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    Summary
    EudraCT Number:2021-001716-29
    Sponsor's Protocol Code Number:SNX-301-020
    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:2022-05-26
    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 number2021-001716-29
    A.3Full title of the trial
    A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour.
    Studio di fase III, multicentrico, randomizzato, in doppio cieco volto a valutare la sicurezza e l'efficacia di emactuzumab rispetto al placebo in soggetti affetti da tumore tenosinoviale a cellule giganti (TGCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to Assess the Safety and Efficacy of Emactuzumab versus Placebo in Patients with Giant Cell Tumours.
    Studio volto a valutare la sicurezza e l'efficacia di emactuzumab rispetto al placebo in soggetti affetti da tumore a cellule giganti (TGCT)
    A.3.2Name or abbreviated title of the trial where available
    TANGENT
    TANGENT
    A.4.1Sponsor's protocol code numberSNX-301-020
    A.5.4Other Identifiers
    Name:INDNumber:153633
    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 SponsorSynOx Therapeutics Limited
    B.1.3.4CountryIreland
    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 supportSynOx Therapeutics Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynOx Therapeutics Ltd
    B.5.2Functional name of contact pointRowena Abbey
    B.5.3 Address:
    B.5.3.1Street Address25-28 North Wall Quay
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD01 H104
    B.5.3.4CountryIreland
    B.5.4Telephone number7789626678
    B.5.5Fax number0000000
    B.5.6E-mailRowena.Abbey@synoxtherapeutics.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 nameEmactuzumab (RO5509554)
    D.3.2Product code [RO5509554]
    D.3.4Pharmaceutical form Concentrate 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 INNEmactuzumab
    D.3.9.2Current sponsor codeRO5509554, RG7155
    D.3.9.3Other descriptive nameChemical Structure: H2L2 polypeptide structure consisting of two light chains and two heavy chains held together by disulfide bonds
    D.3.9.4EV Substance CodeSUB177212
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tenosynovial Giant Cell Tumour
    Tumore Tenosinoviale a Cellule Giganti
    E.1.1.1Medical condition in easily understood language
    Giant Cell Tumours
    Tumore a Cellule Giganti
    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 10025564
    E.1.2Term Malignant giant cell tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the treatment effect of emactuzumab on objective response rate (ORR) by 6 months from initiation of therapy in the blinded phase compared to placebo.
    Valutare l'effetto del trattamento con emactuzumab sul tasso di risposta obiettiva (objective response rate, ORR) entro 6 mesi dall'inizio della terapia nella fase in cieco rispetto al placebo.
    E.2.2Secondary objectives of the trial
    -To estimate:
    The effect of emactuzumab on clinical outcome assessments (COAs) for:

    o Physical functioning
    o Range of motion (ROM)
    o Pain
    o Stiffness
    o Patient Global Impressions (PGIs)
    o QoL

    -Further antitumour activity of emactuzumab in TGCT compared to placebo.

    -Surgical Intervention Rate.

    -The Safety Objective of this study is to monitor subject wellbeing and assess treatment tolerability .

    -To assess the health economic impact of treatment with emactuzumab.

    -To further characterize the pharmacokinetic (PK) profile of emactuzumab.
    Valutare:
    • L'effetto di emactuzumab sulle valutazioni degli esiti clinici (Clinical
    Outcome Assessments COAs) per:
    o Funzionalità fisica
    o Ampiezza di movimento (ROM)
    o Dolore
    o Rigidità
    o Impressione Globale del Patiente (PGIs)
    o Qualità della vita (QoL)
    • Ulteriore attività antitumorale di emactuzumab nel TGCT rispetto al
    placebo
    • Tasso di Intervento Chirurgico
    • L'obiettivo di sicurezza di questo studio è monitorare il benessere del
    soggetto e valutare la tollerabilità del trattamento.
    • Valutare l'impatto economico-sanitario del trattamento con
    emactuzumab
    • Caratterizzare ulteriormente il profilo farmacocinetico (pharmacokinetic, PK) di emactuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Biopsy-confirmed (standard of care diagnosis history) TGCT where surgical resection would be associated with potentially worsening functional limitations, have an anticipated high risk of early recurrence as determined by the multidisciplinary tumor
    board or any other morbidity associated with the surgery, or surgical treatment is not expected to improve the clinical outcomes of the subject.
    3. Measurable disease: longest diameter =20 mm.
    4. Age >12 years.
    5. Adequate organ and bone marrow function: haemoglobin (Hb) >10.0 g/dL, neutrophils >1.5 × 109/L and platelets >100 × 109/L.
    6. Minimum mean score of 4 on NRS for Worst Pain during 7 days prior to randomization, based upon a minimum of 4 days of completed diary data.
    7. Minimum mean score of 4 on NRS for Worst Stiffness during 7 days prior to randomization, based upon a minimum of 4 days of completed diary data.
    8. Women of childbearing potential (WOCBP) must have a negative urine and serum pregnancy test prior to starting treatment. Both WOCBP and men must agree to use a highly effective method of contraception throughout the treatment period and for 5 months after discontinuation of treatment.
    9. For Open-Label Phase ONLY:
    Subjects must either:
    -Have responded based on RECIST v1.1 (CR or PR) to initial treatment with emactuzumab during the Double-Blind Phase and then progressed (objective progressive disease on imaging) within 9-18 months of initial treatment on D 1 (Visit 1) with a minimum 6-month washout period between treatments; or
    -Have received placebo and completed the 6-month visit on D 181/Visit 10
    (3 months treatment and 3 months observation) of the Double-Blind Phase and
    have not completed more than 18 months of the study since initial treatment on D1 (Visit1).
    1. Consenso informato scritto.
    2. TGCT localizzato o diffuso confermato da biopsia (anamnesi diagnostica con trattamento standard) in cui la resezione chirurgica sarebbe associata a un probabile peggioramento delle limitazioni funzionali dovuto a danni chirurgici alle articolazioni e ai tessuti molli adiacenti, e/o il soggetto presenta un elevato rischio anticipato di recidiva precoce come determinato da una commissione oncologica multidisciplinare o equivalente*, o qualsiasi altra morbilità associata all'intervento chirurgico, e/o trattamento chirurgico non si prevede migliori gli esiti clinici del soggetto.
    *la commissione oncologica multidisciplinare o equivalente deve comprendere almeno due persone: l'Investigatore più almeno un altro medico qualificato (chirurgo ortopedico o oncologi medico) non coinvolto in questo studio.
    3. Malattia misurabile: diametro maggiore =20 mm.
    4. Età =12 anni.
    5. Funzione degli organi e del midollo osseo adeguata: emoglobina Hb >10,0 g/dl, neutrofili >1,5 × 109/l e piastrine >100 × 109/l.
    6. Punteggio medio minimo di 4 nella Scala di Valutazione Numerica (NRS) del dolore più forte durante i 7 giorni precedenti la randomizzazione, basato su un minimo di 4 giorni di dati del diario completati.
    7. Punteggio medio minimo di 4 nella NRS della peggiore rigidità durante i 7 giorni precedenti la randomizzazione, basato su un minimo di 4 giorni di dati del diario completati.
    8. Le donne in età fertile devono presentare un test di gravidanza negativo sulle urine e sul siero prima dell'inizio del trattamento. Le donne in età fertile devono acconsentire all'uso di un metodo contraccettivo altamente efficace per tutta la durata del periodo di trattamento e per 7 mesi dopo l'interruzione del trattamento. I metodi contraccettivi accettabili sono:
    • contraccezione ormonale associata a inibizione dell'ovulazione. I contraccettivi orali e ormonali per via parenterale (cerotti, prodotti iniettabili e impianti) che possono essere influenzati dai farmaci a induzione enzimatica vanno impiegati esclusivamente in associazione a un metodo a barriera;
    • dispositivo intrauterino (IUD);
    • sistema intrauterino a rilascio ormonale (IUS);
    • occlusione bilaterale delle tube;
    • partner vasectomizzato;
    • astinenza sessuale, secondo lo stile di vita preferito e consueto del soggetto. L'astinenza periodica (ad es. metodi basati sul calendario, sull'ovulazione, sintotermici e post-ovulatori) e il coito interrotto non sono ritenuti metodi contraccettivi accettabili.
    Tutti gli uomini con partner in età fertile o in stato di gravidanza devono utilizzare contraccettivi a barriera per tutta la durata della somministrazione dell'IMP e successivamente per altri 5 mesi, a meno che non siano chirurgicamente sterili.
    9. SOLO per la Fase in Aperto:
    I soggetti devono:
    • aver risposto in base ai criteri RECIST v1.1 (CR o PR) al trattamento iniziale con emactuzumab durante la Fase in Doppio Cieco e poi mostrato una progressione (progressione oggettiva della malattia all'imaging MRI, confermata centralmente) entro 9-18 mesi dal trattamento iniziale al G1 (Visita 1) con un periodo minimo di 6 mesi di washout tra i trattamenti;
    oppure
    avere ricevuto il placebo, completato la visita a 6 mesi al G181/Visita 10 (3 mesi di trattamento e 3 mesi di osservazione) della Fase in Doppio Cieco e avere i) progressione secondo RECIST v1.1 (progressione di malattia oggettiva all'imaging MRI, confermata centralmente) entro 6-18 mesi dal trattamento iniziale al G 1 (Visita 1), oppure ii) avere stabilità di malattia secondo RECIST v1.1 (all'imaging MRI, confermata centralmente) e deterioramento clinicamente rilevante come valutato
    dall'Investigatore e confermato dal Medical Monitor entro 6-18 mesi dal trattamento iniziale al G 1 (Visita 1)
    E.4Principal exclusion criteria
    1. Pregnant or breast feeding.
    2. Medical conditions, including auto-immune, requiring systemic immunosuppression. Any systemic treatment for these conditions (eg, glucocorticoids) is not allowed within 4 weeks of Screening and during the study. All Lupus Erythematosus are excluded irrespective of treatment.
    3. Metastatic TGCT.
    4. TGCT currently affecting multiple joints.
    5. Pexidartinib therapy within 3 months of Screening.
    6. Nilotinib, imatinib; other chemotherapy, radiotherapy, or investigational therapy within 4 weeks of Screening.
    7. Unresolved clinically significant toxicity from a previous treatment or any history of serious liver toxicity.
    8. Current or chronic history of liver disease. This includes, but is not limited to, hepatitis virus infections, drug- or alcohol-related liver disease, nonalcoholic steatohepatitis, autoimmune hepatitis, haemochromatosis, Wilson’s disease, a-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease which in the opinion of the Investigator is considered clinically significant.
    9. Renal function: Serum creatinine >1.5 × ULN, or creatinine clearance <60 mL/min (Cockcroft-Gault formula).
    10. Liver function: ALT >3.0 × ULN; OR total bilirubin >1.5 × ULN.
    11. Within 6 months of baseline has experienced: clinically significant myocardial infarction, severe/unstable angina pectoris, congestive heart failure New York Heart Association (NYHA) Class III or IV, or pulmonary disease (NYHA Criteria 1994).
    12. Clinically significant active infection requiring systemic antibiotic treatment. Rescreening may occur any time after 7 days post completion of treatment.
    13. Systemic antiretroviral therapy within 3 months of baseline.
    14. Other active cancer that requires concurrent treatment or history of malignancy other than TGCT, unless there is the expectation that the malignancy has been cured, and tumor specific treatment for the malignancy has not been administered within the previous 5 years.
    15. Planned surgery during the course of the study with the exception of dental treatment.
    16. Inability to comply with the study procedures.
    17. For the Double-Blind Phase ONLY: Previous exposure to emactuzumab and/or neutralizing antibodies.
    1. Donne in gravidanza, che pianificano una gravidanza o allattamento.
    2. Condizioni mediche, inclusa malattia autoimmune,che necessitano di immunosoppressone sistemica. Ogni trattamento sistemico per tali condizioni (ad es. Glucocorticoidi) non è permesso nelle 4 settimane precedenti allo Screening e durante lo studio.Tutti i casi di Lupus Eritematoso sono esclusi indipendentemente dal trattamento.
    3. TGCT metastatico.
    4. TGTC che colpisce attualmente più articolazioni.
    5. Terapia con Pexidartinib, nei 3 mesi precedenti allo Screening.
    6. Nilotinib, imatinib; altra chemioterapia, radioterapia o terapia sperimentale nelle 4 settimane precedenti allo screening;
    7. Tossicità clinicamente significativa non risolta per un trattamento precedente o qualsiasi tossicità epatica grave pregressa;
    8. Anamnesi attuale o cronica di malattia epatica, comprese, a titolo esemplificativo ma non esaustivo, le infezioni da virus dell'epatite, malattia epatica correlata a farmaci o alcol, steatoepatite non alcolica, epatite autoimmune, emocromatosi, malattia di Wilson, deficit di a-1 antitripsina, colangite biliare primitiva, colangite sclerosante primitiva o qualsiasi altra patologia epatica che, secondo il parere dello sperimentatore, sia considerata clinicamente significativa;
    9. Funzione renale: clearance della creatinina <60 ml/min (formula di Cockcroft-Gault);
    10. Funzione epatica: ALT >3,0 × ULN; OPPURE bilirubina totale >1,5 × ULN;
    11. Soggetti che entro 6 mesi dal basale hanno avuto: infarto miocardico clinicamente significativo, angina pectoris grave/instabile, insufficienza cardiaca congestizia di classe III o IV secondo la classificazione della New York Heart Association (NYHA) o malattia polmonare (criteri NYHA 1994);
    12. Infezione attiva clinicamente significativa che richieda un trattamento antibiotico sistemico. La ripetizione dello screening può avvenire in qualsiasi momento dopo 7 giorni dal termine del trattamento;
    13. Terapia antivirale sistemica entro 3 mesi dal basale;
    14. Altro cancro attivo che richiede trattamento simultaneo o pianificato o anamnesi di neoplasia maligna diversa da TGCT, salvo qualora si preveda che la neoplasia sia stata curata e il trattamento tumorale specifico per la neoplasia maligna non sia stato somministrato entro i 5 anni precedenti;
    15. Intervento chirurgico programmato durante lo studio, a eccezione dei trattamenti odontoiatrici;
    16. Incapacità/impossibilità a rispettare le procedure dello studio;
    17. SOLO per la fase in Doppio Cieco:
    Precedente esposizione a emactuzumab e/o anticorpi neutralizzanti.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) by 6 months from initiation of therapy based on independent, blinded central review.
    Tasso di risposta obiettiva (objective response rate, ORR) entro 6 mesi dall'inizio della terapia nella fase in cieco rispetto al placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    By 6 months from initiation of therapy based on independent, blinded central review.
    ORR entro 6 mesi dall'inizio della terapia sulla base di una revisione centralizzata, indipendente e in cieco
    E.5.2Secondary end point(s)
    Change in Patient-Reported Outcomes Measurement Information System-Physical Function(PROMIS-PF) TGCT from baseline to 6 months.

    Other secondary endpoints:
    -Change in PROMIS-PF TGCT from baseline over time.
    -Physician/Healthcare Professional (HCP)-Reported Joint Mobility Score by goniometry from baseline over time.
    -Change in Worst Pain Numerical Rating Scale (NRS) from baseline over time.
    -Change in Short Form 12-Item Survey version 2 (SF-12 v2) from baseline over time.
    -Change in Worst Stiffness NRS from baseline over time.
    -PGI of change and severity over time.
    -Change in EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L) from baseline over time.
    -Duration of response (DoR) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 based on independent, blinded central review.
    -Disease control rate (DCR) as measured by RECIST v1.1 based on independent, blinded central review
    -Time to progression as measured by RECIST v1.1 based on independent, blinded central review.
    -Change in Tumour volume score (TVS) from baseline over time.
    -Surgical intervention rate, defined as the number of subjects who undergo surgery for TGCT during the study.
    -AEs.
    -Deaths.
    -Any laboratory abnormalities.
    • Variazione nella funzionalità fisica valutata mediante il Sistema informativo basato sulla valutazione dell'esito riferita dal paziente TGTC (Patient-Reported Outcomes Measurement Information System -Physical Function, PROMIS-PF) dal basale ai 6 mesi
    Altri endpoint secondari
    • Cambio in PROMIS-PF TGCT dal basale nel tempo
    • Punteggio relativo alla Mobilità Articolare riferita dal medico o da altro operatore sanitario (HCP) tramite misurazione goniometrica dal basale nel tempo
    • Variazione nella Scala di valutazione numerica (Numerical Rating Scale, NRS) del dolore più forte dal basale nel tempo
    • Variazione nel Sondaggio breve a 12 domande, versione 2 (Short Form 12-Item Survey version 2, SF-12 v2) dal basale nel tempo
    • Variazione nella NRS della peggiore rigidità dal basale nel tempo
    • PGI di cambiamento e severità nel tempo
    • Variazione nel questionario EuroQoL a 5 dimensioni e a 5 livelli (EQ- 5D-5L) dal basale nel tempo
    • Durata della risposta (Duration of Response, DoR) misurata in base ai Criteri di valutazione della risposta nei tumori solidi (Response Evaluation Criteria in Solid Tumours, RECIST) versione 1.1 sulla base di una revisione centralizzata, indipendente e in cieco
    • Tasso di controllo della malattia (Disease Control Rate, DCR) misurato secondo i criteri RECIST v1.1 sulla base di una revisione centralizzata, indipendente e in cieco
    • Tempo di progressione, misurato secondo i criteri RECIST v1.1 sulla base di una revisione centralizzata, indipendente e in cieco
    • Variazione nel punteggio del volume del tumore (Tumour Volume Score, TVS) dal basale nel tempo
    • Tasso di intervento chirurgico: definito come numero di soggetti sottoposti a intervento chirurgico durante lo studio per TGCT
    • AEs
    • Decessi
    • Eventuali anomalie di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline over time.
    Dal basale nel corso del tempo
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Austria
    France
    Poland
    Sweden
    Netherlands
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    United Kingdom
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    A subject is considered to have completed the study if he/she has completed all periods of the
    study including the last visit.
    La fine dello studio è definita come la data dell'ultima visita dell'ultimo paziente in studio.
    Un soggetto è considerato aver completato lo studio se esso/essa ha completato tutti i periodi dello studio, inclusa l'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 months0
    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 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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors from 12 to 17 years old
    Minori 12-17 anni
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 160
    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 Decision2022-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-09-20
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