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    Summary
    EudraCT Number:2017-003649-10
    Sponsor's Protocol Code Number:CA40192
    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:2017-12-01
    Trial results View 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 number2017-003649-10
    A.3Full title of the trial
    A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE
    ESTUDIO DE FASE I, ABIERTO Y ALEATORIZADO PARA EVALUAR LA FARMACOCINÉTICA, LA FARMACODINAMIA Y LA SEGURIDAD DE ETROLIZUMAB SEGUIDO DE UNA EXTENSIÓN ABIERTA Y UNA VIGILANCIA DE LA SEGURIDAD EN PACIENTES PEDIÁTRICOS DE ENTRE 4 Y MENOS DE 18 AÑOS DE EDAD CON COLITIS ULCEROSA O ENFERMEDAD DE CROHN MODERADA O GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease
    Estudio farmacocinético, farmacodinámico y de seguridad de Etrolizumab seguido de una extensión abierta y una vigilancia de la seguridad en pacientes pediátricos de entre 4 años y 18 años de edad con colitis ulcerosa o enfermedad de Crohn moderada o grave
    A.4.1Sponsor's protocol code numberCA40192
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/148/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoche Farma S.A. (Soc unipersonal) que realiza el ensayo en España y que actúa como represntante de FHoffmann-La Roche
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number34913257300
    B.5.5Fax number34913248195
    B.5.6E-mailspain.start_up_unit@roche.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 nameEtrolizumab
    D.3.2Product code 549-0261/F02-01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETROLIZUMAB
    D.3.9.1CAS number 1044758-60-2
    D.3.9.2Current sponsor codeRO5490261/F02-01
    D.3.9.3Other descriptive nameETROLIZUMAB
    D.3.9.4EV Substance CodeSUB75320
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized monoclonal antibody
    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
    Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
    Colitis ulcerosa moderada o grave (CU); enfermedad de Crohn moderada o grave (EC)
    E.1.1.1Medical condition in easily understood language
    UC and CD are types of inflammatory bowel disease (IBD) that affects the lining of the digestive tract
    La CU y la EC son tipos de enfermedad inflamatoria del intestino (EII) que afecta el revestimiento del tracto digestivo
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 pharmacokinetics (PK) and pharmacodynamics (PD)of etrolizumab in a pediatric IBD patient population (Randomized Treatment Phase)
    Evaluar la farmacocinética (PK) y la farmacodinamia (PD) de etrolizumab en una población pediátrica con EII (fase de tratamiento aleatorizado)
    E.2.2Secondary objectives of the trial
    •To evaluate the overall safety and tolerability of etrolizumab in pediatric population (Randomized Treatment Phase)
    •To evaluate long-term safety and efficacy of etrolizumab in pediatric population (Open–label Extension Phase)
    •Post-trial safety surveillance with focus on progressive multifocal leukoencephalopathy (PML) monitoring in patients who have stopped treatment (PML Monitoring Phase)
    -Evaluar la seguridad y la tolerabilidad generales de etrolizumab en una población pediátrica (fase de tratamiento aleatorizado)
    -Evaluar la seguridad a largo plazo de etrolizumab en una población pediátrica (fase de extensión abierta)
    -Vigilancia de la seguridad posterior al ensayo, con especial atención a la aparición de LMP, en los pacientes que hayan interrumpido el tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age of 4 years to < 18 years
    - Weight of 13 kg or more
    - Diagnosis of UC or CD confirmed by biopsy and established for >= 3 months prior to screening
    - Inadequate response, loss of response or intolerance to prior immunosuppressants and/or corticosteroid treatment and/or anti-TNF therapy

    - For patients with UC: moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic subscore >= 2 and a rectal bleeding subscore 3>= 1
    - For patients with CD: moderately to severely active CD as determined by a Pediatric Crohn’s Disease Activity Index (PCDAI) score of >30 at baseline
    - Patients must meet the surveillance colonoscopy requirements such as document evidence of surveillance for dysplasia every 1 to 2 years, beginning approximately 7 to 10 years after their initial diagnosis
    - For postpubertal females of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 24 weeks after the last dose of etrolizumab
    - For male patients: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm for at least 24 weeks after the last dose of study drug to avoid exposing the embryo to study drug
    -Edad de entre 4 y < de 18 años
    -Peso de 13 kg o más
    -Diagnóstico de CU o EC confirmado mediante biopsia y establecido durante  3 meses antes de la selección
    -Respuesta insuficiente, pérdida de respuesta o intolerancia al tratamiento previo con inmunosupresores y/o corticosteroidesy/o terapias anti-TNF
    -Pacientes con CU: CU moderada o grave activa, según lo determinado por una puntuación MCS de 6-12 con una subpuntuación endoscópica >= 2 y una subpuntuación de hemorragia rectal 3>= 1.
    -Pacientes con EC: enfermedad de Crohn moderada o grave activa, según lo determinado por una puntuación PCDAI (Índice de actividad de la enfermedad de Crohn pediátrica) 30 en el momento basal.
    -Los pacientes deben cumplir los siguientes requisitos relacionados con la práctica de colonoscopias de vigilancia:
    – Constancia documental de vigilancia en busca de displasia cada 1 a 2 años, empezando entre 7 y 10 años después del diagnóstico inicial.
    -Mujeres pospuberales en edad fértil: compromiso de practicar abstinencia o de utilizar métodos anticonceptivos aceptables durante el período de tratamiento y hasta al menos 24 semanas después de la última dosis de etrolizumab
    -Varones: compromiso de practicar abstinencia y donar semen hasta al menos 24 semanas después de la última dosis del fármaco del estudio para evitar la exposición del embrión al fármaco del estudio
    E.4Principal exclusion criteria
    For IBD
    - Prior extensive colonic resection, subtotal or total colectomy, or planned surgery
    - Past or present ileostomy or colostomy and a history or current evidence of colonic mucosal dysplasia
    - Diagnosis of indeterminate colitis, toxic megacolon within 12 months of initial screening visit
    - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
    - Abdominal abscessl
    - Patients with any stricture of the colon and having history or evidence of adenomatous colonic polyps that have not been removed and who are not up to date on vaccinations per the local vaccine schedule will be excluded

    For UC
    - Severe extensive colitis per investigator judgment that colectomy is imminent or the patient has two of the mentioned five symptoms at screening or baseline visit such as 6 bowel movements daily with obvious blood, abdominal examination worrisome for imminent surgery, persistent fever, tachycardia and anemia

    For CD
    - Sinus tract with evidence for infection in the clinical judgment of the investigator, short-bowel syndrome and evidence of abdominal or perianal abscess
    - Expected to require surgery to manage CD-related complications during the study

    For Prior or Concomitant Therapy
    - Any prior treatment with anti-integrins, ustekinumab,anti-adhesion molecules and rituximab
    - Use of intravenous (IV) steroids within 30 days prior to screening with the exception of a single administration of IV steroid, use of agents that deplete B or T cells within 12 months prior to Day (D)1, with the exception of azathioprine and 6 mercaptopurine; use of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 4 weeks prior to D1, other biologics within 8 weeks before dosing and use of chronic nonsteroidal anti-inflammatory drug and anticoagulants and apheresis within 2 weeks prior to D1
    - Received any investigational treatment including investigational vaccines within 12 weeks prior to D1 of the study or 5 half-lives of the investigational product
    - History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies, fusion proteins, or murine proteins or hypersensitivity to etrolizumab or any of excipients
    - Tube feeding, defined formula diets, or parenteral alimentation/nutrition who have not discontinued these treatments > 3 weeks prior to D1

    For General Safety
    - Lack of peripheral venous access
    - Congenital or acquired immune deficiency
    - Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestoinal disorders (excluding UC and CD) and clinically significant abnormalities on the screening PML Subjective Checklist
    - Neurological conditions or diseases that may interfere with PML monitoring
    - History of demyelinating disease , major neurological disorder and cancer
    - Conditions other than UC or CD that could require treatment with >10 mg/day of prednisone during course of the study

    For Infection Risk
    - Congenital or acquired immune deficiency
    - Patients must undergo screening for HIV and test positive for preliminary, confirmatory tests and hepatitis B virus
    - Positive hepatitis C virus (HCV) antibody test result, unless patient who has undetectable HCV RNA levels for >6 months after completing a successful course of HCV anti-viral treatment and an undetectable HCV RNA at screening or who has a known history of HCV antibody positivity with a history of undetectable HCV RNA and undetectable HCV RNA at screening in absence of history of HCV anti-viral treatment
    - Positive stool test result for ova or parasites or positive stool culture for pathogens at time of screening
    - Evidence of or treatment for Clostridium difficile, other intestinal pathogens and clinically significant cytomegalovirus colitis within 60,30 and 60 days prior to D1 respectively. Laboratory confirmation of CMV from colon biopsy sample is required during screening evaluation only if clinical suspicion is high and to determine the need for CMV treatment
    - History of active or latent treated tuberculosis (TB) and organ transplant and recurrent opportunistic and/or history of severe disseminated viral infections
    - Suspicion of active TB on chest radiograph taken within 3 months of randomization
    - Any major episode of infection requiring treatment with IV antibiotics or oral antibiotics within 8 and within 4 weeks prior to screening and received a live attenuated vaccine within 4 weeks prior to D1
    For Laboratory Values (at Screening)
    - Serum creatinine >1.5 times upper limit of normal (ULN), alanine transaminase or aspartate transaminase >3 ULN, or alkaline phosphatase >3 ULN, or total bilirubin >2.5 ULN
    - In patients with diabetes: glycosylated hemoglobin > 8.0%, platelet count <100,000/mL, hemoglobin <8 g/dL, absolute neutrophil count <1500/mL, absolute lymphocyte count <500/mL
    Criterios de exclusión relacionados con la enfermedad inflamatoria intestinal
    -Resección extensa del colon, colectomía subtotal o total o cirugía programada.
    -Ileostomía o colostomía pasada o presente y antecedentes o datos presentes de displasia de la mucosa del colon
    -Diagnóstico de colitis indeterminada,diagnóstico de megacolon tóxico en los 12 meses previos a la visita de selección inicial
    -Sospecha de colitis isquémica, colitis por radiación o colitis microscópica
    -Absceso abdominal
    -Se excluirán los pacientes con cualquier estenosis del colon y que tengan antecedentes o evidencia de pólipos colónicos adenomatosos que no se hayan extirpado y que no estén actualizados con las vacunas según el programa de vacunación local.
    Criterios de exclusión relacionados con la colitis ulcerosa
    -Colitis extensa grave según el criterio del investigador de colectomía inminente O el paciente presenta dos de los cinco síntomas siguientes en la visita de selección o basal como 6 deposiciones diarias con sangre evidente, exploración abdominal preocupante por cirugía inminente,fiebre persistente,taquicardia,anemia
    Criterios de exclusión relacionados con la enfermedad de Crohn
    -Trayecto fistuloso con datos de infección (p. ej., secreción purulenta) según el criterio clínico del investigador, síndrome de intestino corto,signos de absceso abdominal o perianal
    -Previsión de necesitar cirugía para tratar complicaciones relacionadas con la EC durante el estudio.
    Criterios de exclusión relacionados con el tratamiento previo o concomitante
    Cua-lquier tratamiento previo con inhibidores de integrinas,ustekinumab,inhibidores de moléculas de adherencia,rituximab
    -Uso de esteroides IV en los 30 días previos a la selección, con la excepción de una única administración de esteroides IV,Uso de fármacos que reducen los linfocitos B o T,en los 12 meses previos al día 1, con la excepción de AZA y 6-MP,
    Uso de ciclosporina, tacrolimus, sirolimus o micofenolato mofetilo (MMF) en las cuatro semanas previas al día 1,Uso de otros productos biológicos en las ocho semanas previas a la administración,Uso crónico de antiinflamatorios no esteroideos,anticoagulantes, y aféresis en las 2 semanas previas al día 1.
    E.5 End points
    E.5.1Primary end point(s)
    1.Maximum concentration observed (Cmax) (Randomized Treatment Phase)
    2.Area under the concentration-time curve within a dosing interval (AUCtau) (Randomized Treatment Phase)
    3.Elimination half-life (t1/2) (Randomized Treatment Phase)
    4.Steady-state concentration at the end of a dosing interval (Ctrough) (Randomized Treatment Phase)
    5.PD parameters: β7 receptor occupancy by flow cytometry on peripheral blood lymphocytes (Randomized Treatment Phase)
    Concentración máxima observada (Cmax) (Fase de tratamiento aleatorizado)
    2.Área bajo la curva de concentración-tiempo dentro de un intervalo de dosificación (AUCtau) (Fase de tratamiento aleatorizado)
    3.Eliminación de la vida media (t1 / 2) (Fase de tratamiento aleatorizado)
    4. Concentración de estado fijo al final de un intervalo de dosificación (Ctrough) (Fase de tratamiento aleatorizado)
    5.PD parámetros: ocupación del receptor β7 por citometría de flujo en linfocitos de sangre periférica (fase de tratamiento aleatorizado)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-4. Treatment period: D1 of Week (W)0;D4;D28 (W4); D56 (W8); D60 and 70; D84 (W12); D88 and 98; D112 (W16) and at unscheduled visit and early withdrawal from treatment or discontinuation
    Safety follow-up period: At D126 (W18), D140 (W20) and D168 (W24) or early withdrawal visit
    5. Treatment period: D1 (W0), D4, D56 (W8), D84 (W12), D98, D112 (W16) and at unscheduled visit and early withdrawal from treatment or discontinuation
    Safety follow-up period: At D126 (W18), D140 (W20) and D168 (W24) or early withdrawal visit
    4. Período de tratamiento: D1 de la semana (W) 0; D4; D28 (W4); D56 (W8); D60 y 70; D84 (W12); D88 y 98; D112 (W16) y en visita no programada y retiro temprano del tratamiento o interrupción
    Periodo de seguimiento de seguridad: en D126 (W18), D140 (W20) y D168 (W24) o visita de retirada anticipada
    5. Período de tratamiento: D1 (W0), D4, D56 (W8), D84 (W12), D98, D112 (W16) y en visita no programada y retirada anticipada del tratamiento o interrupción
    Periodo de seguimiento de seguridad: en D126 (W18), D140 (W20) y D168 (W24) o visita de retirada anticipada
    E.5.2Secondary end point(s)
    1.Incidence and severity of infection-related adverse events (Randomized Treatment and Open–Label Extension Phase)
    2.Incidence of immunogenic responses (anti-drug antibodies [ADAs]) (Randomized Treatment Phase)
    3.Incidence and severity of hypersensitivity reaction events (Randomized Treatment and Open–Label Extension Phase)
    4.Incidence and severity of malignancies (Open–Label Extension Phase)
    5.Incidence of ADAs to etrolizumab (Open–Label Extension Phase)
    6.Clinical response at W132, as assessed by the Pediatric Ulcerative Colitis Activity Index (UC) and Pediatric Crohn's Disease Activity Index (CD) (Open–Label Extension Phase)
    7.Occurrence of confirmed PML events (PML Monitoring Phase)
    .Incidencia y gravedad de los eventos adversos relacionados con la infección (tratamiento aleatorizado y fase de extensión de etiqueta abierta)
    2.Incidencia de respuestas inmunogénicas (anticuerpos antidrogas [ADA]) (Fase de tratamiento aleatorizado)
    3.Incidencia y severidad de los eventos de reacción de hipersensibilidad (tratamiento aleatorizado y fase de extensión de etiqueta abierta)
    4. Incidencia y severidad de malignidades (Fase de extensión de etiqueta abierta)
    5.Incidencia de ADAs a etrolizumab (Fase de extensión de etiqueta abierta)
    6. Respuesta clínica en W132, evaluada por el índice de actividad de colitis ulcerativa pediátrica (CU) y el índice de actividad de la enfermedad de Crohn pediátrica (CD) (fase de extensión de etiqueta abierta)
    7.Ocurrencia de eventos confirmados de PML (Fase de monitoreo de PML)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5. Up to 5 years
    6. At W132
    7. Up to 104 weeks
    -5. Hasta 5 años
    6. En W132
    7. Hasta 104 semanas
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pediatric
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Belgium
    Germany
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for PK/PD or statistical analysis or safety follow-up is received from the last patient, whichever occurs later. The end of the study is expected to occur 60 months after the last patient is enrolled. The total length of the study, from screening of the first patient to the end of the study, is expected to be
    approximately 5 years.
    El final de este estudio se define como la fecha en que se produzca la última visita del último pte (LVLP) o la fecha en la que se reciban los últimos datos nec para los análisis de FC/FD o estadísticos o el seg de la seguridad del último pte, lo que ocurra más tarde. Está previsto que el final del estudio tenga lugar 60 meses desp de la inclusión del último pte.
    Se prevé que la duración total del estudio, desde la selección del primer pte hasta el final , sea de aproximadamente 5 años.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 60
    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: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 45
    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
    Subjects under age incapable of giving consent personally - Signed Informed Consent Form by parent or legal guardian
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 60
    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)
    The Sponsor will offer continued access to Roche IMP etrolizumab free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to IMP: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf.
    In addition, patients that are >18 years of age have the option to enroll in the adult open–label extension studies of GA28951 for UC and GA29145 for CD if they meet eligibility criteria
    El Sponsor ofrecerá acceso continuo a etrolizumab de Roche IMP de forma gratuita a los pacientes elegibles de acuerdo con la Política Global de Roche sobre el acceso continuo a IMP: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf.
    Además, los pacientes mayores de 18 años tienen la opción de inscribirse en los estudios de extensión abierta para adultos de GA28951 para UC y GA29145 para CD si cumplen con los criterios de elegibilidad
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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