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    Summary
    EudraCT Number:2019-000747-27
    Sponsor's Protocol Code Number:049/SI
    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:2020-10-07
    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 number2019-000747-27
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to evaluate the Safety and Efficacy of Pro-ocular™ 0.5% and 1% in Patients with Dry Eye Syndrome
    Studio di fase II multicentrico, randomizzato, in doppio mascheramento, controllato con placebo per valutare la sicurezza e l’efficacia di Pro-ocular™ 0,5% e 1% in pazienti con sindrome dell’occhio secco
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the Safety and Efficacy of Pro-ocular™ topical gel in two different concentration, 0.5% and 1%, when administered in the forehead twice a day for 12 weeks in Patients diagnosed with Dry Eye Syndrome.
    Studio clinico per valutare la sicurezza e l'efficacia del gel topico Pro-ocular™ in due diverse concentrazioni, 0.5% e 1%, applicato sulla fronte due volte al giorno per 12 settimane su pazienti affetti da sindrome dell'occhio secco
    A.3.2Name or abbreviated title of the trial where available
    ProGIFT
    ProGIFT
    A.4.1Sponsor's protocol code number049/SI
    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 SponsorSOCIETÀ INDUSTRIA FARMACEUTICA ITALIANA (SIFI) SPA
    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 supportSOCIETA' INDUSTRIA FARMACEUTICA ITALIANA (SIFI) s.p.a
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOCIETA' INDUSTRIA FARMACEUTICA ITALIANA (SIFI) s.p.a
    B.5.2Functional name of contact pointANNA RITA BLANCO
    B.5.3 Address:
    B.5.3.1Street AddressVia Ercole Patti 36
    B.5.3.2Town/ cityAci Sant'Antonio
    B.5.3.3Post code95025
    B.5.3.4CountryItaly
    B.5.4Telephone number0957922201
    B.5.5Fax number0957922201
    B.5.6E-mailrita.blanco@sifigroup.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 namePro-ocular
    D.3.2Product code [Pro-ocular]
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 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 namePro-ocular
    D.3.2Product code [Pro-ocular]
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dry Eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which tear film instability, hyperosmolarity, ocular surface inflammation and damage, neurosensory abnormalities play an etiological role. Patient-reported symptoms for DE include dryness, grittiness, itching, redness, fluctuating visual disturbances and ocular fatigue.
    L'occhio secco è una malattia multifattoriale della superficie oculare dovuta alla perdita di omeostasi del film lacrimale, in cui la sua instabilità e l'iperosmolarità, infiammazione, danneggiamento della superficie oculare e anormalità neurosensorie giocano un ruolo eziologico. I sintomi riportati dai pazienti contano secchezza oculare, sensazione di corpo estraneo, arrossamento, disturbi della vista ed affaticamento.
    E.1.1.1Medical condition in easily understood language
    Dry Eye syndrome is characterized by tear film's alterations. Patient-reported symptoms for DE include dryness, grittiness, itching, redness, fluctuating visual disturbances and ocular fatigue.
    La sindrome dell'occhio secco è dovuta ad alterazioni del film lacrimale. I sintomi riportati sono secchezza oculare, sensazione di corpo estraneo, arrossamento, disturbi della vista ed affaticamento.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10013777
    E.1.2Term Dry eye syndrome
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients with moderate to severe dry eye syndrome.
    L'obiettivo principale di questo studio è quello di valutare l'efficacia del gel topico a base di progesterone (0.5% e 1%) confrontato con placebo, applicato due volte al giorno per 3 mesi (12 settimane) su pazienti con sindrome dell'occhio secco da moderata a severa.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to further evaluate the efficacy of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome. The secondary objectives also include the safety of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.
    Gli obiettivi secondari di questo studio sono quelli di valutare ulteriormente l'efficacia del gel topico a base di progesterone (0.5% e 1%) confrontato con placebo, applicato due volte al giorno per 3 mesi (12 settimane) su pazienti con sindrome dell'occhio secco da moderata a severa. Gli obiettivi secondari di questo studio includono la sicurezza del gel topico a base di progesterone (0.5% e 1%) confrontato con placebo, applicato due volte al giorno per 3 mesi (12 settimane) su pazienti con sindrome dell'occhio secco da moderata a severa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients (male or female) must be >= 18 years of age
    - Able and willing to provide voluntary written Informed Consent prior to any study related procedure
    - Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0)
    - Have all the following in the same eye at Visit 0: Fluorescein staining (Cornea) on NEI (National Eye Institute) grading scale > 3; Average Tear Film Break up Time =< 5 seconds; Schirmer Test (without anesthesia) >= 1 and < 10mm
    - Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.
    - Pazienti (maschi e femmine) con età maggiore o uguale a 18 anni
    - In grado di provvedere un Consenso Informato volontario firmato prima di qualsiasi procedura di studio
    - Pazienti con diagnosi di occhio secco di qualsiasi entità da almeno 3 mesi prima della visita di screening (V0)
    - Pazienti con tutte e quattro le seguenti caratteristiche alla visita di screening (V0): Fluorescein staining (Cornea) on NEI (National Eye Institute) maggiore di 3; tempo medio di rottura del film lacrimale inferiore o uguale a 5 secondi; risultato del test di Schirmer (senza anestesia) maggiore o uguale a 1 e inferiore a 10 millimetri
    - In grado di seguire le istruzioni dello studio, inclusa la partecipazione a tutte le procedure di studio e alle visite, secondo l'opinione dell'Investigatore.
    E.4Principal exclusion criteria
    - Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessment, such as such as glaucoma, active neuronal trigeminal disease, neuralgia
    - Best corrected visual acuity (BCVA) baseline <20/200
    - Condition or history other than ocular that, in the opinion of the investigator, may interfere significantly with the patient's participation in the study, such as dementia, psychosis, Parkinson’s disease (interference)
    - Patient using a contact ocular lens within 7 days prior to administration of the first dose and not willing to cease using them during all study duration
    - Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit
    - Females who are of childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable non-hormonal contraceptive precautions can be included
    - Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study
    - A known adverse reaction and/or sensitivity to the study drug or its components
    - Use of topical ocular cyclosporine, corticosteroids or any other topical anti-inflammatory treatments within 15 days prior to Visit 0 and during all study duration
    - Routine use (more than twice a week) of a chlorinated swimming pool during the study period
    - Unwilling or unable to cease using during the study period the forbidden medications: any topical ocular ointments or gels; topical and systemic glaucoma therapies; systemic drugs with anticholinergic activity: anticonvulsants, antihistamines, antipsychotics, antidepressants, antimuscarinics, anti-Parkinson agents, cardiovascular agents (disopyramide), gastrointestinal agents, muscle relaxants, respiratory medications (pseudoephedrine, theophylline); lipidic artificial tears and artificial tears with preservative
    - Unwilling to cease the use of sunscreen on the forehead or eye area during the study period
    - Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day
    - Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.
    - Comorbilità con altre condizioni oculari gravi o croniche che, a giudizio dello sperimentatore, interferiranno con la valutazione dello studio, come ad esempio glaucoma, malattia del trigemino neuronale attiva, nevralgia
    - Migliore acuità visiva corretta (BCVA) basale <20/200
    - Condizione o storia diversa da quella oculare che, secondo il parere dello sperimentatore, può interferire in modo significativo con la partecipazione del paziente allo studio, come demenza, psicosi, morbo di Parkinson (interferenza)
    - Paziente che usa lenti a contatto nei 7 giorni precedenti la somministrazione della prima dose e non vuole smettere di usarle durante tutta la durata dello studio
    - Pazienti di sesso femminile incinte, che allattano al seno o che stanno pianificando una gravidanza o allattamento alla Visita di screening
    - Donne potenzialmente fertili e che non prendono adeguate precauzioni contraccettive sono escluse dalla sperimentazione. Possono essere incluse le donne in età fertile che assumono precauzioni contraccettive non ormonali accettabili
    - Uomini con partner in gravidanza o in allattamento o in età fertile che non sono disposti a usare il preservativo per tutta la durata dello studio
    - Reazione avversa nota e/o sensibilità al farmaco in studio o ai suoi componenti
    - Uso di ciclosporina topica oculare, corticosteroidi o qualsiasi altro trattamento antinfiammatorio topico entro 15 giorni prima della Visita 0 e durante tutta la durata dello studio
    - Uso di routine (più di due volte a settimana) di una piscina contenente cloro durante l'intera durata dello studio
    - Paziente non disposto o impossibilitato a interrompere l’uso durante il periodo di studio dei farmaci vietati: qualsiasi pomata o gel oculare topico; terapie per il glaucoma topico e sistemico; farmaci sistemici con attività anticolinergica: anticonvulsivanti, antistaminici, antipsicotici, antidepressivi, antimuscarinici, agenti anti-Parkinson, agenti cardiovascolari (disopiramide), agenti gastrointestinali, rilassanti muscolari, farmaci respiratori (pseudoefedrina, teofillina); lacrime artificiali lipidiche e lacrime artificiali con conservante
    - Paziente non disposto a interrompere l’uso della protezione solare sulla fronte o sulla zona degli occhi per la durata dello studio
    - Fumatore abituale di sigaretta (tabacco, sigaretta elettronica, marijuana), più di 4 sigarette al giorno
    - Partecipazione a un altro studio clinico contemporaneamente al presente e nei 30 giorni precedenti alla Visita 0
    E.5 End points
    E.5.1Primary end point(s)
    - Mean change from baseline (Visit 1 pre-dose) in fluorescein corneal staining assessed by NEI scale at Week 12 (Day 84)
    - Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 12 (Day 84)
    - Variazione media rispetto al basale (visita 1 pre-dose) nella colorazione corneale con fluoresceina valutata con scala NEI alla settimana 12 (giorno 84)
    - Variazione media rispetto al basale (visita 1 pre-dose) in termini di frequenza e intensità della sensazione di secchezza/irritazione del paziente valutata mediante questionario SANDE alla settimana 12 (giorno 84)
    E.5.1.1Timepoint(s) of evaluation of this end point
    84 days
    84 giorni
    E.5.2Secondary end point(s)
    - Mean change from baseline (Visit 1 pre-dose) in corneal staining assessed by NEI scale at Week 12 (Day 84).; Mean change from baseline (Visit 1 pre-dose) in TearScan grading at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 0 Screening) in Schirmer Test at Week 4 (Day 28) and at Week 12 (Day 84).; Mean change from baseline (Visit 1 pre-dose) in Visual Analogue Scale 7 symptoms items to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Impact of dry eye on quality of life by using Dry Eye-Related Quality-of-Life questionnaire (DEQS).; Absolute score of each symptom item in Visual Analogue Scale to each post baseline visit.; Mean change from baseline (Visit 1 pre-dose) in Corneal Sensitivity to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 0 Screening) in Slit Lamp Examination to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 1 pre-dose) in Non-Invasive Keratograph Tear Film Break Up Time (NIKBUT) at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 2, 4, 8 (Day 14, 28, 56) as intermediate study visits.; Mean change from baseline (Visit 1 pre-dose) in Fluorescein Tear Film Break UP (TBUT) at Week 12 (Day 84).; Mean change from baseline (Visit 1 pre-dose) in Tear Meniscus Height (TMH) at each applicable post baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 2, 4, 8 (Day 14, 28, 56) as intermediate study visits.; Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 2, 4, 8, 16 (Day 14, 28, 56, 114) as intermediate study visits.; Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 12 (Day 84).; Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 12 (Day 84) (with LOCF imputation).; Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 12 (Day 84).
    - Variazione media rispetto al basale (Visita 1 pre-dose) nella colorazione corneale valutata mediante scala NEI alla settimana 12 (Giorno 84).; Variazione media rispetto al basale (visita 1 pre-dose) nella valutazione tramite Tear Scan ad ogni visita post-basale applicabile [settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84)].; Variazione media rispetto al basale (Visita 0 Screening) nel test di Schirmer alla settimana 4 (giorno 28) e alla settimana 12 (giorno 84).; Variazione media rispetto al basale (Visita 1 pre-dose) dei 7 sintomi tramite scala VAS (Visual Analogue Scale) a ciascuna visita post-basale applicabile [settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84)].; Impatto dell’occhio secco sulla qualità della vita utilizzando il questionario DEQS (Dry Eye-Related Quality-of-Life); Valore assoluto di ogni sintomo nella scala VAS (Visual Analogue Scale) ad ogni visita post-basale.; Variazione media rispetto al basale (visita 1 pre-dose) nella sensibilità corneale a ciascuna visita post-basale applicabile [settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84)].; Variazione media rispetto al basale (Visita 0 Screening) nell’esame alla lampada a fessura a ciascuna visita post-basale applicabile [settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84)].; Variazione media rispetto al basale (visita 1 pre-dose) del tempo di rottura del film lacrimale con cheratografia non invasiva (NIKBUT) ad ogni visita post-basale applicabile [settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84)].; Variazione media rispetto al basale (visita 1 pre-dose) nella colorazione congiuntivale con fluoresceina valutata con scala NEI alla settimana 2, 4, 8 (giorno 14, 28, 56) come visite di studio intermedie.; Variazione media rispetto al basale (visita 1 pre-dose) del tempo di rottura del film lacrimale con fluoresceina (TBUT) alla settimana 12 (giorno 84).; Variazione media rispetto al basale (visita 1 pre-dose) nell’altezza del menisco lacrimale (TMH) ad ogni visita post-basale applicabile [settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84)].; Variazione media rispetto al basale (Visita 1 pre-dose) nella colorazione corneale con fluoresceina valutata con scala NEI alla settimana 2, 4, 8 (giorno 14, 28, 56) come visite di studio intermedie.; Variazione media rispetto al basale (Visita 1 pre-dose) nella somma in termini di frequenza ed intensità della sensazione di secchezza/irritazione del paziente valutata mediante questionario SANDE alla settimana 2, 4, 8, 16 (giorno 14, 28, 56, 114) come visite di studio intermedie.; Variazione media rispetto al basale (Visita 1 pre-dose) nella somma in termini di frequenza ed intensità della sensazione di secchezza/irritazione del paziente valutata mediante questionario SANDE alla settimana 12 (giorno 84).; Variazione media rispetto al basale (Visita 1 pre-dose) nella colorazione congiuntivale con fluoresceina valutata con scala NEI alla settimana 12 (giorno 84) (con imputazione LOCF).; Variazione media rispetto al basale (Visita 1 pre-dose) nella colorazione congiuntivale con fluoresceina valutata con scala NEI alla settimana 12 (giorno 84).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 84; Week 2, 4, 8, 12 (Day 14, 28, 56, 84).; Week 4 (Day 28) and Week 12 (Day 84).; Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; N/A; Week 2, 4, 8, 12 (Day 14, 28, 56, 84).; Week 2, 4, 8, 12 (Day 14, 28, 56, 84).; Week 2, 4, 8, 12 (Day 14, 28, 56, 84).; Week 2, 4, 8, 12 (Day 14, 28, 56, 84); Week 2, 4, 8 (Day 14, 28, 56); Week 12 (Day 84).; Week 2, 4, 8, 12 (Day 14, 28, 56, 84); Week 2, 4, 8 (Day 14, 28, 56); Week 2, 4, 8, 16 (Day 14, 28, 56, 114); Day 84; Day 84; Day 84
    Giorno 84; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84).; Settimana 4 (giorno 28) e settimana 12 (giorno 84).; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84).; N/A; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84).; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84).; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84).; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84); Settimana 2, 4, 8 (giorno 14, 28, 56); Settimana 12 (giorno 84).; Settimana 2, 4, 8, 12 (giorno 14, 28, 56, 84); Settimana 2, 4, 8 (Giorno 14, 28, 56); Settimana 2, 4, 8, 16 (giorno 14, 28, 56, 114); Giorno 84; Giorno 84; Giorno 84
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 months7
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days7
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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)
    No treatment nor cure is provided after the subject has completed his/her study participation. The medical care is provided as standard medical practice.
    Non è fornito alcun trattamento o cura dopo che il soggetto ha concluso la sua partecipazione allo studio. La cura viene garantita da normale pratica clinica.
    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 Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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