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    Summary
    EudraCT Number:2017-004471-31
    Sponsor's Protocol Code Number:I4V-MC-JAHX
    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:2019-05-29
    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 number2017-004471-31
    A.3Full title of the trial
    A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA)
    Estudio de fase 3, multicéntrico, en el que se evalúan la seguridad y la eficacia a largo plazo de baricitinib en pacientes de entre 1 y menos de 18 años con artritis idiopática juvenil (AIJ)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)
    Estudio de baricitinib en niños con artritis idiopática juvenil (AIJ)
    A.4.1Sponsor's protocol code numberI4V-MC-JAHX
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/157/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly Cork Ltd
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, Eastgate Road, Eastgate Business Park, Little
    B.5.3.2Town/ cityCo. Cork
    B.5.3.3Post codeT45 KD39
    B.5.3.4CountryIreland
    B.5.4Telephone number34918362958
    B.5.6E-mailensayosclinicos@lilly.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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    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.IMP: 3
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Suspension for oral suspension
    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 INNBARICITINIB
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    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 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 Yes
    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
    Juvenile Idiopathic Arthritis
    Artritis idiopática juvenil
    E.1.1.1Medical condition in easily understood language
    Childhood Arthritis
    Artritis en la infancia
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 of this protocol is to evaluate the long-term safety and tolerability of baricitinib in patients with JIA or sJIA
    El objetivo principal de este protocolo es evaluar la seguridad y la tolerabilidad a largo plazo de baricitinib en pacientes con AIJ o AIJs.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are
    -to evaluate the long-term efficacy of baricitinib in children with JIA or sJIA
    -to assess the long-term efficacy of baricitinib in children with JPsA
    -to evaluate the long-term efficacy of baricitinib in children with ERA or JPsA
    -to evaluate the potential effects of baricitinib on the cellular and humoral immune system
    Los objetivos secundarios de este estudio son:
    -Evaluar la eficacia de baricitinib a largo plazo en niños con AIJ o AIJs.
    -Evaluar la eficacia a largo plazo de baricitinib en niños con APJs.
    -Evaluar la eficacia a largo plazo de baricitinib en niños con ARE o APJs.
    -Evaluar los posibles efectos de baricitinib sobre el sistema inmunitario celular y humoral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have either completed participation in or terminated early from Study JAHV or Study JAHU and have not completed Post Treatment Follow up in those studies.
    - Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent (if applicable) and consent, respectively, according to local guidelines.
    -Male or nonpregnant, nonbreastfeeding female patients. Patients of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle).Otherwise, patients and their partners of childbearing potential must agree to use 2 effective methods of contraception..
    - Haber completado o haber finalizado de forma prematura la participación en el estudio JAHV o el estudio JAHU y no haber completado el seguimiento posterior al tratamiento de esos estudios.
    - Tanto el niño/adolescente como un padre o el tutor legal son capaces de comprender y participar completamente en las actividades del estudio clínico y firmar el asentimiento (si corresponde) y el consentimiento, respectivamente, de conformidad con las directrices locales.
    - Varones o mujeres que no estén embarazadas ni en período de lactancia. Pacientes fértiles que practiquen la abstinencia (si es completa y coherente con el estilo de vida preferente y habitual de la paciente). En cualquier otro caso, los pacientes y sus parejas fértiles deben estar de acuerdo en utilizar 2 métodos anticonceptivos eficaces..
    E.4Principal exclusion criteria
    - Had investigational product permanently discontinued in the originating study
    - Had temporary investigational product interruption at the final study visit of the originating study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the current study
    Medical Conditions
    - Have a known hypersensitivity to baricitinib or any component of this investigational product
    - Active anterior uveitis or receiving concurrent treatment for anterior uveitis
    - Have significant uncontrolled cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that developed during the originator study that, in the opinion of the investigator, could constitute an unacceptable risk to the patient if investigational product continues
    - Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
    - Intends to donate blood during the course of the study
    - Intend to receive a live vaccine (except booster immunization with attenuated vaccine for measles, mumps, and rubella [MMR] or varicella-zoster virus [VZV]) during the course of the study, or up to 28 days after the last dose of study drug. Booster vaccination for MMR or VZV may be considered if it is essential based on the local guideline and/or in the opinion of the investigator.
    - Currently enrolled in any other clinical study (except the originating study at screening for the current study) involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
    - Haber dejado de recibir de forma permanente el producto en fase de investigación en el estudio anterior.
    - Haber dejado de recibir temporalmente el producto en fase de investigación en la visita final del estudio anterior y, en opinión del investigador, que ello constituya un riesgo inaceptable para el paciente en caso de que participe en el estudio.
    Enfermedades o situaciones médicas
    - Presentar hipersensibilidad a baricitinib o a cualquiera de los componentes de este producto en fase de investigación.
    - Uveítis anterior activa o recibir en la actualidad tratamiento para la uveítis anterior.
    - Haber desarrollado durante el estudio anterior trastornos cardiovasculares, respiratorios, hepáticos, gastrointestinales, endocrinos, hematológicos, neurológicos o neuropsiquiátricos sin controlar, o cualquier otra enfermedad grave o inestable que, en opinión del investigador, podrían constituir un riesgo inaceptable para el paciente si continúa tomando el producto en fase de investigación.
    - Presentar cualquier otra enfermedad que, en opinión del investigador, impida al paciente entender la naturaleza, el alcance y las posibles consecuencias del estudio o le impida seguir y completar el protocolo.
    - Tener previsto donar sangre durante el estudio.
    - Tener previsto recibir una vacuna elaborada con microbios vivos (excepto la inmunización de refuerzo con vacunas atenuadas contra el sarampión, las paperas y la rubeola (SPR) o el virus de la varicela-zóster [VVZ]) durante el transcurso del estudio o hasta 28 días después de la última dosis del fármaco del estudio. Podrá considerarse la administración de vacunas de refuerzo contra SPR o el VVZ si es crucial de acuerdo con las directrices locales o el criterio del investigador.
    - Participar en la actualidad en cualquier otro ensayo clínico (salvo el estudio anterior en el momento de la selección del estudio actual) en el que se administre un producto en fase de investigación o en cualquier otro tipo de investigación médica que se considere que es incompatible con el estudio, desde un punto de vista científico o médico.
    E.5 End points
    E.5.1Primary end point(s)
    - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
    - Temporary investigational product interruptions and permanent investigational product discontinuations
    - Vital signs, growth and development, and laboratory evaluations (including chemistry and hematology)
    - Acontecimientos adversos surgidos durante el tratamiento (AAST), acontecimientos adversos de especial interés (AAEI) y acontecimientos adversos graves (AAG).
    - Interrupciones transitorias y permanentes de la administración del producto en fase de investigación
    - Constantes vitales, crecimiento y desarrollo, y pruebas analíticas (incluidas pruebas de bioquímica y hematología)
    E.5.1.1Timepoint(s) of evaluation of this end point
    through Week 264
    Hasta la semana 264
    E.5.2Secondary end point(s)
    Through Week 264:
    -Proportion of patients who achieve PedACR30/50/70/90/100 response rates using baseline of the originator study
    -Proportion of patients who demonstrate durability of PedACR30/50/70/90/100 response rates from the time of randomization in the originator study.
    -Proportion of patients who maintain PedACR30/50/70/90/100 response rates from baseline of the current study
    -Proportion of patients who have disease flare.
    -Time to disease flare
    - Changes from baseline in each of the 6 individual components of the PedACR core set values of the originator study
    - Change from baseline in the Physical Summary Score (PhS) and Psychosocial Summary Score (PsS) of the originator study of the Child Health Questionnaire-Parent Form 50 (CHQ-PF50)

    -Change from baseline of the originator study in caregiver burden as measured by the Parental Impact‑Time and Parental Impact‑Emotion scales of the CHQ-PF50
    -Proportion of patients with inactive disease (as defined by Wallace et al 2011).
    -Proportion of patients with minimal disease activity (as defined by Consolaro et al 2012).
    -Proportion of patients in remission (as defined by Wallace et al 2012)
    -Change from baseline of originating study in Juvenile Arthritis Disease Activity Score-27 (JADAS27).
    -Change from baseline of originating study in arthritis-related pain severity, as measured by the CHAQ pain severity Visual Analogue Scale (VAS) item.
    In patients with JPsA:
    -Change from baseline of originating study in Psoriasis Area and Severity Index (PASI)
    In patients with ERA or JPsA:
    -Change from baseline of originating study in SPARCC enthesis index
    -Change from baseline of originating study in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
    -Change from baseline of originating study in immunoglobulin levels and peripheral blood immunophenotyping (including T and B cells, T cell subsets, and NK cells)
    -Change of IgG titers from pre-vaccination to 4 weeks and 12 weeks post vaccination in patients eligible for vaccination with tetanus, diphtheria, and pertussis (TDaP) and/or pneumococcal according to local guidelines.
    Hasta la semana 264:
    - Porcentaje de pacientes que alcancen una respuesta PedACR30/50/70/90/100 respecto al período inicial del estudio anterior.
    - Porcentaje de pacientes que presenten durabilidad de la respuesta PedACR30/50/70/90/100 desde la fecha de aleatorización del estudio anterior.
    - Porcentaje de pacientes que mantengan las tasas de respuestas PedACR30/50/70/90/100 respecto al período inicial de este estudio.
    - Porcentaje de pacientes con exacerbación de la enfermedad.
    -Tiempo de exacerbación de la enfermedad.
    - Variaciones en cada una de las 6 variables del conjunto principal de componentes del PedACR respecto al período inicial del estudio anterior.
    - Variaciones en la calidad de vida (CdV) relacionada con la salud respecto al período inicial del estudio anterior de acuerdo con el cuestionario de salud infantil para padres 50 (CHQ-PF50).
    - Variaciones en la carga del cuidador respecto al período inicial del estudio anterior de acuerdo con los dominios de los padres/la familia del CHQ-PF50.
    - Porcentaje de pacientes con enfermedad inactiva (según la definición de Wallace et al., 2011).
    - Porcentaje de pacientes con actividad mínima de la enfermedad (según la definición de Consolaro et al., 2012).
    - Porcentaje de pacientes en remisión (según la definición de Wallace et al., 2012).
    - Variación respecto al período inicial del estudio anterior en la puntuación de la actividad de la artritis juvenil 27 (JADAS27).
    - Variación respecto al período inicial del estudio anterior en el dolor relacionado con la artritis de acuerdo con el ítem del dolor del CHAQ.
    En los pacientes con APJ:
    - Variación respecto al período inicial del estudio anterior en el índice de gravedad y área de la psoriasis (PASI).
    En los pacientes con ARE o APJ:
    - Variación respecto al período inicial del estudio anterior en el índice de entesitis del SPARCC.
    - Variación respecto al período inicial del estudio anterior en el índice de actividad de la espondiloartritis juvenil (JSpADA).
    - Variación respecto al período inicial del estudio anterior en las concentraciones de inmunoglobulinas y en el inmunofenotipado de la sangre periférica (linfocitos T y B, tipos de linfocitos B y linfocitos citolíticos naturales [LCN]).
    - Variación en los títulos de IgG entre el momento previo a la vacunación y la cuarta y la duodécima semana posteriores a la vacunación en pacientes tributarios de la vacuna de la difteria, la tosferina y el tétanos (DTT), y la vacuna antineumocócica de acuerdo con las directrices locales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    through Week 264
    Hasta la semana 264
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Belgium
    Brazil
    China
    Czech Republic
    Denmark
    France
    Germany
    India
    Israel
    Italy
    Japan
    Mexico
    Poland
    Russian Federation
    Spain
    Turkey
    United Kingdom
    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
    The date of the last visit or last scheduled procedure for the last patient
    in the 28-day follow-up period.
    La fecha de la última visita o del último procedimiento programado para el último paciente en el período de seguimiento de 28 días.
    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 months2
    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 months2
    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: 410
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 195
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 195
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients from 1 to 18 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 236
    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)
    After the conclusion of the study, continued access to baricitinib will not be provided.
    Tras la finalización del estudio no se proporcionará acceso continuado a baricitinib.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Ancillare
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation IQVIA
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation ICON Clinical Research LLC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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