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    Summary
    EudraCT Number:2020-005760-57
    Sponsor's Protocol Code Number:CA42750
    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:2021-06-23
    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 number2020-005760-57
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
    ESTUDIO DE FASE III, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE OBINUTUZUMAB EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus
    Estudio para evaluar la eficacia y seguridad de Obinutuzumab en pacientes con lupues eritematoso sistémico
    A.4.1Sponsor's protocol code numberCA42750
    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 SponsorRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    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 number+34913257300
    B.5.5Fax number+34913248196
    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 Yes
    D.2.1.1.1Trade name Gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRo 507-2759/F06-01
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus (SLE)
    LUPUS ERITEMATOSO SISTÉMICO (LES)
    E.1.1.1Medical condition in easily understood language
    SLE is an autoimmune disease in which the immune system attacks its own tissues, causing tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys and blood vessels.
    LES es una enfermedad autoinmune que el sist.inmunitario ataca sus propios tejidos,causando daños en órganos afectados.Puede afectar a articulaciones,piel,cerebro,pulmones,riñones y vasos sanguíneos
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    • To evaluate the efficacy of obinutuzumab compared with placebo based on proportion of participants who achieve systemic lupus erythematosus responder index (SRI) (4)
    Evaluar la eficacia de obinutuzumab en comparación con placebo basándose en la proporción de participantes que logren una respuesta en el Índice de respuesta en el lupus eritematoso sistémico (SRI) (4)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of obinutuzumab compared with placebo based on proportion of participants who achieve SRI (6), SRI (4), and SRI (8), proportion of participants who achieve sustained corticosteroid control, proportion of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA), proportion of participants who achieve Lupus Low Disease Activity State (LLDAS), time to first British Isles Lupus Assessment Group (BILAG) flare, change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale from baseline, change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain domain scale from baseline and change in SF-36 v2 Physical Component Summary scale from baseline
    • To evaluate the safety of obinutuzumab compared with placebo
    • To characterize the obinutuzumab pharmacokinetics (PK) profile
    • To evaluate the immune response to obinutuzumab
    -Evaluar la eficacia de obinutuzumab en comparación con placebo basado en la proporción de pacientes que alcancen SRI(6), SRI(4) y SRI 8), proporción de participantes que logren un control mantenido de los corticosteroides, roporción de participantes que logren una respuesta BICLA(evaluación combinada del lupus según el British Isles Lupus Assessment Group), Proporción de participantes que logren una respuesta LLDAS(Lupus Low Disease Activity State), Tiempo hasta la primera exacerbación BILAG,Variación de la escala FACIT-F(Functional Assessment of Chronic Illness Therapy-Fatigue)desde el momento basal, Variación de la escala del dominio de dolor corporal del cuestionario SF-36 v2(36-Item Short Form Survey, Version2), Variación de la escala PCS(Índice de salud física) del cuestionario SF-36 v2 desde el momento basal
    -Evaluar la seguridad de obinutuzumab en comparación con placebo
    -Determinar el perfil farmacocinético de obinutuzumab
    -Evaluar la respuesta inmunitaria a obinutuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants who are age 18-75 years at the time of signing Informed Consent Form
    • Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria >=12 weeks prior to screening
    • Anti-nuclear antibody (ANA) >=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
    • Low C3, C4, and/or CH50 as determined by the central laboratory at screening
    • High disease activity at screening, based on; BILAG-2004 (level A disease in >=1 organ system and/or Level B disease in >=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score >=8) and Physician’s Global Assessment (PGA) (score >=1.0 on a 0 to 3 visual analogue scale [VAS])
    • High disease activity on Day 1, based on; SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS)
    • Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
    • For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception including at least one method with a failure rate of <1% per year, during the treatment period and for 18 months after the final dose of obinutuzumab or placebo
    - Participantes de 18-75 años de edad en el momento de firmar el documento de consentimiento informado
    - Diagnóstico de LES según los criterios de clasificación European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) de 2019 >= 12 semanas antes de la selección
    - Anticuerpos antinucleares >= 1:80 y/o anticuerpos anti ADN bicatenario o anti Sm por encima del límite superior de la normalidad (LSN), según lo determinado por el laboratorio central en la selección
    - C3, C4 y/o CH50 bajos según lo determinado por el laboratorio central en la selección
    - Actividad alta de la enfermedad en la selección, definida por:BILAG 2004: enfermedad de nivel A en >=1 sistema orgánico y/o enfermedad de nivel B en >=2 sistemas orgánicos, Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) puntuación SLEDAI 2K >=8 y Evaluación global por el médico (PGA): Puntuación >=1,0 en una escala analógica visual (EAV) de 0 a 3
    - Actividad alta de la enfermedad el día 1, definida por: Puntuación SLEDAI 2K >=8 y puntuación PGA >=1,0 en una EAV de 0 a 3
    - Recepción actual de >=1 de las siguientes clases de terapias estándar para el tratamiento del LES en dosis estables: corticoides orales (CO), antipalúdicos, inmunodepresores convencionales
    - Mujeres con capacidad reproductiva: compromiso de practicar la abstinencia sexual (abstención de relaciones heterosexuales) o de utilizar métodos anticonceptivos incluido al menos uno con una tasa de fallos anual de >=1 % al año, durante el período de tratamiento y durante al menos 18 meses después de la última dosis de obinutuzumab o placebo
    E.4Principal exclusion criteria
    • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo
    • Presence of significant lupus-associated renal disease and/or renal impairment
    • Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies
    • Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
    • Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
    • History of non-SLE inflammatory skin or joint disease within one year of Day 1 that, in the opinion of the investigator, could interfere with assessments of skin or joint manifestations of SLE
    • History of any non-SLE disease treated with oral, intravenous (IV), or intramuscular (IM) corticosteroids for more than 14 days in total during the one year prior to Day 1
    • Receipt of any of the following excluded therapies: a) Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ocrelizumab, ofatumumab, or bortezomib less than 9 months prior to screening or during screening; b) Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening; c) Any biologic therapy (other than anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening; d) Inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening; e) Any live vaccine during the 28 days prior to screening or during screening
    • High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
    • Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
    • Human immunodeficiency virus (HIV) infection
    • Tuberculosis (TB) infection
    • Active infection of any kind, excluding fungal infection of the nail beds
    • Any major episode of infection
    • History of serious recurrent or chronic infection
    • History of progressive multifocal leukoencephalopathy (PML)
    • History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
    • Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
    • Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
    • Intolerance or contraindication to study therapies
    - Participantes embarazadas o en período de lactancia, o con intención de quedarse embarazadas durante el estudio o en los 18 meses siguientes a la última dosis de obinutuzumab o el placebo
    - Presencia de nefropatía y/o insuficiencia renal lúpica importante
    - Enfermedad neuropsiquiátrica activa grave o inestable asociada al lupus o que, en opinión del investigador, probablemente requiera tratamiento con medicamentos no permitidos por el protocolo
    - Síndrome de solapamiento activo con enfermedad mixta del tejido conjuntivo o esclerosis sistémica en los 12 meses previos a la selección o durante la selección
    - Síndrome antifosfolipídico grave o catastrófico en los 12 meses previos a la selección o durante la selección
    - Antecedentes de enfermedad inflamatoria cutánea o articular distinta del LES en el año previo al día 1 que, en opinión del investigador, podría interferir en las evaluaciones de las manifestaciones cutáneas o articulares del LES
    - Antecedentes de cualquier enfermedad distinta del LES tratada con corticosteroides orales, IV o IM durante más de 14 días en total en el año previo al día 1
    - Recepción de cualquiera de los siguientes tratamientos excluidos: a)Cualquier tratamiento reductor de los linfocitos B (p. ej., anti CD20, anti CD19) o anti células plasmáticas, entre otros, obinutuzumab, rituximab, ocrelizumab, ofatumumab o bortezomib menos de 9 meses antes de la selección o durante la selección, b) Ciclofosfamida, tacrolimús, ciclosporina o voclosporina durante los 2 meses previos a la selección o durante la selección. C)Cualquier tratamiento biológico (distinto de anti CD20, anti CD19 o anti células plasmáticas), entre otros, belimumab, ustekinumab, anifrolumab, secukinumab o atacicept durante los 2 meses previos a la selección o durante la selección. D)Inhibidores de la cinasa asociada a Janus (JAK), la tirosina cinasa de Bruton (BTK) o la tirosina cinasa 2 (TYK2), como baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib o fenebrutinib, o cualquier fármaco en investigación, en los 2 meses previos a la selección o durante la selección. E)Cualquier vacuna de microorganismos vivos en los 28 días previos a la selección o durante la selección.
    - Riesgo elevado de hemorragia de importancia clínica o cualquier afección que requiera plasmaféresis, inmunoglobulina intravenosa o transfusiones agudas de hemoderivados.
    - Enfermedad física significativa o no controlada que, en opinión del investigador, impida la participación del paciente.
    - Infección por el VIH.
    - Tuberculosis (TB).
    - Infección activa de cualquier tipo, excluida la micosis de los lechos ungueales.
    - Cualquier episodio importante de infección
    - Antecedentes de infección recurrente o crónica grave.
    - Antecedentes de leucoencefalopatía multifocal progresiva (LMP).
    - Antecedentes de cáncer incluidos tumores sólidos, neoplasias malignas hematológicas y carcinoma in situ, en los últimos 5 años.
    - Intervención de cirugía mayor con necesidad de hospitalización en las 4 semanas previas a la selección o durante la selección.
    - Alcoholismo o abuso de drogas en la actualidad o antecedentes de alcoholismo o abuso de drogas en los 12 meses previos a la selección o en la selección.
    - Intolerancia o contraindicación a los fármacos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants who achieve SRI (4) at Week 52
    1. Proporción de participantes que logren una respuesta SRI(4) en la semana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 52
    1. en la semana 52
    E.5.2Secondary end point(s)
    1. Percentage of participants who achieve SRI (6) at Week 52
    2. Percentage of participants who achieve Sustained Corticosteroid Control from Week 40 through Week 52
    3. Percentage of participants who achieve Sustained SRI (4) response from Week 40 through Week 52
    4. Percentage of participants who achieve BICLA at Week 52
    5. Percentage of participants who achieve SRI (8) at Week 52
    6. Percentage of participants who achieve SRI (4) at Week 24
    7. Percentage of participants who achieve clinical SRI (4) at Week 52
    8. Percentage of participants who achieve SRI (4) at Week 52 on low-dose corticosteroids
    9. Percentage of participants who achieve LLDAS at Week 52
    10. Time to first BILAG flare over 52 weeks
    11. Change in FACIT-F scale from baseline to Week 52
    12. Change in SF-36 v2 Bodily Pain domain scale from baseline to Week 52
    13. Change in SF-36 v2 Physical Component Summary scale from baseline to Week 52
    14. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
    15. Percentage of participants with adverse events of special interest, including, among others, infusion-related reactions (IRRs), neutropenia, infections, and thrombocytopenia
    16. Change from baseline in targeted vital signs
    17. Change from baseline in targeted clinical laboratory test results
    18. Serum concentration of obinutuzumab at specified timepoints
    19. Prevalence of anti-drug antibodies (ADAs) against obinutuzumab at baseline
    20. Incidence of ADAs against obinutuzumab during the study
    1. Proporción de participantes que logren una respuesta SRI(6) en la semana 52
    2. Proporción de participantes que logren un control mantenido de los corticosteroides entre las semanas 40 y 52
    3. Proporción de participantes que logren una respuesta SRI(4) mantenida entre las semanas 40 y 52
    4. Proporción de participantes que logren una respuesta BICLA en la semana 52
    5. Proporción de participantes que logren una respuesta SRI(8) en la semana 52
    6. Proporción de participantes que logren una respuesta SRI(4) en la semana 24.
    7. Proporción de participantes que logren una respuesta SRI(4) clínica en la semana 52
    8. Proporción de participantes que logren una respuesta SRI(4) en la semana 52 con una dosis baja de corticosteroides
    9. Proporción de participantes que logren una respuesta LLDAS en la semana 52
    10. Tiempo hasta la primera exacerbación BILAG durante 52 semanas
    11. Variación de la escala FACIT-F entre el momento basal y la semana 52.
    12. Variación de la escala del dominio de dolor corporal del cuestionario SF-36 v2 entre el momento basal y la semana 52
    13. Variación de la escala PCS (Índice de salud física) del cuestionario SF-36 v2 entre el momento basal y la semana 52
    14. Incidencia e intensidad de los acontecimientos adversos, con determinación de la intensidad conforme a los criterios National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
    15. Proporción de pacientes con acontecimientos adversos de interés especial, como reacciones relacionadas con la infusión (RRI), neutropenia, infecciones y trombocitopenia
    16. Variación de las constantes vitales de interés con respecto al momento basal.
    17. Variación de los resultados analíticos de interés con respecto al momento basal
    18. Concentración sérica de obinutuzumab en momentos especificados
    19. Prevalencia de anticuerpos contra el fármaco (ACF) en el momento basal
    20. Incidencia de ACF durante el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Week 52
    2-3. From Week 40 to Week 52
    4-5. At Week 52
    6. At Week 24
    7-9. At Week 52
    10. Up to Week 52
    11-13. Baseline (Day 1) to Week 52
    14-15. Through completion of Study Follow Up
    16-17. Baseline (Day 1) through completion of Study Follow Up
    18. Double blind period: At Weeks 2, 4, 12, 24, 26, 36, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 58, 66, 78, 80, 90, 104 and at early study discontinuation visit
    19. Baseline (Day 1)
    20. Double blind period: At Weeks 2, 4, 12, 24, 26, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 66, 78, 80, 104 and at early study discontinuation visit
    1. en la semana 52
    2-3. se la semana 40 a la 52
    4-5. en la semana 52
    6. en la semana 24
    7-9. en la semana 52
    10. hasta la semana 52
    11-13. momento basal (Dia 1) hasta la semana 52
    14-15. Hasta la finalización del seguimiento del estudio
    16-17. momento basal (Dia 1) Hasta la finalización del seguimiento del estudio
    18. Periodo doble enmascarado: en las semanas 2, 4, 12, 24, 26, 36, 52 y en la visita de discontinuación temprana;Periodo abierto: en las semanas 54, 56, 58, 66, 78, 80, 90, 104 y en la visita de discontinuación temprana
    19. omento basal (Dia 1)
    20. Periodo doble enmascarado: en las semanas 2, 4, 12, 24, 26, 52 y en la visita de discontinuación temprana; Periodo abierto: en las semanas 54, 56, 66, 78, 80, 104 y en la visita de discontinuación temprana
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Australia
    Brazil
    Mexico
    New Zealand
    Peru
    Russian Federation
    South Africa
    United States
    France
    Italy
    Poland
    Spain
    United Kingdom
    Argentina
    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 end of this study is defined as the date of the scheduled last participant, last visit (LPLV) or when all participants are discontinued from the study, whichever occurs earlier. No further study follow up visits will occur after the following date: 18 months after all participants have completed or discontinued study drug infusions (blinded and open-label). The end of the study is expected to occur approximately 3 years after the last participant
    is enrolled.
    El final de este estudio se define como la fecha de última visita programada del último participante(UVUP)o cuando todos los participantes se retiren del estudio lo que ocurra antes.No habrá más visitas de seguimiento del estudio después de la siguiente fecha:18meses después de que todos los participantes hayan completado o suspendido las infusiones del fármaco del estudio(ciego y abierto).El final del estudio se espera que ocurra aprox. 3años después de que el último participante se incluya
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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
    The study allows for LAR to provide consent on behalf of participants.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 200
    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)
    Upon completion of the study, the Sponsor will offer continued access to Roche IMP (obinutuzumab) free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Products (see Section 6.6 in the Protocol).
    Una vez finalizado el estudio, el promotor ofrecerá a los participantes elegibles el acceso continuado al PEI de Roche (obinutuzumab) de forma gratuita, de acuerdo con la política global de Roche sobre el acceso continuado a los medicamentos en investigación (véase la sección 6.6 del protocolo).
    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 Decision2021-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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