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    Summary
    EudraCT Number:2021-003749-39
    Sponsor's Protocol Code Number:NGF0221
    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:2021-10-15
    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 number2021-003749-39
    A.3Full title of the trial
    A 4 week, Phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of Cenegermin (Oxervate®) 20 mcg/mL ophthalmic solution versus vehicle, in patients with severe Sjogren’s dry eye disease under treatment with Cyclosporine A.
    Studio di fase III, multicentrico, di 4 settimane, a doppio mascheramento, controllato con veicolo, volto a valutare la sicurezza e l'efficacia di Cenegermin (Oxervate®)20 mcg/ml soluzione oftalmica rispetto al veicolo, in pazienti affetti da sindrome dell'occhio secco di Sjögren grave in trattamento con Ciclosporina A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 4 week, Phase III, multicenter, double-masked, study to evaluate safety and efficacy of Oxervate® (cenegermin) 20 mcg/mL ophthalmic solution in patients with severe Sjogren’s dry eye disease under treatment with Cyclosporine A.
    Studio di 4 settimane, di Fase III, multicentrico, in doppio cieco, per valutare la sicurezza e l'efficacia della soluzione oftalmica di Oxervate® (cenegermin) 20 mcg/mL in pazienti affetti da sindrome dell'occhio secco di Sjögren grave in trattamento con Ciclosporina A
    A.3.2Name or abbreviated title of the trial where available
    NGF0221
    NGF0221
    A.4.1Sponsor's protocol code numberNGF0221
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportDompé farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé farmaceutici S.p.A.,
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia S. Martino 12
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number+3902583831
    B.5.5Fax number+390258383324
    B.5.6E-mailinfo@dompe.it
    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 Oxervate
    D.2.1.1.2Name of the Marketing Authorisation holderDompé farmaceutici S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameOXERVATE
    D.3.2Product code [Recombinant Human Nerve Growth Factor (rhNGF)]
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCenegermin
    D.3.9.1CAS number 1772578-74-1
    D.3.9.2Current sponsor codeCenegermin
    D.3.9.3Other descriptive nameRecombinant form of human nerve growth factor produced in Escherichia Coli.
    D.3.9.4EV Substance CodeSUB184674
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEar drops
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Sjogren’s dry eye disease
    Sindrome dell'occhio secco di Sjögren grave
    E.1.1.1Medical condition in easily understood language
    Severe Sjogren’s dry eye disease
    Sindrome dell'occhio secco di Sjögren grave
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy and safety of cenegermin ophthalmic solution at 20 mcg/mL concentration administered three times daily for 4 weeks in patients with severe Sjogren’s dry eye disease.
    L'obiettivo primario del presente studio è valutare l'efficacia e la sicurezza di cenegermin soluzione oftalmica in una concentrazione di 20 mcg/ml, somministrata tre volte al giorno per 4 settimane in pazienti affetti da sindrome dell'occhio secco di Sjögren grave.
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged = >18 years
    2. Patients with a confirmed diagnosis of Sjögren's syndrome or other autoimmune disease known to induce Sjögren’s DED.
    3. Patients with severe Sjögren’s DED characterized by the following clinical features:
    a. Corneal and/or conjunctival staining with fluorescein using National Eye Institute (NEI) grading system = >3
    b. SANDE questionnaire >25 mm
    c. Schirmer test I (without anaesthesia) ) 2 e 5mm/5min inclusive
    4. The same eye (eligible eye) must fulfill all the above criteria
    5. Patients diagnosed with severe Sjögren’s DED at least 3 months before enrolment (current use or recommended use of artificial tears for the treatment of Sjogren’s related DE)
    6. Best corrected distance visual acuity (BCDVA) score of = 0.1 decimal units (20/200 Snellen value) in each eye at the time of study enrolment
    7. If a female with childbearing potential, have a negative pregnancy test
    8. Patients who have given written informed consent before any study-related procedures not part of standard medical care are performed.
    9. Patients must have the ability and willingness to comply with study procedures.
    10. Patients under treatment with topical cyclosporine (CsA), or topical ophthalmic treatments of the same class for at least 30 days before screening visit (day 8).
    1. Soggetti di sesso maschile o femminile di età = >18 anni
    2. Pazienti con una diagnosi confermata di sindrome di Sjogren o altra malattia autoimmune che notoriamente induce la DED di Sjögren.
    3. Pazienti affetti da DED di Sjögren grave caratterizzata dalle seguenti caratteristiche cliniche:
    a. Colorazione corneale e/o congiuntivale con fluoresceina utilizzando il sistema di classificazione del National Eye Institute (NEI) = >3
    b. Punteggio globale nel questionario globale sull'occhio secco (SANDE) > 25 mm
    c. Test di Schirmer I (senza anestesia) tra 2 e 5 mm/5 min, inclusi
    4. I criteri di cui sopra devono essere soddisfatti dallo stesso occhio (occhio idoneo).
    5. Diagnosi di DED di Sjögren grave almeno 3 mesi prima dell'arruolamento (uso attuale o raccomandato di lacrime artificiali per il trattamento della secchezza oculare correlata alla sindrome di Sjögren)
    6. Punteggio della migliore acuità visiva a distanza corretta (Best Corrected Distance Visual Acuity, BCDVA) di = >0,1 unità decimali (valore Snellen pari a 20/200) in ciascun occhio al momento dell'arruolamento nello studio
    7. Test di gravidanza negativo per le donne in età fertile
    8. I pazienti devono fornire il consenso informato scritto prima di eseguire qualsiasi procedura correlata allo studio che non rientri nell'assistenza medica standard.
    9. I pazienti devono avere la capacità e volontà di attenersi alle procedure dello studio.
    10. Pazienti in trattamento con ciclosporina topica (CsA) o trattamenti oftalmici topici della stessa classe per almeno 30 giorni prima della visita di screening (giorno 8)
    E.4Principal exclusion criteria
    1. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
    2. Evidence of an active ocular infection, in either eye
    3. Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study in either eye
    4. History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
    5. Intraocular inflammation defined as Tyndall score >0
    6. History of malignancy in the last 5 years
    7. Systemic disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study
    8. Patient had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or had a clinically significant allergy to drugs, foods, amide local anesthetics or other materials including commercial artificial tears (in the opinion of the investigator)
    9. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
    a. are currently pregnant or,
    b. have a positive result at the urine pregnancy test (Baseline/Day 1) or,
    c. intend to become pregnant during the study treatment period or,
    d. are breast-feeding or,
    e. are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD - during the entire course of and 30 days after the study treatment periods
    10. Any concurrent medical condition, that in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
    11. Use of topical corticosteroids, lifitegrast, autologous serum tears in either eye during the study (previous use not an exclusion criteria but must be discontinued at the screening visit)
    12. Contact lenses, true tear device, moisture googles, sutureless amniotic membrane or punctum plug use during the study (previous use not an exclusion criteria but must be discontinued at the screening visit)
    13. History of drug addiction or alcohol abuse in the last 2 years
    14. Any prior ocular surgery (including refractive, palpebral and cataract surgery) if within 90 days before the screening visit
    15. Participation in a clinical trial with a new active substance during the past 3 months
    16. Participation in another clinical trial study at the same time as the present study.
    1. Capacità di esposizione e comprensione della lingua locale non sufficiente a comprendere la natura dello studio, fornire un consenso informato scritto e consentire il completamento di tutte le valutazioni dello studio
    2. Evidenza di un'infezione oculare attiva in uno qualsiasi degli occhi
    3. Presenza di qualsiasi altro disturbo o condizione oculare che richieda l'uso di farmaci topici per tutta la durata dello studio in uno qualsiasi degli occhi
    4. Anamnesi di allergia sistemica o allergia oculare grave (inclusa la congiuntivite stagionale) o di congiuntivite cronica e/o cheratite dovuta a una causa diversa dalla secchezza oculare (DE)
    5. Infiammazione intraoculare definita secondo un punteggio di Tyndall >0
    6. Anamnesi di neoplasia maligna negli ultimi 5 anni
    7. Malattia sistemica non stabilizzata entro 1 mese prima della visita di screening (ad es. diabete con glicemia al di fuori dell'intervallo, malfunzionamento tiroideo) o giudicata dallo sperimentatore incompatibile con lo studio (ad es. infezioni sistemiche attuali) o condizione incompatibile con la valutazione frequente richiesta dallo studio
    8. Pazienti con anamnesi di reazione avversa grave o ipersensibilità significativa a qualsiasi farmaco o composto chimicamente correlato o allergia clinicamente significativa ad alimenti, anestetici locali amidi o altri materiali, comprese le lacrime artificiali in commercio (a giudizio dello sperimentatore)
    9. Le donne in età fertile (che non sono sterilizzate chirurgicamente o in post-menopausa da almeno 1 anno) sono escluse dalla partecipazione allo studio se soddisfano una delle seguenti condizioni:
    a. gravidanza in corso o
    b. risultato positivo al test di gravidanza sulle urine (Basale/Giorno 1) o
    c. intenzione di avviare una gravidanza durante il periodo di trattamento dello studio o
    d. in allattamento o
    e. non disponibile ad utilizzare metodi contraccettivi altamente efficaci, quali contraccettivi ormonali (orali, impiantati, transdermici o iniettabili) e/o metodi di barriera meccanici (spermicida in abbinamento a un metodo di barriera quali preservativo o diaframma o IUD) durante l'intero ciclo del periodo di trattamento dello studio e 30 giorni dopo tale periodo
    10. Qualsiasi condizione medica concomitante che, a giudizio dello sperimentatore principale, potrebbe interferire con la conduzione dello studio, confondere l'interpretazione dei risultati dello studio o mettere in pericolo il benessere del paziente
    11. Uso di corticosteroidi topici, lifitegrast e lacrime di siero autologo in un occhio qualsiasi durante lo studio (l'uso passato non costituisce un criterio di esclusione, purché tale uso sia interrotto alla visita di screening)
    12. Lenti a contatto, dispositivi true tear, occhiali umidificati, membrana amniotica senza sutura o tappi per il punctum durante lo studio (l'uso precedente non è un criterio di esclusione ma deve essere interrotto alla visita di screening)
    13. Anamnesi di dipendenza da droghe o abuso di alcol nell'ultimo anno
    14. Qualsiasi precedente intervento chirurgico oculare (ivi inclusi intervento refrattivo, palpebrale e di cataratta) eseguito entro 60 giorni prima della visita di screening
    15. Partecipazione a uno studio clinico su un nuovo principio attivo negli ultimi 3 mesi prima dello screening
    16. Partecipazione ad un altro studio clinico contemporaneamente al presente studio
    E.5 End points
    E.5.1Primary end point(s)
    • Schirmer I test (without anesthesia) >10mm/5min at week 4.
    Test di Schirmer I (senza anestesia) >10 mm/5 min alla Settimana 4 nell'occhio idoneo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    Settimana 4
    E.5.2Secondary end point(s)
    • Change from baseline in SANDE global score [Time frame: week 8, 12 and 16];
    • Change from baseline in Schirmer I test (without anesthesia) [Time frame: week 4, 8, 12 and 16];
    • Change from baseline in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute [NEI] scales) [Time frame: week 4, 8, 12 and 16];
    • Change from baseline in Tear Film Break-Up Time (TFBUT) [Time frame: week 4, 8, 12 and 16];
    • Change from baseline in SANDE scores for severity and frequency [Time frame: week 8, 12 and 16];
    • Number of patients experiencing a worsening in SANDE and/or NEI score = 50% assessed at week 4;
    • Quality of life (IDEEL) questionnaire [Time frame: week 4, 8, 12 and 16].
    Exploratory Endpoints
    Proportion and frequency of preservative free artificial tears use (n° drops/day) during the treatment period;
    • Frequency of preservative free artificial tears use (n° drops/day) during the follow up period;
    • Change from baseline in Schirmer I test (without anesthesia) Vs week 2;
    • Change from baseline in SANDE global score [Time frame: week 2 and 4];
    • Change from baseline in SANDE scores for severity and frequency [Time frame: week 2 and 4];
    • Change from baseline in Cornea and conjunctiva vital staining with fluorescein (NEI scales) Vs week 2;
    • Change from baseline in TFBUT Vs week 2;
    • Number of patients experiencing a worsening in SANDE and/or NEI score = > 50% assessed at week 2;
    • Change from baseline in Schirmer test II (with topical Anesthesia) vs Week 4.
    • Change from baseline in BCDVA
    Safety Endpoint
    Incidence and frequency of Adverse Events (AEs) and Treatment-emergent adverse events (TEAEs), assessed throughout the study.
    • Variazioni dal basale del punteggio globale SANDE (tempistica: settimane 8, 12 e 16);
    • Variazione dal basale del test di Schirmer I (senza anestesia) (tempistica: settimane 4, 8, 12 e 16);
    • Variazione dal basale della colorazione vitale di cornea e congiuntiva con fluoresceina (scale del National Eye Institute [NEI]) (tempistica: settimane 4, 8, 12 e 16)
    • Variazione dal basale del tempo di rottura del film lacrimale (Tear Film Break-Up Time, TFBUT) (tempistica: settimane 4, 8, 12 e 16);
    • Variazione dal basale nei punteggi SANDE relativi alla gravità e alla frequenza (tempistica: settimane 8, 12 e 16);
    • Numero di pazienti che hanno presentato un peggioramento nel punteggio SANDE e/o nel punteggio NEI = >50% secondo la valutazione della settimana 4;
    • Questionario sulla qualità della vita (IDEEL) (tempistica: settimane 4, 8, 12 e 16)
    Endpoint esplorativi
    • Percentuale e frequenza dell'uso di lacrime artificiali senza conservanti (n. gocce/giorno) durante il periodo di trattamento;
    • Frequenza dell'uso di lacrime artificiali senza conservanti (n. gocce/giorno) durante il periodo di follow-up;
    • Variazione dal basale del test di Schirmer I (senza anestesia) rispetto alla settimana 2;
    • Variazione dal basale del punteggio globale SANDE (tempistica: settimane 2 e 4);
    • Variazione dal basale dei punteggi SANDE relativi alla gravità e alla frequenza (tempistica: settimane 2 e 4);
    • Variazione dal basale nella colorazione vitale di cornea e congiuntiva con fluoresceina (scale del NEI) rispetto alla settimana 2;
    • Variazione dal basale del TFBUT rispetto alla settimana 2;
    • Numero di pazienti che hanno presentato un peggioramento nel punteggio SANDE e/o nel punteggio NEI = > 50% secondo la valutazione della settimana 2;
    • Variazione dal basale del test di Schirmer II (con anestesia topica) rispetto alla settimana 4;
    • Variazione dal basale del BCDVA.
    Endpoint di sicurezza
    • Incidenza e frequenza degli eventi avversi (AE) e degli eventi avversi correlati al trattamento (Treatment-Emergent Adverse Event, TEAE), valutate nel corso dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, 8, 12, 16
    Settimana 4, 8, 12, 16
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 concerned4
    E.8.5The trial involves multiple Member States No
    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
    Italy
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days6
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 48
    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.
    For the purpose of this trial, the End of Study is defined as the date of the last visit of the last patient. The Investigator and the Sponsor have the right to discontinue the study at any time for reasonable medical and/or administrative reasons. As far as possible, this should occur after mutual consultation.
    Nessuno.
    Ai fini di questo studio, la Fine dello Studio è definita come la data dell'ultima visita dell'ultimo paziente. Lo sperimentatore e lo sponsor hanno il diritto di interrompere lo studio in qualsiasi momento per ragionevoli motivi medici e/o amministrativi. Per quanto possibile, ciò dovrebbe avvenire previa consultazione reciproca.
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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