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    Summary
    EudraCT Number:2021-000097-29
    Sponsor's Protocol Code Number:WA42985
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-09-23
    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 ConcernedItaly - Italian Medicines Agency
    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
    STUDIO DI FASE II, RANDOMIZZATO, IN DOPPIO CIECO,
    CONTROLLATO CON PLACEBO, MULTICENTRICO, VOLTO A
    VALUTARE L’EFFICACIA, LA SICUREZZA E LA
    FARMACOCINETICA DI OBINUTUZUMAB IN PAZIENTI
    ADOLESCENTI AFFETTI DA NEFRITE LUPICA ATTIVA DI CLASSE
    III O IV
    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
    STUDIO DI FASE II, RANDOMIZZATO, CONTROLLATO VOLTO A VALUTARE L’EFFICACIA, LA SICUREZZA E LA FARMACOCINETICA DI OBINUTUZUMAB IN PAZIENTI ADOLESCENTI AFFETTI DA NEFRITE LUPICA ATTIVA DI CLASSE III O IV
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    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 SponsorF. 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.5.6E-mailglobal.rochegenentechtrials@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-EU/1/14/937/001
    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 suspension for injection
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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-EU/1/07/438/003
    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.3.2Product code [na]
    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 INNMICOFENOLATO MOFETILE
    D.3.9.2Current sponsor codena
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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)
    NEFRITE LUPICA
    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 nefrite lupica è infiammazione rene causata da lupus eritematoso sistemico (LES). Il LES è una malattia autoimmune, in cui il sistema immunitario del corpo attacca il proprio tessuto corporeo sano.
    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
    Valutare l’efficacia di obinutuzumab rispetto al placebo in partecipanti adolescenti con NL di classe III/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
    Valutare l’efficacia di obinutuzumab rispetto al placebo
    Valutare la sicurezza di obinutuzumab rispetto al placebo
    Caratterizzare il profilo PK di obinutuzumab
    Caratterizzare il profilo PD di obinutuzumab
    Valutare le variazioni dell’affaticamento dei partecipanti trattati con obinutuzumab rispetto al placebo
    Valutare la variazione dell’attività di malattia LES dei partecipanti trattati con obinutuzumab rispetto al placebo
    Valutare le variazioni della qualità di vita dei partecipanti trattati con obinutuzumab rispetto al 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
    Partecipanti di età compresa tra 12 e <18 anni al momento della randomizzazione
    Capacità di rispettare il protocollo di studio, a giudizio dello sperimentatore
    International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 LN attivo di classe III o IV dimostrato su biopsia renale eseguita nei 12 mesi precedenti o durante lo screening Test attuale o storico positivo per anticorpi antinucleo (ANA) e/o anticorpi contro il DNA a doppia elica (dsDNA)
    La malattia di classe V può essere presente in aggiunta alla LN di classe III o IV, ma i partecipanti con malattia di classe V isolata non sono ammissibili
    Proteinuria significativa definita da un rapporto proteina/creatinina urinaria (UPCR) superiore a >0,5 sulla base di una raccolta di feci al primo mattino (FMV) allo screening
    Durante i 12 mesi precedenti o durante lo screening, tutti i partecipanti devono aver ricevuto almeno una dose di metilprednisolone IV a impulsi (tipicamente 30 mg/kg, massimo 1000 mg per dose) o equivalente per il trattamento dell'episodio in corso di LN
    Per le donne in età fertile: i partecipanti che accettano di rimanere astinenti (astenersi da rapporti eterosessuali) o di utilizzare la contraccezione e accettano di astenersi dal donare ovuli durante il periodo di trattamento e per 18 mesi dopo la dose finale di obinutuzumab e per 6 settimane dopo l'ultima dose di micofenolato mofetile (MMF)
    Per i maschi: partecipanti che accettano di rimanere astinenti (astenersi da rapporti eterosessuali) o utilizzare metodi contraccettivi e accettano di astenersi dal donare sperma, durante il periodo di trattamento e per 90 giorni dopo la dose finale di 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
    Partecipanti in gravidanza o allattamento, o che intendono iniziare una gravidanza durante lo studio o entro 18 mesi dalla dose finale di obinutuzumab o placebo, o entro 6 settimane dalla dose finale di MMF
    SLE grave e attivo del sistema nervoso centrale (SNC), inclusi retinite, disturbi convulsivi scarsamente controllati, stato confusionale acuto, mielite, ictus, atassia cerebellare o demenza
    Compromissione renale grave, definita da una velocità di filtrazione glomerulare (GFR) <30 mL/min/1,73 m^2 (stimata utilizzando l'equazione di Schwartz al capezzale) o dalla necessità di trapianto renale, plasmaferesi o dialisi allo screening
    Sclerosi in >50% dei glomeruli alla biopsia renale
    Malattia puramente cronica di Classe III(c) o Classe IV(c) alla biopsia renale, definita come l'assenza di lesioni attive
    Presenza di glomerulonefrite rapidamente progressiva
    Pura Classe V LN
    Intolleranza o controindicazione allo studio delle terapie
    Ricezione di una delle seguenti terapie escluse:
    – Ciclofosfamide, tacrolimus, ciclosporina o voclosporina durante i 2 mesi precedenti o durante lo screening
    – Qualsiasi terapia anti-CD20 come, ma non solo, rituximab, ocrelizumab o ofatumumab entro 12 mesi prima dello screening o durante lo screening
    – Qualsiasi terapia biologica (diversa dall'anti-CD20) come, a titolo esemplificativo, belimumab, ustekinumab, anifrolumab, secukinumab o atacicept durante i 2 mesi precedenti o durante lo screening
    – Inibitori orali della chinasi associata a Janus (JAK), tirosin chinasi di Bruton (BTK) o tirosin chinasi 2 (TYK2), inclusi baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib o fenebrutinib o qualsiasi agente sperimentale durante i 2 mesi precedenti alla proiezione o durante la proiezione
    – Qualsiasi vaccino vivo durante i 28 giorni precedenti lo screening o durante lo screening
    Infezione attiva di qualsiasi tipo (esclusa l'infezione fungina del letto ungueale) o qualsiasi episodio maggiore di infezione che richieda l'ospedalizzazione o il trattamento con farmaci antinfettivi EV entro 4 settimane prima dello screening, o completamento degli antinfettivi orali entro 2 settimane prima della randomizzazione
    Storia di o immunodeficienza primaria o secondaria attualmente attiva, inclusa storia nota di infezione da HIV e altre gravi malattie da immunodeficienza del sangue
    Storia di infezione grave ricorrente o cronica
    Storia di leucoencefalopatia multifocale progressiva (PML)
    Anamnesi o cancro in atto, inclusi tumori solidi, neoplasie ematologiche e carcinoma in situ negli ultimi 5 anni
    Chirurgia maggiore che richiede l'ospedalizzazione durante le 4 settimane precedenti lo screening o durante lo screening
    Alto rischio di sanguinamento clinicamente significativo o di qualsiasi condizione che richieda plasmaferesi, immunoglobuline endovenose o trasfusioni acute di emoderivati
    Malattia medica concomitante significativa o non controllata che, a parere dello sperimentatore, precluderebbe la partecipazione del partecipante
    Abuso di alcol o droghe attualmente attivo o storia di abuso di alcol o droghe
    Uno dei seguenti parametri di laboratorio allo screening:
    Aspartato aminotransferasi (AST) o alanina transaminasi (ALT) >2,5Xlimite superiore della norma (ULN) (per età e sesso) che non può essere attribuito al LES sottostante
    Amilasi o lipasi >2XULN
    Conta assoluta dei neutrofili (ANC) <1,5X10^3/microlitro
    Emoglobina <7 g/dL, a meno che non sia causata da anemia emolitica autoimmune derivante da LES
    Conta piastrinica <50.000/microlitro
    Antigene di superficie dell'epatite B positivo (HBsAg)
    Sierologia positiva per epatite C
    Gonadotropina corionica umana sierica positiva misurata allo screening
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants who achieve a complete renal response (CRR) at Week 76
    Percentuale di partecipanti che raggiungono una risposta renale completa (CRR) alla settimana 76
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 76
    Alla Settimana 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
    Percentuale di partecipanti che ottengono un CRR alle settimane 24 e 52
    Percentuale di partecipanti che raggiungono una risposta renale parziale (PRR) alla settimana 76
    Percentuale di partecipanti che ottengono una risposta complessiva (CRR o PRR) alle settimane 24, 52 e 76
    Variazione del rapporto proteine ¿¿urinarie/creatinina (UPCR) dal basale alla settimana 76
    Variazione della velocità di filtrazione glomerulare stimata (eGFR) dal basale alla settimana 76
    Tempo all'insorgenza della CRR nel corso di 76 settimane
    Percentuale di partecipanti che hanno sperimentato il fallimento del trattamento dalla settimana 12 alla settimana 76
    Variazione dei livelli di complemento C3 dal basale alla settimana 76
    Variazione dei livelli di complemento C4 dal basale alla settimana 76
    Incidenza, natura e gravità degli eventi avversi, con gravità determinata secondo i criteri comuni di terminologia per gli eventi avversi del National Cancer Institute (NCI CTCAE) dal basale alla settimana 76
    Incidenza di anomalie di laboratorio o dei segni vitali dal basale alla settimana 76
    Concentrazioni sieriche di obinutuzumab a tempi specificati
    Percentuale di partecipanti che raggiungono l'esaurimento delle cellule B tramite citometria a flusso altamente sensibile (HSFC), a tempi specificati
    Variazione dell'inventario della qualità della vita pediatrica-Scala multidimensionale della fatica (PedsQL)-Punteggio totale della fatica dal basale alla settimana 76
    Variazione dell'indice di attività della malattia del lupus eritematoso sistemico 2000 (SLEDAI-2K) dal basale alla settimana 76
    Variazione dal basale nei punteggi di dominio del Child Health Questionnaire-Parent Form 28 (CHQ-PF28) dal basale alla settimana 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. Alle settimane 24 e 52
    2. Alla settimana 76
    3. Alle settimane 24, 52 e 76
    4-6. Linea di base alla settimana 76
    7. Dalla settimana 12 alla settimana 76
    8-11. Linea di base alla settimana 76
    12. Al basale e alle settimane 2, 4, 12, 24, 26, 36, 52, 64 e 76
    13. Al basale e alle settimane 4, 24, 52 e 76
    14-16. Linea di base alla settimana 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    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.
    La fine di questo studio è definita come la data in cui si verifica la LPLV o la data in cui
    l'ultimo punto dati richiesto per l'analisi statistica del follow-up di sicurezza è
    ricevuto dall'ultimo partecipante, a seconda di quale evento si verifica in seguito.
    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 months6
    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 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 Yes
    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)."
    Il consenso informato scritto per la partecipazione allo studio deve essere ottenuto da un genitore o da un tutore prima di eseguire qualsiasi procedura correlata allo studio (comprese le valutazioni di screening)."
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    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.
    Lo Sponsor offrirà un accesso continuo agli IMP di Roche (obinutuzumab e MMF) gratuitamente ai partecipanti idonei in conformità con la Roche Global Policy on Continued Access to Investigational Medicinal Product, come indicato NELLA SEZIONE 6.6 del protocollo.
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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