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    Summary
    EudraCT Number:2021-001644-10
    Sponsor's Protocol Code Number:D5272C00002
    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:2021-09-17
    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 number2021-001644-10
    A.3Full title of the trial
    A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis
    (EXPEDITION OLE)
    Studio di fase 2 in aperto e di estensione a lungo termine volto a esaminare la sicurezza di Brazikumab in partecipanti con Colite ulcerosa da moderatamente a gravemente attiva (EXPEDITION OLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Extension Study of Brazikumab in Ulcerative Colitis
    Studio di estensione in aperto su Brazikumab in partecipanti con Colite Ulcerosa
    A.3.2Name or abbreviated title of the trial where available
    EXPEDITION OLE
    EXPEDITION OLE
    A.4.1Sponsor's protocol code numberD5272C00002
    A.5.4Other Identifiers
    Name:INDNumber:137684
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBrazikumab
    D.3.2Product code [MEDI2070]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN( L ) ASCORBATO DI CALCIO
    D.3.9.1CAS number 1610353-18-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
    D.3.9.4EV Substance CodeSUB188673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale IgG2 completamente umano
    D.IMP: 2
    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 nameBrazikumab
    D.3.2Product code [MEDI2070]
    D.3.4Pharmaceutical form Solution for injection/infusion 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 INN( L ) ASCORBATO DI CALCIO
    D.3.9.1CAS number 1610353-18-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
    D.3.9.4EV Substance CodeSUB188673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis is a type of inflammatory bowel disease that causes the
    lining of the large intestine (colon) to become inflamed (irritated and
    swollen) which may cause ulcers and bleeding.
    La Colite Ulcerosa è un tipo di malattia infiammatoria intest che provoca infiammazione (irritazione e gonfiore) del rivestimento dell’intestino crasso (colon) e può causare ulcere e sanguinamenti.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of long-term treatment with brazikumab in UC
    participants who previously completed or discontinued participation due
    to lack of efficacy after Week 10 in the lead-in Study D5272C00001
    (Legacy #3151-201-008)
    Per valutare la sicurezza del trattamento a lungo termine con brazikumab nei partecipanti con colite ulcerosa che in precedenza hanno completato o interrotto la partecipazione a causa di una mancanza di efficacia dopo la settimana 10 nello studio preliminare D5272C00001.
    (precedente #3151-201-008)
    E.2.2Secondary objectives of the trial
    Not applicable.
    Non applicabile.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female participants who:
    1. successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001.
    AND Meets 1 of the following criteria for successful completion or early termination from Study D5272C00001:
    (a) Participant completed Study D5272C00001, received scheduled study interventions, completed scheduled visits, and completed Week 54 assessments.
    (b) Participant discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001, received scheduled study interventions, and completed Early Termination Visit assessments.
    2. No known history of active TB or latent TB without completion of appropriate intervention.
    3. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Nonsterilized men who are sexually active with a female partner of childbearing potential should use condom during treatment and for 18 weeks after the last dose of study intervention
    4. Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention
    5. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
    6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    7. Written informed consent from the participant has been obtained prior to any study related procedures.
    8. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g.,Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
    9. Demonstration of adequate compliance with the study procedures in Study D5272C00001, in the opinion of the investigator and/or sponsor.
    10. Willingness and ability to attend all study visits, comply with the study procedures, and be able to complete the study period.
    11. Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF.
    Complete inclusion criteria are in the study protocol.
    Partecipanti maschi o femmine che:
    1. abbiano completato la partecipazione con successo o interrotta per mancanza di efficacia dopo la settimana 10 nello studio preliminare D5272C00001 E
    Soddisfino uno dei seguenti criteri per il completamento con successo o interruzione anticipata dello studio D5272C00001:
    (a) Il partecipante ha completato lo studio D5272C00001,ricevuto il trattamento di studio programmato e completato le visite programmate e le valutazioni della settimana 54.
    (b) Il partecipante ha interrotto la partecipazione nello studio D5272C00001 a causa della mancanza di efficacia dopo la settimana 10 , ha ricevuto i trattamenti di studio programmati e ha completato le valutazioni della visita di conclusione anticipata.
    2. Nessuna storia nota di TB attiva o TB latente senza il completamento di un intervento appropriato.
    3. Partecipanti di sesso maschile disposti a ridurre al minimo il rischio di indurre una gravidanza per la durata dello studio clinico e del periodo di follow-up. Uomini non sterilizzati che sono sessualmente attivi con una partner in età fertile dovrebbero usare il preservativo durante il trattamento e per 18 settimane dopo l'ultima dose di trattamento dello studio.
    4. Le partecipanti in età fertile devono avere un test di gravidanza sulle urine negativo prima della somministrazione del trattamento di studio e
    devono accettare di utilizzare un metodo contraccettivo altamente efficace (confermato dallo sperimentatore) a partire dalla randomizzazione, per tutta la durata dello studio
    e per almeno 18 settimane dopo l'ultima dose di trattamento dello studio.
    5. Le donne non in età fertile sono definite come donne che sono sterilizzate in modo permanente (isterectomia, ovariectomia bilaterale, o salpingectomia bilaterale), o che sono in post-menopausa.
    6. In grado di fornire il consenso informato firmato, il quale include la conformità con i requisiti e le restrizioni elencate nell'ICF e in questo protocollo.
    7. È stato ottenuto il consenso informato scritto del partecipante prima di qualsiasi procedura relativa allo studio.
    8. La documentazione scritta è stata ottenuta in conformità con i requisiti di privacy nazionali e locali, ove applicabile (ad esempio Autorizzazione scritta per l'uso e il rilascio di studi sanitari e di ricerca Informativa [siti USA] e consenso scritto sulla protezione dei dati [siti UE]).
    9. Dimostrazione di un adeguato rispetto delle procedure nello Studio D5272C00001 secondo il parere dello sperimentatore e/o dello sponsor.
    10. Disponibilità e capacità di partecipare a tutte le visite di studio, di rispettare le procedure di studio ed essere in grado di completare il periodo di studio.
    11. Il partecipante deve avere un'età compresa tra i 18 e gli 80 anni, al momento della firma dell'ICF.
    I criteri di inclusione completi sono nel protocollo di studio.
    E.4Principal exclusion criteria
    1. Any part with an unresolv. AE from the lead-in st that, in the inv.'s opinion, would limit the partic's ability to partic. in or complete this st. Any unresolv. AE rel. to an infec. will require further discuss. with the st med. monit. prior to enroll.
    2. Current diagn. of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, prim. sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other condit. that may potentially confound asses. must be treated prior to bas.
    3. Organ or cell-based transpl. with the exc. of corneal transpl.
    4. Any other condit. or finding that, in the investigator's or sponsor's opinion, would either confound proper interpr of the st or expose a part to unacc. risk.
    5. The follow. are exclus. with regards to malignancy:
    a) Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy.
    b) Any diagn. of malignancy that requires discont. of st interv. from lead-in st.
    c) Any new diagn. of malignancy after compl. of the lead-in st.
    d) Carcinoma in situ of the cervix, with app. succ. cur. ther. within 12 mon. prior to W 0.
    6. Part meets criteria for discont. of st interv. during prior lead-in st.
    7. Chronic hepatitis B or C infec.
    8. Known history of prim. immunodef., splenectomy, or any underlying condic that predisposes the part to infect., including HIV infect.
    9. Prolong. QTcF int. or condit. leading to additional risk for QT prolong. Part with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolong. are to be corrected prior to enrollm.
    10. Clinically signif kidney dis. incl. but not limited to:
    (a) Chronic kidney dis. with an estim. glomer. filtr. rate of less than 30 ml/min calculated by Modif of Diet in Renal Disease eq.
    11. Part requires additional immunosuppressive ther. (aside from permitted concom. medic. in the prot.), biologic treat. or prohibited treat.
    12. Part rec. a prohibited medic. during part. in the D5272C00001 st.
    13. Part rec. a Bacille Calmette-Guérin vacc. within 12 mon. of W 0 or any other live vacc. < 4 w prior to W 0, or is planning to receive any such vacc. over the course of the st.
    14. Part has rec. an investig product after discont from St D5272C00001 and prior to enrolling in this st or participant is planning to receive an investig. drug (other than st interv.) or investig device at any time during St D5272C00002.
    15. Part who discon. part due to lack of eff. after W 10 in St D5272C00001 and did not receive all 3 IV infus of st interv. scheduled for W 0 (D 1), W 2 (D 15), and W 6 (D 43), and SC at W 10 (D 71) in acc. with the prot. for St D5272C00001.
    16. Par who discont. due to lack of eff. after W 10 in St D5272C00001 but curr. demonstrates clin resp and/or meets endosc. Mayo Score of 0-1 prior to W 54 in St D5272C00001:
    Clin Resp defined as: Red in mMS = 2 p from bas AND = 30% from bas, AND a decr in the rectal bleeding score = 1 p from bas or a score of 0-1, in St D5272C00001.
    Note: Part are encouraged to remain in the lead-in St D5272C00001 if the part is demonstrating evid. of clin resp. Part should not early terminate that st due to lack of eff. if this excl is met.
    17. Abn. lab res. at screen. as described in the prot.
    18. Females who are pregnant, breast feeding, or planning a pregnancy during the study OR females who are of childbearing potent. and do not agree to use contrac.
    19. Part is dir. or indir. involved in the plan. and/or conduct. and administ. of this st as st staff member, or employee of the sponsor, or the part is a first-degree family member, significant other, or relative residing with one of the above persons involved dir or indir in the st; or the part is enrol. in this st at another clin st site.
    20. Judg. that the part should not partic in the st if the partic is unlikely to comply with st proced., restrict., and requir.
    21. Previous enroll. in the present st.
    Comp exc criteria are in the st prot.
    1. Qls part con un EA irrisolto nello st di Induz che secondo l'opin dello sperim, limiterebbe la capacità del part di partec o completare questo st. Qls EA irrisolto relativo a un infez richiederà ulteriori discus con il monitor med dello st prima dell'arruol.
    2. Diagn att di colite fulminante, MC o colite indeterm, pres di fistola compatibile con MC, colangite sclerosante primit, celiachia o megacolon tossico. Malassorbimento degli ac biliari e altre condiz che possono potenzialm confondere le valutaz devono essere tratt prima della Bas.
    3. Trap di org o cell ad eccezione del trapi corneale.
    4. Qls altra condiz o accert che, a giudizio dello sperim o dello spons, confonderebbe la corretta interpret dello st o esporrebbe un part a un rischio inaccett.
    5. Sono escl a causa della malignità:
    a) Evid di displasia epitel intest nell'endoscopia, conferm dalla biopsia al part.
    b) Qls diagn di tum malig che richieda l'interruz del tratt di st nello st di Induz.
    c) Qls nuova diag di tum malig dopo il complet dello st di Induz.
    d) Carcinoma in situ della cervice, con app successo della terap di cura nei 12 ms preced alla sett 0.
    6. Il part soddisfa i criteri per l'interruz del tratt di st durante il preced st di Induz.
    7. Infez cronica da epat B o C.
    8. Storia nota di immunodef prim, splenectomia o altra condiz che predispone il part all'infez, compresa l'infez da HIV.
    9. Int QTcF prolung o condiz che comportano un rischio agg per il prolungam del QT. Part con anom elettrolitiche come ipokalemia e ipomagnesemia che aumenterebbero il rischio di prolungam del QT, devono essere corrette prima dell'arruolam.
    10. Malatt ren clin signific, incl ma non limit a:
    (a) Malatt ren cronica con una vel di filtraz glomer stimata < di 30 ml/min calcol con la Modif della dieta nell' eq della malatt Ren.
    11. Il part richiede una ter immunosoppressiva agg (a parte i farm concom consent nel prot), tratt biolog o tratt vietato.
    12. Il part ha ricev un farm proibito durante la partec allo st D5272C00001.
    13. Il part ha ricev una vaccinaz Bacille Calmette-Guérin entro 12 ms della sett 0 o qls altro vacc vivo entro 4 sett prima della sett 0, o sta pianif di ricevere un tale vacc nel corso dello st.
    14. Il part ha ricev un prod in sperim dopo inter dallo St D5272C00001 e prima dell'arruolam a questo st o il part sta pianif di ricev un farm sperim (diverso rispetto al trat in studio) o disp sperim in qls mom durante St D5272C00002.
    15. Part che ha interrotto la partec per manc di effic dopo la sett 10 nello st D5272C00001 e non ha ricev le tre infus IV del trat di st program per la Sett 0 (G 1), Sett 2 (G 15) e Sett 6 (G 43) e SC alla Sett 10 (G 71) in accordo con il prot dello St D5272C00001.
    16. Part che ha interrotto per manc di effic dopo la sett 10 nello stud D5272C00001 ma attual dimostra una risp clin e/o soddisfa il punt Mayo endoscop di 0-1 prima della sett 54 nello st D5272C00001:
    Risp clin definita come: rid di mMS = 2 p rispetto al bas E = 30% rispetto al bas, E una dim del punt del sanguinam rett = 1 p dalla bas o un punt di 0-1, nello st D5272C00001.
    Nota: i part sono incoraggiati a riman nello st D5272C00001 se il part sta dimostr una evid di risp clin. I part non dovrebbero interrom anticip lo st per manc di eff se tale esclus è soddisf.
    17. Risult di lab anorm allo screen come desc nel prot.
    18. Don incinte, che allattano o stanno pianific una grav durante lo st O don in età fert che non accettano di usare la contracc.
    19. Il partec è dirett o indirett coinvolto nella pianificaz e/o conduz e amministraz di questo st come memb del person dello st, o dipend dello spons, o il part è un famil di 1° grad, altro signif o parente resid con una delle preced pers coinvolte dirett o indirett nello st; o il part è arruol in questo st in un altro sito di st clin.
    20. Sentenza che il part non dovrebbe part allo st se è improb che il part rispetti proced di st, restriz e requisiti.
    21. Prec arruolm al pres st.
    I criteri di escl completi sono nel prot di st.
    E.5 End points
    E.5.1Primary end point(s)
    - AEs
    - Clinical laboratory values
    - Vital signs
    - Physical exams
    - ECGs
    - Eventi avversi
    - Valori clinici di laboratorio
    - Segni vitali
    - Esami fisici
    - ECG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Across the 52-week treatment period for each primary endpoints
    Durante il periodo di trattamento di 52 settimane per ciascun endpoint primario.
    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 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 di estensione
    Extension 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Austria
    Canada
    Czechia
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Poland
    Russian Federation
    South Africa
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days5
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 180
    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)
    Not applicable.
    Non applicabile.
    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 Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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