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    Summary
    EudraCT Number:2015-001600-64
    Sponsor's Protocol Code Number:RPC01-3102
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-21
    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 number2015-001600-64
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
    Ensayo de prolongación de fase 3, multicéntrico, sin enmascaramiento con RPC1063 oral como terapia para la colitis ulcerosa de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).
    El propósito de este estudio es determinar si RPC1063 es seguro y eficaz
    en el tratamiento de la colitis ulcerosa (CU).
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis
    Estudio de eficacia y seguridad de RPC1063 a largo plazo en la colitis ulcerosa
    A.4.1Sponsor's protocol code numberRPC01-3102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02531126
    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 SponsorCelgene International II Sàrl
    B.1.3.4CountrySwitzerland
    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 supportCelgene International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReceptos Services, LLC
    B.5.2Functional name of contact pointTruenorth Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address3033 Science Park Road, Suite 300
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18442669299
    B.5.6E-mailtruenorth@quintiles.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 name0.25 mg RPC1063
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.3Other descriptive name(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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.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 name1.0 mg RPC1063
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.3Other descriptive name(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis
    Colitis ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    Colitis ulcerosa
    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 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 long-term safety and efficacy of RPC1063 for the treatment of patients with moderate to severe ulcerative colitits
    El objetivo de este ensayo es evaluar la seguridad y eficacia a largo plazo de RPC1063 para el tratamiento de pacientes con colitis ulcerosa (CU) moderada a grave.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previously participated in a trial of RPC1063 for UC and meet the criteria for participation in the open label extension as outlined in the prior trial
    2. Female patients of childbearing potential:
    Must agree to practice a highly effective method of contraception throughout the trial until completion of the safety follow-up visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in the trial are the following:
    - combined hormonal (oestrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
    - progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
    - placement of an intrauterine device (IUD)
    - placement of an intrauterine hormone-releasing system (IUS)
    - bilateral tubal occlusion
    - vasectomised partner
    - sexual abstinence
    Male patients:
    Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the trial until completion of the safety follow-up visit.
    All patients:
    Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
    3. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments, which must be obtained prior to any trial-related procedures.
    1. Participaron anteriormente en un ensayo con RPC1063 para la CU y cumplen los criterios para participar en la prolongación sin enmascaramiento como se indica en el ensayo anterior.
    2. Pacientes mujeres con capacidad de concebir:
    Deben aceptar la utilización de un método anticonceptivo altamente eficaz durante todo el ensayo hasta haber completado la visita de seguimiento de seguridad. Los métodos anticonceptivos altamente eficaces son aquellos que por sí solos o bien combinados con otro tengan como resultado una tasa de fracaso calculada mediante el Índice de Pearl inferior al 1 % anual al utilizarse de manera sistemática y adecuada. Los métodos anticonceptivos aceptables de este ensayo son los siguientes:
    - métodos anticonceptivos hormonales combinados (con estrógeno y progestágeno), que pueden ser orales, intravaginales o transdérmicos
    - métodos anticonceptivos hormonales con progestágeno únicamente asociados con la inhibición de la ovulación, que pueden ser orales, inyectables o implantables
    - colocación de un dispositivo intrauterino (DIU)
    - colocación de un sistema intrauterino liberador de hormonas (SIU)
    - ligadura de trompas
    - vasectomía de la pareja
    - abstinencia sexual
    Pacientes varones:
    Deben aceptar el uso de un preservativo de látex durante el contacto sexual con mujeres con capacidad de concebir durante su participación en el ensayo y hasta haber finalizado la visita de seguimiento de seguridad.
    Todos los pacientes:
    La abstinencia periódica (método del calendario, método sintotérmico, método post-ovulación), el método de la marcha atrás (coitus interruptus), el uso de espermicidas únicamente, y el método de la amenorrea durante la lactancia no se consideran métodos anticonceptivos aceptables. No deben utilizarse preservativos femeninos y preservativos masculinos de forma combinada
    3. Deben otorgar el consentimiento informado por escrito y ser capaces de cumplir con el calendario de evaluaciones del protocolo, el cual debe obtenerse antes de realizar cualquier procedimiento relacionado con el ensayo.
    E.4Principal exclusion criteria
    Exclusions Related to Medications:
    1. Have received any of the following therapies since the first dose of investigational drug in the prior RPC1063 trial:
    - Treatment with a biologic agent
    - Treatment with an investigational agent other than RPC1063
    - Treatment with D-penicillamine, leflunomide, thalidomide, natalizumab or fingolimod
    - Treatment with lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
    - Treatment with a live vaccine within 4 weeks prior to Visit 1 of this trial
    2. Are currently receiving or require initiation of any of the following therapies:
    - Treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg
    - Treatment with immunosuppressive agents (e.g., azathioprine, 6-MP, or methotrexate)
    - Chronic non-steroidal anti-inflammatory drug (NSAID) use (Note: occasional use of NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day is permitted)
    - Treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with two or more agents in combination known to prolong PR interval

    Exclusions Related to General Health:
    3. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG)
    4. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial difficult or that would put the patient at risk by participating in the trial or that would have required a patient to discontinue treatment in previous RPC1063 trial
    5. Clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea

    Exclusions Related to Laboratory Results:
    6. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN), or direct bilirubin 3 times the ULN
    7. FEV1 or FVC < 50% of predicted values
    Exclusiones relacionadas con los medicamentos:
    1. Han recibido cualquiera de los siguientes tratamientos desde la primera dosis del fármaco en investigación en el ensayo anterior con RPC1063:
    - Tratamiento con un agente biológico
    - Tratamiento con un agente en investigación distinto de RPC1063
    - Tratamiento con una vacuna de organismos vivos en las 4 semanas anteriores a la Visita 1 de este ensayo
    - Tratamiento con D-penicilamina, leflunomida, talidomida, natalizumab o fingolimod
    - Tratamiento con terapias para la disminución del número de linfocitos (p. ej., Campath, anti-CD4, cladribina, rituximab, ocrelizumab, ciclofosfamida, mitoxantrona, irradiación corporal total, trasplante de médula ósea, alemtuzumab, daclizumab)
    2. Reciben actualmente o deben iniciar cualquiera de los siguientes tratamientos:
    - Tratamiento con corticosteroides a una dosis que supere el equivalente de prednisona de > 40 mg
    - Tratamiento con agentes inmunosupresores (p. ej., azatioprina, 6-MP o metotrexato)
    - Uso crónico de fármacos antiinflamatorios no esteroideos (AINE) (Nota: está permitido el uso ocasional de AINEs y paracetamol [p. ej., cefalea, artritis, mialgias o calambres menstruales] y ácido acetilsalicílico hasta 325 mg/día)
    - Tratamiento con fármacos antiarrítmicos clase Ia o clase III o tratamiento con dos o más agentes combinados que se sabe que prolongan el intervalo PR.

    Exclusiones relacionadas con el estado de salud general:
    3. Embarazo, lactancia o resultado positivo de gonadotropina coriónica humana (hCG) beta en suero
    4. Enfermedad clínicamente relevante hepática, neurológica, pulmonar, oftalmológica, endocrina, psiquiátrica u otra enfermedad sistémica importante que dificulte la implementación del protocolo o la interpretación del ensayo o que pondría al paciente en riesgo al participar en el ensayo o que hubiera requerido que el paciente interrumpiera el tratamiento en el ensayo anterior con RPC1063
    5. Afecciones cardiovasculares clínicamente relevantes, que incluyen antecedentes o presencia de infarto de miocardio reciente, angina de pecho inestable, accidente cerebrovascular, accidente isquémico transitorio, insuficiencia cardíaca descompensada que requiere hospitalización, insuficiencia cardíaca de clase III/IV, síndrome de disfunción sinusal o apnea del sueño grave no tratada.

    Exclusiones relacionadas con resultados de las pruebas analíticas:
    6. Deterioro de la función hepática o elevaciones persistentes de la aspartato-aminotransferasa (AST) o la alanina-aminotransferasa (ALT) 5 veces el límite superior de la normalidad (LSN) o bilirrubina directa 3 veces el LSN
    7. Volumen espiratorio forzado en el primer segundo (forced expiratory volumen in one second, FEV1) o capacidad vital forzada (CVF) < 50 % de los valores previstos
    E.5 End points
    E.5.1Primary end point(s)
    Due to the open-label nature of the trial and the lack of a control group, all data will be summarized and no hypothesis testing will be performed. Each efficacy endpoint will be summarized and 95% confidence intervals around the estimates may also be presented.

    Efficacy Endpoints:
    - Proportion of patients in clinical remission.
    - Proportion of patients with a clinical response
    - Proportion of patients with endoscopic improvement
    - Proportion of patients with mucosal healing
    - Proportion of patients with corticosteroid-free remission
    - Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score
    - Proportion of patients with histologic remission
    - Proportion of patients with clinical response, clinical remission, or endoscopic improvement in patients who had previously received anti-TNF therapy

    Safety Endpoints:
    The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), TEAEs leading to discontinuation of investigational drug, and TEAEs of special interest will be summarized, as well as changes from Baseline for clinical laboratory measures, vital signs, ECGs, and pulmonary function tests.
    Debido a la naturaleza abierta del ensayo y la falta de un grupo de control, todos los datos se resumirán y no se realizarán pruebas de hipótesis. Cada variable principal de eficacia se resumirá y también se podrán presentar intervalos de confianza del 95% alrededor de las estimaciones.

    Criterios de valoración de la eficacia:
    - Porcentaje de pacientes en remisión clínica
    - Porcentaje de pacientes con respuesta clínica
    - Porcentaje de pacientes con mejoría endoscópica
    - Porcentaje de pacientes con curación de mucosas
    - Porcentaje de pacientes en remisión sin corticosteroides
    - Cambio con respecto al inicio en el índice Mayo total, índice Mayo parcial y índice Mayo de 9 puntos
    - Porcentaje de pacientes en remisión histológica
    - Porcentaje de pacientes con respuesta clínica, remisión clínica o mejoría endoscópica entre los pacientes que habían recibido anteriormente tratamiento anti-TNF.

    Criterios de valoración de la seguridad:
    - Incidencia, intensidad y relación de los acontecimientos adversos aparecidos durante el tratamiento (AAAT), AA graves (AAG), AAAT que dan lugar a la interrupción del fármaco en investigación y AAAT de interés especial
    - Cambios con respecto al inicio en las determinaciones analíticas, las constantes vitales, el ECG y las pruebas de función pulmonar
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy assessments will be performed at the following visits;
    Day 1 (Baseline/Visit 1) - All
    Week 5 (Visit 2)
    Week 10 (Visit 3)
    Week 16 (Visit 4)
    Week 22 (Visit 5)
    Thereafter, additional visits at 12-week intervals (Visit 5 onwards).

    Mayo partial score assessment to be performed at each visit.
    Full Mayo score assessment performed at Visit 1, Visit 7, at each additional visit (12-week intervals), and at the End of Treatment/Early Termination Visit.

    Endoscopy and colonic biopsies will be performed at Week 1, Visit 7, at each additional visit (12-week intervals), and at the End of Treatment/Early Termination Visit.
    Las evaluaciones de eficacia se realizarán en las siguientes visitas;
    Día 1 (Línea de base / Visita 1) - Todo
    Semana 5 (Visita 2)
    Semana 10 (Visita 3)
    Semana 16 (Visita 4)
    Semana 22 (Visita 5)
    A partir de entonces, visitas adicionales en intervalos de 12 semanas (Visita 5 en adelante).

    La evaluación del índice Mayo parcial se realizará en cada visita.
    La evaluación del índice Mayo total se realizará en la Visita 1, Visita 7, en cada visita adicional (intervalos de 12 semanas) y al final del tratamiento / Visita de finalización anticipada.

    La endoscopia y las biopsias de colon se realizarán en la semana 1, visita 7, en cada visita adicional (intervalos de 12 semanas) y al final del tratamiento / visita de finalización anticipada.
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    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
    Australia
    Austria
    Belarus
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Ukraine
    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
    Patients will receive treatment until the end of 2020, or until marketing approval of RPC1063 for UC is obtained in their country, or until the Sponsor discontinues the development program.
    Los pacientes recibirán tratamiento hasta el final de 2020, o hasta que se obtenga la aprobación de comercialización de RPC1063 para UC en su país, o hasta que el promotor interrumpa el programa de desarrollo.
    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 years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days25
    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: 1164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 569
    F.4.2.2In the whole clinical trial 1200
    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)
    Expected normal treatment for the condition
    Tratamiento normal esperado para la condición
    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 Decision2018-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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