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    Summary
    EudraCT Number:2020-005776-35
    Sponsor's Protocol Code Number:230LE304
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-27
    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 number2020-005776-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di BIIB059 in partecipanti adulti con lupus eritematoso sistemico attivo che ricevono la terapia standard di base non biologica per il lupus
    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 BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
    Studio per valutare l’efficacia e la sicurezza di BIIB059 in partecipanti adulti con lupus eritematoso sistemico attivo che ricevono la terapia standard di base non biologica per il lupus
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code number230LE304
    A.5.4Other Identifiers
    Name:INDNumber:117288
    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 SponsorBIOGEN IDEC RESEARCH LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaltrials@biogen.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 nameNot applicable
    D.3.2Product code [BIIB059]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM
    D.3.9.2Current sponsor codeBIIB059
    D.3.9.4EV Substance CodeSUB208560
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typerecombinant monoclonal antibody
    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 placeboSolution for injection
    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
    systemic lupus erythematosus
    lupus eritematoso sistemico
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    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
    The primary objective of this study is to demonstrate efficacy of BIIB059 compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.
    L'obiettivo primario dello studio è di Dimostrare l’efficacia di BIIB059 rispetto al placebo nel ridurre l’attività della malattia in partecipanti affetti da LES attivo che stanno ricevendo una terapia SOC di base per il lupus
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    * to demonstrate:
    - early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, receiving SOC in reducing disease activity;
    - organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, receiving SOC in reducing joint disease activity;
    - effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use;
    - organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE receiving SOC in reducing skin disease activity and in reducing occurrence of flare up to Week 52;
    *to evaluate:
    - additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures and OCS use
    - the safety, tolerability and immunogenicity of BIIB059 in participants with active SLE;
    * to assess the difference between BIIB059 and placebo on participant-reported HRQoL, symptoms, and impacts of SLE;
    Gli obiettivi secondari sono:
    * dimostrare
    comparsa precoce dell’efficacia di BIIB059 rispetto al placebo
    - efficacia organo-specifica di BIIB059 rispetto al placebo
    - effetto di BIIB059 rispetto al placebo nel ridurre l’uso di corticosteroidi orali (OCS)
    - efficacia di BIIB059 rispetto al placebo nel ridurre gli episodi di riacutizzazione fino alla Settimana 52
    * valutare
    - efficacia aggiuntiva di BIIB059 rispetto al placebo nel ridurre l’attività della malattia con ulteriori misurazioni dell’attività della malattia
    - sicurezza,tollerabilità e immunogenicità di BIIB059
    *Valutare la differenza tra BIIB059 e placebo sulla Qualità della vita correlata alla salute
    (HRQoL), sui sintomi e sugli effetti del LES riferiti dal partecipante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - Participant must be diagnosed with SLE at least 24
    weeks prior to screening and must meet the 2019
    European League Against Rheumatism
    (EULAR)/American College of Rheumatology (ACR)
    classification criteria for SLE, at screening by a qualified
    physician.
    - Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score =6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
    - Participant has a modified clinical SLEDAI-2K score =4 (excluding anti-dsDNA, low complement component 3 [C3] and/or complement component 4 [C4], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization.
    - Participant has BILAG-2004 grade A in =1 organ system or BILAG-2004 grade B in =2 organ systems at screening (adjudicated) and randomization.
    - Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated =12 weeks prior to screening and at stable dose =4 weeks prior to randomization,
    a. Antimalarials as stand-alone treatment
    b. Antimalarial treatment in combination with OCS and/or immunosuppressants
    c. Treatment with OCS and/or immunosuppressants.
    Note: Other protocol defined inclusion criteria may apply.
    Principali criteri di inclusione:
    - Il partecipante deve aver ricevuto una diagnosi di LES almeno 24 settimane prima dello screening e deve soddisfare i criteri di classificazione del LES del 2019 della Lega europea contro le malattie reumatiche (European League Against Rheumatism, EULAR)/del Collegio americano di reumatologia (American College of Rheumatology, ACR) allo screening, come confermato da un medico qualificato.
    - Il partecipante presenta un punteggio dell’Indice di attività della malattia nel lupus eritematoso sistemico 2000 (SLEDAI-2K) modificato =6 (escluse alopecia, febbre, cefalea correlata al lupus e sindrome cerebrale organica) allo screening (convalidato).
    - Il partecipante presenta un punteggio SLEDAI-2K clinico modificato =4 (esclusi anti-dsDNA, complemento componente 3 [C3] e/o complemento componente 4 [C4] basso, alopecia, febbre, cefalea correlata al lupus e sindrome cerebrale organica) allo screening (convalidato) e alla randomizzazione.
    - Il partecipante presenta grado A secondo il Gruppo di valutazione del lupus nelle Isole Britanniche del 2004 (BILAG-2004) in =1 sistema di organi o grado B secondo BILAG-2004 in =2 sistemi di organi allo screening (convalidato) e alla randomizzazione.
    - Il partecipante deve essere trattato con una delle seguenti terapie di standard di cura (SOC) di base non biologiche per il lupus, iniziate =12 settimane prima dello screening e a una dose stabile =4 settimane prima della randomizzazione:
    a. Antimalarici come trattamento indipendente
    b. Trattamento antimalarico in combinazione con corticosteroidi orali (OCS) e/o immunosoppressori
    c. Trattamento con OCS e/o immunosoppressori.
    Nota: possono essere applicati altri criteri di inclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - History of or positive test result for human immunodeficiency virus (HIV).
    - Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody and detectable HCV ribonucleic acid [RNA]).
    - Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or total hepatitis
    B core antibody [anti-HBc]).
    - History of severe herpes infection.
    - Presence of uncontrolled or New York Heart
    Association class III or IV congestive heart failure.
    - Active severe lupus nephritis where, in the opinion of the investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach,
    such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or
    urine protein-creatinine ratio >2.0 or severe chronic kidney disease (estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square [mL/min/1.73
    m^2]) calculated using the abbreviated Modification of Diet in Renal Disease equation.
    - Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
    - History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
    - Active neuropsychiatric SLE.
    - Use of oral prednisone (or equivalent) above 20 mg/day.
    Note: Other protocol defined Exclusion criteria may apply.
    Principali criteri di esclusione:
    - Anamnesi o risultato positivo al test per il virus dell’immunodeficienza umana (HIV).
    - Infezione da epatite C in corso (definita come positività agli anticorpi per il virus dell’epatite C [HCV] e acido ribonucleico [RNA] dell’HCV rilevabile).
    - Infezione da epatite B in corso (definita come positività all’antigene di superficie dell’epatite B [HBsAg] e/o anticorpi totali anti-antigene core dell’epatite B [HBcAb]).
    - Anamnesi di infezione da herpes grave.
    - Presenza di scompenso cardiaco congestizio di classe III o IV in base alla New York Heart Association.
    - Nefrite attiva grave da lupus per la quale, a giudizio dello sperimentatore, il SOC specificato dal protocollo è insufficiente ed è indicato l’uso di un approccio terapeutico più aggressivo, quale l’aggiunta di ciclofosfamide per via endovenosa (EV) e/o terapia corticosteroidea EV ad alto dosaggio o altri trattamenti non consentiti nel protocollo; o rapporto proteina-creatinina nelle urine >2.0 o malattia renale cronica grave (velocità di filtrazione glomerulare stimata <30 millilitri al minuto per 1,73 metri quadrati [ml/min/1,73 m^2]) calcolata utilizzando l’equazione abbreviata della Modifica della dieta nella malattie renali.
    - Qualsiasi condizione cutanea attiva diversa dal lupus eritematoso cutaneo (LEC) che possa interferire con la valutazione dello studio del LEC, quale, a titolo esemplificativo ma non esaustivo, psoriasi, dermatomiosite, sclerosi sistemica, manifestazione di lupus cutaneo non LES o lupus farmaco-indotto.
    - Anamnesi o diagnosi attuale di sindrome da vasculite non correlata al LES clinicamente significativa.
    - LES neuropsichiatrico attivo.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants Who Achieved a Systemic Lupus Erythematosus
    Responder Index of 4 (SRI-4) Response at Week 52
    Percentuale di partecipanti che hanno ottenuto un punteggio pari a 4 dell’Indice di risposta nel Lupus eritematoso sistemico (SRI-4) alla Settimana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    alla Settimana 52
    E.5.2Secondary end point(s)
    1. Percentage of Participants Who Achieved an SRI-4 Response at Week 24
    2. Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
    3. Percentage of Participants with OCS =10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to =7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52
    4. Percentage of Participants with a CLASI-A Score =10 at Baseline Who Achieved a 50% Improvement from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16
    5. Annualized Flare Rate Through Week 52
    6. Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by
    Visit
    7. Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
    8. Time to Onset of SRI-4 Response Sustained Through
    Week 52
    9. Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
    10. Percentage of Participants with Joint-50 Response by Visit
    11. Percentage of Participants with Baseline CLASI-A Score =10 Who Achieved a CLASI- 20, -50, -70, or -90 Response by Visit
    12. Percentage of Participants with Baseline CLASI-A Score =10 Who Achieved a CLASI-A Score of =1 by Vis
    13. Time to First British Isles Lupus Activity Group-2004
    (BILAG-2004) Severe Flare by Visit
    14. Time to First Severe Flare as Defined by Safety of
    Estrogens in Systemic Lupus Erythematosus National
    Assessment - Systemic Lupus Erythematosus Disease
    Activity Index Flare Index (SFI)
    15. Percentage of Participants With Baseline OCS =10
    mg/day Who Achieved =7.5 mg/day at Week 52
    16. Change from Baseline in Lupus-Specific Health-
    Related Quality-of-Life Questionnaire (LupusQoL) Score
    17. Change from Baseline in Short Form Health Survey-36 (SF-36) Score
    18. Change from Baseline in Functional Assessment of
    Chronic Illness Therapy- Fatigue (FACIT-Fatigue) Score
    19. Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
    20. Change from Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
    21. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    22. Number of Participants with Antibodies to BIIB059
    1. Percentuale di partecipanti che hanno ottenuto una risposta SRI-4 alla Settimana 24.
    2. Percentuale di partecipanti con almeno 4 articolazioni (sia tumefatte sia dolenti) al basale che hanno ottenuto una risposta Joint-50 alla Settimana 52.
    3. Percentuale di partecipanti con OCS =10 milligrammi al giorno (mg/die) al basale che hanno ottenuto una riduzione di OCS pari a =7,5 mg/die alla Settimana 40, che si mantiene fino alla Settimana 52 senza peggioramento della malattia dalla Settimana 40 alla Settimana 52.
    4. Percentuale di partecipanti con un punteggio dell’Indice di gravità e area della malattia del lupus eritematoso cutaneo relativo all’attività (CLASI-A) =10 al basale che hanno ottenuto un miglioramento del 50% rispetto al basale nella risposta dell’Indice di attività dell’area e gravità del lupus eritematoso cutaneo (CLASI-50) alla Settimana 16.
    5. Tasso annualizzato di riacutizzazioni fino alla Settimana 52.
    6. Variazione rispetto al basale nel punteggio della Valutazione globale del medico (PGA) - Scala analogica visiva (VAS) per visita.
    7. Percentuale di partecipanti che hanno ottenuto una risposta in base alla Valutazione combinata del lupus (BICLA) secondo il Gruppo di valutazione del lupus nelle Isole Britanniche (BILAG) per visita.
    8. Tempo all’insorgenza della risposta SRI-4 che si mantiene fino alla Settimana 52.
    9. Percentuale di partecipanti che hanno ottenuto una risposta SRI-4, -5 o -6 per visita.
    10. Percentuale di partecipanti con una risposta di Joint-50 per visita.
    11. Percentuale di partecipanti con un punteggio CLASI-A =10 al basale che hanno ottenuto una risposta CLASI-20, -50, -70 o -90 per visita.
    12. Percentuale di partecipanti con un punteggio CLASI-A =10 al basale che hanno ottenuto un punteggio CLASI-A =1 per visita.
    13. Tempo alla prima riacutizzazione grave per visita secondo il Gruppo di valutazione del lupus nelle Isole Britanniche del 2004 (BILAG-2004).
    14. Tempo alla prima riacutizzazione grave definita in base alla Sicurezza degli estrogeni con valutazione nazionale sul lupus eritematoso-Indice di attività della malattia nel lupus eritematoso sistemico (SFI).
    15. Percentuale di partecipanti con OCS al basale =10 mg/die che hanno ottenuto =7,5 mg/die alla Settimana 52.
    16. Variazione rispetto al basale nel punteggio del Questionario sulla qualità della vita correlato alla salute specifico per il lupus (LupusQoL).
    17. Variazione rispetto al basale nel punteggio del Questionario sullo stato di salute - Modulo abbreviato a 36 voci (SF-36).
    18. Variazione rispetto al basale nel punteggio della Valutazione funzionale della terapia per le malattie croniche - Affaticamento (FACIT-Fatigue).
    19. Variazione rispetto al basale nel punteggio del Questionario sulla salute del paziente a 9 voci (PHQ-9).
    20. - Variazione rispetto al basale nel punteggio dell’Indice di compromissione della produttività lavorativa e delle attività quotidiane (WPAI): Punteggio del lupus.
    21. Numero di partecipanti con eventi avversi emergenti dal trattamento (TEAE) ed eventi avversi seri (SAE).
    22. Numero di partecipanti con anticorpi diretti contro BIIB059.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. wk 24
    2. wk 52
    3. wk 40 up to wk 52
    4. wk 16
    5. up to wk 52
    6. up to wk 52
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    1. wk 24
    2. wk 52
    3. wk 40 up to wk 52
    4. wk 16
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    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 and tolerability
    immunogenicità e tollerabilità
    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 trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Argentina
    Belgium
    Canada
    China
    Colombia
    Czechia
    Germany
    Hungary
    Israel
    Italy
    Japan
    Netherlands
    Romania
    United Kingdom
    United States
    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
    LSLV
    LSLV
    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 months4
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days4
    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: 528
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 540
    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)
    Participants who successfully complete the 52-week treatment
    period with study treatment are treatment period completers. Treatment period completers will be offered to either participate in the LTE study or enter the 24-week SFU. The LTE study is not part of this study and is planned to be developed as a separate protocol.
    I partecipanti che completano con successo il periodo di trattamento di 52 settimane con il trattamento in studio sono i c treatment period completers. A chi ha completato il periodo di trattamento verrà offerto di partecipare allo studio LTE o di entrare nell'SFU di 24 settimane. Lo studio LTE non fa parte di questo studio ed è previsto che venga sviluppato come protocollo separato.
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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