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    Summary
    EudraCT Number:2021-000933-15
    Sponsor's Protocol Code Number:215360
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-10-22
    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 number2021-000933-15
    A.3Full title of the trial
    A 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.
    Studio a braccio singolo in aperto della durata di 52 settimane per valutare l'efficacia e la sicurezza di mepolizumab SC in partecipanti di età compresa tra 6 e 17 anni con sindrome ipereosinofila.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in Paediatrics with HypEREosinophilic syndrome (SPHERE)
    Studio in pazienti pediatrici con sindrome ipereosinofila (SPHERE)
    A.3.2Name or abbreviated title of the trial where available
    SPHERE
    SPHERE
    A.4.1Sponsor's protocol code number215360
    A.5.4Other Identifiers
    Name:INDNumber:11295
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/384/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park
    B.5.3.2Town/ cityWest Uxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448007839733
    B.5.5Fax number000000
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.1.1.1Trade name Nucala
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Trading Services Limited
    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 nameNucala
    D.3.2Product code [SB-240563]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMepolizumab
    D.3.9.1CAS number 196078-29-2
    D.3.9.2Current sponsor codeMEPOLIZUMAB
    D.3.9.3Other descriptive nameAnti-interleukin 5 (IL-5) humanized monoclonal
    D.3.9.4EV Substance CodeSUB21650
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    Hypereosinophilic syndrome (HES)
    Sindrome ipereosinofila (HES)
    E.1.1.1Medical condition in easily understood language
    Hypereosinophilic syndrome
    Sindrome ipereosinofila
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10048643
    E.1.2Term Hypereosinophilic syndrome
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of mepolizumab SC given every 4 weeks in participants aged 6 to 17 years with HES
    Valutare l'efficacia di mepolizumab SC somministrato ogni 4 settimane in partecipanti di età compresa tra 6 e 17 anni con HES
    E.2.2Secondary objectives of the trial
    - To assess the effect of mepolizumab SC given every 4 weeks on the change in OCS dose in participants aged 6 to 17 years with HES that are taking OCS at baseline;
    - To assess the effect of mepolizumab SC giver every 4 weeks on the change in OCS dose in participants aged 6 to 17 years with HES;
    - To assess the efficacy of mepolizumab SC giver every 4 weeks on the fatigue in OCS dose in participants aged 6 to 17 years with HES;
    - To evaluate the immunogenicity of mepolizumab SC giver every 4 weeks in participants aged 6 to 17 years with HES;
    - To assess the effect of long-term use of mepolizumab SC on a PD marker in participants aged 6 to 17 years with HES;
    - To assess the PK of mepolizumab SC in participants aged 6 to 17 years with HES.
    - Valutare l'effetto di mepolizumab SC somministrato ogni 4 settimane sulla variazione della dose di corticosteroidi (OCS) per via orale nei partecipanti dai 6 ai 17 anni con HES che assumono OCS al basale;
    - Valutare l'effetto di mepolizumab SC somministrato ogni 4 settimane sulla variazione della dose di corticosteroidi (OCS) per via orale nei partecipanti dai 6 ai 17 anni con HES;
    - Valutare l'efficacia di mepolizumab SC somministrato ogni 4 settimane in condizioni di affaticamento con dose di corticosteroidi (OCS) per via orale in partecipanti di età compresa tra 12 e 17 anni con HES;
    - Valutare l'immunogenicità di mepolizumab SC somministrato ogni 4 settimane in partecipanti di età compresa tra 6 e 17 anni con HES;
    - Valutare l'effetto dell'uso a lungo termine di mepolizumab SC su un marcatore di farmacodinamica (PD) nei partecipanti dai 6 ai 17 anni con HES;
    - Valutare la farmacocinetica (PK) di mepolizumab SC in partecipanti di età compresa tra 6 e 17 anni con HES.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional genetics analysis component assessment

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Valutazione facoltativa dei componenti dell'analisi genetica
    E.3Principal inclusion criteria
    Age:
    1. Participant must be aged 6 to 17 years inclusive, at Screening (Visit 1);
    Type of Participant and Disease Characteristics:
    2. Participants who have been diagnosed with HES for at least 6 months prior to enrolment (Visit 2);
    3. A history of 2 or more HES flares within the past 12 months prior to Screening (Visit 1);
    4. Participants must have blood eosinophil count > o = 1000 cells/µl present at Screening;
    5. Participants must be on a stable dose of HES therapy for the 4 weeks prior to the first dose of mepolizumab (Visit 2);
    Sex and Contraceptive/Barrier Requirements:
    6. Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement).
    Contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of paediatric participants and as required by local regulations.
    A female participant is eligible to participate if she is either: premenarcheal or not pregnant as confirmed by a negative urine (or serum if required by local regulations) human chorionic gonadotrophin (hCG) test if of reproductiive potential.
    Females of childbearing potential must commit to consistent and correct use of an acceptable method of contraception (see Section 10.4, Appendix 4 of protocol) for the duration of the trial and 16 weeks after the last dose of study drug. A urine pregnancy test is required of female of childbearing potential.
    Informed Consent and Assent
    7. The PI will obtain written informed consent form each study participant's and the participant's assent.
    8. The participants capable of providing signed and dated written assent signs and dates a written assent form and the parent/guardians signs and dates a written ICF.
    9. A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up; support the participant to attended assessment days according to the SoA; consistently and consecutively be available to provide information on the participant using the rating scales; accurately and reliably dispense study intervention as directed.
    Età:
    1. I partecipanti devono avere un' età compresa tra 6 e 17 anni, durante lo screening (Visita 1);
    Tipo di partecipante e caratteristiche della malattia:
    2. i partecipanti ai quali è stato diagnosticato HES da almeno 6 mesi prima dell'arruolamento (visita 2);
    3. Anamnesi di almeno 2 o più eventi di riacutizzazione dell'HES negli ultimi 12 mesi precedenti lo screening (visita 1);
    4. I partecipanti devono avere un numero di eosinofili del sangue > o = 1000 cellule/µl presenti allo screening;
    5. I partecipanti devono assumere una dose stabile di terapia HES per le 4 settimane precedenti la prima dose di Mepolizumab (visita 2);
    Sesso e contraccettivi/ Requisiti di barriera:
    6. Maschi e/o femmine (secondo i loro organi riproduttivi e le funzioni assegnate dal complemento cromosomico).
    La contraccezione e le barriere, così come i test di gravidanza, sono richiesti in modo appropriato per l'età e l'attività sessuale dei partecipanti pediatrici e come richiesto dalle normative locali.
    Una partecipante femminile ha diritto a partecipare se lei è: premenarcheale o non incinta, come confermato da un test gonadotropina corionica umana (hCG) dell'urina negativo (o siero, se richiesto dalle normative locali) se di potenziale riproduttivo.
    Le femmine con potenziale riproduttivo devono impegnarsi ad un uso coerente e corretto di un metodo di contraccezione accettabile (vedi Sezione 10.4, Appendice 4 del protocollo) per la durata della sperimentazione e 16 settimane dopo l'ultima dose di farmaco in studio. Un test di gravidanza delle urine è richiesto per la femmina potenzialmente fertile.
    Consenso informato e assenso:
    7. Il PI ottiene il consenso scritto informato da parte di ciascun partecipante allo studio e l'assenso del partecipante.
    8. I partecipanti in grado di fornire un assenso scritti firmato e datato firma e data un modulo di assenso scritto e i genitori/tutori firmano e datano un ICF scritto.
    9. Un tutore legale o un caregiver primario devono essere disponibili per aiutare il personale del centrodi studio a garantire il follow-up; per sostenere il partecipante a partcipare ai giorni di valutazione secondo la SoA; ad essere costantemente e consecutivamente disponibili per fornire informazioni sul partecipante che utilizza le scale di rating; per dispensare in modo accurato e affidabile l'intervento di studio come indicato.
    E.4Principal exclusion criteria
    1. Life-threatening HES or life-threatening HES co-morbidities: imminently lifethreatening HES disease severity such that (a) likelihood of death is high unless the course of the disease is interrupted within 12 weeks prior to Visit 2 (b) likelihood of severe deterioration of HES is high unless immediate therapeutic intervention is provided. 2. Other concurrent medical conditions that may affect the participant's safety: participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any ither system abnormalities that are not associated with HES and are uncontrolled with standard treatment. 3. Eosinophilia of unknown significance. 4. FIP1L1-PDGFRa (F/P) Status: participants who test positive for F/P. 5. Clinical diagnosis of EGPA. 6. Infection: - participants with chronic or ongoing active infections requiring systemic treatment, as well as participants who have experienced clinically significant infections due to viruses, bacteria, and fungi within 4 weeks prior to enrolment (Visit 2), - participants with a pre-existing parasitic infestation within 6 months prior to enrolment (Visit 2). 7. Participants with a know immunodeficiency (eg HIV), other than that explained by the use of OCS or other therapy taken for HES. 8. Participants with documented history of any clinically significant cardiac damage prior to Screening (Visit 1) that, in the opinion of the PI, would impact the participant's participation during the study. 9. Malignancy: - participants with a history of or current lymphoma; - participants with current malignancy or previous history of cancer in remission for less than 12 months prior to Screening (Visit 1). Participants that had localised carcinoma of the skin that was resected for cure will not be excluded. 10. Participants who are not responsive to OCS based on clinical response or blood eosinophil counts. 11. Participants who have previously received mepolizumab in the 4 months prior to enrolment (Visit 2). 12. Participants receiving any of the following: - IV or SC corticosteroids in the 4-week period prior to enrolment (Visit 2); - any other monoclonal antibodies within 30 days or 5 half-lives of enrolment (Visit 2). 13. Participants who have received treatment with an investigational agent within the past 30 days or 5 drug half-lives prior to enrolment. 14. Use of candidate COVID-19 vaccines that have not received limited, accelerated or full authorisation/approval, and are only in use as part of a clinical trial. 15. Participants who are currently participating in any other interventional clinical study. 16. Participants with any history of hypersensitivity to any monoclonal antibody. 17. 12-lead ECG finding. For all participants: an abnormal ECG finding from 12-lead ECG conducted at Visit 1 if considered to be clinically significant and would impact the participation during the study based in the evaluation of PI. For participants aged 6-11yrs: - QT interval corrected using QTcF > 450msec; - left bundle branch block. For participant aged 12-17yrs: QTcF > 450msec or QTc > 480msec (participants with bundle branch block). 18. Liver abnormality/disease. 19. Other laboratory abnormalities.
    1. HES letali o co-morbosità HES pericolosa per la vita: gravità della malattia HES che minaccia la vita in modo tale che (a) la probabilità di morte è elevata, a meno che il decorso della malattia non sia interrotto entro 12 settimane prima della visita 2 (b) la probabilità di deterioramento grave dell'HES è elevata, a meno che non venga fornito un intervento terapeutico immediato. 2. Altre condizioni mediche concomitanti che possono influire sulla sicurezza del partecipante: partecipanti che hanno avuto problema endocrino clinicamente significativo, autoimmune, metabolico, neurologico, renale, gastrointestinale, epatico, ematologico, problemi respiratori o anomalie del sistema che non sono associate a HES e non sono controllate con il trattamento standard. 3. Eosinofilia di significato sconosciuto. 4. Stato FIP1L1-PDGFRa (F/P): partecipanti che risultano positivi a F/P. 5. Diagnosi clinica dell'EGPA. 6. Infezione: - partecipanti con infezioni attive croniche o in corso che richiedono un trattamento sistemico, nonché partecipanti che hanno avuto infezioni clinicamente significative a causa di virus, batteri e funghi entro 4 settimane prima dell'arruolamento (Visita 2), - partecipanti con un'infestazione parassitaria preesistente nei 6 mesi precedenti l'arruolamento (Visita 2). 7. Partecipanti con immunodeficienza nota (ad esempio HIV), diversa da quella dovuta all'uso di OCS o di altre terapie per l'HES. 8. Partecipanti con una storia documentata di qualsiasi danno cardiaco clinicamente significativo prima dello screening (visita 1) che, secondo il parere del PI, avrebbe un impatto sulla partecipazione del partecipante durante lo studio. 9. Malignità: - partecipanti con una storia di linfoma o linfoma corrente; - partecipanti con malignità corrente o precedenti di cancro in remissione per meno di 12 mesi prima dello screening (Visita 1). I partecipanti che avevano localizzato il carcinoma della pelle che è stato resecato per la cura non saranno esclusi. 10. Partecipanti che non rispondono all'OCS sulla base della risposta clinica o del numero di eosinofili nel sangue. 11. I partecipanti che hanno precedentemente ricevuto Mépolizumab nei 4 mesi precedenti l'arruolamento (Visita 2). 12. I partecipanti che ricevono uno dei seguenti farmaci: - corticosteroidi IV o SC nelle quattro settimane precedenti l'arruolamento (Visita 2); - qualsiasi altro anticorpo monoclonale entro 30 giorni o 5 emivite dall'arruolamento (visita 2). 13. Partecipanti che hanno ricevuto un trattamento con un farmaco sperimentale negli ultimi 30 giorni o 5 emivite del farmaco prima dell'arruolamento. 14. Uso di vaccini candidati COVID-19 che non hanno ricevuto un'autorizzazione/approvazione limitata, accelerata o completa e sono utilizzati solo come parte di una sperimentazione clinica. 15. Partecipanti che attualmente partecipano a qualsiasi altro studio clinico interventistico. 16. Partecipanti con precedenti di ipersensibilità a qualsiasi anticorpo monoclonale. 17. Individuazione dell'ECG a 12 derivazioni. Per tutti i partecipanti: un ECG anomalo rilevato da ECG a 12 derivazioni condotto durante la visita 1, se considerato clinicamente significativo e avrebbe un impatto sulla partecipazione durante lo studio basato sulla valutazione del PI. Per i partecipanti di età compresa tra 6 e 11 anni: - intervallo QT corretto utilizzando QTcF > 450msec; - blocco di branca sinistro. Per i partecipanti di età compresa tra 12 e 17 anni: QTcF > 450msec o QTc > 480msec (partecipanti con blocco di branca sinistro). 18. Anomalia/malattia epatica. 19. Altre anomalie di laboratorio.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of HES flares over the 52-week study treatment period
    Frequenza di riacutizzazione della HES durante il periodo di trattamento dello studio di 52 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the 52-week study treatment period
    Durante il periodo di trattamento dello studio di 52 settimane
    E.5.2Secondary end point(s)
    - Change in the mean daily OCS dose (prednisone/prednisolone or equivalent) from weeks 0 to 4 compared with weeks 48 to 52;
    - Reduction of > o = 50% in mean daily OCS dose (prednisone/prednisolone or equivalent) from weeks 0 to 4 compared with weeks 48 to 52;
    - Achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of < o = 7.5 mg during weeks 48 to 52;
    - Change from baseline in fatigue severity based on weekly average score of BFI item 3 (worst level of fatigue during past 24 hours) for week 52;
    - Occurrence of ADA and NAb;
    - Ratio to baseline in absolute blood eosinophil count at discrete time points during the 52-week study treatment period;
    - Mepolizumab plasma concentration at discrete time points during the 52-week study treatment period.
    - Variazione della dose media giornaliera di OCS (prednisone/prednisolone o equivalente) dalle Settimane da 0 a 4 alle Settimane da 48 a 52;
    - Riduzione > o = 50% della dose media giornaliera di OCS (prednisone/prednisolone o equivalente) nelle Settimane da 0 a 4 rispetto alle Settimane da 48 a 52;
    - Raggiungimento di una dose media giornaliera di OCS (prednisone/prednisolone o equivalente) di < o = 7,5 mg durante le Settimane da 48 a 52;
    - Variazione rispetto al basale della gravità dell'affaticamento in base al Punteggio medio settimanale del Brief Fatigue Inventory (BFI) livello 3 (peggior livello di affaticamento nelle ultime 24 ore) per la Settimana 52;
    - Presenza di anticorpi anti-farmaco (ADA) e di anticorpi neutralizzanti (NAb);
    - Rapporto al basale nel numero assoluto di granulociti eosinofili nel sangue in punti temporali discreti durante il periodo di trattamento dello studio di 52 settimane;
    - Concentrazione plasmatica di mepolizumab in punti temporali discreti durante il periodo di trattamento dello studio di 52 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints.
    Come indicato nella lista degli endpoints.
    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
    Immunogenicity and optional pharmacogenetic
    Immunogenicità e farmacogenetica facoltativa
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Brazil
    Israel
    Mexico
    Russian Federation
    Turkey
    United States
    Italy
    Spain
    United Kingdom
    Argentina
    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 months10
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 25
    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)
    Eligible participants may enter an expanded access program (EAP), where available, immediately after completion of the 52-week study period.
    I partecipanti idonei possono accedere ad un programma di accesso ampliato (EAP), se disponibile, immediatamente dopo il completamento del periodo di studio di 52 settimane.
    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 Decision2022-05-03
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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