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    Summary
    EudraCT Number:2021-002537-41
    Sponsor's Protocol Code Number:20170104
    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:2022-03-09
    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 number2021-002537-41
    A.3Full title of the trial
    A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
    Estudio de fase 2 de búsqueda de dosis, aleatorizado, doble ciego,
    controlado con placebo y multicéntrico para evaluar la seguridad y la eficacia del tratamiento
    de inducción con efavaleucina alfa en sujetos con colitis ulcerosa activa de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis
    seguridad y eficacia de efavaleucina alfa en sujetos con
    colitis ulcerosa activa de moderada a grave
    A.4.1Sponsor's protocol code number20170104
    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 SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona s/n, Edifici Sud, 7ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08039
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936001860
    B.5.6E-mailinformacion.medica.es@amgen.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 nameEfavaleukin Alfa
    D.3.2Product code AMG 592
    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 INNEFAVALEUKIN ALFA
    D.3.9.2Current sponsor codeAMG 592
    D.3.9.4EV Substance CodeSUB195522
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Active Ulcerative Colitis
    colitis ulcerosa (CU)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    colitis ulcerosa
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of efavaleukin alfa on induction of clinical remission
    Evaluar el efecto de efavaleucina alfa en la inducción de la remisión clínica.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of efavaleukin alfa on induction of clinical response
    - To evaluate the effect of efavaleukin alfa as induction therapy on endoscopic remission
    - To evaluate the effect of efavaleukin alfa as induction therapy on mucosal healing
    - To evaluate the effect of efavaleukin alfa as induction therapy on change in histological score
    - To evaluate the safety and tolerability of efavaleukin alfa
    -Evaluar el efecto de efavaleucina alfa en
    la inducción de la respuesta clínica.
    -Evaluar el efecto de efavaleucina alfa en la inducción de la remisión endoscópica.
    -Evaluar el efecto de efavaleucina alfa en
    la inducción de la remisión sintomática.
    -Evaluar el efecto de efavaleucina alfa
    como tratamiento de inducción en la
    cicatrización de la mucosa.
    -Evaluar el efecto de efavaleucina alfa
    como tratamiento de inducción en el
    cambio de la puntuación histológica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent prior to initiation of study .
    102 Aged from 18 years to 80 years at screening visit, except in South Korea where from age 19 years to 80 years at screening visit; and in Taiwan where age from 20 years to 80 years at screening visit.
    103 Diagnosis of UC established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
    104 Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read rectosigmoidoscopy endoscopic subscore at least 2 and no subscore less than 1 prior to day 1.
    105 Has documentation of
    A surveillance colonoscopy within 12 months of day 1 visit for subjects with pancolitis of at least 8 years duration, or subjects with left-sided colitis of over 12 years duration, or subjects with
    primary sclerosing cholangitis.
    For all other subjects, up-to-date colorectal cancer surveillance
    (performed according to local standard). Subjects who do not have a
    colonoscopy report available in source documentation will have a
    colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study, at the discretion of the investigator.
    106 Subjects must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, JAK-inhibitor).
    Conventional therapy failed subjects:
    - Corticosteroids (corticosteroid-refractory colitis, defined as signs
    and/or symptoms of active UC despite oral prednisone (or equivalent)
    at doses of at least 30 mg/day for a minimum of 2 weeks; or
    corticosteroid-dependent colitis, defined as: an inability to reduce
    corticosteroids below the equivalent of prednisone 10 mg/day within
    3 months of starting corticosteroids without a return of signs and/or
    symptoms of active UC; or a relapse within 3 months of completing a
    course of corticosteroids
    - History of intolerance of corticosteroids (including, but not limited to,
    Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, or
    neuropsychiatric side-effects, including insomnia, associated with
    corticosteroid treatment)
    - Immunomodulators: signs and/or symptoms of persistently active
    disease despite at least 3 months treatment with one of the following
    at locally approved doses: oral azathioprine or 6-mercaptopurine, or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing
    - History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-TNF
    antibody, anti-integrin antibody, or IL-12/23 antagonists) that is
    indicated for the treatment of UC
    Biologic or targeted small molecule therapy failed subjects: those who
    demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors).
    The therapy used to qualify the subject for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Subjects must fulfil one of the following criteria:
    Inadequate response: signs and symptoms of persistently active
    disease despite induction treatment at the approved induction dosing
    that was indicated in the product label at the time of use
    Loss of response: recurrence of signs and symptoms of active
    disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as
    having failed or being intolerant to UC biological therapy or JAK
    inhibitor)
    Intolerance: history of intolerance to infliximab, adalimumab,
    golimumab, vedolizumab, ustekinumab, tofacitinib or other approved
    biologicals or JAK inhibitors (including but not limited to
    infusion-related event, demyelination, congestive heart failure, or any
    other drug-related adverse event that led to a reduction in dose or
    discontinuation of the medication)
    107 If receiving any of the following therapies, subjects must have stable dosage for the specified duration:
     5-aminosalicylates (ASAs), stable dosage for at least 2 weeks prior to screening endoscopy
     Oral corticosteroids: prednisone up to 20 mg/day or its equivalent, stable dose for 2 weeks prior to screening endoscopy
     Budesonide: extended release tablets 9 mg/day [budensonide MMX], stable dose for at least 2 weeks prior to screening endoscopy
     Conventional immunomodulators: azathioprine, 6-mercaptopurine,
    methotrexate, stable dosage for at least 8 weeks prior to screening endoscopy
    Los sujetos son elegibles para ser incluidos en el estudio solo si cumplen todos los
    criterios siguientes:
    101 El sujeto ha proporcionado su consentimiento informado antes de iniciar
    cualquier procedimiento o actividad específico del estudio. En Japón, si un
    sujeto es menor de 20 años en el momento de firmar el consentimiento
    informado, se debe obtener el consentimiento informado tanto del sujeto como
    de su representante legal.
    102 Edad comprendida entre ≥ 18 y < 80 años en la visita de selección, excepto en
    Corea del Sur, donde la edad oscila entre ≥ 19 y < 80 años en la visita de
    selección, y en Taiwán, donde la edad oscila entre ≥ 20 y < 80 años en la
    visita de selección.
    103 Diagnóstico de CU establecido ≥ 3 meses antes de la inclusión mediante
    evidencia clínica y endoscópica y corroborado por un informe histopatológico.
    Si no se dispone de un informe histopatológico en el momento de la selección,
    se pueden realizar biopsias adicionales durante el período de selección para
    corroborarlo mediante un análisis histopatológico local.
    104 CU activa de moderada a grave, definida por una puntuación de Mayo
    modificada de 5 a 9, con una subpuntuación endoscópica mediante una
    rectosigmoidoscopia de lectura centralizada de ≥ 2 y sin una subpuntuación de
    < 1 antes del día 1.
    105 Poseer documentación de
    • Una colonoscopia de vigilancia (realizada de acuerdo con el tratamiento
    estándar local) en los 12 meses posteriores a la visita del día 1 para los
    sujetos con pancolitis de > 8 años de duración, para los sujetos con colitis
    en el lado izquierdo de > 12 años de duración o para los sujetos con
    colangitis esclerosante primaria.
    • En todos los demás sujetos, vigilancia actualizada del cáncer colorrectal
    (realizada de acuerdo con el tratamiento estándar local). A los sujetos que
    no dispongan de un informe de colonoscopia en la documentación original
    se les realizará una colonoscopia en lugar de una rectosigmoidoscopia
    como endoscopia de selección en el estudio, según el criterio del
    investigador.
    106 Los sujetos deben haber demostrado una respuesta inadecuada, pérdida de
    respuesta o intolerancia a al menos 1 tratamiento convencional, tratamiento
    biológico o tratamiento dirigido con fármacos de molécula pequeña (es decir,
    un inhibidor de la JAK).
    Ver protocolo para resto de criterios de inclusión
    E.4Principal exclusion criteria
    201 Diagnosis of Crohn’s disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn’s disease.
    202 Disease limited to the rectum.
    203 Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
    204 Previous bowel resection or intestinal or intra-abdominal surgery.
    Have had extensive surgery for UC, or are likely to require surgery for the treatment of UC during the study. Subjects who have had limited surgery for UC may be allowed in the study, if this does not affect the assessment of efficacy. Discussion with the sponsor must occur prior to screening of such subjects.
    Have had any small bowel or colonic surgery within 6 months of day 1.
    Have had any nonintestinal intra-abdominal surgery within 3 months of day 1.
    205 Adenoma and dysplasia exclusion criteria:
    Any current sporadic adenoma without dysplasia that has not been removed. Once completely removed, the subject is eligible for study.
    Dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia-associated lesions or masses will be managed as follows:
    Any history or current evidence of high-grade dysplasia.
    Any history or current evidence of dysplasia occurring in flat mucosa.
    This includes histopathology reporting indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia.
    Any history or current evidence of a nonadenoma-like
    dysplasia-associated lesions or masses, with or without evidence of
    dysplasia.
    Any current sporadic adenoma containing dysplasia or any current
    adenoma-like dysplasia-associated lesions or masses that has not been
    removed. Once completely removed, the patient is eligible for the study.
    206 Stool positive for Clostridium difficile toxin at screening and other enteric pathogens including but not limited to ova, parasites, Campylobacter, salmonella, shigella, E coli 0157:H7, and Yersinia enterocolitica.
    207 History or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia Suicide Severity Rating Scale (C-SSRS) at screening
    208 Active infection for which anti-infectives were indicated within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
    209 Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
    210 Positive test for TB during screening defined as: either a positive or indeterminate QuantiFERON-TB or T-spot test OR positive purified protein derivative. Subjects with a positive PPD and a history of Bacillus Calmette-Guerin vaccination are allowed to enroll with a negative QuantiFERON®-TB or T-Spot test and negative chest X-ray.
    Indeterminate QuantiFERON®-TB or T-spot test can be repeated once,
    based on investigator judgment. Subjects can enroll if second result is
    negative. Subjects with persistent indeterminate or positive test results must proceed as below.
    Subjects with a positive PPD test or a positive or indeterminate QuantiFERON®-TB or T-Spot test are allowed to enroll if they meet ALL the following criteria at screening:
    No symptoms per tuberculosis worksheet provided by Amgen
    documented history of adequate TB treatment or prophylactic treatment for latent TB
    No known exposure to a case of active tuberculosis after most recent
    treatment/prophylaxis
    Chest X-ray with no new radiographic findings suggestive of active TB
    211 Any history of malignancy
    212 Presence of 1 or more significant concurrent medical conditions per the investigator judgement
    213 Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody or hepatitis B surface antibody in the presence of detectable viral DNA in peripheral blood, assessed by polymerase chain reaction. Subjects positive for HBcAb and/or HBsAb without history of prior vaccination and without detectable viral DNA by PCR are allowed to enroll, provided the subject undergoes monitoring of viral DNA by PCR at every
    2 months during the treatment period and up to 6 weeks after the end of treatment for the study. Patients with a history of hepatitis B vaccination without history of hepatitis B infection are allowed to enroll.
    214 Positive for hepatitis C antibody in the presence of detectable viral RNA in peripheral blood, assessed by PCR. Subjects positive for HCAb without detectable viral RNA by PCR are allowed to enroll.
    215 Known history of Human Immunodeficiency Virus (HIV) or positive HIV test at screening.
    216 Inherited immunodeficiency syndrome.
    217 Required systemic corticosteroid use for any indication other than UC.
    218 Have had a bone marrow or solid organ transplantation.
    219 Have had extra-abdominal surgery without full recovery prior to screening.
    Relacionados con la enfermedad
    201 Diagnóstico de enfermedad de Crohn, enfermedad inflamatoria intestinal no
    clasificada (colitis indeterminada), colitis microscópica, colitis isquémica o
    hallazgos clínicos indicativos de enfermedad de Crohn.
    202 Enfermedad limitada al recto (es decir, a menos de 10 cm del borde anal).
    203 Evidencia de megacolon tóxico, colitis fulminante, absceso intraabdominal o
    estenosis/estrechez dentro del intestino delgado o del colon.
    204 Resección intestinal previa o cirugía intestinal o intraabdominal.
    • Haberse sometido a una cirugía extensa para la CU (por ejemplo,
    colectomía subtotal), o es probable que requieran cirugía para el
    tratamiento de la CU durante el estudio. Los sujetos que se hayan sometido
    a una cirugía limitada para la CU (por ejemplo, resección segmentaria de
    colon) podrán participar en el estudio, si esto no afecta a la evaluación de
    la eficacia. Se debe hablar con el promotor antes de la selección de dichos
    sujetos.
    • Haberse sometido a una cirugía de intestino delgado o de colon en los
    6 meses posteriores al día 1.
    • Haberse sometido a una cirugía intraabdominal no intestinal en los
    3 meses posteriores al día 1.
    205 Criterios de exclusión relativos a adenomas y displasias:
    • Cualquier adenoma esporádico actual sin displasia (pólipos adenomatosos
    que se produzcan cerca de las zonas conocidas de colitis) que no se haya
    extirpado. Una vez extirpado por completo, el sujeto es elegible para el
    estudio.
    • La displasia que se produce en la mucosa plana, los adenomas
    esporádicos que contienen displasia y las lesiones o masas asociadas a la
    displasia se tratarán de la manera siguiente:
    − Cualquier antecedente o evidencia actual de displasia de alto grado.
    − Cualquier antecedente o evidencia actual de displasia en la mucosa
    plana. Esto incluye una histopatología que considere como indefinidas
    la displasia, la displasia de bajo grado y la displasia de alto grado.
    − Cualquier antecedente o evidencia actual de lesiones o masas
    asociadas a displasias distintas de las del adenoma, con o sin evidencia
    de displasia.
    − Cualquier adenoma esporádico actual que contenga displasia o
    cualquier lesión o masa asociada a displasia actual similar a la del
    adenoma que no se haya extirpado. Una vez extirpado por completo, el
    paciente es elegible para el estudio.
    206 Heces positivas para la toxina Clostridium difficile en el momento de la
    selección y otros patógenos entéricos, como óvulos, parásitos, Campylobacter,
    Salmonella, Shigella, E. coli 0157:H7 y Yersinia enterocolitica.
    207 Antecedentes o evidencia de ideación suicida (gravedad de 4 o 5) o cualquier
    comportamiento suicida basado en una evaluación con la escala Columbia para
    evaluar el riesgo de suicidio (C-SSRS) en el momento de la selección.
    Para resto de criterios de exclusión ver protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission at week 12
    Remisión clínica en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    semana 12
    E.5.2Secondary end point(s)
    Clinical response at week 12
    Endoscopic remission at week 12
    Symptomatic remission at week 12
    Combined endoscopic remission and histologic remission of the colon tissue at week 12
    Change from baseline in histological score at week 12 as measured by Geboes score
    Treatment-emergent adverse events
    -Respuesta clínica en la semana 12.
    -Remisión endoscópica en la
    semana 12.
    -Remisión sintomática en la semana 12.
    -Combinación de remisión
    endoscópica y remisión
    histológica del tejido del colon en
    la semana 12.
    -Cambio respecto al valor basal
    en la puntuación histológica en la
    semana 12 según la puntuación
    de Geboes.
    -Acontecimientos adversos
    aparecidos durante el
    tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) 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 No
    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 trial4
    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 EEA12
    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
    Argentina
    Canada
    Japan
    Korea, Democratic People's Republic of
    Mexico
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Denmark
    Finland
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Spain
    Switzerland
    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
    End of long-term treatment (Long-term extension is additional 40 week +6 week follow-up)
    Fin del tratamiento a largo plazo (la extensión a largo plazo es un seguimiento adicional de 40 semanas + 6 semanas)
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 320
    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)
    6 week follow up
    6 semanas de seguimiento
    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 Decision2022-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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