correlati al trattamento del SNC).
    7. Anamnesi di gravi reazioni di ipersensibilità ad anticorpi monoclonali (mAb) o preparati di immunoglobuline endovenose.
    8. Cardiopatia clinicamente significativa,
    9. Anamnesi di allergia o intolleranza (EA inaccettabili) a componenti del farmaco dello studio o a infusioni contenenti polisorbato 80.
    Nota: il polisorbato 80 è un tampone utilizzato per produrre NT-I7.
    10. Somministrazione di un vaccino vivo nelle 4 settimane precedenti la prima dose del farmaco dello studio. I vaccini antinfluenzali stagionali per iniezione sono generalmente vaccini contenenti virus uccisi e sono consentiti.
    11. Soggetti che si sono sottoposti a un trapianto allogenico di tessuti/organi solidi o trapianto di midollo osseo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) and objective response rate (ORR) assessed by the investigators using RECIST 1.1 criteria are the primary endpoints for Phase 2.
    OS is defined as the time from first study treatment to death from any cause.
    ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1.
    La sopravvivenza complessiva (OS) e il tasso di risposta obiettiva (ORR) valutati dagli
    sperimentatori utilizzando i criteri RECIST 1.1 sono gli endpoint primari per la
    Fase 2.
    La OS è definita come il tempo dall’inizio del trattamento dello studio al decesso per qualsiasi
    causa.
    L’ORR è definito come la percentuale di partecipanti con una migliore
    risposta complessiva (BOR) di una risposta completa (CR) o di una risposta parziale (PR),
    secondo i criteri RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 2 years.
    Per un massimo di 2 anni.
    E.5.2Secondary end point(s)
    Duration of response (DoR), disease control rate (DCR), progressionfree
    survival (PFS) and Incidence of anti-drug antibodies (ADA) to NT-I7
    during the study relative to baseline are the secondary endpoints for
    Phase 2.
    DOR is defined as the time from the first occurrence of a documented
    objective response to the time of the first documented disease
    progression or death from any cause, whichever occurs first, per RECIST
    1.1.
    DCR is defined as the percentage of participants with a best overall
    response (BOR) of complete response (CR), partial response (PR), or
    stable disease (SD), per RECIST 1.1.
    PFS is defined as the time from the first study treatment to the first
    occurrence of disease progression or death of any cause, whichever
    occurs first, per RECIST 1.1.
    La durata della risposta (DoR), il tasso di controllo della malattia (DCR), la sopravvivenza libera da
    progressione (PFS) e l’incidenza di anticorpi anti-farmaco (ADA) contro NT-I7
    durante lo studio rispetto al basale sono gli endpoint secondari per la
    Fase 2.
    La DOR è definita come il tempo dalla prima occorrenza di una risposta
    obiettiva documentato al momento della prima progressione documentata
    della malattia o decesso per qualsiasi causa, a seconda di quale evento si verifica per primo, secondo i criteri RECIST 1.1.
    Il DCR è definito come la percentuale di partecipanti con una migliore
    risposta complessiva (BOR) della risposta completa (CR), della risposta parziale (PR) o
    della malattia stabile (SD), secondo i criteri RECIST 1.1.
    La PFS è definita come il tempo dall’inizio del trattamento dello studio alla prima
    occorrenza di progressione della malattia o decesso per qualsiasi causa, a seconda di quale evento
    si verifica per primo, secondo i criteri RECIST 1.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 years.
    Per un massimo di 3 anni.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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
    To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab;
    To make a preliminary assessment of biomarkers that might act as pharmacodynamic indicators of antitumor activity of NT-I7 in combination with nivolumab in the treated subjects;
    To make a preliminary assessment of biomarkers that might act as predictors of antitumor activity of NT-I7 in combination with nivolumab in the treated subjects.
    Valutare l’immunogenicità di NT-I7 somministrato in combinazione con nivolumab; Effettuare una valutazione preliminare dei biomarcatori che potrebbero agire come indicatori farmacodinamici dell’attività antitumorale di NT-I7 in combinazione con nivolumab nei soggetti trattati; Effettuare una valutazione preliminare dei biomarcatori che potrebbero agire come predittori dell’attività antitumorale di NT-I7 in combinazione con nivolumab nei soggetti trattati.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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 concerned6
    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
    United States
    France
    Italy
    Poland
    Spain
    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 months3
    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 days2
    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: 107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 127
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who continue to receive clinical benefit after 24 months from the date of first dose, may continue to receive the treatment on this study, via a rollover study requiring approval by the responsible Health Authority (HA) and ethics committee, or through another mechanism at the discretion of the Sponsor. The Sponsor reserves the right to terminate access to study treatment due to any of the reasons described in the protocol (section 7.8).
    Soggetti che continuano a ricevere benefici clinici dopo 24 mesi dalla data della prima dose, potranno continuare a ricevere il trattamento in questo studio, tramite uno studio di rollover che richiede l'approvazione dell'Autorità sanitaria (HA) e comitato etico responsabili, o tramite un altro meccanismo a discrezione dello Sponsor. Lo Sponsor si riserva il diritto di interrompere l'accesso al trattamento in studio a causa di una qualsiasi delle ragioni descritte nel protocollo (sezione 7.8).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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