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    Summary
    EudraCT Number:2020-003566-39
    Sponsor's Protocol Code Number:NN9500-4656
    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:2021-07-27
    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 number2020-003566-39
    A.3Full title of the trial
    Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial
    Investigación de la eficacia y la seguridad de NNC0194-0499 administrado conjuntamente con semaglutida en pacientes con esteatohepatitis no alcohólica: ensayo de búsqueda de dosis y controlado con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study on whether a combination of 2 medicines (NNC0194-0499 and semaglutide) works in people with non-alcoholic steatohepatitis (NASH)
    Estudio de investigación para determinar si una combinación de 2 medicamentos (NNC0194-0499 y semaglutida) funciona en personas con esteatohepatitis no alcohólica (EHNA)
    A.4.1Sponsor's protocol code numberNN9500-4656
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1255-5551
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Transparency (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNNC0194-0499 B 50 mg/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number *MASKED*
    D.3.9.3Other descriptive nameNNC0194-0499
    D.3.9.4EV Substance CodeSUB185034
    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 nameSemaglutide B 3 mg/mL PDS290
    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 INNSEMAGLUTIDE
    D.3.9.1CAS number 910463-68-2
    D.3.9.3Other descriptive nameSEMAGLUTIDE
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.3.2Product code NNC0174-0833 A 10 mg/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number *MASKED*
    D.3.9.3Other descriptive nameNNC0174-0833
    D.3.9.4EV Substance CodeSUB90530
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Non-alcoholic steatohepatitis
    Esteatohepatitis no alcohólica
    E.1.1.1Medical condition in easily understood language
    Non-alcoholic steatohepatitis (NASH)
    Esteatohepatitis no alcohólica (EHNA)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the effect of NNC0194-0499 30 mg once weekly in combination with semaglutide 2.4 mg once weekly versus placebo once weekly on fibrosis in subjects with NASH and fibrosis stage 2−4 (F2−F4).
    Confirmar el efecto de 30 mg de NNC0194-0499 una vez a la semana en combinación con 2,4 mg de semaglutida una vez a la semana en comparación con placebo una vez a la semana sobre la fibrosis en pacientes con EHNA y fibrosis en estadio 2−4 (F2−F4).
    E.2.2Secondary objectives of the trial
    In subjects with NASH and F2−F4:
    • To investigate the dose-response relationship of NNC0194-0499 (7.5 mg, 15 mg and 30 mg) once weekly in combination with semaglutide 2.4 mg once weekly on liver histology and tolerability.
    • To investigate the safety and tolerability of NNC0194-0499 30 mg once weekly alone, NNC0194-0499 7.5 mg, 15 mg and 30 mg once weekly in combination with semaglutide 2.4 mg once weekly and NNC0174-0833 2.4 mg once weekly in combination with semaglutide 2.4 mg once weekly.
    En sujetos con EHNA y F2−F4:
    • Investigar la relación dosis-respuesta de NNC0194-0499 (7,5 mg, 15 mg y 30 mg) una vez a la semana en combinación con 2,4 mg de semaglutida una vez a la semana sobre la histología hepática y la tolerabilidad.
    • Investigar la seguridad y la tolerabilidad de 30 mg de NNC0194-0499 una vez a la semana en monoterapia, de 7,5 mg, 15 mg y 30 mg de NNC0194-0499 una vez a la semana en combinación con 2,4 mg de semaglutida una vez a la semana y de 2,4 mg de NNC0174-0833 una vez a la semana en combinación con 2,4 mg de semaglutida una vez a la semana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged greater than or equal to 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged greater than or equal to 19 years. In Japan, subjects must be aged greater than or equal to 20 years. In Singapore, subjects must be aged greater than or equal to 21 years.
    - Histological evidence of non-alcoholic steatohepatitis (NASH) based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to visit 1.
    - Histological evidence of fibrosis stage 2, 3 or 4 according to the Non-alcoholic Steatohepatitis Clinical Research Network (NASH CRN) classification based on a central pathologist evaluation of the baseline liver biopsy.
    - Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greater than or equal to 4 for subjects with F2/F3 or greater than or equal to 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.
    • 18 años o más en el momento de firmar el documento de consentimiento informado. En la República de Corea, los sujetos deberán tener una edad de 19 años o más. En Japón, los sujetos deberán tener 20 años o más. En Singapur, los sujetos deberán tener 21 años o más.
    • Signos histológicos de esteatohepatitis no alcohólica (EHNA) según la evaluación de la biopsia hepática basal realizada por un anatomopatólogo central. La biopsia hepática basal puede ser una biopsia previa obtenida en los 180 días previos a la visita 1.
    • Signos histológicos de fibrosis en estadio 2, 3 o 4 según la clasificación de la Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) basados en la evaluación de la biopsia hepática basal realizada por un anatomopatólogo central.
    • Puntuación histológica de actividad de la enfermedad por hígado grado no alcohólica (EHGNA) (NAS) igual o mayor a 4 en los sujetos con F2/F3 o mayor o igual a 3 en los sujetos con F4 según la evaluación realizada por un anatomopatólogo central de la biopsia hepática basal. Todos los sujetos deberán tener una puntuación de 1 o más en esteatosis, inflamación lobulillar y balonización de los hepatocitos.
    E.4Principal exclusion criteria
    - Documented causes of chronic liver disease other than NAFLD.
    - Positive Hepatitis B surface antigen (HBsAg), positive anti-human immunodeficiency virus (HIV), positive hepatitis C virus ribonucleic acid (HCV RNA) at screening visit 2A (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
    - Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.
    - Presence or history of gastro-oesophageal varices greater than or equal to grade 2 at V2A. For subjects with F4, an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be available at V2A.
    - Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
    - Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
    - Treatment with glucagon-like peptide-1 receptor agonist (GLP-1 RAs) within 90 days prior to V2A. Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until V2A.
    - Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
    - Causas documentadas de hepatopatía crónica distinta de EHGNA.
    - Positividad para antígeno de superficie de Hepatitis B (HBsAg), positividad para anticuerpos del virus de la inmunodeficiencia humana (VIH), positividad para el ácido ribonucleico del virus de la hepatitis C (ARN VHC) en la visita de selección 2A (V2A) o cualquier presencia conocida de ARN del VHC o HBsAg en los dos años previos a la selección (V2A).
    -Presencia o antecedentes de ascitis superior a grado 1, hemorragia por varices, encefalopatía hepática, peritonitis bacteriana espontánea o trasplante de hígado en la V2A.
    -Presencia o antecedentes de varices gastroesofágicas de grado mayor o igual a 2 en la V2A. En los pacientes con F4 en la V2A deberá disponerse de una esofagogastroduodenoscopia realizada no más de 52 semanas antes de la V2A.
    -Confirmación o sospecha de consumo excesivo de alcohol (superior a 20 g/día en las mujeres o superior a 30 g/día en los varones) o dependencia del alcohol (evaluado mediante la prueba de identificación de Trastornos Relacionados con el Consumo de Alcohol [cuestionario AUDIT]).
    -Tratamiento con vitamina E (en dosis igual o superior a 800 UI/día) o pioglitazona o medicamentos autorizados para el tratamiento de la EHNA que, en opinión del investigador, no se hayan mantenido en una dosis estable en el período correspondiente a los 90 días previos a la V2A. Además, en los pacientes con biopsias hepáticas previas obtenidas más de 90 días antes de la V2A, el tratamiento deberá haberse administrado en una dosis estable, en opinión del investigador, desde el momento de la biopsia hasta la V2A.
    -Tratamiento con agonista del receptor similar al glucagón tipo 1 (AR GLP-1) en los 90 días previos a la V2A. Se excluirá a los sujetos con una biopsia hepática previa obtenida más de 90 días previos a la V2A si reciben tratamiento con AR GLP-1 desde el momento de la biopsia hasta la V2A.
    -Tratamiento con hipoglucemiantes (distintos de los AR GLP-1), hipolipemiantes o medicación para perder peso que, en opinión del investigador, no se hayan mantenido en dosis estables en los 90 días previos a la V2A. Además, en los pacientes con biopsias hepáticas previas obtenidas más de 90 días previos a la V2A, el tratamiento deberá haberse administrado en una dosis estable, en opinión del investigador, desde el momento de la biopsia hasta la V2A.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in liver fibrosis and no worsening of NASH (Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale. No worsening of NASH is defined as no increase from baseline in NAS score for ballooning, inflammation or steatosis.) (Yes/No)
    Mejoría de la fibrosis hepática y ausencia de empeoramiento de la EHNA (La mejoría de la fibrosis se define como una mejoría ≥1 grado en la escala de fibrosis de la CRN en la EHNA. Ningún empeoramiento de la EHNA se define como la ausencia de aumento de la puntuación NAS de balonización, inflamación o esteatosis con respecto al momento basal.) (Sí/No)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (week 0) to week 52
    Entre el momento basal (semana 0) y la semana 52.
    E.5.2Secondary end point(s)
    1. Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
    2. Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis(Yes/No)
    3. Change in histology-assessed liver collagen proportionate area
    4. Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
    5. Improvement in liver fibrosis (Yes/No)
    6. Progression of liver fibrosis (Yes/No)
    7. Worsening in steatohepatitis (Yes/No)
    8. Improvement in ballooning (Yes/No)
    9. Improvement in inflammation (Yes/No)
    10. Improvement in steatosis (Yes/No)
    11. Change in ALT (alanine aminotransferase)
    12. Change in AST (aspartate aminotransferase)
    13. Change in inflammation assessed by HsCRP (high sensitivity C-reactive protein)
    14. Change in (Enhanced Liver Fibrosis) ELF score
    15. Change in (glycated haemoglobin) HbA1c
    16. Change in triglycerides
    17. Change in free fatty acids
    18. Change in low density lipoprotein (LDL) cholesterol
    19. Change in high density lipoprotein (HDL) cholesterol
    20. Relative change in body weight
    21. Change in (36-item Short Form Survey) SF-36 bodily pain
    22. Change in Patient reported outcome measure for non-alcoholic steatohepatitis (NASH-CHECK) pain
    23. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score
    24. Number of treatment emergent adverse events (TEAEs)
    1. Resolución de la esteatohepatitis y ausencia de empeoramiento de la fibrosis hepática (Sí/No)
    2. Mejora de la esteatohepatitis con al menos reducción de 2 puntos en la escala NAS y ausencia de empeoramiento de la fibrosis (Sí/No)
    3. Cambio en el área proporcional de colágeno hepático evaluada por histología
    4. Resolución de la esteatohepatitis y mejoría de la fibrosis hepática (Sí/No)
    5. Mejoría de la fibrosis hepática (Sí/No)
    6. Progresión de la fibrosis hepática (Sí/No)
    7. Empeoramiento de la esteatohepatitis (Sí/No)
    8. Mejoría de balonización (Sí/No)
    9. Mejoría de inflamación (Sí/No)
    10. Mejoría de esteatosis (Sí/No)
    11. Cambio en ALT (alanina aminotransferasa)
    12. Cambio en AST (aspartato aminotransferasa)
    13. Cambio en inflamación evaluado por HsCRP (high sensitivity C-reactive protein)
    14. Cambio en la escala ELF (Enhanced Liver Fibrosis)
    15. Cambio en la HbA1c
    16. Cambio en los triglicéridos
    17. Cambio en los ácidos grasos libres
    18. Cambio en el colesterol LDL
    19. Cambio en el colesterol HDL
    20. Cambio relativo en el peso corporal
    21. Cambio en dolor corporal en el formulario SF-36 (encuesta de formulario corto de 36 ítems)
    22. Cambio en el dolor en el Cuestionario de Esteatohepatitis No Alcohólica para pacientes (NASH-CHECK)
    23. Cambio en la puntuación de fatiga en el Patient-Reported Outcomes Measurement Information System (PROMIS)
    24. Número de acontecimientos adversos emergentes del tratamiento (TEAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-23. From baseline (week 0) to week 52
    24. From baseline (week 0) to week 59
    1.-23. Entre el momento basal (semana 0) y la semana 52.
    24. Entre el momento basal (semana 0) y la semana 59.
    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 No
    E.6.7Pharmacodynamic No
    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
    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 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 trial10
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Russian Federation
    Singapore
    United States
    European Union
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days13
    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: 504
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 672
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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