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    Summary
    EudraCT Number:2020-000440-63
    Sponsor's Protocol Code Number:GR41984
    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:2021-01-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000440-63
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH MACULAR EDEMA SECONDARY TO BRANCH RETINAL VEIN OCCLUSION
    STUDIO DI FASE III, RANDOMIZZATO, MULTICENTRICO, A
    DOPPIO MASCHERAMENTO E CONTROLLATO CON PRINCIPIO
    ATTIVO, PER VALUTARE L’EFFICACIA E LA SICUREZZA DI FARICIMAB IN PAZIENTI CON EDEMA MACULARE SECONDARIO
    A OCCLUSIONE VENOSA DI BRANCA RETINICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Branch Retinal Vein Occlusion
    UNO STUDIO PER VALUTARE L’EFFICACIA E LA SICUREZZA DI FARICIMAB IN PAZIENTI CON EDEMA MACULARE SECONDARIO
    A OCCLUSIONE VENOSA DI BRANCA RETINICA
    A.3.2Name or abbreviated title of the trial where available
    BALATON
    BALATON
    A.4.1Sponsor's protocol code numberGR41984
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann La-Roche Ltd - Basel
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche LTD
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameFaricimab
    D.3.2Product code [RO6867461/F06]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfaricimab
    D.3.9.1CAS number 1607793-29-2
    D.3.9.2Current sponsor codeRO6867461
    D.3.9.3Other descriptive nameVA2, VEGF-Ang2 ophtha Humanized anti-VEGF-A anti-Ang-2 bispecific Antibody
    D.3.9.4EV Substance CodeSUB126170
    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 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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG EU/1/12/797/002
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameaflibercept
    D.3.2Product code [aflibercept]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAFLIBERCEPT
    D.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeRo 717-1571
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    Macular edema secondary to Branch Retinal Vein Occlusion
    Edema maculare secondario a occlusione venosa di branca retinica
    E.1.1.1Medical condition in easily understood language
    Macular edema is a leading cause of vision impairment in patients with branch retinal vein occlusion. It is caused by fluid accumulation in the macula due to a blockade in blood flow.
    edema maculare è una delle principali cause di compromissi della vista nei pz con occlusione venosa del ramo retinica, causato da accumulo liquidi nella macula a causa di blocco del flusso sanguigno.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10038907
    E.1.2Term Retinal vein occlusion
    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 evaluate the efficacy of faricimab 6 mg intravitreal (IVT) injections on best corrected visual acuity (BCVA) outcomes
    valutare l’efficacia di faricimab 6 mg per via
    intravitreale (IVT) Q4W rispetto ad aflibercept 2 mg IVT Q4W sulla base del seguente endpoint:
    ¿ variazione della BCVA alla Settimana 24 rispetto al basale.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of faricimab on additional BCVA outcomes
    • To evaluate the frequency of faricimab treatment administration
    • To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT)
    • To evaluate the ocular and systemic safety and tolerability of faricimab
    • To characterize the systemic pharmacokinetics of faricimab
    • To evaluate the immune response to faricimab
    -Valutare l'efficacia di faricimab su ulteriori esiti BCVA
    • Valutare la frequenza della somministrazione del trattamento con faricimab
    • Valutare l'efficacia di faricimab sulle misure di esito anatomico utilizzando la tomografia a coerenza ottica (OCT)
    • Valutare la sicurezza oculare e sistemica e la tollerabilità di faricimab
    • Caratterizzare la farmacocinetica sistemica di faricimab
    • Valutare la risposta immunitaria al faricimab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >= 18 years
    • Ability to comply with the study protocol
    • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
    • Foveal center–involved macular edema due to branch retinal vein occlusion (BRVO)
    • Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
    • Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
    Età> = 18 anni
    • Capacità di rispettare il protocollo di studio
    • Per le donne in età fertile: accordo per rimanere in astinenza o usare la contraccezione e accordo per astenersi dalla donazione di uova durante il periodo di trattamento e per 3 mesi dopo la dose finale del trattamento in studio
    • Edema maculare coinvolto nel centro della fovea a causa dell'occlusione della vena della retina (BRVO)
    • Acuità visiva (BCVA) più corretta corretta da 73 a 19 lettere, compreso (equivalente di Snellen approssimativo da 20/40 a 20/400) il giorno 1
    • Mezzi oculari sufficientemente chiari e dilatazione pupillare adeguata per consentire l'acquisizione di immagini retiniche di buona qualità per confermare la diagnosi
    E.4Principal exclusion criteria
    • Any major illness or major surgical procedure within 1 month before screening
    • Uncontrolled blood pressure
    • Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
    • Pregnant or breastfeeding, or intending to become pregnant during the study

    Ocular Exclusion Criteria for Study Eye
    ¿ History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
    ¿ Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye
    ¿ Macular laser (focal/grid) in the study eye at any time prior to Day 1
    ¿ Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
    ¿ Any prior or current treatment for macular edema; macular neovascularization, including DME and nAMD; and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
    ¿ Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
    ¿ Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

    Ocular Exclusion Criteria for Both Eyes
    • Prior IVT administration of faricimab in either eye
    • History of idiopathic or autoimmune-associated uveitis in either eye
    • Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
    Qualsiasi malattia grave o procedura chirurgica maggiore entro 1 mese prima dello screening
    • Pressione sanguigna incontrollata
    • Ictus (incidente vascolare cerebrale) o infarto del miocardio entro 6 mesi prima del Giorno 1
    • Gravidanza o allattamento, o intenzione di rimanere incinta durante lo studio

    Criteri di esclusione oculare per lo studio dell'occhio
    -Storia di precedenti episodi di edema maculare dovuto a RVO o edema maculare persistente dovuto a RVO diagnosticato più di 4 mesi prima dello screening
    -Qualsiasi condizione oculare attuale che, secondo l'opinione dello sperimentatore, sta attualmente causando o si prevede che possa contribuire alla perdita irreversibile della vista a causa di una causa diversa dall'edema maculare dovuto all'RVO nell'occhio dello studio
    -Laser maculare (focale / griglia) nell'occhio dello studio in qualsiasi momento prima del Giorno 1
    -Fotocoagulazione panretinale nell'occhio dello studio entro 3 mesi prima del primo giorno o anticipata entro 3 mesi dall'inizio dello studio il primo giorno
    -Qualsiasi trattamento precedente o attuale per l'edema maculare; neovascolarizzazione maculare, inclusi DME e nAMD; e anomalie dell'interfaccia vitreomaculare, incluso, ma non limitato a, il trattamento IVT con anti-VEGF, steroidi, attivatore del plasminogeno tissutale, ocriplasmina, C3F8, iniezione d'aria o perioculare
    -Qualsiasi intervento precedente con terapia fotodinamica con verteporfina, laser a diodi, termoterapia transpupillare o chirurgia vitreo-retinica inclusa la sheatotomia
    -Qualunque uso precedente di impianto steroideo incluso impianto intravitreale di desametasone (Ozurdex) e impianto intravitreale di fluocinolone acetonide (Iluvien)
    Criteri di esclusione oculari per l’occhio non in studio
    I pazienti che soddisferanno il seguente criterio di esclusione oculare per l’occhio non in studio alla visita di
    screening ed il Giorno 1 non potranno accedere allo studio:
    ¿ Mancata funzionalità dell’occhio non in studio, definita in base ad una delle due seguenti condizioni:
    – BCVA di 20/320 o peggiore
    – assenza fisica dell’occhio non in studio (paziente monocolo).
    Criteri di esclusione oculare per entrambi gli occhi
    • Prima somministrazione IVT di faricimab in entrambi gli occhi
    • Storia di uveite idiopatica o autoimmune in entrambi gli occhi
    • Infiammazione o infezione perioculare, oculare o intraoculare attiva (incluso il sospetto) in entrambi gli occhi il primo giorno
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in BCVA at Week 24
    1. Variazione rispetto al basale in BCVA alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline, Week 24
    1. Baseline, settimana 24
    E.5.2Secondary end point(s)
    1. Change from baseline in BCVA at specified timepoints
    2. Proportion of patients with an increase from baseline of >= 15 letters in BCVA at Week 24
    3. Proportion of patients with an increase from baseline of >= 15, >= 10, >= 5, or > 0 letters in BCVA at specified timepoints
    4. Proportion of patients avoiding a loss of >= 15, >= 10, >= 5, or > 0 letters in BCVA from baseline at specified timepoints
    5. Proportion of patients achieving >= 84 letters (20/20 Snellen equivalent) in BCVA at specified timepoints
    6. Proportion of patients with BCVA Snellen equivalent of 20/40 or better at specified timepoints
    7. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse at specified timepoints
    8. Change from baseline in CST at specified timepoints
    9. Change from baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) composite score at specified timepoints
    10. Proportion of patients on a Q4W, every 8 weeks (Q8W), every 12 weeks (Q12W), or Q16W treatment interval at Week 72
    11. Number of study drug injections received from Week 24 through Week 72
    12. Incidence and severity of ocular adverse events, with severity determined according to Adverse Event Severity Grading Scale
    13. Incidence and severity of non-ocular adverse events, with severity determined according to Adverse Event Severity Grading Scale
    14. Plasma concentration of faricimab over time
    15. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
    1. Modifica dalla linea di base in BCVA ai punti temporali specificati
    2. Proporzione di pazienti con un aumento dal basale di> = 15 lettere in BCVA alla settimana 24
    3. Proporzione di pazienti con un aumento dal basale di> = 15,> = 10,> = 5 o> 0 lettere in BCVA a punti temporali specifici
    4. Proporzione di pazienti che evitano una perdita di> = 15,> = 10,> = 5 o> 0 lettere in BCVA dal basale a punti temporali specifici
    5. Proporzione di pazienti che raggiungono> = 84 lettere (20/20 Snellen equivalenti) in BCVA a punti temporali specifici
    6. Proporzione di pazienti con BCVA Snellen equivalente di 20/40 o superiore a punti temporali specifici
    7. Proporzione di pazienti con BCVA Snellen equivalente di 20/200 o peggio a punti temporali specifici
    8. Modifica dalla linea di base in CST a punti temporali specificati
    9. Variazione rispetto al basale del punteggio composito del National Eye Institute (NEI VFQ-25) a 25 voci con punti temporali specifici
    10. Proporzione di pazienti con Q4W, ogni 8 settimane (Q8W), ogni 12 settimane (Q12W) o intervallo di trattamento Q16W alla settimana 72
    11. Numero di iniezioni di farmaci in studio ricevute dalla settimana 24 alla settimana 72
    12. Incidenza e gravità degli eventi avversi oculari, con gravità determinata in base alla Scala di classificazione della gravità degli eventi avversi
    13. Incidenza e gravità degli eventi avversi non oculari, con gravità determinata in base alla Scala di classificazione della gravità degli eventi avversi
    14. Concentrazione plasmatica di faricimab nel tempo
    15. Prevalenza di anticorpi anti-farmaco (ADA) al basale e incidenza di ADA durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-9. Part I: Baseline to Week 24, Part II: From Week 24 to Week 72
    10. At Week 72
    11. From Week 24 through Week 72
    12.-13. Up to Week 72
    14.-15. Day 1, Week 4, 24, 28, 52, 72
    1-9. Parte I: baseline alla settimana 24, parte II: dalla settimana 24 alla settimana 72
    10. Alla settimana 72
    11. Dalla settimana 24 alla settimana 72
    12.-13. Fino alla settimana 72
    14.-15. Giorno 1, settimana 4, 24, 28, 52, 72
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Biomarker
    Immunogenicità Biomarker
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Argentina
    Australia
    Brazil
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Singapore
    Taiwan
    United States
    Austria
    Czechia
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 520
    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
    na
    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 Decision2020-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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