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    Summary
    EudraCT Number:2020-005107-40
    Sponsor's Protocol Code Number:SNDX-6352-0504
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 number2020-005107-40
    A.3Full title of the trial
    AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy
    AGAVE-201, Studio multicentrico di fase 2, in aperto, randomizzato per valutare l’efficacia, la sicurezza e la tollerabilità di axatilimab a 3 dosi diverse in pazienti con malattia cronica del trapianto contro l’ospite recidivante o refrattaria attiva che hanno ricevuto almeno 2 linee di terapia sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of Axatilimab at 3 Different Doses in Patients with Chronic Graft Versus Host Disease
    Studio di fase 2 di axatilimab a 3 dosi diverse in pazienti con malattia cronica del trapianto contro l’ospite
    A.3.2Name or abbreviated title of the trial where available
    AGAVE-201
    AGAVE-201
    A.4.1Sponsor's protocol code numberSNDX-6352-0504
    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 SponsorSYNDAX PHARMACEUTICALS, 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 supportSyndax Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyndax Pharmaceuticals, Inc
    B.5.2Functional name of contact pointChristine Quaranto
    B.5.3 Address:
    B.5.3.1Street Address35 Gatehouse Drive, Building D, Floor 3
    B.5.3.2Town/ cityWALTHAM
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number17816849824
    B.5.5Fax number000000
    B.5.6E-mailcquaranto@syndax.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 nameAxatilimab
    D.3.2Product code [SNDX-6352]
    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 INNAxatilimab
    D.3.9.1CAS number 2155851-88-8
    D.3.9.2Current sponsor codeSNDX-6352
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Recurrent/Refractory Active Chronic Graft Versus Host Disease
    Malattia cronica del trapianto contro l’ospite recidivante o refrattaria
    E.1.1.1Medical condition in easily understood language
    Recurrent/Refractory Active Chronic Graft Versus Host Disease
    Malattia cronica del trapianto contro l’ospite recidivante o refrattaria
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066261
    E.1.2Term Chronic graft versus host disease
    E.1.2System Organ Class 10021428 - Immune 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 overall response rate (ORR) of axatilimab at 0.3mg/kg Q2W, 1 mg/kg Q2W, and 3 mg/kg Q4W in patients with cGVHD
    Valutare il tasso di risposta complessiva (ORR) di axatilimab a 0,3 mg/kg ogni 2 settimane (Q2W), 1 mg/kg EV Q2W e 3 mg/kg EV ogni 4 settimane (Q4W) in pazienti con cGVHD
    E.2.2Secondary objectives of the trial
    Efficacy:
    1. To evaluate secondary measures of clinical benefit.
    Safety:
    1. To evaluate the safety and tolerability of axatilimab in patients with cGVHD
    2. Bone morphology
    PK/PD:
    1. To assess the plasma population PK (pop PK) profile of axatilimab in patients with cGVHD
    2. To assess pharmacodynamic profile of axatilimab
    3. To determine or assess the changes in monocyte level with response
    4. To determine or assess the baseline in monocyte level with response
    Immunogenicity:
    1. Immunogenicity
    Efficacia:
    • Valutare misure secondarie principali di beneficio clinico
    Sicurezza.
    • Valutare misure secondarie di beneficio clinico
    • Valutare la sicurezza e la tollerabilità di axatilimab in pazienti con cGVHD
    Farmacocinetica (PK)/Farmacodinamica:
    • Morfologia ossea
    • Valutare il profilo di PK plasmatica di popolazione (pop PK) di axatilimab in pazienti con cGVHD
    • Valutare il profilo farmacodinamico di axatilimab
    • Determinare o valutare le variazioni nei livelli di monociti con la risposta
    • Determinare o valutare il valore basale dei livelli di monociti con la risposta
    Immunogenicità:
    • Immunogenicità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be 2 years of age or older, at the time of signing the informed consent.
    2. Patients who are allogeneic HSCT recipients with active cGVHD requiring systemic immune suppression. Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD (Jagasia 2015).
    3. Patients with refractory or recurrent active cGVHD after at least 2 lines of systemic therapy.
    Refractory disease defined as meeting any of the following criteria:
    - The development of 1 or more new sites of disease while being treated for cGVHD.
    - Progression of existing sites of disease despite at least 1 month of standard or investigation therapy for cGVHD.
    - Patients who have not achieved a response within 3 months on their prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.
    - Recurrent cGVHD is active, symptomatic disease (after an initial response to prior therapy) as defined, based on the NIH 2014 consensus criteria, by organ-specific or global assessment or for which the physician believes that a new line of systemic therapy is required.
    4. Patients may have persistent active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
    5. Karnofsky Performance Scale of =60 (if aged 16 years or older); Lansky Performance Score of =60 (if aged <16 years).
    6. Adequate organ and bone marrow functions evaluated during the 14 days prior to randomization.
    7. Creatinine clearance (CrCl) =50 mL/min/1.73 m^2 based on the Cockcroft-Gault formula in adult patients and Schwartz formula in pediatric patients.
    8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    9. Concomitant use of CNI or sirolimus is allow but not required.
    10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A parent/legal guardian should provide consent for pediatric patients unable to provide consent themselves, in addition, where applicable pediatric patients should sign their own assent form.
    1) Il paziente deve avere compiuto almeno 2 anni di età al momento della firma del consenso informato.
    2) Pazienti sottoposti a HSCT allogenico affetti da cGVHD attiva richiedente immunosoppressione sistemica.
    La cGVHD attiva è definita come la presenza di segni e sintomi di cGVHD secondo il Progetto di sviluppo di consenso NIH 2014 sui criteri per le sperimentazioni cliniche nella cGVHD
    3) Pazienti con cGVHD attiva refrattaria o recidivante nonostante almeno 2 linee di terapia sistemica.
    • Malattia refrattaria definita come soddisfacimento di uno qualsiasi dei seguenti criteri:
    ¿ Sviluppo di 1 o più nuovi siti di malattia durante il trattamento per la cGVHD.
    ¿ Progressione dei siti di malattia esistenti nonostante almeno 1 mese di terapia standard o sperimentale per la cGVHD.
    ¿ Pazienti che non hanno ottenuto una risposta entro 3 mesi dalla precedente terapia per la cGVHD e per i quali il medico curante ritenga necessaria una nuova terapia sistemica.
    • La cGVHD ricorrente è una malattia sintomatica attiva (dopo una risposta iniziale alla precedente terapia) come definita, sulla base dei criteri di consenso NIH 2014, dalla valutazione organo-specifica o globale o per la quale il medico ritenga necessaria una nuova linea di terapia sistemica.
    4) I pazienti possono presentare manifestazioni persistenti di malattia acuta e cGVHD (sindrome da sovrapposizione), come definito dal Progetto di sviluppo di consenso NIH 2014 sui criteri per le sperimentazioni cliniche nella cGVHD.
    5) Punteggio della scala di valutazione di Karnofsky =60 (se di età pari o superiore a 16 anni); punteggio della scala di valutazione di Lansky =60 (se di età <16 anni)
    6) Adeguate funzioni d’organo e midollare valutate durante i 14 giorni precedenti la randomizzazione
    7) Clearance della creatinina (CrCl) =30 ml/min/1,73 m2 in base alla formula di Cockcroft-Gault nei pazienti adulti e alla formula di Schwartz nei pazienti pediatrici.
    8) L’uso di contraccettivi da parte di uomini o donne deve essere coerente con le normative locali riguardanti i metodi contraccettivi per coloro che partecipano a studi clinici.
    9) L'utilizzo concomitante di CNi o sirolimus è consentito ma non richiesto
    10) Capacità di fornire il consenso informato firmato, compresa la compliance ai requisiti e alle restrizioni elencati nel modulo di consenso informato (ICF) e nel presente protocollo. Un genitore/tutore deve fornire il consenso per i pazienti pediatrici che non siano in grado di fornire autonomamente il consenso; inoltre, ove applicabile, i pazienti pediatrici devono firmare il proprio modulo di assenso.
    E.4Principal exclusion criteria
    1. Has acute GVHD without manifestations of cGVHD.
    2. Any evidence (histologic, cytogenetic, molecular, hematologic, orvmixed) of relapse of the underlying cancer or post-transplantvlymphoproliferative disease at the time of screening.
    3. History of acute or chronic pancreatitis.
    4. History of myositis.
    5. History or other evidence of severe illness, uncontrolled infection orvany other conditions that would make the patient, in the opinion of thevInvestigator, unsuitable for the study.
    6. Patients with acquired immune deficiency syndrome (AIDS).
    7. Hepatitis B (defined as hepatitis B virus [HBV] surface antigenvpositive and HBV core antibody positive, with positive HBVvdeoxyribonucleic acid [DNA], or HBV positive core antibody alone withvpositive HBV DNA. Hepatitis C (defined as positive hepatitis C [HCV]vantibody with positive HCV ribonucleic acid [RNA]).
    8. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of randomization, unless previously treated with curative intent and approved by Sponsor's Medical Monitor (eg, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
    9. Female patient who is pregnant or breastfeeding.
    10. Previous exposure to CSF1-R targeted therapies.
    11. Taking agents other than a corticosteroid and either a CNI or sirolimus is prohibited. See inclusion criteria 9 for guidelines regarding the appropriate use of corticosteroids, CNI, and sirolimus in combination with study treatment.
    12. For approved or commonly used agents, other than corticosteroids, CNI and sirolimus, a washout of 2 weeks or 5 half-lives, whichever is shorter, is required at study enrollment.
    13. Receiving another investigational treatment within 28 days of randomization
    14. Patients should not be participating in any other interventional study. Pediatric patients are encouraged to also participate in the ongoing development studies of the Pediatric cGVHD Symptom Scale (PCSS).
    1. Presenza di GVHD acuta senza manifestazioni di cGVHD.
    2. Qualsiasi evidenza (istologica, citogenetica, molecolare, ematologica o mista) di recidiva del tumore sottostante o malattia linfoproliferativa post-trapianto al momento dello screening.
    3. Anamnesi di pancreatite acuta o cronica.
    4. Anamnesi di miosite.
    5. Anamnesi o altra evidenza di malattia grave, infezione non controllata o qualsiasi altra condizione che, a giudizio dello sperimentatore, renderebbe il paziente non idoneo allo studio.
    6. Pazienti con sindrome da immunodeficienza acquisita (AIDS).
    7. Epatite B (definita come antigene di superficie positivo per il virus dell'epatite B [HBV] e anticorpo core positivo per l’HBV, con acido desossiribonucleico [DNA] positivo per l’HBV o solo anticorpo core positivo per l’HBV con DNA positivo per l’HBV). Epatite C (definita come anticorpo contro il virus dell’epatite C [HCV] positivo con acido ribonucleico [RNA] positivo per l’HCV).
    8. Diagnosi di un altro tumore maligno (diverso da quello per cui è stato eseguito il trapianto) entro 3 anni dalla randomizzazione, a meno che non sia stato precedentemente trattato con intento curativo e approvato dal responsabile del monitoraggio medico dello sponsor (ad es. carcinoma cutaneo basocellulare o squamocellulare completamente resecato, tumore maligno in situ del collo dell’utero sottoposto a resezione, carcinoma duttale in situ della mammella sottoposto a resezione o carcinoma prostatico a basso rischio dopo resezione curativa).
    9. Paziente di sesso femminile in gravidanza o durante il periodo di allattamento al seno.
    10. Precedente esposizione a terapie mirate al recettore del fattore 1 stimolante le colonie (CSF1-R).
    11. È vietato assumere agenti per il trattamento della cGVHD diversi dai corticosteroidi e da un CNI o sirolimus. Per le linee guida relative all’uso appropriato di corticosteroidi, CNI e sirolimus in combinazione con il trattamento dello studio, consultare i Criteri di inclusione 9 e 10.
    12. Per agenti approvati o di uso comune, diversi da corticosteroidi, CNI o sirolimus, è richiesto un washout di 2 settimane o 5 emivite, a seconda di quale sia il periodo più breve, in occasione dell’arruolamento nello studio.
    13. Ricezione di un trattamento sperimentale entro 28 giorni dalla randomizzazione.
    14. I pazienti non devono partecipare ad altri studi interventistici. I pazienti pediatrici sono inoltre incoraggiati a partecipare agli studi in corso sullo sviluppo della scala pediatrica dei sintomi della cGVHD (PCSS).
    E.5 End points
    E.5.1Primary end point(s)
    ORR in the first 6 cycles as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
    ORR nei primi 6 cicli come definito dal Progetto di sviluppo di consenso del National Institutes of Health (NIH) 2014 sui criteri per le sperimentazioni cliniche nella cGVHD
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the first 6 cycles, where the first 6 cycles is defined as the time from randomization up to Day 169 or the beginning of Cycle 7
    Durante i primi 6 cicli, definiti come tempo dalla randomizzazione fino al giorno 169 o all'inizio del ciclo 7
    E.5.2Secondary end point(s)
    Efficacy:
    1. Proportion of patients with a >5-point improvement in modified Lee Symptom Scale Score (mLSS).
    2. ORR on study as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
    3. Duration of response (DOR) defined as the time from best response of PR or CR until documented progression of cGVHD, start of new therapy, or death for any cause (Definition 1)
    4. DOR defined as the time from initial response of PR or CR until
    documented progression of cGVHD, start of new therapy, or death for
    any reason (Definition 2)
    5. Sustained response rate (SRR)
    6. Organ-specific response rate based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
    7. Joints and fascia response rate based on refined NIH response algorithm for cGVHD
    8. Percent reduction in average daily dose (or equivalent) of corticosteroids
    9. Proportion of patients who discontinue corticosteroid use after study entry
    10. Percent reduction in average daily dose (or equivalent) of calcineurin inhibitors
    11. Proportion of patients who discontinue calcineurin inhibitors use after study entry; Safety:
    1. Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
    2. Change from baseline in values for vital signs, safety laboratory parameters, physical and neurological examination, ECG and Karnofsky/Lansky performance scale
    3. Change from baseline in bone turnover markers
    4. Change from baseline in bone density; Pharmacodynamics (PK)
    1. Axatilimab PK parameters and patient factors that may explain variability in drug exposure
    2. Change from baseline in colony stimulating factor 1 (CSF-1), interleukin 34 (IL-34) levels and its association with cGVHD response
    3. Change from baseline in circulating monocyte number and phenotype (CD14/16)
    4. Baseline circulating monocyte number and phenotype (CD14/16); Immunogenicity:
    1. Presence of anti-drug antibody (ADA)
    Efficacia:
    • Percentuale di pazienti con un miglioramento >5 punti nel punteggio della Scala dei sintomi di Lee modificata (mLSS)
    • ORR durante lo studio, come definito dal Progetto di sviluppo di consenso NIH 2014 sui criteri per le sperimentazioni cliniche nella cGVHD
    • Durata della risposta (DOR) definita come l’intervallo di tempo che va dalla migliore risposta di risposta parziale (PR) o risposta completa (CR) fino alla progressione documentata della cGVHD, all’inizio di una nuova terapia o al decesso per qualsiasi causa (Definizione 1)
    • DOR definita come l’intervallo di tempo che va dalla risposta iniziale di PR o CR fino alla progressione documentata della cGVHD, all’inizio di una nuova terapia o al decesso per qualsiasi causa (Definizione 2)
    • Tasso di risposta sostenuta (SRR)
    • Tasso di risposta organo-specifica basato sul Progetto di sviluppo di consenso NIH 2014 sui criteri per le sperimentazioni cliniche nella cGVHD
    • Tasso di risposta articolare e fasciale basato su un algoritmo di risposta NIH perfezionato per la cGVHD (Inamoto 2020)
    • Riduzione percentuale della dose media giornaliera (o equivalente) di corticosteroidi
    • Percentuale di pazienti che interrompono l’uso di corticosteroidi dopo l’ingresso nello studio
    • Riduzione percentuale della dose media giornaliera (o equivalente) di inibitori della calcineurina
    • Percentuale di pazienti che interrompono l’uso di inibitori della calcineurina dopo l’ingresso nello studio; Sicurezza:
    • Frequenza e gravità degli eventi avversi (EA) e degli eventi avversi seri (SAE)
    • Variazione rispetto al valore basale nei valori dei segni vitali, dei parametri di laboratorio di sicurezza, dell’esame obiettivo e neurologico, dell’elettrocardiogramma (ECG) e della scala di valutazione di Karnofsky/Lansky
    • Variazione rispetto al valore basale nei marcatori del turnover osseo
    • Variazione rispetto al valore basale nella densità ossea; Farmacocinetica (PK)/Farmacodinamica:
    • Parametri PK di axatilimab e fattori del paziente che possono spiegare la variabilità nell’esposizione al farmaco
    • Variazione rispetto al valore basale nei livelli di fattore stimolante le colonie 1 (CSF-1), interleuchina 34 (IL-34) e la sua associazione con la risposta della cGVHD
    • Variazione rispetto al valore basale nel numero di monociti circolanti e relativo fenotipo (CD14/16)
    • Numero e fenotipo di monociti circolanti al valore basale (CD14/16); Immunogenicità:
    • Presenza di anticorpi anti-farmaco (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study; Throughout the study; Throughout the study; Day 1 up to Cycle 12, EOT and follow-up visit
    Lungo tutto lo studio; Lungo tutto lo studio; Lungo tutto lo studio; Al Giorno 1 fino al ciclo 12, alla visita di fine studio e a quella di follow up
    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 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
    studio randomizzato in aperto
    Open-label, randomized study
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Canada
    Korea, Republic of
    Singapore
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    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
    Last patient last visit (LPLV)
    Last patient last visit (LPLV)
    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 months6
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 210
    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)
    At the completion of the trial, the patient will be supported onto standard of care.
    A completamento del trial il paziente verrà trattato secondo Standard Of Care
    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 Decision2021-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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