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    Summary
    EudraCT Number:2021-000097-29
    Sponsor's Protocol Code Number:WA42985
    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:2021-07-08
    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 number2021-000097-29
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF OBINUTUZUMAB IN ADOLESCENT PATIENTS WITH ACTIVE CLASS III OR IV LUPUS NEPHRITIS
    ESTUDIO FASE II, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA, SEGURIDAD Y FARMACOCINÉTICA DE OBINUTUZUMAB EN PACIENTES ADOLESCENTES CON NEFRITIS LÚPICA DE CLASE III O IV ACTIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Randomized Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients with Active Class III or IV Lupus Nephritis
    Estudio fase II, aleatorizado y controlado paraevaluar la eficacia, seguridad y farmacocinética de obinutuzumab en pacientes adolescentes con nefritis lúpica de casle III o IV activa
    A.4.1Sponsor's protocol code numberWA42985
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/050/2021
    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. Hoffman-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 code4047
    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.3.1Product nameObinutuzumab
    D.3.2Product code RO5072759
    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 codeRO5072759
    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.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 Myfenax
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    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 namemycophenolate mofetil
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmycophenolate mofetil
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    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 placeboConcentrate for concentrate 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
    Lupus Nephritis (LN)
    Nefritis lúpica (NL)
    E.1.1.1Medical condition in easily understood language
    Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE). SLE is an autoimmune disease, in which the body’s immune system attacks its own healthy body tissue.
    La nefritis lúpica es una inflamación del riñón causada por el lupus eritematoso sistémico(LES).LES es una enfermedad autoinmune,en la que el sistema inmune del cuerpo ataca sus propios tejidos sanos
    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 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary 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 in adolescent participants with Class III/IV LN
    Evaluar la eficacia de obinutuzumab comparado con placebo en pacientes adolescentes con NL de clase III o IV
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of obinutuzumab compared with placebo
    To evaluate the safety of obinutuzumab compared with placebo
    To characterize obinutuzumab pharmacokinetic (PK) profile
    To characterize obinutuzumab pharmacodynamic (PD) profile
    To evaluate changes in fatigue of participants treated with obinutuzumab compared with placebo
    To evaluate change in SLE disease activity of participants treated with obinutuzumab compared with placebo
    To evaluate changes in the quality of life of participants treated with obinutuzumab compared with placebo
    Evaluar la eficacia de obinutuzumab comparado con placebo
    Evaluar la seguridad de obinutuzumab comparado con placebo
    Caracterización del perfil farmacocinético (FC) de obinutuzumab
    Caracterización del perfil farmacodinámico (FD) de obinutuzumab
    Evaluación de las variaciones en el grado de fatiga de los participantes tratados con obinutuzumab en comparación con placebo
    Evaluación de la variación en la actividad del LES en los participantes tratados con obinutuzumab en comparación con placebo
    Evaluación de los cambios en la calidad de vida de los participantes tratados con obinutuzumab en comparación con placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants who are age 12 to <18 years at the time of randomization
    Ability to comply with the study protocol, in the investigator's judgment
    International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
    Positive current or historical test for antinuclear antibody (ANA) and/or antibodies to double-stranded DNA (dsDNA)
    Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
    Significant proteinuria defined by a urine protein-to-creatinine ratio (UPCR) above >0.5 based on a first-morning void (FMV) collection at screening
    During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN
    For females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 18 months after the final dose of obinutuzumab and for 6 weeks after the final dose of mycophenolate mofetil (MMF)
    For males: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, during the treatment period and for 90 days after the final dose of MMF
    Participantes de 12 a <18 años en el momento de la aleatorización
    Capaces de cumplir el protocolo del estudio, según el criterio del investigador
    NL activa de clase III o IV de la ISN/RPS 2003 demostrada en una biopsia renal realizada en los 12 meses previos a la selección o durante esta
    Prueba actual o histórica inequívocamente positiva de anticuerpos antinucleares (ANA) y/o anticuerpos contra el ADN bicatenario (ADNbc).
    Puede haber enfermedad de clase V además de NL de clase III o IV, pero no podrán participar pacientes con enfermedad aislada de clase V
    Proteinuria significativa, definida por un cociente entre proteínas y creatinina en orina (CPCO) >0,5 según una muestra de la primera micción de la mañana (PMM) en la selección
    Durante los 12 meses previos a la selección o durante la misma, todos los participantes deberán haber recibido al menos una dosis de metilprednisolona IV en pulsos (normalmente 30 mg/kg, máximo de 1000 mg por dosis) o equivalente para el tratamiento del episodio actual de NL activa
    Mujeres en edad fértil: pacientes que estén de acuerdo en practicar la abstinencia sexual (abstenerse de mantener relaciones heterosexuales) o en utilizar métodos anticonceptivos y estén de acuerdo en no donar óvulos durante el período de tratamiento y hasta 18 meses después de la última dosis de obinutuzumab y 6 semanas después de la última dosis de MMF
    Varones: participantes que se comprometan a practicar la abstinencia sexual (abstenerse de mantener relaciones heterosexuales) o utilizar métodos anticonceptivos y a no donar semen durante el período de tratamiento y durante los 90 días siguientes a la dosis final de MMF
    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, or within 6 weeks after the final dose of MMF
    Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
    Severe renal impairment, as defined by glomerular filtration rate (GFR) <30 mL/min/1.73m^2 (as estimated using the Bedside Schwartz equation) or the need for renal transplant, plasmapheresis or dialysis at screening
    Sclerosis in >50% of glomeruli on renal biopsy
    Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
    Presence of rapidly progressive glomerulonephritis
    Pure Class V LN
    Intolerance or contraindication to study therapies
    Receipt of any of the following excluded therapies:
    – Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
    – Any anti-CD20 therapy such as, but not limited to, rituximab, ocrelizumab, or ofatumumab within 12 months prior to screening or during screening
    – Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening
    – Oral 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
    – Any live vaccine during the 28 days prior to screening or during screening
    Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization
    History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders
    History of serious recurrent or chronic infection
    History of progressive multifocal leukoencephalopathy (PML)
    History of or current 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
    High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
    Significant or uncontrolled concomitant medical disease which, in the investigator’s opinion, would preclude participant participation
    Currently active alcohol or drug abuse or history of alcohol or drug abuse
    Any of the following laboratory parameters at screening:
    Aspartate aminotransferase (AST) or alanine transaminase (ALT) >2.5Xupper limit of normal (ULN) (for age and sex) that cannot be attributed to underlying SLE
    Amylase or lipase >2XULN
    Absolute neutrophil count (ANC) <1.5X10^3/microliter
    Hemoglobin <7 g/dL, unless caused by autoimmune hemolytic anemia resulting from SLE
    Platelet count <50,000/microliter
    Positive hepatitis B surface antigen (HBsAg)
    Positive hepatitis C serology
    Positive serum human chorionic gonadotropin measured at screening
    Participantes que estén embarazadas o en lactancia, o tengan intención de quedarse embarazadas durante el estudio o en los 18 meses siguientes a la última dosis de obinutuzumab o placebo o en las 6 semanas siguientes a la última dosis de MMF
    LES activo y grave del sistema nervioso central (SNC), como retinitis, trastorno convulsivo mal controlado, estado confusional agudo, mielitis, ictus, ataxia cerebelosa o demencia
    Insuficiencia renal grave, definida por una filtración glomerular (FG) >30 ml/min/1,73 m2 (calculada mediante la ecuación de Schwartz bedside) o necesidad de trasplante renal, plasmaféresis o diálisis en la selección
    Esclerosis de >50 % de los glomérulos en la biopsia renal
    Enfermedad puramente crónica de clase III(c) o clase IV(c) en la biopsia renal, definida como la ausencia de lesiones activas
    Presence of rapidly progressive glomerulonephritis
    Presencia de glomerulonefritis rápidamente progresiva
    Intolerancia o contraindicación a los fármacos del estudio
    Recepción de cualquiera de los siguientes tratamientos excluidos:
    – Ciclofosfamida, tacrolimus, ciclosporina o voclosporina durante los 2 meses previos a la selección o durante la selección
    – Cualquier tratamiento anti-CD20 como, entre otros, rituximab, ocrelizumab u ofatumumab en los 12 meses previos a la selección o durante la selección
    – Cualquier tratamiento biológico (distinto de anti-CD20) como, entre otros, belimumab, ustekinumab, anifrolumab, secukinumab o atacicept durante los 2 meses previos a la selección o durante la selección
    – Inhibidores orales 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
    – Cualquier vacuna de microorganismos vivos en los 28 días previos a la selección o durante la selección
    Infección activa de cualquier tipo (excluida la micosis de los lechos ungueales) o cualquier episodio importante de infección con necesidad de hospitalización o tratamiento con antiinfecciosos IV en las 4 semanas previas a la selección o finalización de antiinfecciosos orales en las 2 semanas previas a la aleatorización
    Antecedentes o presencia activa de inmunodeficiencia primaria o secundaria, incluidos los antecedentes conocidos de infección por el VIH y otros trastornos sanguíneos graves de inmunodeficiencia
    Antecedentes de infección recurrente o crónica grave
    Antecedentes de leucoencefalopatía multifocal progresiva (LMP)
    Antecedentes o presencia de cáncer, como 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
    Riesgo elevado de hemorragia de importancia clínica o cualquier afección que requiera plasmaféresis, inmunoglobulina intravenosa o transfusiones agudas de hemoderivados
    Enfermedad física concomitante significativa o no controlada que, en opinión del investigador, impida la participación del paciente
    Alcoholismo o toxicomanía activos en la actualidad o antecedentes de alcoholismo o toxicomanía
    Cualquiera de los siguientes parámetros analíticos en la selección:
    Aspartato aminotrasnferasa (AST) o alanino aminotrasferasa(ALT) > 2,5 x límite superior de la normalidad (LSN) (para la edad y el sexo) que no puede atribuirse al LES subyacente
    Amilasa o lipasa 2 xveces el LSN
    Recuento absoluto de neutrófilos (RAN)  1,5x 10E3/microL
    Hemoglobina <7 g/dl, a menos que esté causada por una anemia hemolítica autoinmunitaria resultante del LES
    Recuento de plaquetas <50 000/microL
    Positividad para el antígeno de superficie de la hepatitis B (HBsAg)
    Serología positiva para la hepatitis C
    Positividad para la gonadotropina coriónica humana en suero en la selección
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants who achieve a complete renal response (CRR) at Week 76
    Proporción de participantes que logran una respuesta renal completa (RRC) en la semana 76
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 76
    En la semana 76
    E.5.2Secondary end point(s)
    Proportion of participants achieving a CRR at Weeks 24 and 52
    Proportion of participants who achieve a partial renal response (PRR) at Week 76
    Proportion of participants achieving an overall response (CRR or PRR) at Weeks 24, 52, and 76
    Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Week 76
    Change in estimated glomerular filtration rate (eGFR) from baseline to Week 76
    Time to onset of CRR over the course of 76 weeks
    Proportion of participants who experience treatment failure from Week 12 to Week 76
    Change in C3 complement levels from baseline to Week 76
    Change in C4 complement levels from baseline to Week 76
    Incidence, nature, and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) from baseline to Week 76
    Incidence of laboratory or vital sign abnormalities from baseline to Week 76
    Serum concentrations of obinutuzumab at specified timepoints
    Proportion of participants achieving B-cell depletion via highly sensitive flow cytometry (HSFC), at specified timepoints
    Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue scale (PedsQL)-Fatigue total score from baseline to Week 76
    Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) from baseline to Week 76
    Change from baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) domain scores from baseline to Week 76
    Proporción de participantes que logren una RRC en las semanas 24 y 52
    Proporción de participantes que logren una respuesta renal parcial (RRP) en la semana 76
    Proporción de participantes que logren una respuesta global (RRC o RRP) en las semanas 24, 52 y 76
    Variación del cociente proteína/creatinina en orina (CPCO) entre el momento basal y la semana 76
    Variación de la filtración glomerular estimada (FGe) entre el momento basal y la semana 76
    Tiempo hasta el inicio de la RRC a lo largo de 76 semanas
    Proporción de participantes que presenten fracaso del tratamiento entre las semanas 12 y 76
    Variación en el nivel de C3 del complemento entre el momento basal y la semana 76
    Variación en el nivel de C4 del complemento entre el momento basal y la semana 76
    Incidencia, naturaleza e intensidad de los acontecimientos adversos, con determinación de la intensidad conforme a los CTCAE del NCI entre el momento basal y la semana 76
    Incidencia de anomalías analíticas o de las constantes vitales entre el momento basal y la semana 76
    Concentraciones séricas de obinutuzumab en momentos especificados
    Proporción de participantes que logren una reducción de los linfocitos B mediante citometría de flujo de alta sensibilidad, en momentos especificados
    Variación de la puntuación total del Cuestionario pediátrico de calidad de vida-Escala multidimensional de fatiga (PedsQL-Fatiga) entre el momento basal y la semana 76
    Variación de la Índice 2000 de actividad del lupus eritematoso sistémico (SLEDAI-2K) entre el momento basal y la semana 76
    Variación de las puntuaciones de los dominios del Cuestionario de salud infantil-Formulario para padres 28 (CHQ-PF28) entre el momento basal y la semana 76
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Weeks 24 and 52
    2. At Week 76
    3. At Weeks 24, 52, and 76
    4-6. Baseline to Week 76
    7. From Week 12 to Week 76
    8-11. Baseline to Week 76
    12. At Baseline and Weeks 2, 4, 12, 24, 26, 36, 52, 64, and 76
    13. At Baseline and Weeks 4, 24, 52 and 76
    14-16. Baseline to Week 76
    1. Entree las semanas 24 y 52
    2. En la semana 76
    3. En las semanas 24, 52, y 76
    4-6. Momento basal a la semana 76
    7. De la semana 12 a la semana 76
    8-11. Momento basal a la 76
    12. En el momento basal y las semanas 2, 4, 12, 24, 26, 36, 52, 64 y 76
    13. En la momento basal y las semanas 4, 24, 52 y 76
    14-16. Momento basal a la semana 76
    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) 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States No
    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
    Brazil
    Canada
    Peru
    Russian Federation
    South Africa
    United States
    France
    Italy
    Poland
    Spain
    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 end of this study is defined as the date when the LPLV occurs or the date at which the last data point required for statistical analysis of safety follow-up is received from the last participant, whichever occurs later.
    El final de este estudio se define como la fecha en la que se produce la UVUP o la fecha en la que se recibe del último participante el último punto de datos necesario para el análisis estadístico del seguimiento de seguridad, lo que ocurra más tarde.
    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: 30
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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
    Written informed consent for participation in the study must be obtained from a parent or guardian before performing any study-related procedures (including screening evaluations)."
    Antes de realizar cualquier procedimiento relacionado con el estudio (incluidas las evaluaciones de selección) debe obtenerse el consentimiento informado por escrito de los padres o tutores para participar en el estudio."
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 30
    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 IMPs (obinutuzumab and MMF) free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined IN SECTION 6.6 of the protocol.
    El promotor ofrecerá el acceso continuado a los PEI de Roche (obinutuzumab y MMF) de forma gratuita a los participantes que reúnan los requisitos necesarios, de acuerdo con la política global de Roche sobre el acceso continuado a los medicamentos en investigación, como se indica en 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 Decision2021-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-10
    P. End of Trial
    P.End of Trial StatusOngoing
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