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    Summary
    EudraCT Number:2020-003979-18
    Sponsor's Protocol Code Number:LT4030-301
    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:2021-05-20
    Trial results View 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 number2020-003979-18
    A.3Full title of the trial
    Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
    Valutazione dell’efficacia e della sicurezza delle gocce oculari T4030 versus Ganfort® UD in pazienti glaucomatosi o con ipertensione oculare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
    Valutazione dell’efficacia e della sicurezza delle gocce oculari T4030 versus Ganfort® UD in pazienti glaucomatosi o con ipertensione oculare
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberLT4030-301
    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 SponsorLABORATOIRES THEA
    B.1.3.4CountryFrance
    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 supportLABORATOIRES THEA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoires THEA
    B.5.2Functional name of contact pointResearch and Development Department
    B.5.3 Address:
    B.5.3.1Street Address12 rue Louis Blériot
    B.5.3.2Town/ cityClermont-Ferrand CEDEX 2
    B.5.3.3Post code63017
    B.5.3.4CountryFrance
    B.5.6E-mailSandrine.Guyon@theapharma.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 nameunpreserved fixed combination of bimatoprost 0.01% and timolol 0.1%
    D.3.2Product code [T4030]
    D.3.4Pharmaceutical form Eye gel
    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 INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeT4030
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOLO MALEATO
    D.3.9.1CAS number 26921-17-5
    D.3.9.2Current sponsor codeT4030
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ganfort® UD
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland EU/1/06/340/001
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namena
    D.3.2Product code [na]
    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 INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOLO
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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.IMP: 3
    D.1.2 and D.1.3IMP Role
    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 Fluoresceine Faure 0.5 %
    D.2.1.1.2Name of the Marketing Authorisation holderSERB SA, 325 754-4
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameFluoresceine Faure 0.5 %
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Eye drops, solution in single-dose container
    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 INNFLUORESCEINA SODICA
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary open-angle glaucoma or Ocular hypertension
    Glaucoma primario ad angolo aperto o ipertensione oculare
    E.1.1.1Medical condition in easily understood language
    over tension in the eye
    ipertensione dell’occhio
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of T4030 (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1%) with Ganfort UD (unpreserved fixed combination of bimatoprost 0.03% and timolol 0.5% eye drops) in terms of efficacy.
    Dimostrare la non inferiorità di T4030 (associazione a dose fissa senza conservanti di bimatoprost 0,01% e timololo 0,1%) con Ganfort UD (associazione a dose fissa senza conservanti di bimatoprost 0,03% e timololo 0,5% collirio) in termini di efficacia.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of T4030 versus Ganfort UD.
    Valutare l’efficacia e la sicurezza di T4030 rispetto a Ganfort UD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent signed and dated
    AT SCREENING (Visit #1):
    2. Patient aged =18 years old
    3. Both eyes with a central corneal thickness assessment =500 µm and =600 µm assessed within 6 months or during the Screening visit
    4. Both eyes with diagnosed ocular hypertension or open angle glaucoma (primary open-angle, pseudoexfoliative or pigmentary glaucoma) currently treated with a first-line monotherapy (PGA or beta-blocker), insufficiently controlled in the opinion of the investigator, and requiring a dual therapy (bitherapy)
    AT RANDOMISATION VISIT (Visit #2):
    5. IOP =22 mmHg in both eyes at 08:00
    6. IOP asymmetry between eyes =4 mmHg at 08:00
    7. IOP <36 mmHg in both eyes at all time points (08:00, 10:00, 16:00)
    8. Patient having respected the wash out period of at least 28 days
    1. Consenso informato firmato e datato
    ALLO SCREENING (Visita n. 1):
    2. Paziente di età =18 anni
    3. Entrambi gli occhi con una valutazione dello spessore corneale centrale = 500 µm e = 600 µm valutati entro 6 mesi o durante la visita di screening
    4. Entrambi gli occhi con diagnosi di ipertensione oculare o glaucoma ad angolo aperto (glaucoma primario ad angolo aperto, pseudoesfoliativo o pigmentario) attualmente trattati con una monoterapia di prima linea (PGA o betabloccante), controllato in modo inadeguato secondo il parere dello sperimentatore e che richiede una doppia terapia (biterapia)
    ALLA VISITA DI RANDOMIZZAZIONE (Visita n. 2):
    5. IOP = 22 mmHg in entrambi gli occhi alle 08:00
    6. Asimmetria della IOP tra gli occhi = 4 mmHg alle 08:00
    7. IOP <36 mmHg in entrambi gli occhi in tutti i punti temporali (08:00, 10:00, 16:00)
    8. Il paziente ha rispettato il periodo di washout di almeno 28 giorni
    E.4Principal exclusion criteria
    1. Ophthalmic Exclusion Criteria in AT LEAST ONE EYE
    Patient experiencing at Screening visit or having experienced:
    1.1 Inability to safely discontinue use of IOP-lowering ocular medication for the specified wash-out period according to the investigator’s judgement
    1.2 Visual field not available within previous 6 months and not performed at the Screening visit
    1.3 History of narrow angle and/or angle closure glaucoma
    1.4 Advanced stage of glaucoma
    2. Systemic/non Ophthalmic Exclusion Criteria
    Patient experiencing AT Screening or Randomisation visits:
    2.1 Uncontrolled diabetes
    2.2 Overt cardiac failure, cardiogenic shock
    2.3 Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
    2.4 Heart rate <50 bpm and/or systolic arterial blood pressure =90 mmHg
    2.5 Presence or history of reactive airway disease (e.g bronchial asthma or severe chronic obstructive pulmonary disease)
    2.6 Any other history of, or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigator’s judgement
    1. Criteri di esclusione oftalmici in ALMENO UN OCCHIO
    Pazienti che si sono sottoposti alla visita di screening o che hanno manifestato:
    1.1 Incapacità di interrompere in modo sicuro l’uso del farmaco oculare che riduce la IOP per il periodo di washout specificato secondo il giudizio dello sperimentatore
    1.2 Campo visivo non disponibile nei precedenti 6 mesi e non eseguito alla visita di screening
    1.3 Anamnesi di glaucoma ad angolo stretto e/o chiuso
    1.4 Stadio avanzato del glaucoma
    2. Criteri di esclusione sistemici/non oftalmici
    Paziente che alle visite di screening o di randomizzazione manifesta:
    2.1 Diabete non controllato
    2.2 Evidente insufficienza cardiaca, shock cardiogeno
    2.3 Bradicardia sinusale, sindrome del nodo del seno, blocco seno-atriale, blocco atrioventricolare di secondo o terzo grado non controllato con pacemaker
    2.4 Frequenza cardiaca <50 bpm e/o pressione sanguigna arteriosa sistolica = 90 mmHg
    2.5 Presenza o anamnesi di malattia reattiva delle vie aeree (ad es. asma bronchiale o broncopneumopatia cronica ostruttiva grave)
    2.6 Qualsiasi altra anamnesi o condizione sistemica pertinente in fase attiva che sia incompatibile con lo studio o che possa interferire con i risultati dello studio o la sicurezza del paziente secondo il giudizio dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    1. The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP at 08:00 in the study eye.
    1. L’endpoint primario di efficacia è la variazione rispetto al basale (Giorno 1) alla Settimana 12 della IOP alle ore 08:00 nell’occhio oggetto di studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Settimana 12
    E.5.2Secondary end point(s)
    1)Safety and tolerability endpoints:
    Frequency distribution and change from Baseline (Day 1) in each eye at week 6 and week 12:
    • for the conjunctival hyperaemia on McMonnies scale
    • for each ocular sign at slit lamp
    • for CFS on Oxford grading scale
    Frequency distribution of patients with clinically significant appearance and/or worsening of ocular symptom(s) throughout the day and/or upon instillation
    - Far Best-Corrected Visual Acuity (BCVA) expressed in LogMAR
    - Ocular tolerance assessed by the investigator
    - Ocular tolerance assessed by the patient
    - Ocular and systemic treatment-emergent adverse events (TEAE), serious TEAE, drug-related TEAE, TEAE leading to premature IMP discontinuation by System Organ Class (SOC) and Preferred Term (PT).
    - Cardiovascular parameters (heart rate and blood pressure)

    2)Patient questionnaire outcome:
    Scores at Week 6 and Week 12 as assessed by the patient in the quality of life questionnaires (TSS-IOP Questionnaire).

    3)efficacy endpoints:
    Change from Baseline (Day 1) to Week 12 in IOP at 10:00, 16:00 in the study eye
    Change from Baseline (Day 1) to Week 12 in mean diurnal IOP in the study eye
    Change from Baseline (Day 1) to Week 12 in IOP at three time points (08:00, 10:00, 16:00) in the contralateral eye
    Change from Baseline (Day 1) to Week 12 in mean diurnal IOP in the contralateral eye
    Change from Baseline to Week 6 in IOP at three time points (08:00; 10:00; 16:00) in the worse eye and in the contralateral eye
    Efficacy assessed by the investigator
    1) Endpoint di sicurezza e tollerabilità:
    Distribuzione della frequenza e variazione rispetto al basale (Giorno 1) in ciascun occhio alla Settimana 6 e alla Settimana 12:
    • per l'iperemia congiuntivale sulla scala McMonnies
    • per ciascun segno oculare con lampada a fessura
    • per CFS sulla scala di classificazione Oxford
    Distribuzione della frequenza dei pazienti con aspetto clinicamente significativo e/o peggioramento dei sintomi oculari per tutto il giorno e/o al momento dell’instillazione
    - Migliore acuità visiva corretta (BCVA) espressa in LogMAR
    - Tolleranza oculare valutata dallo sperimentatore
    - Tolleranza oculare valutata dal paziente
    - Eventi avversi emergenti dal trattamento (TEAE) oculari e sistemici, TEAE gravi, TEAE correlati al farmaco, TEAE che portano all’interruzione prematura dell’IMP in base alla classe sistemica organica (SOC) e al termine preferito (PT).
    - Parametri cardiovascolari (frequenza cardiaca e pressione sanguigna)
    2) Esito del questionario per il paziente:
    Punteggi alla Settimana 6 e alla Settimana 12 valutati dal paziente nei questionari per misurare la qualità della vita (Questionario TSS-IOP).

    3) Endpoint di efficacia:
    Variazione rispetto al basale (Giorno 1) alla Settimana 12 della IOP alle ore 10:00, 16:00 nell’occhio oggetto di studio
    Variazione rispetto al basale (Giorno 1) alla Settimana 12 della IOP media diurna nell’occhio oggetto di studio
    Variazione rispetto al basale (Giorno 1) alla Settimana 12 della IOP in tre punti temporali (08:00, 10:00, 16:00) nell’occhio controlaterale
    Variazione rispetto al basale (Giorno 1) alla Settimana 12 nella IOP media diurna nell’occhio controlaterale
    Variazione rispetto al basale alla Settimana 6 della IOP in tre punti temporali (08:00; 10:00; 16:00) nell’occhio peggiore e nell’occhio controlaterale
    Efficacia valutata dallo sperimentatore
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 6 and week 12
    Settimana 6 e settimana 12
    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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    India
    Russian Federation
    Ukraine
    Belgium
    Bulgaria
    France
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 500
    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 Decision2021-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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