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    Summary
    EudraCT Number:2019-000465-20
    Sponsor's Protocol Code Number:NN7769-4513
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-000465-20
    A.3Full title of the trial
    Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without factor VIII inhibitors
    Seguridad, tolerabilidad, farmacocinética y farmacodinámica de dosis subcutáneas únicas y múltiples de NNC0365-3769 (Mim8) en pacientes sanos y en pacientes con hemofilia A con o sin inhibidores del factor VIII.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study of how a new medicine NNC0365-3769 (Mim8) works in the body of healthy people and patients with bleeding disorder
    Estudio de investigación para evaluar el fármaco NNC0365-3769 (Mim8) en sujetos sanos y sujetos con desorden en la coagulación
    A.3.2Name or abbreviated title of the trial where available
    FRONTIER1
    FRONTIER 1
    A.4.1Sponsor's protocol code numberNN7769-4513
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1227-4220
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 nameNNC0365-3769 A 10 mg/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number *MASKED*
    D.3.9.2Current sponsor codeNNC0365-3769
    D.3.9.3Other descriptive nameNNC0365-3769
    D.3.9.4EV Substance CodeSUB198393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 nameNNC0365-3769 A 100 mg/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number *MASKED*
    D.3.9.2Current sponsor codeNNC0365-3769
    D.3.9.3Other descriptive nameNNC0365-3769
    D.3.9.4EV Substance CodeSUB198393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (Haemophilia A with or without inhibitors)
    Haemophilia A
    Haemophilia A with inhibitors
    Voluntarios sanos (Hemofilia A con o sin inhibidores)
    Hemofilia A
    Hemofilia A con inhibidores
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    Bleeding disorder inherited deficiency in clotting factor VIII
    Bleeding disorder inherited deficiency in clotting F VIII with antibodies to clotting factor replacement therapy
    Voluntarios sanos
    Trastorno hemorrágico hereditario en F VIII coagulación
    Trastorno hemorrágico hereditario en F VIII coagulación con anticuerpos para terapia de reposición del F de coagulación
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018938
    E.1.2Term Haemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of subcutaneous Mim8 in healthy subjects and in subjects with severe haemophilia A with or without FVIII inhibitors
    Investigar la seguridad y la tolerabilidad de Mim8 subcutáneo en sujetos sanos y en sujetos con hemofilia A grave con o sin inhibidores del FVIII
    E.2.2Secondary objectives of the trial
    1. To investigate the pharmacokinetics of subcutaneous Mim8 in healthy subjects and in subjects with severe haemophilia A with or without FVIII inhibitors
    2. To investigate the pharmacodynamics of subcutaneous Mim8 in healthy subjects and in subjects with severe haemophilia A with or without FVIII inhibitors
    1.Investigar la farmacocinética de Mim8 subcutáneo en sujetos sanos y en sujetos con hemofilia A grave con o sin inhibidores del FVIII.
    2. Investigar la farmacodinámica de Mim8 subcutáneo en sujetos sanos y en sujetos con hemofilia A grave con o sin inhibidores del FVIII
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Single ascending dose (SAD) part:
    - Male, aged 18−45 years (both inclusive) at the time of signing informed consent
    - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

    Multiple ascending dose (MAD) part:
    - Male, aged 12−64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
    - Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records

    Exploratory biomarker cohort:
    - Male, aged ≥12 years at the time of signing informed consent (Germany and Japan have local requirements)
    - Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records
    Parte de DUA (Dosis única ascendente):
    • Varón de 18-45 años (ambos inclusive) en el momento de firmar el documento de consentimiento informado
    • Sujeto considerado sano en general de acuerdo con los antecedentes médicos, la exploración física y los resultados de las constantes vitales, el electrocardiograma y los análisis clínicos realizados durante la visita de selección, según el criterio del investigador.

    Parte de DMA (Dosis múltiple ascendente):
    • Varón de 12-64 años (ambos inclusive) en el momento de firmar el documento de consentimiento informado (Alemania y Japón tienen sus requerimientos locales)
    • Diagnóstico de hemofilia A congénita con una actividad del factor VIII menor del 1 %, según la historia clínica

    Cohorte de biomarcadores exploratorios:
    • Varones de 12 años o más en el momento de firmar el documento de consentimiento informado (Alemania y Japón tienen sus requerimientos locales)
    • Diagnóstico de hemofilia A congénita con una actividad del factor VIII menor del 1 %, según la historia clínica
    E.4Principal exclusion criteria
    SAD part:
    - Factor VIII activity ≥150% at screening
    - Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
    - Any clinical signs or established diagnosis of venous or arterial thromboembolic disease

    MAD part:
    - Known congenital or acquired coagulation disorders other than haemophilia A
    - Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
    - Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
    - Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke)
    - Any autoimmune disease that may increase the risk of thrombosis
    - Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration
    - Ongoing or planned immune tolerance induction therapy

    Exploratory biomarker cohort:
    - Known congenital or acquired coagulation disorders other than haemophilia A
    - Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
    - Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
    - Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke)
    - Any autoimmune disease that may increase the risk of thrombosis
    - Ongoing or planned immune tolerance induction therapy
    Parte de DUA:
    • Actividad del factor VIII del 150 % o más en la selección
    • Aumento del riesgo de trombosis; p. ej., antecedentes conocidos de trombosis venosa profunda no provocada en familiares de primer grado
    • Cualquier signo clínico o diagnóstico establecido de enfermedad tromboembólica venosa o arterial

    Parte de DMA:
    • Trastornos congénitos o adquiridos conocidos de la coagulación distintos de la hemofilia A
    • Aumento del riesgo de trombosis; p. ej., antecedentes conocidos de trombosis venosa profunda no provocada en familiares de primer grado
    • Cualquier signo clínico o diagnóstico establecido de enfermedad tromboembólica venosa o arterial
    • Aterosclerosis avanzada (p. ej., antecedentes conocidos de cardiopatía o ictus isquémicos).
    • Cualquier enfermedad autoinmunitaria que pueda aumentar el riesgo de trombosis
    • Recepción de emicizumab o medicamentos con mecanismos de acción similares en el plazo de 5 semividas antes de la administración del producto del ensayo
    • Tratamiento de inducción de la tolerancia inmunitaria en curso o previsto

    Cohorte de biomarcadores exploratorios:
    • Trastornos congénitos o adquiridos conocidos de la coagulación distintos de la hemofilia A
    • Aumento del riesgo de trombosis; p. ej., antecedentes conocidos de trombosis venosa profunda no provocada en familiares de primer grado
    • Cualquier signo clínico o diagnóstico establecido de enfermedad tromboembólica venosa o arterial
    • Aterosclerosis avanzada (p. ej., antecedentes conocidos de cardiopatía o ictus isquémicos).
    • Cualquier enfermedad autoinmunitaria que pueda aumentar el riesgo de trombosis
    • Tratamiento de inducción de la tolerancia inmunitaria en curso o previsto
    E.5 End points
    E.5.1Primary end point(s)
    1. Single ascending dose (SAD) part: Number of treatment emergent adverse events
    2. Multiple ascending dose (MAD) part: Number of treatment emergent adverse events
    1.Parte de dosis única ascendente (DUA): Número de acontecimientos adversos de aparición durante el tratamiento
    2.Parte de dosis múltiple ascendente (DMA): Número de acontecimientos adversos de aparición durante el tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From time of dosing (Day 1) to Week 16
    2. From time of first dosing (Day 1) to Week 12
    1.Desde el momento de la administración (día 1) hasta la semana 16
    2.Desde el momento de la primera administración (día 1) hasta la semana 12
    E.5.2Secondary end point(s)
    SAD part:
    1. Number of injection site reactions
    2. Relative change in D-dimer
    3. Relative change in prothrombin fragment 1 and 2
    4. Relative change in fibrinogen
    5. Relative change in platelets
    6. Cmax, SD: the maximum concentration of Mim8 after a single dose
    7. AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose
    8. t1/2, SD: the terminal half-life of Mim8 after a single dose
    9. tmax, SD: the time to maximum concentration of Mim8 after a single dose
    10. Change in activated partial thromboplastin time
    MAD part (weekly and monthly dosing):
    11. Number of injection site reactions
    12. Occurrence of anti-Mim8 antibodies
    13. Relative change in D-dimer
    14. Relative change in prothrombin fragment 1 and 2
    15. Relative change in fibrinogen
    16. Relative change in platelets
    MAD part, PK session 2 (weekly dosing):
    17. Cmax, MD: the maximum concentration of Mim8 after multiple doses
    18. AUCτ, MD: the area under the Mim8 concentration-time curve in the dosing interval after multiple doses
    MAD part, PK session 2 (monthly dosing):
    19. Cmax, MD: the maximum concentration of Mim8 after multiple doses
    20. AUCτ, MD: the area under the Mim8 concentration-time curve in the dosing interval after multiple doses
    MAD part (weekly dosing):
    21. Mean of maximum thrombin generation (peak height)
    MAD part (monthly dosing):
    22. Mean of maximum thrombin generation (peak height)
    Parte DUA:
    1. Número de reacciones en el lugar de inyección
    2. Variación relativa del dímero D
    3. Variación relativa de los fragmentos 1 y 2 de la protrombina
    4. Variación relativa del fibrinógeno
    5. Variación relativa de las plaquetas
    6. Cmáx, DE: concentración máxima de Mim8 después de una dosis única
    7. ABC0-inf, DE: área bajo la curva de concentración-tiempo de Mim8 desde el momento 0 hasta el infinito después de una dosis única
    8. t1/2, DE: semivida terminal de Mim8 después de una dosis única
    9. tmáx, DE: tiempo hasta la concentración máxima de Mim8 después de una dosis única
    10. Variación del tiempo de la tromboplastina parcial activada
    Parte DMA (administración semanal y mensual):
    11. Número de reacciones en el lugar de inyección
    12. Presencia de anticuerpos anti-Mim8
    13. Variación relativa del dímero D
    14. Variación relativa de los fragmentos 1 y 2 de la protrombina
    15. Variación relativa del fibrinógeno
    16. Variación relativa de las plaquetas
    Parte DMA, sesión farmacocinética 2 (dosis semanal):
    17. Cmáx., DM: la concentración máxima de Mim8 después de varias dosis
    18. ABCτ, MD: área bajo la curva de concentración-tiempo de Mim8 en el intervalo de administración después de varias dosis
    Parte DMA, sesión farmacocinética 2 (dosis mensual):
    19. Cmáx., DM: la concentración máxima de Mim8 después de varias dosis
    20. ABCτ, MD: área bajo la curva de concentración-tiempo de Mim8 en el intervalo de administración después de varias dosis
    Parte DMA (dosis semanal):
    21. Media de la generación máxima de trombina (altura máxima)
    Parte DMA (dosis mensual):
    22. Media de la generación máxima de trombina (altura máxima)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From time of dosing (Day 1) to Week 16
    2-10. From baseline (Day 1) to Week 16
    11. From time of first dosing (Day 1) to Week 12
    12-16. From baseline (Day 1) to Week 12
    17-18. From Day 57 to Day 64
    19-20. From Day 57 to Day 85
    21. From Day 57 to Day 64
    22. From Day 57 to Day 85
    1. Desde el momento de la administración (día 1) hasta la semana 16
    2-10. Desde el momento basal (día 1) hasta la semana 16
    11. Desde el momento de la primera administración (día 1) hasta la semana 12
    12-16. Desde el momento basal (día 1) hasta la semana 12
    17-18. Del día 57 al día 64
    19-20. Del día 57 al día 85
    21. Del día 57 al día 64
    22. Del día 57 al día 85
    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 No
    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
    Tolerability and exploratory efficacy
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.7.1Other trial design description
    SAD part phase 1 placebo-controlled double-blind within cohorts - MAD part phase 2 open-label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    Japan
    Serbia
    South Africa
    Switzerland
    Turkey
    United Kingdom
    United States
    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
    UVUP
    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 months7
    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 months7
    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 Yes
    F.1.1Number of subjects for this age range: 6
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 82
    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
    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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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