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    Summary
    EudraCT Number:2021-001716-29
    Sponsor's Protocol Code Number:SNX-301-020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-24
    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 number2021-001716-29
    A.3Full title of the trial
    A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour.
    Estudio de fase III, multicéntrico, aleatorizado y doble ciego para evaluar la seguridad y la eficacia de Emactuzumab frente a placebo en sujetos con tumor de células gigantes tenosinoviales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to Assess the Safety and Efficacy of Emactuzumab versus Placebo in Patients with Giant Cell Tumours.
    Un estudio para evaluar la seguridad y eficacia de Emactuzumab frente a placebo en pacientes con tumor de células gigantes
    A.3.2Name or abbreviated title of the trial where available
    TANGENT
    TANGENT
    A.4.1Sponsor's protocol code numberSNX-301-020
    A.5.4Other Identifiers
    Name:INDNumber:153633
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSynOx Therapeutics Ltd
    B.1.3.4CountryIreland
    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 supportSynOx Therapeutics Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinipace S.A.
    B.5.2Functional name of contact pointOfelia Rodriguez Nievas
    B.5.3 Address:
    B.5.3.1Street AddressRivadavia 755, Piso 3 Oficina E
    B.5.3.2Town/ cityCiudad Autónoma de Buenos Aires
    B.5.3.3Post codeC1002AAF
    B.5.3.4CountryArgentina
    B.5.4Telephone number54115352 0140
    B.5.6E-mailEUClinicalTrials@clinipace.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 nameEmactuzumab (RO5509554)
    D.3.2Product code RO5509554
    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 INNEMACTUZUMAB
    D.3.9.2Current sponsor codeRO5509554, RG7155
    D.3.9.3Other descriptive nameRO5509554, RG7155
    D.3.9.4EV Substance CodeSUB177212
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 placeboConcentrate and solvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tenosynovial Giant Cell Tumour
    Tumor de células gigantes tenosinoviales
    E.1.1.1Medical condition in easily understood language
    Giant Cell Tumours
    Tumor de células gigantes
    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 LLT
    E.1.2Classification code 10025564
    E.1.2Term Malignant giant cell tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the treatment effect of emactuzumab on objective response rate (ORR) by 6 months from initiation of therapy in the blinded phase compared to placebo.
    Calcular el efecto del tratamiento de emactuzumab en la tasa de respuesta objetiva (TRO) en los 6 meses desde el inicio del tratamiento en la fase enmascarada en comparación con placebo.
    E.2.2Secondary objectives of the trial
    -To estimate:
    The effect of emactuzumab on clinical outcome assessments (COAs) for:

    o Physical functioning
    o Range of motion (ROM)
    o Pain
    o Stiffness
    o Patient Global Impressions (PGIs)
    o QoL

    -Further antitumour activity of emactuzumab in TGCT compared to placebo.

    -Surgical Intervention Rate.

    -The Safety Objective of this study is to monitor subject wellbeing and assess treatment tolerability .

    -To assess the health economic impact of treatment with emactuzumab.

    -To further characterize the pharmacokinetic (PK) profile of emactuzumab.
    Los objetivos secundarios de eficacia del estudio son calcular:
    El efecto del emactuzumab en evaluaciones de resultados clínicos (ERC) para:
    o Función física
    o Rango de movimiento (RdM)
    o Dolor
    o Rigidez
    o Impresiones globales del paciente (IGP)
    o CdV

    Actividad antitumoral adicional del emactuzumab en la TGCT en comparación con placebo

    Tasa de intervención quirúrgica

    El objetivo de seguridad de este estudio es vigilar el bienestar de los sujetos y evaluar la tolerabilidad del tratamiento.

    Evaluar el impacto económico sanitario del tratamiento con emactuzumab

    Para determinar el perfil farmacocinético (FC) del emactuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Biopsy-confirmed (standard of care diagnosis history) local or diffuse TGCT where surgical resection would be associated with predicted worsening functional limitations due to surgical damage to the joint and adjacent soft tissues, and/or subject presents with an anticipated high risk of early recurrence as determined by a multidisciplinary tumour board or equivalent*, or any other morbidity associated with the surgery, and/or surgical treatment is not expected to improve the clinical outcomes of the
    subject.
    *The multidisciplinary tumour board or equivalent must comprise at least 2 individuals: the Investigator plus at least one other qualified physician (orthopaedic surgeon or medical oncologist) not involved in this study.
    3. Measurable disease: longest diameter ≥20 mm.
    4. Age >12 years.
    5. Adequate organ and bone marrow function: haemoglobin (Hb) >10.0 g/dL, neutrophils >1.5 × 109/L and platelets >100 × 109/L.
    6. Minimum mean score of 4 on NRS for Worst Pain during 7 days prior to randomization, based upon a minimum of 4 days of completed diary data.
    7. Minimum mean score of 4 on NRS for Worst Stiffness during 7 days prior to randomization, based upon a minimum of 4 days of completed diary data.
    data.
    8. Women of childbearing potential (WOCBP) must have a negative urine and serum pregnancy test prior to starting treatment. WOCBP must agree to use a highly effective method of contraception throughout the treatment period and for 7 months after
    discontinuation of treatment. Acceptable methods of contraception according to protocol description.
    9. For Open-Label Phase ONLY:
    Subjects must either:
    -Have responded based on RECIST v1.1 (CR or PR) to initial treatment with emactuzumab during the Double-Blind Phase and then progressed (objective progressive disease on imaging) within 9-18 months of initial treatment on D 1 (Visit 1) with a minimum 6-month washout period between treatments; or
    -Have received placebo and completed the 6-month visit on D 181/Visit 10 (3 months treatment and 3 months observation) of the Double-Blind Phase and have not completed more than 18 months of the study since initial treatment on D1 (Visit1).
    1. Consentimiento informado por escrito.
    2. TGCT local o difuso confirmado por biopsia (historial de diagnóstico estándar) en el que la resección quirúrgica se asociaría con un previsible empeoramiento de las limitaciones funcionales debido a los daños quirúrgicos en la articulación y los tejidos blandos adyacentes, y/o el sujeto presenta un alto riesgo anticipado de recidiva temprana según lo determinado por una junta tumoral multidisciplinar o equivalente*, o cualquier otra morbilidad asociada a la cirugía, y/o no se espera que el tratamiento quirúrgico mejore los resultados clínicos del del sujeto.
    *La junta tumoral multidisciplinar o equivalente debe estar formada por al menos dos personas: el investigador y al menos otro médico cualificado (cirujano ortopédico u oncólogo médico) que no participe en este estudio.
    3. Enfermedad medible: diámetro más largo ≥20 mm.
    4. Edad >12 años.
    5. Función orgánica y de médula ósea adecuada: hemoglobina (Hb) >10,0 g/dL, neutrófilos >1,5 × 109/L y plaquetas >100 × 109/L.
    6. Puntuación media mínima de 4 en la NRS del peor dolor durante los 7 días anteriores a la aleatorización,
    basada en un mínimo de 4 días de datos diarios completados.
    7. Puntuación media mínima de 4 en la NRS para la peor rigidez durante los 7 días anteriores a la aleatorización, basada en un mínimo de 4 días de datos diarios completados.
    8. Las mujeres en edad fértil (MEEF) deben tener una prueba de embarazo negativa en orina y suero negativos antes de iniciar el tratamiento. Las MEEF deben
    aceptar utilizar un método anticonceptivo altamente eficaz durante todo el periodo de tratamiento y durante los 7 meses siguientes a la descontinuación del tratamiento.
    Métodos anticonceptivos aceptables según la descripción del protocolo.
    9. Únicamente para la fase abierta:
    Los sujetos deben:
    -Haber respondido según RECIST v1.1 (RC o PR) al tratamiento inicial con emactuzumab durante la Fase Doble Ciego y luego haber progresado (enfermedad progresiva objetiva en las imágenes) dentro de los 9-18 meses del tratamiento inicial en D 1 (Visita 1) con un período de lavado mínimo de 6 meses entre los tratamientos; o
    -Haber recibido placebo y completado la visita de 6 meses en D 181/Visita 10 (3 meses de tratamiento y 3 meses de observación) de la fase doble ciego y no haber completado más de 18 meses del estudio desde el tratamiento inicial en D1 (Visita1).
    E.4Principal exclusion criteria
    1. Pregnant or breast feeding.
    2. Medical conditions, including auto-immune, requiring systemic immunosuppression. Any systemic treatment for these conditions (eg, glucocorticoids) is not allowed within 4 weeks of Screening and during the study. All Lupus Erythematosus are excluded
    irrespective of treatment.
    3. Metastatic TGCT.
    4. TGCT currently affecting multiple joints.
    5. Pexidartinib therapy within 3 months of Screening.
    6. Nilotinib, imatinib; other chemotherapy, radiotherapy, or investigational therapy within 4 weeks of Screening.
    7. Unresolved clinically significant toxicity from a previous treatment or any history of serious liver toxicity.
    8. Current or chronic history of liver disease. This includes, but is not limited to, hepatitis virus infections, drug- or alcohol-related liver disease, nonalcoholic steatohepatitis, autoimmune hepatitis, haemochromatosis, Wilson’s disease, α-1 antitrypsin deficiency,
    primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease which in the opinion of the Investigator is considered clinically significant.
    9. Renal function: creatinine clearance <60 mL/min (Cockcroft-Gault
    formula).
    10. Liver function: ALT >3.0 × ULN; OR total bilirubin >1.5 × ULN.
    11. Within 6 months of baseline has experienced: clinically significant myocardial infarction, severe/unstable angina pectoris, congestive heart failure New York Heart Association
    (NYHA) Class III or IV, or pulmonary disease (NYHA Criteria 1994).
    12. Clinically significant active infection requiring systemic antibiotic treatment.
    Rescreening may occur any time after 7 days post completion of treatment.
    13. Systemic antiretroviral therapy within 3 months of baseline.
    14. Other active cancer that requires concurrent treatment or history of malignancy other than TGCT, unless there is the expectation that the malignancy has been cured, and tumor
    specific treatment for the malignancy has not been administered within the previous 5 years.
    15. Planned surgery during the course of the study with the exception of dental treatment.
    16. Inability to comply with the study procedures.
    17. For the Double-Blind Phase ONLY:
    Previous exposure to emactuzumab and/or neutralizing antibodies.
    1. Embarazada o en periodo de lactancia.
    2. Condiciones médicas, incluidas las autoinmunes, que requieran inmunosupresión sistémica. Cualquier tratamiento sistémico para estas condiciones (por ejemplo, glucocorticoides) no está permitido dentro de 4 semanas antes de la selección y durante el estudio. Se excluyen todos los lupus eritematosos
    independientemente del tratamiento.
    3. TGCT metastásico.
    4. TGCT que actualmente afecta a múltiples articulaciones.
    5. Terapia con pexidartinib en los 3 meses anteriores a la selección.
    6. Nilotinib, imatinib; otra quimioterapia, radioterapia o terapia de investigación dentro de las 4 semanas antes de la selección.
    7. Toxicidad clínicamente significativa no resuelta de un tratamiento anterior o cualquier antecedente de toxicidad hepática grave.
    8. Antecedentes actuales o crónicos de enfermedad hepática. Esto incluye, pero no se limita a, infecciones por el virus de la hepatitis, enfermedades hepáticas relacionadas con el alcohol o los medicamentos, esteatohepatitis no alcohólica
    hepatitis autoinmune, hemocromatosis, enfermedad de Wilson, deficiencia de α-1 antitripsina, colangitis biliar primaria, colangitis esclerosante primaria o cualquier otra enfermedad hepática que a juicio del Investigador se considere clínicamente significativa.
    9. Función renal: aclaramiento de creatinina <60 mL/min (fórmula de Cockcroft-Gault).
    10. Función hepática: ALT >3,0 × ULN; O bilirrubina total >1,5 × ULN.
    11. En los 6 meses anteriores al inicio del estudio ha experimentado: infarto de miocardio clínicamente significativo,
    angina de pecho grave/inestable, insuficiencia cardíaca congestiva New York Heart Association (NYHA) Clase III o IV, o enfermedad pulmonar (Criterios NYHA 1994).
    12. Infección activa clínicamente significativa que requiera tratamiento antibiótico sistémico.
    La reselección puede ocurrir en cualquier momento después de 7 días posterior a la finalización del tratamiento.
    13. Terapia antirretroviral sistémica dentro de los 3 meses anteriores a la visita basal.
    14. Otro cáncer activo que requiera tratamiento concurrente o historia de malignidad que no sea TGCT, a menos que se espere que la neoplasia se haya curado, y el tratamiento específico del tumor tratamiento específico para el tumor no se haya administrado en los últimos 5 años.
    15. Cirugía planificada durante el curso del estudio, con la excepción de un tratamiento dental.
    16. Incapacidad para cumplir con los procedimientos del estudio.
    17. Únicamente para la fase de doble ciego:
    Exposición previa a emactuzumab y/o anticuerpos neutralizantes.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy objective of this study is to estimate the treatment effect of emactuzumab on objective response rate (ORR) by 6 months from initiation of therapy in the blinded phase compared to placebo.
    El objetivo primario de eficacia de este estudio es estimar el efecto del tratamiento
    efecto del tratamiento de emactuzumab en la tasa de respuesta objetiva (TRO) a los 6 meses desde el inicio de la terapia en la fase ciega en comparación con el placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR by 6 months from initiation of therapy based on independent, blinded central review.
    TRO a los 6 meses del inicio del tratamiento según una revisión central independiente y ciega, revisión central ciega.
    E.5.2Secondary end point(s)
    Change in Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) TGCT from baseline to 6 months.

    Other secondary endpoints:
    -Change in PROMIS-PF TGCT from baseline over time.
    -Physician/Healthcare Professional (HCP)-Reported Joint Mobility Score by goniometry from baseline over time.
    -Change in Worst Pain Numerical Rating Scale (NRS) from baseline over time.
    -Change in Short Form 12-Item Survey version 2 (SF-12 v2) from baseline over time.
    -Change in Worst Stiffness NRS from baseline over time.
    -PGI of change and severity over time.
    -Change in EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L) from baseline over time.
    -Duration of response (DoR) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 based on independent, blinded central review.
    -Disease control rate (DCR) as measured by RECIST v1.1 based on independent, blinded central review
    -Time to progression as measured by RECIST v1.1 based on independent, blinded central review.
    -Change in Tumour volume score (TVS) from baseline over time.
    -Surgical intervention rate, defined as the number of subjects who undergo surgery for TGCT during the study.
    -AEs.
    -Deaths.
    -Any laboratory abnormalities.
    Cambio en el sistema de información de medición de resultados comunicados por el paciente TGCT de función física (PROMIS-FF) desde el periodo basal hasta los 6 meses.

    • Cambio en PROMIS-FF TGCT entre el período basal y a lo largo del tiempo
    • Puntuación de movilidad articular comunicada por el médico/profesional sanitario por goniometría entre el período basal y a lo largo del tiempo
    • Cambio en la escala de valoración numérica del peor dolor (EVN) entre el periodo basal y a lo largo del tiempo
    • Cambio en el cuestionario abreviado de 12 ítems versión 2 (SF-12 v2) desde el periodo basal y a lo largo del tiempo
    • Cambio en la EVN de peor rigidez desde el periodo basal y a lo largo del tiempo
    • IGP de cambio y gravedad a lo largo del tiempo
    • Cambio en el cuestionario EuroQoL de 5 dimensiones, cuestionario de 5 niveles (EQ-5D-5L) desde el período basal y a lo largo del tiempo
    • Duración de la respuesta (DR), medida mediante los criterios de evaluación de la respuesta en tumores sólidos (RECIST) versión 1.1 basado en una revisión central ciega e independiente
    • Tiempo hasta la progresión según lo medido por RECIST v1.1 basado en una revisión central ciega e independiente
    • Cambio en la puntuación del volumen tumoral (TVS) desde el periodo basal y a lo largo del tiempo
    Tasa de intervención quirúrgica: definida como el número de los sujetos que se someten a una intervención quirúrgica durante el estudio para TGCT.
    • AA
    • Muerte
    • Cualquier anomalía analítica
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline over time.
    Entre el período basal y a lo largo del tiempo
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) 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 EEA45
    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
    Canada
    United States
    Austria
    France
    Poland
    Sweden
    Netherlands
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    United Kingdom
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    A subject is considered to have completed the study if he/she has completed all periods of the study including the last visit.
    El final del estudio se define como la fecha de la última visita del último sujeto del estudio.
    Se considera que un sujeto ha finalizado el estudio si ha completado todos los periodos del del estudio, incluida la última visita.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3
    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: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors from 12 to 17 years old
    Menores de 12 a 17 años
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 160
    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 Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
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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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