Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-004431-24
    Sponsor's Protocol Code Number:67896153MSC3001
    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:2022-08-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-004431-24
    A.3Full title of the trial
    Multi-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, con doble simulación, controlado con tratamiento activo y comparativo para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de ponesimod frente a fingolimod durante 108 semanas de tratamiento en pacientes pediátricos, de 10 a <18 años, con esclerosis múltiple remitente recurrente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis
    Estudio para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de ponesimod frente a fingolimod durante 108 semanas de tratamiento en pacientes pediátricos, de 10 a <18 años, con esclerosis múltiple remitente recurrente.
    A.3.2Name or abbreviated title of the trial where available
    PIONEER
    PIONEER
    A.4.1Sponsor's protocol code number67896153MSC3001
    A.5.4Other Identifiers
    Name:Investigational New Drug (IND)Number:101722
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/066/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailsrodr128@its.jnj.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 namePonesimod
    D.3.2Product code JNJ-67896153/ACT-128800
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNPonesimod
    D.3.9.1CAS number 854107-55-4
    D.3.9.2Current sponsor codeJNJ-67896153
    D.3.9.3Other descriptive nameACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Gilenya hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFingolimod
    D.3.4Pharmaceutical form Capsule
    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 INNFingolimod
    D.3.9.1CAS number 162359-55-9
    D.3.9.4EV Substance CodeSUB31908
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 0.50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Relapsing-remitting Multiple Sclerosis
    Esclerosis múltiple remitente recurrente.
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory disease attacking the CNS
    Enfermedad inflamatoria crónica que ataca al SNC.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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 that ponesimod is not less effective than fingolimod in reducing relapses in pediatric participants with relapsing remitting multiple sclerosis (RRMS) if treatment is taken as directed through Week 108
    El objetivo primario es demostrar que ponesimod no es menos eficaz que fingolimod en la reducción de las recaídas en pacientes pediátricos con esclerosis múltiple remitente recurrente (EMRR) si el tratamiento se toma según las indicaciones hasta la semana 108.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    ●To assess the effect of ponesimod vs fingolimod on the annualized relapse rate (ARR) in pediatric participants with RRMS, as measured by the rate ratio of ponesimod to fingolimod
    ● To assess the effect of ponesimod on MS disability accumulation and magnetic resonance imaging (MRI) lesion accrual in comparison with fingolimod in pediatric participants with RRMS
    ●To evaluate the safety, tolerability, and pharmacodynamics (PD) of ponesimod in comparison with fingolimod in pediatric participants with RRMS
    ●To evaluate the pharmacokinetics(PK) of ponesimod in pediatric participants with RRMS
    ●To study the PK/PD relationship for key efficacy and safety outcomes in pediatric participants with RRMS treated with ponesimod
    Los objetivos secundarios son:
    ●Evaluar el efecto de ponesimod frente a fingolimod en la TRA en pacientes pediátricos con EMRR, determinado por el cociente de tasas de ponesimod frente a fingolimod.
    ●Evaluar el efecto de ponesimod en la acumulación de discapacidad de la EM y en la acumulación de lesiones por resonancia magnética (RM) en comparación con fingolimod en pacientes pediátricos con EMRR.
    •Evaluar la seguridad, tolerabilidad y farmacodinamia (FD) de ponesimod en comparación con fingolimod en pacientes pediátricos con EMRR.
    •Evaluar la farmacocinética (FC) de ponesimod en pacientes pediátricos con EMRR
    •Estudiar la relación FD/FC en cuanto a los resultados clave de eficacia y seguridad en pacientes pediátricos con EMRR tratados con ponesimod.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Open-Label PK sub-study will be conducted in parallel to the main study
    Objective:
    To determine if a maintenance dose of < 20 mg ponesimod in pediatric population with body weight <= 40 kg results in PK exposure and PD effects comparable to those achieved in adult participants with RMS
    Sub-estudio abierto de FC se realizará en pararalelo al estudio principal.
    Objetivo:
    Evaluar si la dosis de mantenimiento < de 20 mg en la población pediátrica con un peso corporal ≤40 kg da lugar a una exposición FC y a efectos FD comparables a los logrados en pacientes adultos con EMR.
    E.3Principal inclusion criteria
    - A diagnosis of relapsing-remitting multiple sclerosis (RRMS) as defined by the 2017 revisions of the McDonald criteria. Central review of the diagnosis of pediatric multiple sclerosis (MS) will be required for all participants prior to Visit 3 (Day 1, randomization).

    - Expanded Disability Status Scale (EDSS) score between 0 and 5.5 (inclusive).

    - At least 1 MS relapse during the previous year or 2 MS relapses in the previous 2 years or evidence of gadolinium-enhancing (Gd+) lesions on magnetic resonance imaging (MRI) 6 months prior to Visit 3 (Day 1, Randomization), including MRI at Visit 2 (Baseline).

    - Must be otherwise healthy per investigator clinical judgement on the basis of physical examination, medical history, vital signs, laboratory tests, and electrocardiogram (ECGs) at Visit 1 (Screening). Any documented abnormalities must be consistent with pediatric MS. This determination must be recorded in participant’s source documents and initiated by Principal investigator (PI).

    - Participants with body weight or body surface area between 5th and 95th percentile for age and sex. Overweight participants greater than 95th percentile and underweight participants less than 5th percentile may participate following medical clearance.

    Refer protocol for all inclusion criteria.
    - Un diagnóstico de esclerosis múltiple remitente-recurrente (EMRR) según la definición de las revisiones de 2017 de los criterios de McDonald. Se requerirá una revisión central del diagnóstico de esclerosis múltiple (EM) pediátrica para todos los participantes antes de la Visita 3 (Día 1, aleatorización).
    - Puntuación de la Escala de Estado de Discapacidad Expandida (EDSS) entre 0 y 5,5 (inclusive).
    - Al menos 1 recaída de la EM durante el año anterior o 2 recaídas de la EM en los 2 años anteriores o evidencia de lesiones con realce de gadolinio (Gd+) en las imágenes de resonancia magnética (IRM) 6 meses antes de la Visita 3 (Día 1, Aleatorización), incluyendo la IRM en la Visita 2 (Inicio).
    - Deben estar sanos, según el criterio clínico del investigador, teniendo como base la exploración física, la historia clínica, los signos vitales, las pruebas de laboratorio y el electrocardiograma (ECG) en la visita 1 (selección). Cualquier anormalidad documentada debe ser consistente con la EM pediátrica. Esta determinación debe registrarse en los documentos fuente del participante y ser iniciada por el investigador principal (IP).
    - Participantes con peso o superficie corporal entre el 5º y el 95º percentil para la edad y el sexo. Los participantes con sobrepeso superior al percentil 95 y los participantes con peso inferior al percentil 5 pueden participar tras recibir la autorización médica.

    Consulte el protocolo para conocer todos los criterios de inclusión.
    E.4Principal exclusion criteria
    - Presenting with a diagnosis of MS with progressive course from onset (that is, primary progressive MS or progressive relapsing MS).

    - Widespread and symmetric white matter alterations in the baseline MRI suggestive of other demyelinating disorders (example, metabolic disorders, mitochondrial disorders).

    - Tested positive for aquaporin 4 (AQP4) or anti-myelin oligodendrocyte glycoprotein (MOG) antibodies at Visit 1 (Screening).

    - Pregnant (defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin laboratory test), or breastfeeding, or planning to become pregnant while enrolled in this study.

    - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

    Refer protocol for all exclusion criteria.
    - Presentar un diagnóstico de EM con curso progresivo desde el inicio (es decir, EM primaria progresiva o EM progresiva recidivante).
    - Alteraciones generalizadas y simétricas de la sustancia blanca en la RM de base que sugieren otros trastornos desmielinizantes (por ejemplo, trastornos metabólicos, trastornos mitocondriales).
    - Prueba positiva para la acuaporina 4 (AQP4) o anticuerpos contra la glicoproteína oligodendrocítica de mielina (MOG) en la visita 1 (selección).
    - Embarazada (definido como el estado de una mujer después de la concepción y hasta la terminación de la gestación, confirmado por una prueba de laboratorio de gonadotropina coriónica humana positiva), o en período de lactancia, o que planea quedar embarazada mientras está participando en este estudio.
    - Cualquier condición por la cual, en opinión del investigador, la participación no sea conveniente para el participante (por ejemplo, comprometiendo su bienestar) o que pudiera impedir, limitar o confundir las evaluaciones especificadas en el protocolo.

    Consulte el protocolo para conocer todos los criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomization to first confirmed relapse
    Tiempo desde la aleatorización hasta la primera recaída confirmada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Randomization to Week 108
    Desde la aleatorización hasta la semana 108.
    E.5.2Secondary end point(s)
    a. ARR, defined as the number of confirmed relapses per participant year
    b. Time to 12- and 24-week confirmed disability accumulation as measured by Expanded Disability Status Scale (EDSS) score
    c. Annualized rate of new/newly enlarging T2 lesions
    d. Adverse events (AEs), including AEs of special interest (AESI)
    e. Electrocardiogram (ECG) parameters, including heart rate (HR), intervals for PR, QRS, QT, and QTcF
    f. Pulmonary function test (PFT), including forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC)
    g. Blood pressure
    h. Laboratory values, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin
    i. Change in body weight/height
    j. Suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS)
    k. Peripheral blood lymphocyte counts
    l. Population PK parameters
    a. TRA, definida como el número de recaídas confirmadas por paciente-año.
    b. Tiempo hasta la acumulación de discapacidad confirmada a las 12 y 24 semanas según lo determinado por la puntuación de la Escala Ampliada del Estado de Discapacidad (EDSS).
    c. Tasa anualizada de lesiones en T2 nuevas/aumentadas.
    d. Acontecimientos adversos (AA), incluidos AA de especial interés (AAEI).
    e. Parámetros del electrocardiograma (ECG), incluidos la frecuencia cardíaca, los intervalos de PR, QRS, QT y QTcF.
    f. Prueba de función pulmonar (PFP), incluidos el volumen espiratorio forzado en 1 segundo (VEM1) y la capacidad vital forzada (CVF).
    g. Presión arterial.
    h. Valores analíticos, incluidas la alanina aminotransferasa (ALT), la aspartato aminotransferasa (AST) y la bilirrubina.
    i. Cambio en el peso corporal/estatura.
    j. Evaluación de tendencias suicidas con la Escala Columbia para Evaluar el Riesgo de Suicidio (C-SSRS).
    k. Recuentos de linfocitos en sangre periférica.
    l. Parámetros FC poblacionales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At timepoints as specified within the protocol
    En los tiempos especificados en el protocolo.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker evaluation, Tolerability, analysis of MRI parameters, cognitive function, fatigue and Health-related quality of life
    Evaluación de biomarcadores, tolerabilidad, análisis de parámetros de RMN, función cognitiva, fatiga y calidad de vida relacionada con la salud.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Doble simulación.
    Double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Brazil
    Canada
    Israel
    Peru
    Puerto Rico
    Taiwan
    United States
    Austria
    Estonia
    Finland
    France
    Poland
    Sweden
    Bulgaria
    Spain
    Switzerland
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Croatia
    Hungary
    Portugal
    Slovakia
    Turkey
    United Kingdom
    Serbia
    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 del 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 days2
    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 days2
    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: 212
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 190
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric population
    Población pediátrica.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 212
    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)
    A long-term extension study may be offered to participants who complete the 108-week double blind treatment (or the 108-week open-label treatment for PK sub-study participants)
    Podría ser ofrecido un estudio de extensión a largo plazo a los participantes que completen el tratamiento doble ciego de 108 semanas (o el tratamiento abierto de 108 semanas para los participantes del subestudio PK).
    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 Decision2022-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA