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    Summary
    EudraCT Number:2020-004436-21
    Sponsor's Protocol Code Number:WN42636
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004436-21
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS
    STUDIO MULTICENTRICO, DI FASE III, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO PER LA VALUTAZIONE DELL'EFFICACIA, DELLA SICUREZZA, DELLA FARMACOCINETICA E DELLA FARMACODINAMICA DI SATRALIZUMAB IN PAZIENTI AFFETTI DA MIASTENIA GRAVE GENERALIZZATA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis
    Questo studio valuterà l'efficacia, la sicurezza, la farmacocinetica e la farmacodinamica di satralizumab rispetto al placebo in pazienti affetti da miastenia grave generalizzata (gMG).
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberWN42636
    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 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. 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 organisationGenentech Inc. c/o F. 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 number0000000
    B.5.5Fax number0000000
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSatralizumab
    D.3.2Product code [RO5333787]
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSATRALIZUMAB
    D.3.9.2Current sponsor codeRO5333787
    D.3.9.4EV Substance CodeSUB195082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Generalized Myasthenia Gravis (gMG)
    Miastenia grave generalizzata (gMG)
    E.1.1.1Medical condition in easily understood language
    Myasthenia gravis is a rare neuromuscular disorder that causes weakness in the skeletal muscles. Myasthenia gravis affecting multiple muscle groups throughout the body is called gMG.
    La miastenia grave è una rara malattia neuromuscolare che causa debolezza nei muscoli scheletrici. La miastenia grave che colpisce più gruppi muscolari in tutto il corpo è chiamata GMG.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of satralizumab versus placebo on function in daily life in the acetylcholine receptor antibody seropositive (AChR+) population
    Valutare l'efficacia di satralizumab rispetto al placebo in termini di funzionamento nella vita quotidiana nella popolazione AChR
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of satralizumab versus placebo on function in daily life in the overall population (OP)
    • To evaluate the efficacy of satralizumab versus placebo in the AChR+ and OP on QMG, QoL, Fatigue, Clinical status and Disease severity
    • To evaluate the durability of the efficacy of satralizumab versus placebo in the AChR+ population and the OP
    • To evaluate the safety of satralizumab versus placebo
    • To confirm target engagement and pathway inhibition in response to satralizumab
    • To investigate the pharmacokinetics (PK) of satralizumab
    • To evaluate the immune response to satralizumab
    - l'efficacia di satralizumab rispetto al placebo in termini di funzionamento nella vita quotidiana nella popolazione AChR ;
    - Valutare l'efficacia di satralizumab rispetto al placebo nella popolazione AChR e nella OP in termini di Funzionamento nella vita quotidiana, QMG, QoL e stanchezza, – QMG, QoL e stanchezza, Gravità della malattia
    - Valutare la durata dell'efficacia di satralizumab rispetto al placebo nella popolazione AChR e OP
    - Valutare la sicurezza di satralizumab rispetto al placebo
    - Confermare il raggiungimento dei valori bersaglio e l'inibizione delle vie di segnalazione in risposta a satralizumab
    - Valutare la farmacocinetica (PK) di satralizumab
    - Valutare la risposta immunitaria a satralizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=12 years at time of signing Informed Consent Form
    • Confirmed diagnosis of gMG
    • MGFA class II, III or IV at screening
    • A total MG-ADL score of >=5 points at screening with more than 50% of this score attributed to non-ocular items
    • Ongoing gMG treatment at a stable dose
    • For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
    • Età >= 12 anni alla data della firma del modulo di consenso informato
    • Diagnosi confermata di gMG
    • Gravità della MG di classe II, III o IV della (MGFA) allo screening
    • Punteggio totale delle attività della vita quotidiana con la miastenia grave (MG ADL) >= 5 punti allo screening e al basale con oltre il 50% di questo punteggio attribuito a elementi non oculari
    • Trattamento in corso per la gMG a una dose stabile
    • Per le donne potenzialmente fertili: consenso a praticare l'astinenza (astenersi dai rapporti eterosessuali) o a utilizzare metodi contraccettivi adeguati durante il periodo di trattamento e per almeno 3 mesi dopo la dose finale di satralizumab.
    E.4Principal exclusion criteria
    Excl Criteria Related to Myasthenia Gravis(MG):
    •History of thymic cysts, thymoma, thymic carcinoma or other neoplasm of the thymus as defined by the 2015 WHO classification of tumors of the thymus unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screen
    •History of thymectomy within 12 months prior to screen
    •Ocular MG (Myasthenia Gravis Foundation of America[MGFA] Class I)
    •Myasthenic crisis within the last 3 months prior to screen(MGFA Class V)
    •Known disease other than gMG that would interfere with the course and conduct of the study
    Excl Criteria Related to Previous or Concomitant Therapy:
    •Use of IVIg within 8 weeks prior to randomization(Day 1)
    •Use of PE within 8 weeks prior to randomization(Day 1)
    •Treat with IL-6 inhibitory therapy(e.g., tocilizumab)at any time
    •Treat with total body irradiation,or bone marrow transplantation at any time
    •Treat with B and/or T cell-depleting agents
    •For pt with prior exposure to anti-CD20 agents, CD19 counts below the normal range, as assessed by the central laboratory at screen or <6 months since last anti-CD20 treat till screen
    •Treat with eculizumab within 6 months prior to screen
    •Treat with neonatal Fc receptor antagonists or anti-B-lymphocyte stimulator monoclonal antibody at any time
    •Treat with cyclophosphamide IV within 6 months prior to screen
    •Treatment with oral cyclophosphamide at any time
    •Treat with methotrexate within 8 weeks prior to screen
    •Treat with any investigational agent within 24 weeks prior to screen or 5 drug-elimination half-lives of the investigational drug (whichever is longer)
    •Use of more than one IST as background therapy except for the combination of an oral corticosteroids (OCS) with another permitted IST drug
    General Safety Excl Criteria:
    •Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
    •Planned surgical procedure (except minor surgeries) during the study
    •Evidence of progressive multifocal leukoencephalopathy
    •Evidence of serious uncontrolled concomitant diseases that may preclude pt participation
    •Congenital or acquired immunodeficiency,including human immunodeficiency virus (HIV)infection
    •Active or presence of recurrent bacterial,viral,fungal,mycobacterial infection or other infection,excluding fungal infection of nail beds or dental caries
    •Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit or oral anti-infective agents within 2 weeks prior to baseline visit
    •Pos screening tests for hepatitis B and C
    •History of drug or alcohol abuse within 1 year prior to baseline
    •History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator’s opinion,may lead to increased risk of complications such as GI perforation
    •Evidence of latent or active tuberculosis
    •Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
    •History of blood donation (1 unit or more),plasma donation or platelet donation within 90 days prior to screening and Day 1
    •History of malignancy within the last 5 years,including solid tumors,hematologic malignancies and in situ carcinoma
    •History of severe allergic reaction to a biologic agent
    •Active suicidal ideation within 6 months prior to screening or history of suicide attempt within 3 years prior to screening
    •Any serious medical condition or abnormality in clinical laboratory tests that,in the investigator's judgment,precludes the pt's safe participation in and completion of the study
    •Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
    Laboratory Excl Criteria(at Screening):
    •WBC <3.0*10^3/microliter •ANC <2.0*10^3/microliter •ALC <0.5*10^3/microliter •Platelet count <10*10^4/microliter
    •AST or ALT >1.5*upper limit of normal (ULN)
    •TSH level <0.9*lower limit of normal or >1.1*ULN and symptoms associated with hyperthyroidism or hypothyroidism
    Criteri di esclusione relativi alla miastenia grave(MG):
    •Anamnesi di cisti timiche,timoma,carcinoma timico o altra neoplasia del timo, definita dalla classificazione dei tumori del timo elaborata dall'OMS nel 2015,a meno che non sia considerato curato mediante trattamento adeguato,senza evidenza di recidiva per >=5 anni prima dello screening
    •Anamnesi di timectomia nei 12 mesi precedenti allo screening
    •MG oculare (classe I MGFA)
    •Crisi miastenica nei 3 mesi precedenti allo screening(classe V MGFA)
    •Malattia nota diversa da gMG che interferirebbe con lo svolgimento e la conduzione dello studio
    Criteri di esclusione correlati a terapia precedente o concomitante:
    •Uso di IVIg nelle 8 settimane precedenti alla randomizzazione(giorno 1)
    •Uso di PE nelle 8 settimane precedenti alla randomizzazione(giorno 1)
    •Trattamento con inibitori dell'interleuchina 6 (IL-6;ex. tocilizumab)in qualsiasi momento
    •Trattamento con irradiazione dell'intero corpo o trapianto di midollo osseo in qualsiasi momento
    •Trattamento con agenti di deplezione di cellule B e/o T (eccetto agenti anti-CD20)
    •Per pazienti con esposizione precedente agli agenti anti-CD20,conta CD19 sotto l'intervallo normale,come valutato dal laboratorio centrale allo screening o <6 mesi dopo l'ultimo trattamento anti-CD20 fino allo screening
    •Trattamento con eculizumab nei 6 mesi precedenti allo screening
    •Trattamento con antagonisti del recettore Fc neonatale o anticorpi monoclonali anti-stimolatori dei linfociti B in qualsiasi momento
    •Trattamento con ciclofosfamide EV nei 6 mesi precedenti allo screening
    •Trattamento con ciclofosfamide orale in qualsiasi momento
    •Trattamento con metotrexato nelle 8 settimane precedenti lo screening
    •Trattamento con qualsiasi farmaco sperimentale nelle 24 settimane precedenti allo screening o in 5 emivite di eliminazione del farmaco sperimentale(a seconda di quale sia il periodo più lungo)
    •Uso di più di un IST come terapia di base,fatta eccezione per l'associazione di un OCS con un altro farmaco IST consentito
    Criteri di esclusione generali di sicurezza:
    •Qualsiasi procedura chirurgica(eccetto interventi chirurgici minori)nelle 4 settimane precedenti al basale
    •Procedura chirurgica pianificata (eccetto interventi chirurgici minori)durante lo studio
    •Evidenza di leucoencefalopatia multifocale progressiva
    •Evidenza di malattie concomitanti serie non controllate che potrebbero precludere la partecipazione del paziente
    •Immunodeficienza congenita o acquisita,inclusa l'infezione da virus dell'immunodeficienza umana
    •Infezione attiva o presenza di infezione ricorrente di origine batterica,virale,micotica,micobatterica o altra infezione,esclusa infezione micotica del letto ungueale o carie dentali
    •Infezione che determina la necessità di ricovero ospedaliero o di trattamento con agenti antinfettivi EV nelle 4 settimane precedenti la visita basale o agenti antinfettivi orali nelle 2 settimane precedenti alla visita basale
    •Test allo screening positivi per l'epatite B e C
    •Anamnesi di abuso di alcol o di sostanze stupefacenti nell'anno precedente al basale
    •Anamnesi di diverticolite o disturbi gastrointestinali (GI) gravi concomitanti che a parere del PI potrebbero causare un aumento del rischio di complicanze come perforazione GI
    •Somministrazione di vaccino vivo o vivo attenuato nelle 6 settimane precedenti al basale
    •Anamnesi di donazione di sangue (1 o più unità), donazione di plasma o donazione di piastrine nei 90 giorni precedenti allo screening e al giorno 1
    •Anamnesi di neoplasia maligna negli ultimi 5 anni, inclusi tumori solidi, neoplasie maligne ematologiche e carcinoma in situ (eccetto carcinoma cutaneo basocellulare e squamocellulare o carcinoma in situ della cervice uterina completamente escisso e curato)
    •Anamnesi di reazione allergica grave a un agente biologico (per es. shock, reazioni anafilattiche)
    •Ideazione suicidaria attiva nei 6 mesi precedenti allo screening o anamnesi di tentativo di suicidio nei 3 anni precedenti allo screening
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean change from baseline in total MG-ADL score (AChR+ population) Week 24
    1.Variazione media del punteggio totale MG-ADL (nella popolazione AChR + ) dal basale alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From baseline to Week 24
    1. Dal basale alla settimana 24
    E.5.2Secondary end point(s)
    1. Mean change from baseline in total MG-ADL score (OP population)
    2. Mean change from baseline in QMG score, MG-QOL 15r total score and Neuro-QoL Fatigue Subscale total score
    3. Mean change from baseline in total Myasthenia Gravis Composite (MGC) score
    4. Percentage of patients with a >=2-point reduction from baseline in total MG-ADL score
    5. Percentage of patients with a >=3-point reduction from baseline in QMG score
    6. Percentage of patients with a >=3-point reduction from baseline in total MGC score
    7. Proportion of patients who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1)
    8. Proportion of patients with at least one gMG-related exacerbation and receiving rescue therapy between baseline and Week 24
    9. Annualized rate of gMG-related exacerbations
    10. Duration (average number of consecutive months) of meaningful improvement, defined as >=2-point reduction from baseline in total MG-ADL score
    11. Absolute values of biomarkers interleukin-6 (IL-6) and soluble interleukin-6 receptor (sIL-6R)
    12. Serum concentrations of satralizumab at specified timepoints
    13. Apparent clearance (CL/F) of satralizumab at specified timepoints
    14. Volume of distribution (V/F) of satralizumab at specified timepoints
    15. Area under the concentration-time curve (AUC) of satralizumab at specified timepoints
    16. Incidence of ADAs against satralizumab during the study
    17. Prevalence of anti-drug antibodies (ADAs) against satralizumab at baseline
    18. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading
    19. Change from baseline in targeted vital signs, ECG results, physical examination findings, targeted clinical laboratory test results, and suicidality
    1. Variazione media rispetto al basale del punteggio MG-ADL totale (popolazione OP)
    2.Variazione media del punteggio QMG, del punteggio totale MG-QOL 15r e del punteggio totale della sottoscala della stanchezza Neuro-QoL dal basale alla settimana 24
    3. Variazione media rispetto al basale nel punteggio totale della Miastenia Gravis Composite (MGC)
    4. Percentuale di pazienti con una riduzione> = 2 punti rispetto al basale nel punteggio MG-ADL totale
    5. Percentuale di pazienti con una riduzione> = 3 punti rispetto al basale nel punteggio QMG
    6. Percentuale di pazienti con una riduzione> = 3 punti rispetto al basale nel punteggio MGC totale
    7. Percentuale di pazienti che hanno raggiunto una manifestazione minima della malattia (punteggio totale MG-ADL di 0 o 1)
    8.Percentuale di pazienti con almeno una esacerbazione correlata a gMG tra il basale e la settimana 24
    9. Tasso annualizzato di esacerbazioni correlate a gMG
    10.Durata (numero medio di mesi consecutivi) di miglioramento significativo, definito come una riduzione di >=2 punti, rispetto al basale, del punteggio totale MG-ADLa
    11.Valori assoluti e variazione dal basale dei livelli sierici dei biomarcatori IL-6 e sIL-6R
    12. Concentrazioni sieriche di satralizumab in momenti temporali specificati
    13. Clearance apparente (CL / F) di satralizumab in momenti temporali specificati
    14. Volume di distribuzione (V / F) di satralizumab in momenti temporali specificati
    15. Stime dei parametri PK secondari (AUC) di satralizumab in momenti temporali specificati
    16. Prevalenza di ADA al basale e incidenza di ADA durante lo studio
    17. Prevalenza di anticorpi anti-farmaco (ADA) satralizumab al basale
    18. Incidenza e gravità degli eventi avversi, con gravità determinata in base alla classificazione NCI CTCAE v5.0
    19. Variazione dal basale di segni vitali mirati, risultati dell'ECG, risultati dell'esame fisico, risultati delle analisi cliniche di laboratorio mirate e suicidalità
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Baseline and Week 24
    4-8. At Week 24
    9. Baseline to Week 24
    10-11. Baseline to Week 24
    12-16. At Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24
    17. Predefined timepoints
    18-19. Baseline to 24 weeks
    1-3. Basale e settimana 24
    4-8. Alla settimana 24
    9. Dal basale alla settimana 24
    10-11. Dal basale alla settimana 24
    12-16. Al giorno 1, settimane 2, 4, 8, 12, 16, 20 e 24
    17. Tempi predefiniti
    18-19. Basale a 24 settimane
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicità
    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 EEA37
    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
    Australia
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Russian Federation
    Turkey
    United States
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Czechia
    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
    LPLV, or the date at which the last data point required for statistical analysis or SFU is received from the last patient, whichever occurs later.
    LPLV, ovvero ultimo paziente nella fase di studio globale o la data in cui vengono ricevuti gli ultimi dati necessari per l'analisi statistica o per il monitoraggio della sicurezza (SFU) dell'ultimo partecipante, a seconda di quale evento si verifichi per ultimo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In 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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 208
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 240
    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)
    Patients can continue to receive treatment with satralizumab in the OLE period until commercial availability of satralizumab in patients with gMG, the availability of satralizumab as post-trial access in accordance with local regulation, or until the Sponsor decides to discontinue the development program.
    I pazienti possono continuare a ricevere il trattamento con satralizumab nel periodo OLE fino alla disponibilità commerciale di satralizumab nei pazienti con gMG, in conformità alle disposizioni locali, o fino a quando lo Sponsor deciderà di interrompere il programma di sviluppo
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
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