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    Summary
    EudraCT Number:2023-000018-16
    Sponsor's Protocol Code Number:OZA22/IM047-048
    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:2023-01-25
    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 number2023-000018-16
    A.3Full title of the trial
    Effect of ozanimod on meningeal inflammation and glial activation in Multiple Sclerosis: one year phase 4 experimental study
    Effetto di ozanimod sull'infiammazione meningea e sull'attivazione gliale di pazienti con Sclerosi multipla: studio sperimentale di fase 4 di un anno
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of ozanimod on meningeal inflammation and glial activation in Multiple Sclerosis
    Effetto di ozanimod sull'infiammazione meningea e sull'attivazione gliale di pazienti con Sclerosi multipla
    A.3.2Name or abbreviated title of the trial where available
    Effect of ozanimod on meningeal inflammation and glial activation in Multiple Sclerosis
    Effetto di ozanimod sull'infiammazione meningea e sull'attivazione gliale di pazienti con SM
    A.4.1Sponsor's protocol code numberOZA22/IM047-048
    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 SponsorAZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Universitaria Integrata Verona
    B.5.2Functional name of contact pointUOC Neurologia B
    B.5.3 Address:
    B.5.3.1Street AddressPiazzale L.A. Scuro, 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37134
    B.5.3.4CountryItaly
    B.5.4Telephone number0458124678
    B.5.6E-mailsupporto.noprofit@aovr.veneto.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 Zeposia 0,92 mg capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameZeposia 0,92 mg capsule rigide
    D.3.2Product code [Ozanimod]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzanimod Cloridrato
    D.3.9.1CAS number 1306760-87-1
    D.3.9.2Current sponsor codeOzanimod
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number920
    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
    Relapsing Multiple Sclerosis (relapsing-remitting, relapsing-progressive)
    Sclerosi multipla recidivante (recidivante-remittente, recidivante-progressiva)
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    Sclerosi multipla recidivante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080700
    E.1.2Term Relapsing multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the project is to clarify the effect of ozanimod on compartmentalized inflammation by studying its effect on meningeal inflammation in CSF.
    L’obiettivo primario di questo studio è quello di chiarificare l’effetto di ozanimod sull’infiammazione compartimentalizzata studiando il suo effetto sull’infiammazione meningea nel liquido cerebrospinale (LCS).
    E.2.2Secondary objectives of the trial
    To clarify whether and how ozanimod treatment is able to reduce/halt meningeal inflammation
    as reflected by additional CSF and serum biomarkers and combined MRI parameters
    ¿ To clarify whether and how ozanimod treatment is able to reduce/halt microglial activation
    ¿ To clarify the effect of ozanimod treatment on neuronal damage
    ¿ To identify specific molecular, peripheral and intrathecal changes related to the ozanimod treatment
    ¿ To identify potential biomarkers of treatment response in terms of clinical and neuropsychological evolution over time
    ¿ To report the known and unknown adverse reactions to ozanimod
    ¿ To characterize the variation of lymphoid and myeloid cells within the CSF in reaction to ozanimod treatment using high-resolution single-cell gene expression analysis
    Gli obiettivi secondari sono:
    • Chiarificare se e come il trattamento con ozanimod sia in grado di ridurre o fermare l’infiammazione meningea misurata tramite biomarkers liquorali e sierici combinati a misure di RM addizionali
    • Verificare se e come il trattamento con ozanimod sia in grado di ridurre o fermare l’attivazione della microglia
    • Chiarificare l’effetto del trattamento con ozanimod sul danno neuronale
    • Identificare specifici cambiamenti molecolari periferici o intratecali in relazione ad ozanimod
    • Identificare potenziali biomarkers di risposta al trattamento in termini di evoluzione clinica e neuropsicologica nel tempo
    • Riportare le reazioni avverse ad ozanimod conosciute e sconosciute
    • Caratterizzare la variazione delle cellule linfoidi e mieloidi nel LCS in relazione ad ozanimod usando analisi ad alta risoluzione dell’espressione genica della singola cellula.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿ Age 18-65 years
    ¿ Relapsing MS (relapsing-remitting, relapsing-progressive) diagnosed according to 2017 revision
    of McDonald criteria
    ¿ Treatment with ozanimod started within 30-90 days before the enrollment
    ¿ Met 1 of the following disease activity criteria:
    1) at least one relapse within 12 months beforethe therapy initiation or
    2) as at least one relapse within 24 months and at least one gadolinium-enhancing lesion
    within 12 months before the therapy initiation
    ¿ EDSS score between 0 and 5 at the time of ozanimod initiation
    ¿ At least 2mL of CSF and 10 mL of blood acquired before the beginning of ozanimod treatment and stored at -80°C
    ¿ Availability of an MRI scan performed at least 90 days before the beginning of ozanimod including 3DT1,3D FLAIR/T2-weighted sequences and 3D Gradient Echo Planar Imaging
    Susceptibility weighted (Magnitude and Phase)
    ¿ Positive varicella zoster virus immunoglobulin G antibody status or varicella zoster virus vaccination at least 28 days before ozanimod initiation
    ¿ Pregnancy test negative and on effective contraceptive drugs.
    • Età 18-65 anni
    • Diagnosi di sclerosi multipla recidivante (recidivante-remittente, recidivante-progressiva) diagnosticata secondo la revisione del 2017 dei criteri diagnostici McDonald
    • Trattamento con ozanimod iniziato entro 30-90 giorni dall’arruolamento
    • Soddisfatto almeno 1 dei seguenti criteri di attività di malattia
    1) Almeno una recidiva negli ultimi 12 mesi prima dell’inizio della terapia o
    2) Almeno una recidiva negli ultimi 24 mesi ed almeno una lesione captante il gadolinio entro i 12 mesi dall’inizio della terapia
    • Punteggio EDSS compreso tra 0 e 5 al momento dell’inizio dell’ozanimod
    • Almeno 2 ml di liquido cerebrospinale e 10 ml di sangue prelevati prima dell’inizio del trattamento con ozanimod e conservati a -80°C
    • Disponibilità di una scansione MRI eseguita almeno 90 giorni prima dell’inizio di ozanimod, incluse sequenze pesate 3DT1, 3D FLAIR/T2 e ponderazione della suscettibilità dell’imaging planare 3D Gradient Echo (magnitudo e fase)
    • Stato anticorpale positivo per l’immunoglobulina G del virus della varicella zoster o vaccinazione contro il virus della varicella zoster almeno 28 giorni prima dell’inizio di ozanimod
    • Test di gravidanza negativo e assunzione di farmaci contraccettivi efficaci
    E.4Principal exclusion criteria
    ¿ Individuals with inactive primary or secondary progressive multiple sclerosis;
    ¿ Disease duration more than 15 years with an EDSS of 2.0 or less;
    ¿ History of relapse or systemic corticosteroid use from 30 days before therapy initiation
    ¿ Hypersensitivity to ozanimod or to any of the listed excipients
    ¿ Primary o secondary immunodeficiency syndrome or lymphocyte count not within normal limits due to any cause, ongoing immunosuppressive therapy (including chronic use of
    steroid)
    ¿ Resting heart rate less than 55 beats per min (bpm) at screening; patients who in the last 6 months experienced myocardial infarction (MI), unstable angina, stroke, transient ischaemic
    attack (TIA), decompensated heart failure requiring hospitalisation or New York Heart Association (NYHA) Class III/IV heart failure, patients with history or presence of second-degree
    atrioventricular (AV) block Type II or third- degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker
    ¿ Primary or secondary immunodeficiency syndrome, lymphocyte count not within normal limits due to any cause
    ¿ Ongoing immunosuppressive therapy (including chronic use of steroid)
    ¿ Platelet count < 100.000/mcL; Hemoglobin < 8.5 g/dL; Leukocytes < 3500/mcL; Neutrophils <1500/mcL
    ¿ Active acute infections or chronic infections (including HBV, HCV, HIV, TBC)
    ¿ Active malignancies or history of malignancies
    ¿ Severe hepatic impairment (Child-Pugh class C)
    ¿ Pregnancy or breastfeeding.
    ¿ Fertile women who do not use effective methods of contraception.
    ¿ Received a live vaccine within 4 weeks prior to ozanimod administration or intends to receive a live vaccination during the trial
    • Pazienti con sclerosi multipla secondaria progressiva o secondaria inattiiva;
    • Durata della malattia superiore a 15 anni con EDSS di 2 o inferiore
    • Storia di recente attacco demielinizzante o uso sistemico di corticosteroidi da 30 giorni prima dall’inizio della terapia
    • Ipersensibilità ad ozanimod ad uno dei qualsiasi eccipienti elencati nella scheda tecnica
    • Sindrome da immunodeficienza primaria o secondaria o conta dei linfociti non entro i limiti normali a causa di qualsiasi causa, terapia immunosoppressiva in corso (incluso l’uso cronico di steroidi)
    • Frequenza cardiaca a riposo inferiore a 55 battiti al minuto (bpm) allo screening; pazienti che negli ultimi 6 mesi hanno manifestato infarto del miocardio (IM), angina instabile, ictus, attacco ischemico transitorio (TIA), scompenso cardiaco scompensato che ha richiesto il ricovero o scompenso cardiaco di classe III/IV della New York Heart Association (NYHA), pazienti con anamnesi o presenza di blocco atrioventricolare (AV) di secondo grado Tipo II o blocco AV di terzo grado o sindrome del seno malato a meno che il paziente non abbia un pacemaker funzionante
    • Sindrome da immunodeficienza primaria o secondaria, conta dei linfociti fuori dai limiti normali per qualsiasi causa
    • Terapia immunosoppressiva in corso (compreso l’uso cronico di steroidi)
    • Conta piastrinica < 100.000/mcL; Emoglobina < 8,5 g/dL; Leucociti < 3500/mcL; Neutrofili <1500/mcL
    • Infezioni acute attive o infezioni croniche (compresi HBV, HCV, HIV, TBC)
    • Tumori maligni attivi o anamnesi di tumori maligni
    • Compromissione epatica grave (Child-Pugh classe C)
    • Gravidanza o allattamento
    • Donne fertili che non usano metodi contraccettivi efficaci.
    • Ha ricevuto un vaccino vivo entro 4 settimane prima della somministrazione di ozanimod o intende ricevere una vaccinazione viva durante la sperimentazione
    E.5 End points
    E.5.1Primary end point(s)
    CSF (and serum) concentration of CXCL13 protein (ng/ml/mgPro) measured before starting ozanimod treatment (Prebaseline) and at T12.
    Concentrazione di CSF (e siero) della proteina CXCL13 (ng/ml/mgPro) misurata prima di iniziare il trattamento con ozanimod (Prebaseline) e a T12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Prebaseline and T12
    Prebaseline e T12
    E.5.2Secondary end point(s)
    CSF (and serum) concentration of specific markers of activated meningeal inflammation (CXCL12, TNF-a, IFN-¿) (ng/ml/mgPro) measured before starting ozanimod treatment (Prebaseline) and at T12.; CSF (and serum) concentration of specific makers of activated microglia/macrophages (Chitinase 3-like1, Osteopontin, sCD163, CX3CL1) (ng/ml/mgPro) measured before starting ozanimod treatment (Prebaseline) and at T12.; Variation global and regional cortical thickness change before starting ozanimod treatment (¿prebaseline-T0) and after 1 year of ozanimod treatment (¿ T0-T12); Significant linear relationship between the variation of the above-mentioned cytokines (¿ T0-T12) and the EDSS change (¿ T0-T12) or the relapse number by the end of the follow-up (T12); To identify a combination of multimodal parameters (CSF, MRI, clinical) at baseline able to identify treatment-responders vs non-responders as assessed by NEDA-3 at the end of follow-up and by the appearance of new cortical lesions or paramagnetic rim positive lesions or SELs expansion.; Known adverse reactions to ozanimod (including upper and lower respiratory tract infections, viral infections, progressive multifocal leukoencephalopathy, lymphopenia, hypersensitivity reactions, headache, macular oedema, bradycardia, blood pressure alterations, peripheral oedema, LFT - liver function tests- alterations, respiratory function test alterations) and unknown adverse reactions to ozanimod report.; Qualitative differences of lymphoid and myeloid cells populations in CSF taken before starting ozanimod treatment (¿ prebaseline-T0) and after one year of ozanimod treatment (T12); CSF (and serum) concentration of specific markers of neuronal/axonal damage (neurofilamentlight chains, parvalbumin) (ng/ml/mgPro) measured before starting ozanimod treatment (Prebaseline) and at T12.; Number and volume of cortical lesions measured before starting ozanimod treatment (Prebaseline) and at T12.; Number and susceptibility of of paramagnetic rim lesions measured before starting ozanimod treatment (Prebaseline), at baseline (T0) and after 1 year of ozanimod treatment (T12).; Variation of the volume of white matter lesions before starting ozanimod treatment (¿ prebaseline-T0) and after 1 year of ozanimod treatment (¿ T0-T12)
    Concentrazione nel liquido cerebrospinale (e sierico) di marcatori specifici di infiammazione meningea attivata (CXCL12, TNF-a, IFN-¿) (ng/ml/mgPro) misurata prima dell'inizio del trattamento con ozanimod (Prebaseline) e al T12.; Concentrazione nel liquido cerebrospinale (e nel siero) di specifici produttori di microglia/macrofagi attivati ¿¿(Chitinase 3-like1, Osteopontin, sCD163, CX3CL1) (ng/ml/mgPro) misurata prima dell'inizio del trattamento con ozanimod (Prebaseline) e al T12.; Variazione del cambiamento dello spessore corticale globale e regionale prima dell'inizio del trattamento con ozanimod (¿ prebasale-T0) e dopo 1 anno di trattamento con ozanimod (¿ T0-T12); Significativa relazione lineare tra la variazione delle suddette citochine (¿ T0-T12) e la variazione dell'EDSS (¿ T0-T12) o il numero di ricadute alla fine del follow-up (T12); Predittori clinici, CSF, MRI prima del basale di 1) responder al trattamento vs non-responder alla fine del follow-up; 2) NEDA-3 alla fine del follow-up; Reazioni avverse note a ozanimod (incluse infezioni del tratto respiratorio superiore e inferiore, infezioni virali, leucoencefalopatia multifocale progressiva, linfopenia, reazioni di ipersensibilità, mal di testa, edema maculare, bradicardia, alterazioni della pressione arteriosa, edema periferico, LFT - test di funzionalità epatica - alterazioni, alterazioni dei test di funzionalità respiratoria) e reazioni avverse sconosciute a ozanimod report; Differenze qualitative delle popolazioni di cellule linfoidi e mieloidi nel CSF prelevate prima di iniziare il trattamento con ozanimod (¿ prebasale-T0) e dopo un anno di trattamento con ozanimod (T12); Concentrazione nel liquido cerebrospinale (e sierico) di marcatori specifici di danno neuronale/assonale (neurofilamenti a catene leggere, parvalbumina) (ng/ml/mgPro) misurata prima dell'inizio del trattamento con ozanimod (Prebaseline) e a T12.; Numero e volume delle lesioni corticali misurate prima dell'inizio del trattamento con ozanimod (Prebaseline) ea T12.; Numero e suscettibilità delle lesioni del bordo paramagnetico misurate prima di iniziare il trattamento con ozanimod (Prebaseline), al basale (T0) e dopo 1 anno di trattamento con ozanimod (T12).; Variazione del volume delle lesioni della sostanza bianca prima di iniziare il trattamento con ozanimod (¿ prebasale-T0) e dopo 1 anno di trattamento con ozanimod (¿ T0-T12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Prebaseline and T12; Prebaseline and T12; (¿prebaseline-T0) and after 1 year of ozanimod treatment (¿ T0-T12); ¿ T0-T12; at baseline and at the end of follow-up; at every timepoint; (¿ prebasale-T0) and T12; Prebaseline and T12; Prebaseline and T12.; Prebaseline, at baseline (T0) and after 1 year of ozanimod treatment (T12); (¿ prebaseline-T0) and after 1 year of ozanimod treatment (¿ T0-T12)
    Prebaseline e T12; Prebaseline e T12; (¿ prebasale-T0) e dopo 1 anno di trattamento con ozanimod (¿ T0-T12); ¿ T0-T12; al basale e fine follow-up; ad ogni timepoint; (¿ prebasale-T0) e T12; Prebaseline e T12; Prebaseline e T12.; Prebaseline, al basale (T0) e dopo 1 anno di trattamento con ozanimod (T12); (¿ prebasale-T0) e dopo 1 anno di trattamento con ozanimod (¿ T0-T12)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 50
    F.1.3Elderly (>=65 years) No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    best practice
    best practice
    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 Decision2023-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-19
    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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