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    Summary
    EudraCT Number:2019-003520-20
    Sponsor's Protocol Code Number:R668-BP-1902
    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:2022-10-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-003520-20
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid
    Estudio multicéntrico, aleatorizado, con doble enmascaramiento, controlado con placebo y con grupos paralelos para evaluar la eficacia y la seguridad de dupilumab en pacientes adultos con penfigoide ampolloso
    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 Dupilumab in Adult Patients with Bullous Pemphigoid
    Estudio para evaluar la eficacia y la seguridad de dupilumab en pacientes adultos con penfigoide ampolloso
    A.3.2Name or abbreviated title of the trial where available
    LIBERTY-BP ADEPT
    A.4.1Sponsor's protocol code numberR668-BP-1902
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 Yes
    D.2.1.1.1Trade name Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Research & Development
    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 namedupilumab
    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 INNdupilumab
    D.3.9.2Current sponsor codeREGN668
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 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
    Bullous pemphigoid (BP)
    Penfigoide ampolloso (PA)
    E.1.1.1Medical condition in easily understood language
    Bullous pemphigoid is a rare, autoimmune skin condition that causes large, fluid-filled blisters
    El penfigoide ampolloso es una afección cutánea autoinmunitaria, poco frecuente, que causa grandes ampollas llenas de líquido
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10034277
    E.1.2Term Pemphigoid
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP).
    El objetivo principal del estudio es demostrar que el dupilumab es superior al placebo a la hora de lograr una remisión prolongada sin corticoesteroides orales (CEO) en pacientes con penfigoide ampolloso (PA)
    E.2.2Secondary objectives of the trial
    -To evaluate the OCS-sparing effects of dupilumab in patients with BP
    -To evaluate the effect of dupilumab on itch in patients with BP
    -To evaluate the effects of dupilumab on health-related quality of life measures in patients with BP
    -To evaluate the effect of dupilumab on circulating BP180 and BP230 autoantibody titers
    -To assess the safety and tolerability of dupilumab administered to patients with BP
    -To characterize the trough concentrations of functional dupilumab over time following administration of dupilumab in patients with BP
    -To assess the immunogenicity of dupilumab in patients with BP over time
    -Evaluar los efectos ahorradores de corticoesteroides orales de dupilumab en pacientes con PA
    -Evaluar el efecto de dupilumab sobre el prurito en pacientes con PA
    -Evaluar los efectos de dupilumab sobre las medidas de la calidad de vida relacionada con la salud en pacientes con PA
    -Evaluar el efecto de dupilumab sobre las concentraciones de autoanticuerpos circulantes frente a BP180 y BP230
    -Evaluar la seguridad y la tolerabilidad de dupilumab al administrarlo a pacientes con PA
    -Caracterizar las concentraciones mínimas de dupilumab funcional a lo largo del tiempo tras su administración a pacientes con PA
    -Evaluar la inmunogenicidad de dupilumab a lo largo del tiempo en pacientes con PA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional genomics sub-study
    Subestudio de genómica opcional
    E.3Principal inclusion criteria
    1. Patients must have characteristic clinical features of BP (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits.
    2. Study participants are required to have a confirmed diagnosis of BP based on histopathology, immunopathology, and serology at the baseline visit.
    3. Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits.
    4. Baseline peak pruritus NRS score for maximum itch intensity ≥4
    5. Male or female, age 18 to 90 at the screening visit
    6. Karnofsky performance status score ≥50% at the screening visit.

    NOTE: Other protocol defined inclusion criteria apply
    1. Los pacientes deben presentar manifestaciones clínicas de PA (p. ej., prurito, ampollas o placas eritematosas, eccematosas o urticarianas) en las visitas de selección e inicial.
    2. Se requiere que los participantes del estudio dispongan de confirmación histológica, inmunopatológica y serológica del PA en el momento de la visita inicial.
    3. Una puntuación >=24 en la actividad de la enfermedad según el índice del área del penfigoide ampolloso (BPDAI, Bullous Pemphigoid Disease Area Index) en las visitas de selección e inicial.
    4. Una puntuación >=4 en la escala numérica (NRS) para la intensidad máxima del prurito en el inicio.
    5. Personas de ambos sexos, de entre 18 y 90 años en la visita de selección.
    6. Una puntuación >=50 % en la valoración funcional de Karnofsky en la visita de selección.
    NOTA: se aplican también otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    1. Forms of pemphigoid other than classic BP (eg. Brunsting Perry cicatricial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or BP with concomitant pemphigus vulgaris)
    2. Patients who are receiving treatments known to cause or exacerbate BP (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) who have not been on a stable dose of these medications for at least 4 weeks prior to the screening visit
    3. Have ever received treatment with an IL-4 or IL-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab.
    4. Treatment with systemic corticosteroids within 7 days before the baseline visit
    5. Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 7 days before the baseline visit
    6. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit.
    7. Treatment with BP-directed biologics as follows:
    a. Any cell-depleting agents including but not limited to rituximab: within 12 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
    b. Other biologics (such as IL-5 inhibitors benralizumab or mepolizumab): within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer
    c. Intravenous immunoglobulin within 16 weeks prior to the baseline visit

    NOTE: Other protocol defined exclusion criteria apply
    1. Tipos de penfigoide distintos al PA clásico (p. ej., el PA de las membranas mucosas, el penfigoide cicatricial de Brunsting Perry, el penfigoide anti-p200, la epidermólisis ampollosa adquirida o el PA con pénfigo vulgar concomitante).
    2. Pacientes que estén recibiendo tratamientos que causan o exacerban el PA (p. ej., inhibidores de la enzima convertidora de la angiotensina, penicilamina, furosemida, fenacetina o inhibidor de la dipeptidil peptidasa-4) que no hayan mantenido una dosis estable de estos medicamentos durante un mínimo de 4 semanas antes de la visita de selección.
    3. Haber recibido anteriormente tratamiento con un antagonista de la IL-4 o la IL-13, como dupilumab, tralokinumab o lebrikizumab.
    4. Tratamiento con corticoesteroides sistémicos durante las 2 semanas anteriores a la visita inicial.
    5. Tratamiento con corticoesteroides tópicos de potencia media o mayor, inhibidor de la calcineurina tópico o crisaborole tópico durante la semana anterior a la visita inicial.
    6. Tratamiento con inmunomoduladores/inmunodepresores no esteroideos (p. ej., micofenolato mofetilo, azatioprina o metotrexato) durante las 4 semanas anteriores a la visita inicial.
    7. Tratamiento con biofármacos dirigidos al PA: -a. Todo fármaco citorreductor incluido, entre otros, rituximab: durante los 12 meses anteriores a la visita inicial o hasta que la cifra de linfocitos y CD19+ retorne a la normalidad, lo que se produzca más tarde -b. Otros biofármacos (como los inhibidores de IL-5 benralizumab o mepolizumab): durante las 5 semividas (si se conoce) o las 16 semanas anteriores a la visita inicial, lo que sea más prolongado -c. Inmunoglobulina intravenosa durante las 16 semanas anteriores a la visita inicial
    NOTA: se aplican también otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The main assessment criterion is the proportion of patients who achieve prolonged remission in week 36, which is defined in the following way:
    • full remission and withdrawal from OCS as very late in week 16 after randomization (note: “full remission” is the absence of new lesions and epithelization of old ones), and
    • absence of illness relapse from the time in which the patient completed progressive reduction of the OCS (as very late in week 16 after randomization) until week 36 (note: a relapse is the appearance of 3 or more new lesions in the month [blisters, eczematous lesions or urticaria plaques] or at least 1 large eczematous lesion or urticaria plaque [>10 cm in diameter] that do not heal in one week), and
    • absence of the need for rescue treatment during the 36-week double-blind treatment period (note: the rescue treatment may consist of increasing the OCS during progressive dose reduction, in resuming the OCS once progressive dose reduction is completed or starting any treatment for the BP).
    El criterio de valoración principal es la proporción de pacientes que logran una remisión prolongada en la semana 36, lo que se define de la siguiente manera:
    • remisión completa y supresión de los CEO como muy tarde en la semana 16 después de la aleatorización (nota: «remisión completa» es la ausencia de nuevas lesiones y la epitelización de las antiguas), y
    • ausencia de recaída de la enfermedad desde el momento en que el paciente finalizó la disminución progresiva de los CEO (como muy tarde en la semana 16 después de la aleatorización) hasta la semana 36 (nota: una recaída es la aparición de 3 o más lesiones nuevas en un mes [ampollas, lesiones eccematosas o placas de urticaria] o como mínimo 1 lesión eccematosa o placa de urticaria grandes [>10 cm de diámetro] que no se curan en una semana), y
    • ausencia de la necesidad de tratamiento de rescate durante el período de tratamiento con doble enmascaramiento de 36 semanas (nota: el tratamiento de rescate puede consistir en aumentar los CEO durante la disminución progresiva de la dosis, en retomar los CEO una vez finalizada la disminución progresiva de la dosis o en iniciar cualquier tratamiento para el PA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    As stated above
    Como se indica anteriormente
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are:
    (1) Total cumulative dose of OCS from baseline to week 36
    (2) Percent change in weekly average of daily peak pruritus numerical rating score (NRS) from baseline to week 36
    (3) Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS ≥4 from baseline to week 36
    (4) Percent change in BPDAI activity score from baseline to week 36

    Other secondary endpoints for efficacy:
    (5) Duration of complete remission while not requiring OCS (up to week 36)
    (6) Proportion of patients who do not achieve control of disease activity or who relapse after achieving control of disease activity (up to week 36) (Note: control of disease activity is defined when new lesions cease to form and existing lesions begin to heal)
    (7) Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% from baseline to week 36
    (8) Change in autoimmune bullous disease quality of life (ABQOL) from baseline to week 36
    (9) Change from baseline to week 36 in percent body surface area (BSA) of BP involvement
    (10) Change in BP180 and BP230 autoantibody (IgG) titers from baseline to week 36
    (11) Proportion of patients with sustained remission at week 52
    (12) Total cumulative dose of OCS from baseline to week 52
    (13) Duration of complete remission while not requiring OCS (up to week 52)
    (14) Proportion of patients who do not achieve control of disease activity or who relapse after achieving control of disease activity (up to week 52)
    (15) Percent change in weekly average of daily peak pruritus NRS from baseline to week 52
    (16) Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS ≥4 from baseline to week 52
    (17) Percent change in BPDAI activity score from baseline to week 52
    (18) Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% from baseline to week 52
    (19) Change in ABQOL from baseline to week 52
    (20) Change from baseline to week 52 in percent BSA of BP involvement
    (21) Change in BP180 and BP230 autoantibody (IgG) titers from baseline to week 52
    (22) Proportion of patients in complete remission and off OCS at week 16
    (23) Percent change in BPDAI activity score from baseline to week 16
    (24) Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% from baseline to week 16
    (25) Percent change in weekly average of daily peak pruritus NRS from baseline to week 16
    (26) Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS ≥4 from baseline to week 16

    Other secondary endpoints for safety:
    (27) Incidence of treatment-emergent adverse events (TEAEs) from baseline through end of treatment (up to week 52)
    (28) Incidence of treatment-emergent serious adverse events (SAEs) from baseline through the end of treatment (up to week 52)
    (29) Incidence of adverse events of special interest (AESIs) from baseline through the end of treatment (up to week 52)
    (30) Incidence of TEAEs from baseline through end of study (up to week 64)
    (31) Incidence of treatment-emergent SAEs from baseline through the end of study (up to week 64)
    (32) Incidence of AESIs from baseline through the end of study (up to week 64)

    Other secondary endpoints for clinical pharmacology and immunogenicity:
    (33) Concentrations of functional dupilumab in serum at each scheduled sampling time
    point from baseline to end of study (up to week 64)
    (34) Incidence of treatment-emergent anti-drug antibody (ADA) responses and titer over time (up to week 64)
    Criterios de valoración de la eficacia secundarios clave:
    • Dosis total acumulada de CEO desde el inicio hasta la semana 36
    • Porcentaje de cambio en el promedio semanal de la PVN para el picor máximo diario desde el inicio hasta la semana 36
    • Proporción de pacientes con una mejora (reducción) ≥4 en el promedio semanal de la PVN para el picor máximo diario desde el inicio hasta la semana 36
    • Porcentaje de cambio en la puntuación de la actividad en el BPDAI desde el inicio hasta la semana 36
    Otros criterios de valoración de la eficacia secundarios:
    • Duración de la remisión completa sin necesidad de CEO (hasta la semana 36)
    • Proporción de pacientes que no consiguen controlar la actividad de la enfermedad o que sufren una recaída tras conseguirlo (hasta la semana 36) (nota: se considera que la enfermedad está controlada cuando dejan de formarse nuevas lesiones y las existentes empiezan a curarse)
    • Proporción de pacientes que logran reducir la puntuación de la actividad en el BPDAI al menos un 50 %, un 75 % y un 90 % desde el momento inicial hasta la semana 36
    • Cambio en la valoración de la calidad de vida para la enfermedad ampollosa autoinmunitaria (ABQOL) desde el momento inicial hasta la semana 36
    • Cambio desde el momento inicial hasta la semana 36 en el porcentaje de superficie corporal (SC) afectada por el PA
    • Cambio en las cantidades de anticuerpos BP180 y BP230 (inmunoglobulina G [IgG]) desde el inicio hasta la semana 36
    • Proporción de pacientes con remisión prolongada en la semana 52
    • Dosis total acumulada de CEO desde el inicio hasta la semana 52
    • Duración de la remisión completa sin necesidad de CEO (hasta la semana 52)
    • Proporción de pacientes que no consiguen controlar la actividad de la enfermedad o que sufren una recaída tras conseguirlo (hasta la semana 52)
    • Porcentaje de cambio en el promedio semanal de la PVN para el picor máximo diario desde el inicio hasta la semana 52
    • Proporción de pacientes con una mejora (reducción) ≥4 en el promedio semanal de la PVN para el picor máximo diario desde el inicio hasta la semana 52
    • Porcentaje de cambio en la puntuación de la actividad en el BPDAI desde el inicio hasta la semana 52
    • Proporción de pacientes que logran reducir la puntuación de la actividad en el BPDAI al menos en un 50 %, un 75 % y un 90 % desde el momento inicial hasta la semana 52
    • Cambio en el ABQOL desde el inicio hasta la semana 52
    • Cambio desde el momento inicial hasta la semana 52 en el porcentaje de SC afectada por el PA
    • Cambio en las cantidades de anticuerpos BP180 y BP230 (IgG) desde el inicio hasta la semana 52
    • Proporción de pacientes en remisión completa y sin tratamiento con CEO en la semana 16
    • Porcentaje de cambio en la puntuación de la actividad en el BPDAI desde el inicio hasta la semana 16
    • Proporción de pacientes que logran reducir la puntuación de la actividad en el BPDAI al menos en un 50 %, un 75 % y un 90 % desde el momento inicial hasta la semana 16
    • Porcentaje de cambio en el promedio semanal de la PVN para el picor máximo diario desde el inicio hasta la semana 16
    • Proporción de pacientes con una mejora (reducción) ≥4 en el promedio semanal de la PVN para el picor máximo diario desde el inicio hasta la semana 16
    Criterios de valoración secundarios para la seguridad:
    • Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST) desde el inicio hasta el final del tratamiento (hasta la semana 52)
    • Incidencia de acontecimientos adversos graves (AAG) surgidos durante el tratamiento desde el inicio hasta el final del tratamiento (hasta la semana 52)
    • Incidencia de acontecimientos adversos de especial interés (AAEI) desde el inicio hasta el final del tratamiento (hasta la semana 52)
    • Incidencia de AAST desde el inicio hasta el final del estudio (hasta la semana 64)
    • Incidencia de AAG surgidos durante el tratamiento desde el inicio hasta el final del estudio (hasta la semana 64)
    • Incidencia de AAEI desde el inicio hasta el final del estudio (hasta la semana 64)
    Criterios de valoración secundarios para la farmacología clínica y la inmunogenia:
    • Concentraciones de dupilumab funcional en suero en cada toma de muestras programada desde el inicio hasta el final del estudio (hasta la semana 64)
    • Incidencia de las respuestas de anticuerpos antifármaco (AAF) surgidas durante el tratamiento y cantidad a lo largo del tiempo (hasta la semana 64)
    Nota: Los criterios de valoración de la seguridad, la farmacología clínica y la inmunogenia no se incluirán en la jerarquía de pruebas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As stated above
    como se indica anteriormente
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Israel
    Japan
    Taiwan
    United States
    France
    Poland
    Germany
    Greece
    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
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months23
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 88
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 98
    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
    Ninguno
    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 Decision2023-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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