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    EudraCT Number:2021-001253-32
    Sponsor's Protocol Code Number:HZNP-HZN-825-303
    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:2021-12-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-001253-32
    A.3Full title of the trial
    A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis
    Ensayo de fase 2b multicéntrico, aleatorizado, doble ciego, controlado con placebo y con dosis múltiples para evaluar la eficacia, la seguridad y la tolerabilidad de HZN-825 en sujetos con fibrosis pulmonar idiopática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis
    Un estudio para evaluar la eficacia, seguridad y tolerabilidad del HZN-825 en sujetos con fibrosis pulmonar idiopática
    A.4.1Sponsor's protocol code numberHZNP-HZN-825-303
    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 SponsorHorizon Therapeutics Ireland DAC
    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 supportHorizon Therapeutics U.S.A., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHorizon Therapeutics U.S.A., Inc.
    B.5.2Functional name of contact pointFarah Ali
    B.5.3 Address:
    B.5.3.1Street Address1 Horizon Way
    B.5.3.2Town/ cityDeerfield, IL
    B.5.3.3Post code60015
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034900834223
    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.3.2Product code HZN-825
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHZN-825
    D.3.9.2Current sponsor codeHZN-825
    D.3.9.3Other descriptive nameSAR100842
    D.3.9.4EV Substance CodeSUB31268
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.1Medical condition in easily understood language
    A condition in which the lungs become scarred and breathing becomes increasingly difficult.
    Una afección en la que los pulmones se cicatrizan y la respiración se vuelve cada vez más difícil.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the efficacy of 2 dose regimens of HZN-825 versus placebo in subjects with IPF, as determined by a comparison of change in forced vital capacity (FVC) % predicted after 52 weeks of treatment.
    El objetivo principal consiste en demostrar la eficacia de dos pautas posológicas de HZN-825, en comparación con un placebo, en sujetos con FPI, determinada mediante una comparación de la variación de la capacidad vital forzada (FVC), expresada como porcentaje del valor teórico, después de 52 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    1.Evaluate the effect of 2 dose regimens of PR1 vs PL1 on subjects with decline in FVC% predicted ≥10% from Baseline after 52 wk of treatment.
    2.Evaluate the effect of 2 dose regimens of PR1 vs PL1 on the changes from Baseline in the 6MWT after 52 wk of treatment.
    3.Evaluate the effect of 2 dose regimens of PR1 vs PL1 on the K-BILD after 52 wk of treatment.
    4.Evaluate the effect of 2 dose regimens of PR1 vs PL1 on the L-IPF after 52 wk of treatment.
    5.Evaluate the effect of 2 dose regimens PR1 vs PL1 on the LCQ after 52 wk of treatment.
    6.Evaluate the effect of 2 dose regimens of PR1 vs PL1 on the rate of hospitalization due to respiratory distress up to 52 wk of treatment.
    7.Evaluate the effect of 2 dose regimens of PR1 vs PL1 on the composite endpoint of PFS, where progression includes decline in FVC% predicted ≥10% from Baseline or death over 52 wk of treatment.
    8.Assess safety and tolerability of PR1 based on AEs, SAEs and AESI.
    9.Evaluate the PK of PR1 and metabolite(s).
    1.Efecto de 2 pautas de PR1 vs PL1 en sujetos con disminución de la FVC ≥10 % del valor teórico con respecto al momento basal después de 52 semanas de tto.2.Efecto de 2 pautas de PR1 vs PL1 en la variación en la prueba de marcha de 6min con respecto al momento basal después de 52sem de tto.3.Efecto de 2 pautas de PR1 vs PL1 en cuestionario K-BILD después de 52sem de tto.4.Efecto de 2 pautas de PR1 vs PL1 en cuestionario L-IPF después de 52sem de tto.5.Efecto de 2 pautas de PR1 vs PL1 en cuestionario LQC después de 52sem de tto.6.Efecto de 2 pautas de PR1 vs PL1 en tasa de hosp por dificultad respiratoria durante 52sem de tto.7.Efecto de 2 pautas de PR1 vs PL1 en criterio de valoración combinado de supervivencia libre de progresión (SLP), de modo que la progresión consiste en una disminución de FVC ≥10 % del valor teórico con respecto al momento basal o la muerte, durante 52sem de tto.8.Seguridad y tolerabilidad de PR1 basándose en los AA, AAG y AAIE.9. FC de PR1 y sus metabolitos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Male or female between the ages of 18 and 80 years, inclusive, at Screening.
    3. Current diagnosis of IPF, as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines [Raghu et al., 2018] and determined by central review; the date of initial diagnosis of IPF should be ≥1 year to ≤7 years prior to Screening.
    4. Not currently being treated with specific IPF therapy for the reasons below:
    a. intolerant or not responsive to approved IPF therapies
    b. ineligible to receive approved IPF therapies
    c. declines approved IPF therapies
    5. Lung HRCT historically performed within 6 months prior to the Screening Visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT. If an evaluable HRCT is not available within 6 months prior to Screening, an HRCT will be performed at Screening to determine eligibility, according to the same requirements as the historical HRCT.
    6. HRCT shows ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing and the extent of
    fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (central reviewer determined).
    7. Meets all of the following criteria during the Screening Period:
    a. FVC ≥45% and ≤80% predicted of normal
    b. forced expiratory volume in 1 second (FEV1)/FVC ≥0.7
    c. DLCO corrected for hemoglobin is ≥30% and ≤90% predicted of normal
    8. Estimated minimum life expectancy of ≥30 months for non-IPF-related disease, in the opinion of the Investigator.
    9. Vaccinations are up to date given age, comorbidities (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]), pneumococcal pneumonia, herpes zoster, tetanus) and local availability prior to trial drug dosing.
    10. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the
    1.Consentimiento informado por escrito.
    2.Varón o mujer de entre 18 y 80 años, ambos inclusive, en el momento de la selección.
    3.Diagnóstico actual de FPI, según la definición de las directrices de la Sociedad Torácica Estadounidense (ATS)/Sociedad Europea de Medicina Respiratoria (ERS)/Sociedad Japonesa de Medicina Respiratoria (JRS)/Asociación Latinoamericana de Tórax (ALAT) [Raghu y cols., 2018] y determinado mediante una revisión central; la fecha del diagnóstico inicial de la FPI debe estar comprendida entre ≥ 1 año y ≤ 7 años antes de la selección.
    4.No estar recibiendo actualmente tratamiento específico para la FPI por los motivos siguientes:
    a.No tolera o no responde a los tratamientos aprobados para la FPI.
    b.No es apto para recibir los tratamientos aprobados para la FPI.
    c.Rechaza los tratamientos aprobados para la FPI.
    5.TCAR pulmonar histórica realizada en los 6 meses previos a la visita de selección y conforme a los requisitos mínimos para el diagnóstico de FPI según una revisión centralizada basada en la TCAR del sujeto. Si no se dispone de una TCAR evaluable en los 6 meses previos a la selección, se realizará una TCAR en la selección para determinar la elegibilidad, con arreglo a los mismos requisitos que la TCAR histórica.
    6.La TCAR muestra fibrosis parenquimatosa (reticulación) ≥10 % y <50 % y un patrón en panal de abeja <25 %, y el grado de las alteraciones fibróticas es mayor que el grado de enfisema en la TCAR más reciente (determinado por un evaluador central).
    7.Cumple todos los criterios siguientes durante el período de selección:
    a.FVC ≥45 % y ≤80 % del valor teórico normal.
    b.Volumen espiratorio forzado en el primer segundo (FEV1)/FVC ≥0,7.
    c.DLCO corregida en función de la hemoglobina ≥30 % y ≤90 % del valor teórico normal.
    8.Esperanza de vida mínima estimada ≥ 30 meses por enfermedades no relacionadas con la FPI, en opinión del investigador.
    9.Vacunas al día teniendo en cuenta la edad, las enfermedades concomitantes (p. ej., coronavirus 2 del síndrome respiratorio agudo grave [SARS-CoV-2]), neumonía neumocócica, herpes zóster, tétanos) y la disponibilidad local antes de la administración del fármaco del ensayo.
    10.Disposición y capacidad para cumplir el protocolo de tratamiento prescrito y las evaluaciones durante todo el ensayo.
    E.4Principal exclusion criteria
    1. Any of the following cardiovascular diseases:
    a. uncontrolled, severe hypertension (≥160/100 mmHg), within 6 months of Screening
    b. myocardial infarction within 6 months of Screening
    c. unstable cardiac angina within 6 months of Screening
    2. Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis and coronavirus disease 2019 [COVID-19]), connective tissue disorders (e.g., rheumatoid arthritis, systemic
    lupus erythematosus, Sjogren’s, dermatomyositis, scleroderma), exposures (e.g., radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone).
    3. Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed). The subject must be 3 months beyond any acute infection with COVID-19 if there has been a prior infection.
    4. Clinically significant pulmonary hypertension requiring chronic medical therapy.
    5. Use of any of the following therapies within 4 weeks prior to Screening, during the Screening Period or planned during the trial: prednisone at steady dose >10 mg/day or equivalent or cyclosporine A. Prednisone ≤10 mg/day (or equivalent dosing of glucocorticoids) is allowed. Treatment with any other immunosuppressant during the Screening Period through the end of trial participation will require consultation with and approval by the trial Medical Monitor.
    6. Use of rifampin within 2 weeks prior to Day 1 or planned during the trial.
    7. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
    8. Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. Women are considered of childbearing potential if they are not postmenopausal and not surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy or hysterectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    9. Pregnant or lactating women and women who plan to become pregnant or breast feed during the trial and within 1 month after the last dose of trial drug.
    10. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the subject.
    11. Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial.
    12. Known history of positive test for human immunodeficiency virus.
    13. Active hepatitis (hepatitis B: positive hepatitis B surface antigen and positive anti-hepatitis B core antibody [anti-HBcAb] and negative hepatitis B surface antibody [HBsAb] or positive for HBcAb with a positive test for HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis C virus [anti-HCV] and positive RNA HCV).
    14. Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis.
    15. Previous organ transplant (including allogeneic and autologous marrow transplant).
    16. International normalized ratio >2, prolonged prothrombin time >1.5 × the upper limit of normal (ULN) or partial thromboplastin time >1.5 × ULN at Screening.
    17. Alanine aminotransferase or aspartate aminotransferase >2.0 × ULN.
    18. Estimated glomerular filtration rate <30 mL/min/1.73 m2 at Screening.
    19. Total bilirubin >2 × ULN. Subjects with documented diagnosis of Gilbert’s syndrome may be enrolled if their total bilirubin is ≤3.0 mg/dL.
    20. Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment according to the Child-Pugh scoring system.
    21. Any verified Grade 4 laboratory abnormality.
    22. Any acute laboratory abnormality at Screening that, in the opinion of the Investigator, would preclude the subject’s participation in the trial.
    23. Exposure to an experimental drug (with the exception of HZN-825) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is the longest, prior to Day 1.
    24. Any other condition that, in the opinion of the Investigator, would preclude enrollment in the trial.
    1.Presencia de alguna de las siguientes enf cardiovasculares:a.Hipertension grave no controlada (≥160/100 mm Hg) en 6 meses previos a selección.b.Infarto de miocardio en los 6 meses previos a selección.c.Angina de pecho inestable en los 6 meses previos a selección.2.Enf pulmonar intersticial asociada a enf primarias conocidas (por ej sarcoidosis, amiloidosis y enf por COVID-19, trastornos del tej conjuntivo (por ej, artritis reumatoide, lupus eritematoso sistémico, síndr de Sjögren, dermatomiositis o esclerodermia), exposiciones (por ej, radiación, sílice, amianto y polvo de carbón) o fármacos (por ej, amiodarona).3.Infec activa conocida por bacterias, virus, hongos, micobacterias u otros microorganismos, incluida tuberculosis y enf por micobacterias atípicas (se permiten micosis de lechos ungueales). Deberán haber pasado 3 meses desde cualquier infec aguda por COVID-19 en caso de que el paciente haya sufrido infec previa.4.HT pulmonar clínicamente significativa con necesidad de tto médico crónico.5.Uso de cualquiera de los ttos siguientes en las 4 semanas previas a selección o durante la selección o uso previsto durante el ensayo: prednisona en dosis estable >10 mg/día o equivalente o ciclosporina A. Se permite el uso de prednisona en dosis ≤10 mg/día (o dosis equivalente de glucocorticoides). El tto con cualquier otro inmunodepresor durante la selección y hasta el final del ensayo requerirá consulta y aprobación del médico del ensayo.6.Uso de rifampicina en las 2sem previas al Día1 o uso previsto durante el ensayo.7.Neoplasia maligna en los últ 5años (excepto carcinoma basocelular o espinocelular de la piel tratado con éxito o cáncer de cuello uterino in situ).8.Mujeres en edad fértil o varones que no acepten utilizar métodos anticonceptivos muy eficaces durante todo el ensayo y durante 1mes después de recibir la últ dosis del fco del ensayo. Los varones deberán abstenerse de donar semen y las mujeres, de donar óvulos durante ese mismo período. Se considerará en edad fértil a las mujeres que no sean posmenopáusicas y no estén esterilizadas quirúrgicamente (salpingectomía bilateral, ovariectomía bilateral o histerectomía documentadas). El estado posmenopáusico se define como 12meses sin menstruación sin una causa médica alternativa. Se puede utilizar una concentración alta de FSH en el intervalo posmenopáusico para confirmar el estado posmenopáusico en mujeres que no usen anticonceptivos hormonales ni tto hormonal sustitutivo. No obstante, cuando no haya habido 12meses de amenorrea, una única determinación de la FSH es insuficiente. Se considera fértil a todo varón después de la pubertad, a menos que haya sido esterilizado de forma permanente mediante una orquiectomía bilateral.9.Mujeres embarazadas o lactantes y mujeres que tengan previsto quedarse embarazadas o dar el pecho durante el ensayo y en el mes siguiente a la últ dosis del fco del ensayo.10.Abuso actual de drogas o alcohol o antecedentes de cualquiera de ellos en los 2años previos, en opinión del investigador o según lo indicado por el sujeto.11.Inscripción previa en este ensayo o participación en ensayo clínico previo de HZN-825 o SAR100842.12.Antecedentes de un resultado positivo en prueba del VIH.13.Hepatitis activa (Hepatitis B: Ag de superficie del VHB positivo, Ac contra el Ag central del VHB [anti-HBc] positivos y Ac contra el Ag de superficie del VHV [anti-HBs] negativos o anti-HBc positivos con anti-HBs positivos y presencia de ADN del VHB en el período de selección; hepatitis C: Ac contra el VHC [anti-VHC] positivos y ARN del VHC positivo).14.Presencia de hepatopatía alcohólica, cirrosis biliar primaria o colangitis esclerosante primaria. 15.Trasplante de órgano previo (incluidos el alotrasplante y el autotrasplante de médula ósea). 16.Cociente internacional normalizado >2, tiempo de protrombina prolongado >1,5 veces el límite superior de la normalidad (LSN) o tiempo de tromboplastina parcial >1,5 veces el LSN en el período de selección. 17.Alanina aminotransferasa o aspartato aminotransferasa >2,0 veces el LSN. 18.Filtración glomerular estimada <30 ml/min/1,73 m2 en el período de selección. 19.Bilirrubina total >2 veces el LSN. Podrán participar sujetos con diagnóstico documentado de síndrome de Gilbert en caso de que la bilirrubina total sea ≤3,0 mg/dl. 20.Insuficiencia hepática moderada (clase B de Child-Pugh) o grave (clase C de Child-Pugh) según el sistema de puntuación de Child-Pugh. 21.Cualquier anomalía analítica de grado 4 comprobada. 22.Cualquier anomalía analítica aguda en la selección que, en opinión del investigador, impida la participación del sujeto en el ensayo. 23.Exposición a un fármaco experimental (con la excepción de HZN-825) o a una vacuna experimental en los 30 días, 5 semividas del fármaco del ensayo o el doble de la duración del efecto biológico del fármaco del ensayo, lo que suponga más tiempo, antes del día 1. 24.Cualquier otro trastorno que, en opinión del investigador, impida la inscripción en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Change in FVC % predicted from Baseline to Week 52.
    Variación de la FVC (porcentaje del valor teórico) entre el momento basal y la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52.
    Entre el momento basal y la semana 52.
    E.5.2Secondary end point(s)
    1. Proportion of subjects with decline in FVC % predicted ≥10% from Baseline at Week 52.
    2. Change from Baseline in the 6MWT results to Week 52.
    3. Change from Baseline in K-BILD scores to Week 52.
    4. Change from Baseline in L-IPF scores to Week 52.
    5. Change from Baseline in LCQ scores to Week 52.
    6. Time to first hospitalization due to respiratory distress from Baseline up to Week 52.
    7. Time to first onset of the composite endpoint of PFS from Baseline up to Week 52, where progression includes decline in FVC % predicted ≥10% or death.
    1. Porcentaje de sujetos con una disminución de la FVC ≥10 % del valor teórico entre el momento basal y la semana 52.
    2. Variación los resultados de la 6MWT entre el momento basal y la semana 52.
    3. Variación de la puntuación K-BILD entre el momento basal y la semana 52.
    4. Variación de la puntuación L-IPF entre el momento basal y la semana 52.
    5. Variación de la puntuación LCQ entre el momento basal y la semana 52.
    6. Tiempo transcurrido hasta la primera hospitalización por dificultad respiratoria entre el momento basal y la semana 52.
    7. Tiempo transcurrido hasta la primera aparición del criterio de valoración combinado de SLP entre el momento basal y la semana 52, de modo que la progresión consiste en una disminución de la FVC ≥10 % del valor teórico o la muerte.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52.
    Entre el momento basal y la semana 52.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    South Africa
    Korea, Republic of
    United Kingdom
    United States
    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
    Ultima visita del último participante
    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 days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 360
    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)
    All subjects who complete the Double-blind Treatment Period will be
    eligible to enter into a 52-week extension trial
    Los sujetos que completen el período de tratamiento doble ciego podrán incorporarse a un ensayo de extensión de 52 semanas
    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 Decision2022-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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