Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-006629-23
    Sponsor's Protocol Code Number:61186372GIC2002
    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:2022-05-27
    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 number2021-006629-23
    A.3Full title of the trial
    A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer
    Estudio en fase Ib/II abierto de amivantamab en monoterapia y añadido a la quimioterapia de referencia en pacientes con cáncer colorrectal avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer
    Estudio en fase Ib/II abierto de amivantamab en monoterapia y añadido a la quimioterapia de referencia en pacientes con cáncer colorrectal avanzado o metastásico
    A.4.1Sponsor's protocol code number61186372GIC2002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5- 7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34647309639
    B.5.6E-mailcgonz130@its.jnj.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 nameAmivantamab
    D.3.2Product code JNJ-61186372
    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 INNAmivantamab
    D.3.9.1CAS number 2171511-58-1
    D.3.9.2Current sponsor codeJNJ-61186372
    D.3.9.3Other descriptive nameANTI-EGFR/C-MET BISPECIFIC ANTIBODY
    D.3.9.4EV Substance CodeSUB193051
    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
    Advanced or Metastatic Colorectal Cancer
    Cáncer colorrectal avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Advanced or Metastatic Colorectal Cancer
    Cáncer colorrectal avanzado o metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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
    To assess the anti-tumor activity of amivantamab as a monotherapy and
    characterize the safety of amivantamab when added to SoC Chemotherapy in participants with mCRC (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b).
    Evaluar la actividad antitumoral de amivantamab como monoterapia y
    caracterizar la seguridad de amivantamab cuando se añade a la quimioterapia de referencia en pacientes con CCRm (cohortes de fase 2), y evaluar la dosis de combinación recomendada de fase 2 (RP2CD) de amivantamab cuando se añade a la quimioterapia de referencia (fase 1b).
    E.2.2Secondary objectives of the trial
    To characterize the safety of amivantamab as a monotherapy and to assess the anti-tumor activity of amivantamab when added to SoC chemotherapy in participants with mCRC.
    Caracterizar la seguridad de amivantamab como monoterapia y evaluar su actividad antitumoral de amivantamab cuando se añade a la quimioterapia de referencia en pacientes con CCRm
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
    2. Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum.
    3. Participant must have previously been characterized as wild-type KRAS, NRAS, BRAF by local testing.
    4. For Ph1b-D and Ph1b-E: Participant must have evaluable disease.
    For Ph 2: Participant must have measurable disease according to RECIST v1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed ≥7 days after the biopsy.
    5. Participant must have ECOG PS 0 or 1.
    6. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony stimulating factor (G-CSF) within 7 days prior to the date of the laboratory test.
    7. Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsies.
    8. Human immunodeficiency virus (HIV)-positive participants are eligible if they meet the criteria
    9. A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
    10. A female participant must be either not of childbearing potential, or of childbearing potential and practicing at least 1 highly effective method of contraception.
    11. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility.
    12. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. If partner is a female of childbearing potential, the male participant must use condoms, and the partner must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom, but the partner is not required to use contraception.
    13. A male participant must agree not to donate sperm for the purposes of reproduction during the study and for 6 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anti-cancer treatments may impair fertility.
    14. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    15. Participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
    1. El participante debe tener ≥18 años de edad (o la edad legal de consentimiento en la jurisdicción en la que se realiza el estudio).
    2. El participante debe haber sido previamente diagnosticado histológica o citológicamente confirmado de adenocarcinoma no resecable o metastásico del colon o el recto.
    3. El participante debe haber sido caracterizado previamente como tipo salvaje KRAS, NRAS, BRAF mediante pruebas locales.
    4. Para Ph1b-D y Ph1b-E: El participante debe tener enfermedad evaluable. Para Ph 2: El participante debe tener enfermedad medible según RECIST v1.1. Si sólo existe una lesión medible, puede utilizarse para la biopsia de cribado siempre que se realicen exploraciones de evaluación tumoral de referencia realizadas ≥7 días después de la biopsia.
    5. El participante debe tener un PS 0 o 1 del ECOG.
    6. El participante debe tener una función orgánica y de médula ósea adecuada como se indica a continuación, sin antecedentes de transfusión de glóbulos rojos, de plaquetas, o del uso de factor estimulante de colonias de granulocitos (G-CSF) en los 7 días anteriores a la fecha de la prueba de laboratorio.
    7. El participante debe tener una lesión tumoral susceptible de biopsia y aceptar a las biopsias de cribado obligatorias definidas por el protocolo.
    8. Los participantes seropositivos al virus de la inmunodeficiencia humana (VIH) son elegibles si cumplen los criterios.
    9. Las mujeres en edad fértil deben tener una prueba de embarazo
    suero negativo en el momento del cribado y en las 72 horas siguientes a la primera dosis del tratamiento del estudio y debe aceptar que se realicen más pruebas de embarazo en suero u orina durante el estudio.
    10. Una participante femenina debe no estar en edad de procrear, o potencialmente fértil y practicar al menos un método anticonceptivo altamente eficaz.
    11. Una participante femenina debe aceptar no donar óvulos (óvulos, oocitos) o congelar para su uso futuro con fines de reproducción asistida durante el estudio y durante un periodo de 6 meses después de recibir la última dosis de tratamiento del estudio. Las participantes deben considerar la conservación de óvulos antes del tratamiento del estudio, ya que los tratamientos anticancerosos afectan a la fertilidad.
    12. Los participantes masculinos deben usar un preservativo cuando realicen cualquier actividad que permita el paso de la eyaculación a otra persona durante el estudio y durante 6 meses después de recibir la última dosis del tratamiento del estudio.
    Si la pareja es una mujer en edad fértil, el participante masculino debe usar preservativos, y la pareja debe practicar un método anticonceptivo altamente eficaz. Un participante masculino vasectomizado debe utilizar un preservativo, pero la pareja no está obligada a utilizar métodos anticonceptivos.
    13. El participante masculino debe aceptar no donar esperma con fines de reproducción durante el estudio y durante los 6 meses siguientes a la recepción de la última dosis del tratamiento del estudio. Los participantes masculinos deben considerar preservación del esperma antes del tratamiento del estudio, ya que los tratamientos anticancerosos pueden perjudicar la fertilidad.
    14. El participante debe firmar un ICF indicando que entiende el propósito y los procedimientos requeridos para el estudio y que está dispuesto a participar en el estudio.
    15. El participante debe estar dispuesto y ser capaz de cumplir con las restricciones de estilo de vida especificadas en este protocolo.
    E.4Principal exclusion criteria
    1. Participant with known ERBB2/HER2 amplification based on the local testing results
    2. Participant with identified mutation in KRAS, NRAS, BRAF, or EGFR ectodomain, or ERBB2/HER2 amplification by central ctDNA testing at screening
    3. Participant has an uncontrolled illness
    4. Participant with symptomatic brain metastasis
    5. History or known presence of leptomeningeal disease
    6. Participant has a history of (non-infectious) ILD/pneumonitis/pulmonary fibrosis, or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening.
    7. Participant has a history of clinically significant cardiovascular disease.
    8. Participant has known allergies, hypersensitivity, or intolerance to excipients of:
    a. amivantamab (refer to the IB, all participants)
    b. 5-FU or leucovorin (Participants in Ph1b-D, Ph1b-E, and Ph2 Cohorts D and E)
    c. Oxaliplatin (Participants in Ph1b-D and Ph2 Cohort D)
    d. Irinotecan (Participants in Ph1b-E and Ph2 Cohort E)
    9. Participant has at screening:
    a. Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Exception: Participants with a prior history of HBV demonstrated by positive hepatitis B core antibody (HBcAb) are eligible if they have at screening 1) a negative HBsAg and 2) an HBV DNA (viral load) below the lower limit of quantification, per local testing. Participants with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
    b. Positive hepatitis C antibody (anti-HCV [hepatitis C virus])
    c. Other clinically active infectious or non-infectious liver disease
    10. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    11. Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study drug. Participants must not have received any anti-EGFR treatment within 28 days of the first dose of study drug.
    12. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or postradiation skin changes [any grade], Grade ≤2 peripheral neuropathy, and Grade ≤2 hypothyroidism stable on hormone replacement).
    13. Participant has, or will have, any of the following:
    a. An invasive operative procedure with entry into a body cavity, within 4 weeks or without complete recovery before the first administration of study treatment. Thoracentesis, if needed, and percutaneous biopsy for baseline tumor tissue sample may be done less than 4 weeks prior to the first administration of study treatment, as long as the participant has adequately recovered from the procedure prior to the first dose of study treatment in the clinical judgement of the investigator
    b. Significant traumatic injury within 3 weeks before the start of the first administration of study treatment (all wounds must be fully healed prior to Day 1)
    c. Expected major surgery while the investigational agent is being administered or within 6 months after the last dose of study treatment
    14. Participant has received an investigational drug (including investigational vaccines, but not including anti-cancer therapy) or used an invasive investigational medical device within 6 weeks before the planned first dose of study treatment.
    1. Participante con amplificación conocida de ERBB2/HER2 basada en los resultados de las pruebas locales.
    2. Participante con mutación identificada en KRAS, NRAS, BRAF o EGFR o amplificación de ERBB2/HER2 mediante pruebas centrales de ctDNA en cribado.
    3. El participante tiene una enfermedad no controlada.
    4. Participante con metástasis cerebral sintomática.
    5. Historia o presencia conocida de enfermedad leptomeníngea.
    6. El participante tiene un historial de (no infeccioso)
    enfermedad pulmonar intersticial/neumonitis/fibrosis pulmonar, o tiene actualmente ILD/neumonitis/fibrosis pulmonar, o cuando se sospeche de EPI/neumonitis/fibrosis pulmonar no pueda ser descartada por imágenes en cribado.
    7. El participante tiene un historial de enfermedad cardiovascular clínicamente significativa.
    8. El participante tiene alergias conocidas, hipersensibilidad o intolerancia a excipientes de:
    a. amivantamab (referirse al IB, todos los participantes)
    b. 5-FU o leucovorina (participantes en Ph1b-D, Ph1b-E y Ph2 de las cohortes D y E)
    c. Oxaliplatino (participantes de Ph1b-D y Ph2 de la cohorte D)
    d. Irinotecán (participantes en la Ph1b-E y en la Ph2 Cohorte E)
    9. El participante tiene en el momento del cribado
    a. Antígeno de superficie de la hepatitis B (virus de la hepatitis B [VHB]) positivo (HBsAg) Excepción: Los participantes con antecedentes de VHB demostrados por anticuerpo central de la hepatitis B (HBcAb) positivo son elegibles si en el momento del cribado tienen cribado 1) un HBsAg negativo y 2) un ADN del VHB (carga viral) inferior al límite inferior de cuantificación, según las pruebas locales. Los participantes con un HBsAg positivo debido a una vacunación reciente son elegibles si el ADN del VHB (carga viral) está por debajo del límite inferior de cuantificación, según las pruebas locales.
    b. Anticuerpos contra la hepatitis C positivos (anti-VHC [virus de la hepatitis C])
    c. Otra enfermedad hepática infecciosa o no infecciosa clínicamente activa
    10. Cualquier condición por la que, en opinión del investigador
    la participación no sería en el mejor interés del participante (p. ej,
    comprometer el bienestar) o que pudiera impedir, limitar o confundir las evaluaciones especificadas en el protocolo.
    11. El participante se ha sometido previamente a quimioterapia, terapia dirigida contra el cáncer inmunoterapia o tratamiento con un agente anticanceroso en investigación en un plazo de 2 semanas o 4 semividas, lo que sea más largo, antes de la primera administración del fármaco del estudio. Los participantes no deben haber recibido ningún tratamiento antiEGFR en los 28 días anteriores a la primera dosis del fármaco del estudio.
    12. Las toxicidades de las terapias anticancerígenas previas deben haberse resuelto a niveles iniciales o al grado 1 o menos antes de la primera dosis del tratamiento del estudio (excepto la alopecia o los cambios cutáneos postradicionales [cualquier grado], neuropatía periférica de grado ≤2 e hipotiroidismo de grado ≤2 estable con sustitución hormonal).
    13. El participante tiene, o tendrá, cualquiera de los siguientes:
    a. Un procedimiento quirúrgico invasivo con entrada en una cavidad corporal, dentro de las 4 semanas o sin recuperación completa antes de la primera administración del tratamiento del estudio. La toracocentesis, si es necesaria, y la biopsia percutánea para muestra de tejido tumoral de referencia pueden realizarse menos de 4 semanas antes de la primera administración del tratamiento del estudio, siempre y cuando el participante se haya recuperado adecuadamente del procedimiento antes de la primera dosis del tratamiento del estudio, según el criterio clínico del investigador
    b. Lesión traumática significativa dentro de las 3 semanas anteriores al inicio de la primera administración del tratamiento del estudio (todas las heridas deben estar completamente curadas antes del día 1)
    c. Cirugía mayor prevista mientras se está administrando el agente de investigación administrado o dentro de los 6 meses siguientes a la última dosis del tratamiento del estudio
    14. El participante ha recibido un medicamento en investigación (incluyendo vacunas en investigación, pero sin incluir la terapia anticancerosa) o ha utilizado un dispositivo médico invasivo en investigación dentro de las 6 semanas anteriores a la
    de la primera dosis prevista del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR)
    Tasa de respuesta objetiva (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks (±1 week) for the first 30 months, then every 12 weeks (±1 week) until disease progression during the treatment period
    Después de 8 semanas (±1 semana) durante los primeros 30 meses, luego cada 12 semanas (±1 semana) hasta la progresión de la enfermedad durante el período de tratamiento
    E.5.2Secondary end point(s)
    Duration of response (DoR), clinical benefit rate (CBR), and progression free survival (PFS) as determined by investigator, according to the Response Criteria in Solid Tumors (RECIST) Version 1.1
    Duración de la respuesta (DoR), tasa de beneficio clínico (CBR) y supervivencia libre de progresión (PFS) según lo determinado por el investigador, de acuerdo con los Criterios de Respuesta en Tumores Sólidos (RECIST) Versión 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 8 weeks (±1 week) for the first 30 months, then every 12 weeks (±1 week) until disease progression during the treatment period
    Después de 8 semanas (±1 semana) durante los primeros 30 meses, luego cada 12 semanas (±1 semana) hasta la progresión de la enfermedad durante el período de tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarker evaluation, Immunogenicity assessments,
    Quality of life
    Tolerabilidad, evaluación de biomarcadores, evaluaciones de inmunogenicidad, calidad de vida
    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) 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.8.2.4Number of treatment arms in the trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Canada
    China
    Korea, Republic of
    Malaysia
    Taiwan
    United States
    France
    Spain
    Germany
    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
    The end of study is considered as the last scheduled study assessment shown in the Schedule of Activities for the last participant in the study
    Se considera que el final del estudio es la última evaluación programada del estudio que aparece en el Programa de Actividades para el último participante en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 225
    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)
    Standard of care
    Estándar de cuidado
    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 Decision2022-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA