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    Summary
    EudraCT Number:2018-003987-29
    Sponsor's Protocol Code Number:APD334-303
    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:2019-12-20
    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 number2018-003987-29
    A.3Full title of the trial
    An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
    Estudio de extensión abierto para evaluar etrasimod cuando se administra a sujetos con colitis ulcerosa activa moderada o grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
    Estudio de extensión abierto para tratamiento de colitis ulcerosa activa moderada o grave
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE UC OLE
    ELEVATE UC OLE
    A.4.1Sponsor's protocol code numberAPD334-303
    A.5.4Other Identifiers
    Name:IND numberNumber:125154
    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 SponsorArena Pharmaceuticals 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 supportArena Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointGiles Hulley
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego - CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number34912071350
    B.5.6E-mailmmartinarranz@salud.madrid.org
    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 nameEtrasimod
    D.3.2Product code APD334
    D.3.4Pharmaceutical form 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 INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 a form of inflammatory bowel disease.
    Colitis ulcerosa como forma de enfermedad inflamatoria intestinal.
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045366
    E.1.2Term Ulcerative colitis, unspecified
    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 assess the safety of long-term administration of etrasimod in subjects with moderately to severely active ulcerative colitis (UC)
    Evaluar la eficacia de etrasimod suministrado a largo plazo en sujetos con colitis ulcerosa (CU) activa de moderada a grave
    E.2.2Secondary objectives of the trial
    To assess the long-term efficacy of etrasimod in subjects with moderately to severely active UC
    Evaluar la eficacia a largo plazo de etrasimod en sujetos con CU activa de moderada a grave
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have met the eligibility criteria and have been enrolled in one of the two parent studies (APD334-301 or APD334-302) and also meet the following additional criteria:
    a. Subjects previously enrolled in Study APD334-301 must have either:
    I. Completed the Week 12 visit and have been assessed to have active UC that had deteriorated from baseline and meet one of the following criteria:
    • Absolute RB ≥ 2 on 2-consecutive days, and confirmation of ES ≥ 2 at or after the Week 12 assessment
    • Absolute RB + SF ≥ 4 on 2-consecutive days, and confirmation of ES ≥ 2 at or after the Week 12 assessment
    • Absolute RB ≥ 2 or RB + SF ≥ 4 (in any order) on 2-consecutive days, and confirmation of ES ≥ 2 at or after the Week 12 assessment
    or
    II. Completed the Week 52 visit
    Note: An endoscopic evaluation is required, however a proctosigmoidoscopy does not need to be repeated if performed within the last 4 weeks
    b. Subjects previously enrolled in APD334-302 must have completed the Week 12 visit
    2. Eligible women of childbearing potential must fulfill the following:
    a. Have a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test
    b. Not breastfeeding
    3. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
    a. A female who is not of childbearing potential must meet 1 of the following:
     Postmenopausal, defined as no menses for 12 months without an alternative medical cause;
     Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
    b. A female who is of childbearing potential must agree to using a highly effective contraception method during treatment and for 4 weeks following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly.
    The following are considered highly effective birth control methods:
     Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal.
     Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted.
     Intrauterine device (IUD).
     Intrauterine hormone-releasing system.
     Bilateral tubal occlusion.
     Vasectomized partner, provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.
     Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject.
    Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable.
    c. A male must agree to using condoms during treatment and for 4 weeks following treatment.
    4. Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of subjects < 18 years should be conducted only if acceptable according to local laws and regulations.
    Los sujetos son aptos para inscribirse en este estudio si cumplen TODO lo siguiente:
    1. Deben haber cumplido los criterios de idoneidad y haberse inscrito en uno de los dos estudios principales (APD334-301 o APD334-302) y también cumplir los siguientes criterios adicionales:
    a. Los sujetos inscritos previamente en el estudio APD334-301 deben:
    I. Haber completado la visita de la semana 12 y haber sido evaluados como que presentan CU activa que había empeorado desde el inicio y cumplir uno de los siguientes criterios:
    • Recuento absoluto de HR ≥2 en 2 días consecutivos y confirmación de PE ≥2 en o después de la evaluación de la semana 12
    • Recuento absoluto de HR + FD ≥4 en 2 días consecutivos y confirmación de PE ≥2 en o después de la evaluación de la semana 12
    • Recuento absoluto de HR ≥2 o HR + FD ≥4 (en cualquier orden) en 2 días consecutivos, y confirmación de PE ≥2 en o después de la evaluación de la semana 12
    o bien
    II. Haber completado la visita de la semana 52
    Nota: Se requiere una evaluación endoscópica; sin embargo, no es necesario repetir la proctosigmoidoscopia si se realiza en las últimas 4 semanas.
    b. Los sujetos inscritos previamente en APD334-302 deben haber completado la visita de la semana 12
    2. Las mujeres en edad fértil aptas deben cumplir lo siguiente:
    a. Tener un resultado negativo de gonadotropina coriónica humana beta (GCH-β) en la prueba de embarazo en orina
    b. No estar en periodo de lactancia
    3. Las mujeres deben cumplir o bien a o bien b de los siguientes criterios, y los hombres deben cumplir el criterio c para ser aptos para el estudio:
    a. Las mujeres que no sean fértiles deben cumplir uno de los siguientes criterios:
     Posmenopáusicas, definido como no haber tenido menstruación durante 12 meses sin una causa médica alternativa
     Procedimiento de esterilización permanente, como histerectomía, salpingectomía bilateral u ovariectomía bilateral.
    b. Las mujeres en edad fértil deben aceptar utilizar un método anticonceptivo altamente eficaz durante el tratamiento y en las 4 semanas posteriores al tratamiento que alcance una tasa de fallo de menos del 1 % al año cuando se utilice de forma continuada y correcta. A continuación se muestran los que se consideran métodos anticonceptivos altamente eficaces:
     Anticonceptivo hormonal combinado (que contenga estrógeno y progesterona) asociado a la inhibición de la ovulación, que puede ser por vía oral, intravaginal o transdérmica.
     Anticonceptivo hormonal únicamente de progesterona asociado a la inhibición de la ovulación, que puede ser por vía oral, inyectado o implantable.
     Dispositivo intrauterino (DIU).
     Sistema intrauterino de liberación de hormonas.
     Ligadura de trompas bilateral.
     Compañero sometido a vasectomía, siempre y cuando el compañero sea la única pareja sexual de la participante del ensayo mujer en edad fértil y que el compañero haya recibido la evaluación médica del éxito de la operación.
     Abstinencia sexual (abstinencia sexual completa definida como evitar las relaciones sexuales heterosexuales durante todo el periodo de riesgo asociado a los tratamientos del estudio). La fiabilidad de la abstinencia sexual debe evaluarse en relación a la duración del estudio clínico y el estilo de vida habitual y preferido de la participante. La abstinencia periódica (métodos del calendario, sintotérmico y posovulación) no son aceptables.
    c. Los hombres deben aceptar utilizar preservativo durante el tratamiento y en las 4 semanas posteriores al tratamiento.
    4. Capacidad de proporcionar consentimiento informado por escrito o asentimiento (el progenitor o tutor legal debe dar su consentimiento para un sujeto <18 años que haya dado su asentimiento para participar en el estudio o según lo requerido por las normativas locales) y de cumplir el calendario de evaluaciones del protocolo. La inscripción de los sujetos <18 años solo debe realizarse si es aceptable de acuerdo con las leyes y normativas locales.
    E.4Principal exclusion criteria
    Subjects who meet ANY of the following exclusion criteria will NOT be eligible for enrollment into the study:
    1. If the Investigator considers the subject to be unsuitable for any reason to participate in the OLE study

    Exclusions related to general health:
    2. Experienced an adverse event that led to discontinuation from parent etrasimod study
    3. Day 1 pre-dose sitting vital sign assessment: heart rate < 50 bpm and systolic BP < 90 mm Hg
    4. Day 1 pre-dose 12-lead electrocardiogram (ECG) in the supine position showing a second or third-degree AV block, periods of asystole > 3 seconds, PR interval > 200 ms, or QTcF ≥ 450 ms (males) or QTcF ≥ 470 ms (females)
    5. Subjects requiring colectomy during the parent study
    6. Subjects requiring treatment with prohibited medications as defined in the parent study

    Exclusions related to laboratory results:
    7. Laboratory values that meet study treatment discontinuation rules
    Note: In the case of any abnormal laboratory results, laboratory tests may be repeated once and if these results are within normal range, the subject is eligible for enrollment.
    Los sujetos que cumplan ALGUNO de los siguientes criterios de exclusión NO serán aptos para inscribirse en el estudio:
    1. Si el investigador considera que el sujeto sea no apto por cualquier motivo para participar en el estudio de EA
    Exclusiones relacionadas con la salud general:
    2. Haber sufrido un acontecimiento adverso que haya requerido retirarle del estudio original de etrasimod
    3. Evaluación de las constantes vitales en posición sedente en el día 1 antes de la dosis: frecuencia cardíaca <50 lpm y TA sistólica <90 mm Hg
    4. Electrocardiograma (ECG) de 12 derivaciones en posición supina en el día 1 antes de la dosis que muestra un bloqueo AV de segundo o tercer grado, periodos de asistolia >3 segundos, intervalo PR >200 ms, o QTcF ≥450 ms (varones) o QTcF ≥470 ms (mujeres)
    5. Sujetos que requieran una colectomía durante el estudio original
    6. Sujetos que requieran tratamiento con medicamentos prohibidos según se define en el estudio principal
    Exclusiones relacionadas con los resultados de laboratorio:
    7. Los valores de laboratorio que cumplan las reglas de interrupción del tratamiento del estudio
    Nota: En el caso de alguna anomalía en los resultados de laboratorio, las pruebas analíticas se podrán repetir una vez y si estos resultados se encuentran dentro del rango normal, el sujeto es apto para la inscripción.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of treatment-emergent adverse events and serious adverse events (SAEs)
    • Incidence and severity of laboratory abnormalities, and change from baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)
    • Incidence of vital sign abnormalities and changes from baseline
    • Incidencia de acontecimientos adversos surgidos durante el tratamiento y acontecimientos adversos graves (AAG)
    • Incidencia e intensidad de las anomalías analíticas y el cambio desde el inicio en los valores de las analíticas (hematología, bioquímica sérica, coagulación y análisis de orina)
    • Incidencia de anomalías en las constantes vitales y cambios desde el inicio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 8, 12, 24, 36, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 2018, 220, 232, 244, 260, 2 week Follow-up visit
    Semana 2, 4, 8, 12, 24, 36, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 2018, 220, 232, 244, 260, 2 semanas visita de seguimiento
    E.5.2Secondary end point(s)
    • Proportion of subjects achieving clinical remission at each of the following weeks: Weeks 52, 104, 156, 208, and 260
    • Proportion of subjects achieving clinical response at each of the following weeks: Weeks 52, 104, 156, 208, and 260
    • Proportion of subjects achieving symptomatic remission at Weeks 52, 104, 156, 208, and 260
    • Proportion of subjects achieving non-invasive response at each of the following weeks: Weeks 12, 24, 36, 52, 104, 156, 208, and 260
    • Proportion of subjects remaining in clinical remission at the following weeks: Weeks 12, 52, 104, 156, 208, and 260
    • Longitudinal change from both OLE and parent study baseline in SF, RB, and SF + RB at each of the following weeks: Weeks 12, 24, 36, 52, 104, 156, 208, and 260
    • Proportion of subjects with remission and response using total Mayo Clinic score at each of Weeks 12, 52, and annually thereafter up to Week 260
    • Histologic improvement at each visit with endoscopy
    • Histologic remission at each visit with endoscopy
    • Time to loss of response, with loss of response defined by:
    − A ≥ 2-point increase from Week 12 in the combined SF + RB scores and combined SF + RB score of ≥ 4, on 2 consecutive visits (≥ 7 days apart), and
    − Confirmed by centrally read ES ≥ 2 and,
    − Confirmation of negative C. difficile testing
    • Proportion of subjects with improvement in EIMs at Weeks 12, 52, 104, 156, 208, and 260, in subjects with EIMs at baseline.
    • Proporción de sujetos que alcanzan remisión clínica en cada una de las siguientes semanas: Semanas 52, 104, 156, 208 y 260
    • Proporción de sujetos que consiguen respuesta clínica en cada una de las siguientes semanas: Semanas 52, 104, 156, 208 y 260
    • Proporción de sujetos que alcanzan remisión sintomática en las semanas 52, 104, 156, 208 y 260
    • Proporción de sujetos que alcanzan una respuesta no invasiva en cada una de las siguientes semanas: Semanas 12, 24, 36, 52, 104, 156, 208 y 260
    • Proporción de sujetos con remisión clínica en las siguientes semanas: Semanas 12, 52, 104, 156, 208 y 260
    • Cambio longitudinal tanto desde el inicio de la EA como del estudio original en FD, HR y en FD + HR en cada una de las siguientes semanas: Semanas 12, 24, 36, 52, 104, 156, 208 y 260
    • Proporción de sujetos con remisión y respuesta mediante la puntuación de la clínica Mayo total en cada una de las semanas 12, 52 y cada año a partir de entonces hasta la semana 260
    • Diagnóstico histológico de mejora en cada visita con endoscopia
    • Diagnóstico histológico de remisión en cada visita con endoscopia
    • Tiempo hasta la pérdida de respuesta, con pérdida de la respuesta definida por:
     aumento de ≥2 puntos desde la semana 12 en las puntuaciones combinadas de FD + HR y una puntuación combinada de FD + HR de ≥4, en 2 visitas consecutivas (≥7 días de diferencia);
     confirmación por la lectura central de la PE ≥2; y
     confirmación de resultado negativo en la prueba de C. difficile.
    • Proporción de sujetos con mejora en las MEI en las semanas 12, 52, 104, 156, 208 y 260, en sujetos con MEI en el inicio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12, 24, 36, 52, 104, 156, 208, and 260
    Semanas 12, 24, 36, 52, 104, 156, 208 y 260
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA253
    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
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Estonia
    France
    Georgia
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Mexico
    Moldova, Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    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
    LVLS
    Última visita Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 25
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 607
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 702
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE.
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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