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    Summary
    EudraCT Number:2019-003298-24
    Sponsor's Protocol Code Number:R4018-ONC-1721
    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:2023-01-31
    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 number2019-003298-24
    A.3Full title of the trial
    A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer
    Estudio en fase I/II de REGN4018 (un anticuerpo biespecífico MUC16xCD3) administrado solo o en combinación con cemiplimab en pacientes con cáncer de ovario recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer
    Un estudio para examinar REGN4018 (un anticuerpo biespecífico MUC16xCD3) administrado solo o en combinación con cemiplimab en pacientes con cáncer de ovario recurrente
    A.4.1Sponsor's protocol code numberR4018-ONC-1721
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03564340
    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
    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.2.5The 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 nameCemiplimab
    D.3.2Product code REGN2810
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEMIPLIMAB
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameREGN4018
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN4018
    D.3.9.2Current sponsor codeREGN4018
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 nameREGN4018
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN4018
    D.3.9.2Current sponsor codeREGN4018
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent Ovarian Cancer
    Recurrent Fallopian Tube Cancer
    Recurrent Primary Peritoneal Cancer
    Cáncer de ovario recurrente
    Cáncer de trompa de Falopio recurrente
    Cáncer peritoneal primario recurrente
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    Fallopian Tube Cancer
    Primary Peritoneal Cancer
    Cáncer de ovario
    Cáncer de trompa de Falopio
    Cáncer peritoneal primario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In the Dose Escalation Phase:
    To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab

    In the Dose Expansion Phase:
    To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    En la fase de escalada de dosis:
    Evaluar la seguridad y la farmacocinética (FC) para determinar una dosis máxima tolerada (DMT) o una dosis recomendada para la fase II (DRF2) de REGN4018 en monoterapia y en combinación con cemiplimab.
    En la fase de expansión de dosis:
    Evaluar la eficacia preliminar de REGN4018 como monoterapia y en combinación con cemiplimab (por separado por cohorte) determinada por la tasa de respuesta objetiva (TRO) según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) 1.1
    E.2.2Secondary objectives of the trial
    Dose Escalation Phase
    To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR by RECIST 1.1
    Dose Expansion Phase
    •To characterize the safety profile in each expansion cohort
    •To characterize the PK of REGN4018 as monotherapy and in combination with cemiplimab
    •To assess the effect of REGN4018 as monotherapy and in combination with cemiplimab on patient-reported outcomes, including health-related quality of life, functioning, and symptoms
    In both Dose Escalation and Dose Expansion Phases
    •To assess preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as measured by ORR based on immune based therapy iRECIST, BOR, DOR, disease control rate, CR rate and PFS based on RECIST 1.1 and iRECIST
    •To assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by CA-125 level
    •Immunogenicity of REGN4018 and cemiplimab
    En la fase de escalada de dosis:
    Evaluar la eficacia preliminar de REGN4018 como monoterapia y en combinación con cemiplimab (por separado por cohorte) determinada mediante la TRO según RECIST 1.1
    En la fase de expansión de dosis:
    •Caracterizar el perfil de seguridad en cada cohorte de expansión
    •Caracterizar la FC de REGN4018 en monoterapia y en combinación con cemiplimab
    •Evaluar el efecto de REGN4018 en monoterapia y en combinación con cemiplimab sobre los resultados notificados por el paciente (RNP), incluida la calidad de vida relacionada con la salud (CdVRS), el funcionamiento y los síntomas.
    Tanto en las fases de escalada de dosis como en la de expansión de la dosis:
    •Evaluar la eficacia preliminar de REGN4018 como monoterapia y en combinación con cemiplimab (por separado por cohorte) medida mediante la TRO según los criterios RECIST (iRECIST) del tratamiento inmunitario, ..
    Refiérase al resumen del protocolo para la información completa en español.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Future Biomedical Research - Optional
    Patients who agree to participate in the future biomedical research sub-study will be required to consent to this optional sub-study before samples are banked for future biomedical research.

    Genomics sub-study - Optional
    Germline DNA will be collected as optional to enable analysis of tumor mutational burden as well as exploratory analysis of variants potentially associated with efficacy and/or safety signals.
    Investigación biomédica futura
    A los pacientes que estén de acuerdo en participar en el subestudio de investigación biomédica futura se les pedirá que den su consentimiento para este sub estudio opcional antes de que las muestras se almacenen para investigación biomédica futura.

    Subestudio de genómica - opcional
    El ADN de la línea germinal se recogerá de forma opcional para permitir el análisis de la carga mutacional del tumor, así como el análisis exploratorio de las variantes potencialmente asociadas a signos de eficacia y/o seguridad.
    E.3Principal inclusion criteria
    1. Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
    a. serum CA-125 level ≥2x upper limit of normal (ULN) (in screening)
    b. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
    c. documented relapse or progression on or after the most recent line of therapy
    d. no standard therapy options likely to convey clinical benefit
    2. Adequate organ and bone marrow function as defined in the protocol
    3. Life expectancy of at least 3 months
    4. Randomized phase 2 expansion cohorts only:
    Platinum resistant ovarian cancer patients who have had 1 to 3 lines of platinum-based therapy or prior treatment with PARP inhibitor or bevacizumab as defined in the protocol.

    Note: Other protocol Inclusion Criteria apply
    1. Pacientes con diagnóstico confirmado histológica o citológicamente de cáncer epitelial de ovario (excepto carcinosarcoma), peritoneal primario o de las trompas de Falopio en estadio avanzado que presentan todo lo siguiente:
    a. nivel de CA-125 en suero ≥2 veces el límite superior de la normalidad (LSN) (en la selección)
    b. ha recibido al menos 1 línea de tratamiento con platino o debe ser intolerante al platino (aplicable para las cohortes de escalada de dosis y las cohortes de expansión de la dosis no aleatorizadas)
    c. recidiva o progresión documentada durante o después de la línea de tratamiento más reciente
    d. no es probable que las opciones de tratamiento estándar proporcionen beneficio clínico
    2. Función orgánica y medular adecuadas, conforme a la definición del protocolo
    3. Esperanza de vida de un mínimo de 3 meses
    4. Solo cohortes de expansión aleatorizadas de la fase II:
    Pacientes con cáncer de ovario resistente al platino que han recibido de 1 a 3 líneas de tratamiento con platino o tratamiento previo con inhibidor de PARP o bevacizumab, según se define en el protocolo.

    Nota: se aplican otros criterios de inclusión del protocolo
    E.4Principal exclusion criteria
    1. Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy
    2. Expansion cohort only: More than 4 prior lines of cytotoxic chemotherapy for platinum-experienced and/or intolerant disease
    3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
    4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression
    5. History and/ or current cardiac findings as defined in the protocol
    6. Moderate to large pleural effusion as defined in the protocol
    7. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

    Note: Other protocol Exclusion Criteria apply
    1. Tratamiento reciente con un anticuerpo antimuerte celular programada (PD-1)/PD-L1
    2. Solo cohorte de expansión: Más de 4 líneas previas de quimioterapia citotóxica para la enfermedad con o sin tratamiento previo con platino
    3. Tratamiento previo con un tratamiento dirigido a la mucina 16 (MUC16)
    4. Tumor cerebral primario activo o no tratado, metástasis en el sistema nervioso central (SNC) o compresión de la médula espinal
    5. Antecedentes y/o hallazgos cardíacos actuales según se definen en el protocolo
    6. Derrame pleural de moderado a importante según se define en el protocolo
    7. Hipertensión grave y/o no controlada en la selección. Los pacientes que toman medicamentos antihipertensivos deben estar recibiendo una pauta antihipertensiva estable

    Nota: se aplican otros criterios de exclusión del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation Phase:
    1. Number of participants with Dose-limiting toxicity (DLTs)
    2. Number of participants with Treatment-emergent adverse event (TEAE)s (including immune (irAEs))
    3. Number of participants with serious adverse events (SAEs)
    4. Number of deaths
    5. Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
    6. Concentration of REGN4018 in serum over time for monotherapy and in combination with cemiplimab
    Dose Expansion Phase:
    7. Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for monotherapy and with cemiplimab
    Fase de escalada de dosis:
    1. Número de participantes con toxicidades limitantes de la dosis (TLD)
    2. Número de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST) (incluidos los acontecimientos inmunitarios [AAri])
    3. Número de participantes con acontecimientos adversos graves (AAG)
    4. Número de muertes
    5. Número de participantes con anomalías analíticas (grado 3 o superior según los Criterios terminológicos comunes para acontecimientos adversos [Common Terminology Criteria for Adverse Events, CTCAE])
    6. Concentración de REGN4018 en suero a lo largo del tiempo para la monoterapia y la combinación con cemiplimab

    Fase de expansión de la dosis:
    7. Tasa de respuesta objetiva (TRO) definida según los Criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria in Solid Tumors, RECIST 1.1) para la monoterapia y la combinación con cemiplimab
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 28 days
    2 - 7. Up to 62 weeks
    1. 28 días como máximo
    2 - 7. Hasta 62 semanas
    E.5.2Secondary end point(s)
    Dose Escalation Phase:
    1. ORR based on RECIST 1.1 for monotherapy and with cemiplimab
    Dose Expansion Phase:
    2. Number of participants with TEAEs (including irAEs)
    3. Number of participants with SAEs
    4. Number of deaths
    5. Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE)
    6. Concentration of REGN4018 in serum over time for monotherapy and in combination with cemiplimab
    7. Change from baseline in QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score
    8. Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score
    9. Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score
    10. Time to deterioration in GHS/QoL, physical functioning, and abdominal symptoms
    11. Change from baseline in QoL as measured by EQ-5D

    Dose Escalation and Dose Expansion Phases:
    12. ORR based on iRECIST for monotherapy and with cemiplimab
    13. Best overall response (BOR) based on RECIST 1.1 and iRECIST for monotherapy and with cemiplimab
    14. Duration of response (DOR) based on RECIST 1.1 and iRECIST for monotherapy and with cemiplimab
    15. Disease control rate based on RECIST 1.1 and iRECIST for monotherapy and with cemiplimab
    16. Progression-free survival (PFS) based on RECIST 1.1 and iRECIST for monotherapy and with cemiplimab
    17. Complete Response (CR) rate
    18. Cancer antigen-125 (CA-125) response
    19. Presence or absence of anti-drug antibodies against REGN4018 and cemiplimab
    Fase de escalada de dosis:
    1. TRO basada en RECIST 1.1 para la monoterapia y la combinación con cemiplimab
    Fase de expansión de la dosis:
    2. Número de participantes con AAST (incluidos AAri)
    3. Número de participantes con AAG
    4. Número de muertes
    5. Número de participantes con anomalías analíticas (grado 3 o superior según los CTCAE)
    6. Concentración de REGN4018 en suero a lo largo del tiempo para la monoterapia y la combinación con cemiplimab
    7. Cambio desde el inicio en la CdV medida por la puntuación del estado de salud general (ESG)/la calidad de vida (CdV) del Cuestionario principal de 30 ítems sobre calidad de vida (QLQ-C30) de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC)
    8. Cambio con respecto al inicio en la función física medida por la puntuación de la función física EORTC QLQ-C30
    9. Cambio con respecto al inicio en los síntomas abdominales medido mediante la puntuación de la Medición de los síntomas y el tratamiento ováricos (MOST)-Índice abdominal
    10. Tiempo hasta el deterioro del ESG/de la CdV, la funcionalidad física y los síntomas abdominales
    11. Cambio desde el inicio en la CdV medida mediante el EQ-5D

    Fases de escalada de dosis y de expansión de la dosis:
    12. TRO basada en iRECIST para la monoterapia y la combinación con cemiplimab
    13. Mejor respuesta global (MRG) basada en RECIST 1.1 e iRECIST para la monoterapia y la combinación con cemiplimab
    14. Duración de la respuesta (DR) basada en RECIST 1.1 e iRECIST para la monoterapia y la combinación con cemiplimab
    15. Tasa de control de la enfermedad basada en RECIST 1.1 e iRECIST para la monoterapia y la combinación con cemiplimab
    16. Supervivencia sin progresión (SSP) basada en RECIST 1.1 e iRECIST para la monoterapia y la combinación con cemiplimab
    17. Tasa de respuesta completa (RC)
    18. Respuesta del antígeno del cáncer-125 (CA-125)
    19. Presencia o ausencia de anticuerpos antifármaco contra REGN4018 y cemiplimab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 19. Up to 62 weeks
    1 - 19 Hasta 62 semanas
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Korea, Republic of
    United States
    France
    Netherlands
    Spain
    Italy
    Belgium
    United Kingdom
    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
    Última visita del último paciente
    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 months8
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 366
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 188
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 554
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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