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    Summary
    EudraCT Number:2021-006378-22
    Sponsor's Protocol Code Number:230LE306
    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:2022-12-21
    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 number2021-006378-22
    A.3Full title of the trial
    A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus
    Studio di estensione a lungo termine di fase 3, multicentrico, randomizzato, con dose in cieco per valutare la sicurezza e l’efficacia continue di BIIB059 in partecipanti adulti affetti da lupus eritematoso sistemico attivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 in Adults with Active Systemic Lupus Erythematosus
    Studio per valutare la sicurezza e l’efficacia continue di BIIB059 in partecipanti adulti affetti da lupus eritematoso sistemico attivo
    A.3.2Name or abbreviated title of the trial where available
    EMERALD
    EMERALD
    A.4.1Sponsor's protocol code number230LE306
    A.5.4Other Identifiers
    Name:IND/IDE NumberNumber: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, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628501000
    B.5.5Fax number+441628501010
    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 Yes
    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 typeAnticorpo monoclonale IgG1 ricombinante, completamente umanizzato, anti-BDCA2 espresso in una linea cellulare di ovaie di criceto cinese (CHO).
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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.1.3Condition 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 Clinical Trial is to evaluate the long-term safety and tolerability of BIIB059 in participants with active SLE.
    L’obiettivo principale di questa sperimentazione clinica è quello di valutare la sicurezza e la tollerabilità a lungo termine di BIIB059 nei partecipanti con LES attivo.
    E.2.2Secondary objectives of the trial
    The Secondary Objectives of this Clinical Trial are:
    - to evaluate the long-term effect of BIIB059 on disease activity in participants with SLE
    - to evaluate the long-term effect of BIIB059 in participants with SLE in maintaining low disease activity
    - to evaluate the effect of BIIB059 in participants with active SLE in preventing irreversible
    organ damage
    - to assess long-term use of OCS6 with participants receiving BIIB059 treatment
    - to assess the impact of BIIB059 on participant-reported HRQoL, symptoms and impacts of SLE
    - to evaluate long-term effect of BIIB059 on laboratory parameters
    - to evaluate immunogenicity of BIIB059
    Gli obiettivi secondari di questa sperimentazione clinica sono:
    - valutare l’effetto a lungo termine di BIIB059 sull’attività della malattia nei partecipanti affetti da LES
    - valutare l’effetto a lungo termine di BIIB059 in partecipanti affetti da LES nel mantenimento di una bassa attività di malattia
    - valutare l’effetto di BIIB059 tra i partecipanti con LES attivo nella prevenzione di danni d’organo irreversibili
    - valutare l’uso a lungo termine di corticosteroidi orali (OCS6) da parte dei partecipanti che ricevono il trattamento con BIIB059
    - valutare l’impatto di BIIB059 sulla qualità della vita correlata alla salute (HRQoL), sui sintomi e sugli effetti del LES riferiti dai partecipanti
    - valutare l’effetto a lungo termine di BIIB059 sui parametri di laboratorio
    - valutare l’immunogenicità di BIIB059
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52.
    2. Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
    3. All women of childbearing potential must agree to practice effective contraception during the study and for 126 days (18 weeks) after their last dose of study treatment. In addition, participants should not donate eggs during the study and for at least 126 days (18 weeks) after their last dose of study treatment. Where applicable, if not previously confirmed in the parent Phase 3 study, postmenopausal status must be confirmed as follows: for women = 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level = 40 mIU/mL; for women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level = 40 mIU/mL, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause.
    CRITERI DI INCLUSIONE PRINCIPALI
    1. Partecipanti che hanno completato 1 degli studi originari di fase 3 in doppio cieco, controllati con placebo, della durata di 52 settimane (230LE303 o 230LE304), hanno assunto i trattamenti dello studio, BIIB059 o placebo, fino alla Settimana 48 e si sono presentati all’ultima visita di valutazione dello studio alla Settimana 52.
    2. Capacità del partecipante e/o del suo rappresentante legale (ad es. genitore, coniuge o tutore legale), come appropriato e pertinente, di comprendere la finalità e i rischi dello studio, fornire il consenso informato e autorizzare l’utilizzo delle informazioni sanitarie riservate in conformità alle normative nazionali e locali sulla privacy.
    3. Tutte le donne in età fertile dovranno acconsentire a utilizzare un metodo contraccettivo efficace nel corso dello studio e per 126 giorni (18 settimane) dopo l’ultima dose assunta del trattamento dello studio. Inoltre, le partecipanti non dovranno donare ovuli durante lo studio e per almeno 126 giorni (18 settimane) dopo l’ultima dose assunta del trattamento dello studio. Ove applicabile, se non precedentemente confermato nello studio originario di fase 3, lo stato post-menopausale dovrà essere confermato come segue: per le donne di età =55 anni, 52 settimane continue di amenorrea naturale (spontanea) senza causa medica alternativa e un livello sierico di FSH =40 mUI/ml; per le donne di età >55 anni, 52 settimane continue di amenorrea naturale (spontanea) senza causa medica alternativa e un livello sierico di FSH =40 mUI/ml o almeno 5 anni continui di amenorrea naturale (spontanea) senza causa medica alternativa.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52).
    2. Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period).
    3. Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the LTE study unsuitable in the opinion of the Investigator.
    4. Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy.
    5. Use of prohibited concurrent medication or therapy during the parent Phase 3 studies.
    6. Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit.
    7. Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
    8. Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study and for 126 days (18 weeks) after the last dose of study treatment.
    9. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered (participation in observational registries is allowed).
    10. Inability to comply with study requirements.
    11. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrollment.
    PRINCIPALI CRITERI DI ESCLUSIONE
    1. Conclusione anticipata del trattamento degli studi originari di fase 3 (partecipanti che hanno interrotto il trattamento dello studio prima della Settimana 52).
    2. Conclusione anticipata degli studi iniziali originari di fase 3 (partecipanti che si sono ritirati dalla partecipazione allo studio e che non hanno completato il periodo di trattamento di 52 settimane).
    3. Partecipanti che hanno sviluppato qualsiasi altra malattia medica, condizione o anomalia, rendendo la loro partecipazione allo studio di estensione a lungo termine (LTE) non idonea a giudizio dello sperimentatore.
    4. Partecipanti che hanno sviluppato un peggioramento da moderato a grave delle manifestazioni di lupus organo-specifico che richiederebbero un cambiamento nella terapia immunosoppressiva.
    5. Uso di farmaci o terapie concomitanti proibiti durante gli studi originari di fase 3.
    6. Immunizzazione con vaccini vivi o vivi attenuati nelle 4 settimane precedenti la visita basale.
    7. Uso di altri farmaci sperimentali o farmaci off-label utilizzati per trattare il LES, il lupus cutaneo o la nefrite lupica durante gli studi originari di fase 3.
    8. Partecipanti di sesso femminile in stato di gravidanza, attualmente in fase di allattamento o che prevedono di avviare una gravidanza durante lo studio e per 126 giorni (18 settimane) dopo l’ultima dose del trattamento dello studio.
    9. Attuale arruolamento o intenzione di arruolarsi in qualsiasi studio clinico interventistico in cui viene somministrato un trattamento sperimentale o una terapia approvata per uso sperimentale (la partecipazione ai registri osservazionali è consentita).
    10. Incapacità di aderire ai requisiti dello studio.
    11. Altre motivazioni non specificate che, a giudizio dello sperimentatore o dello sponsor, rendano il partecipante non idoneo all’arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    Incidence of TEAEs -
    Number of Participants with Treatment Emergent Adverse Events (TEAEs) up to Week 180

    Incidence of SAEs -
    Number of Participants with Serious Adverse Events (SAEs) up to Week 180
    Endpoint primari:
    Incidenza di TEAE - Numero di partecipanti con eventi avversi emergenti dal trattamento (TEAE) fino alla Settimana 180
    Incidenza di SAE - Numero di partecipanti con eventi avversi seri (SAE) fino alla Settimana 180
    E.5.1.1Timepoint(s) of evaluation of this end point
    All endpoints measured within TimeFrame as mentioned in point E.5.1 Primary end point(s)
    Tutti gli endpoint misurati nell’intervallo di tempo menzionato nel punto E.5.1 Endpoint primari
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    - Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response up to Week 180
    - Percentage of Participants who Achieved a Joint-50 Response up to Week 180
    - Percentage of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response up to Week 180
    - Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response up to Week 180
    - Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate up to Week 156
    - Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) up to Week 180
    - Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS up to Week 180
    - Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score up to Week 156
    - Cumulative Exposure to OCS Over Time up to Week 156
    - Percentage of Participants With OCS =7.5 mg up to Week 156
    - Percentage of Participants With OCS =5 mg up to Week 156
    - Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score up to Week 156
    - Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score up to Week 156
    - Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score up to Week 156
    - Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score up to Week 156
    - Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score up to Week 156
    - Change from Baseline in Patient Global Assessment (PtGA) Score up to Week 156
    - Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters up to Week 180
    - Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECGs) Results up to Week 156
    - Number of Participants with Antibodies to BIIB059 up to Week 180
    Endpoint secondari:
    - Percentuale di partecipanti che hanno ottenuto una risposta secondo l’Indice di risposta del lupus eritematoso sistemico (SRI)-4 fino alla Settimana 180
    - Percentuale di partecipanti che hanno ottenuto una risposta Joint-50 fino alla Settimana 180
    - Percentuale di partecipanti che ottengono una risposta secondo il punteggio dell’Indice di area e gravità della malattia nel lupus eritematoso cutaneo (CLASI)-50, CLASI-70 e CLASI-90 fino alla Settimana 180
    - Percentuale di partecipanti che hanno ottenuto una risposta alla Valutazione composito del lupus secondo il Gruppo di valutazione del lupus nelle Isola Britanniche (BICLA) fino alla Settimana 180
    - Sicurezza grave annualizzata di estrogeni nella Valutazione nazionale nel lupus eritematoso sistemico
    - Tasso di riacutizzazione nell’Indice di riacutizzazione dell’Indice di attività della malattia nel lupus eritematoso sistemico (SFI) fino alla Settimana 156
    - Percentuale di tempo trascorso nello Stato di bassa attività del lupus (LLDAS) fino alla Settimana 180
    - Durata dello stato LLDAS sostenuto, definito dal numero di visite durante lo stato LLDAS fino alla Settimana 180
    - Variazione annuale rispetto al valore basale dagli studi originari di fase 3 nelle Cliniche di collaborazione internazionale sul lupus sistemico/punteggio dell’Indice di danno (SDI) del Collegio americano di reumatologia fino alla Settimana 156
    - Esposizione cumulativa agli OCS nel tempo fino alla Settimana 156
    - Percentuale di partecipanti con OCS =7,5 mg fino alla Settimana 156
    - Percentuale di partecipanti con OCS =5 mg fino alla Settimana 156
    - Variazione rispetto al basale nel punteggio del Questionario sulla qualità della vita correlato alla salute specifico per il lupus (LupusQoL) fino alla Settimana 156
    - Variazione rispetto al basale nel punteggio del Questionario sullo stato di salute - Modulo abbreviato a 36 voci (SF-36) (versione acuta) fino alla Settimana 156
    - Variazione rispetto al basale nel punteggio della Valutazione funzionale della terapia per le malattie croniche (FACIT) - Affaticamento fino alla Settimana 156
    - Variazione rispetto al basale nel punteggio del Questionario sulla salute del paziente a 9 voci (PHQ-9) fino alla Settimana 156
    - Variazione rispetto al basale nel punteggio della compromissione della produttività lavorativa e delle attività (WPAI): Punteggio del lupus fino alla Settimana 156
    - Variazione rispetto al basale nel punteggio della valutazione globale del paziente (PtGA) fino alla Settimana 156
    - Numero di partecipanti con anomalie clinicamente rilevanti nei parametri di laboratorio standard fino alla Settimana 180
    - Numero di partecipanti con anomalie clinicamente rilevanti nei risultati degli elettrocardiogrammi (ECG) fino alla Settimana 156
    - Numero di partecipanti con anticorpi diretti contro BIIB059 fino alla Settimana 180
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints measured within TimeFrame as mentioned in point E.5.2 Secondary end point(s)
    Tutti gli endpoint misurati nell’intervallo di tempo menzionato nel punto E.5.2 Endpoint secondari
    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
    long-term tolerability
    long-term effect on disease activity
    tollerabilità a lungo termine, effetto a lungo termine sull'attività della malattina
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Australia
    Brazil
    Canada
    Chile
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Taiwan
    United States
    France
    Poland
    Sweden
    Bulgaria
    Netherlands
    Romania
    Spain
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Hungary
    United Kingdom
    Serbia
    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 EOS is the last visit for the last participant for the final collection of data for the primary outcome.
    La data di fine studio è l'ultima visita dell'ultimo partecipante per la raccolta finale dei dati per l'outcome primario.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 844
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 864
    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 156-week treatment period with assigned study treatments are treatment period completers, and they will be encouraged to enter the 24 week SFU. Participants who discontinue assigned study treatments before Week 152 are early treatment terminators, and they will be encouraged to complete all study assessments for the ET Visit as soon as possible but within 4 weeks of discontinuation of study treatment.
    I partecipanti che completano il periodo di trattamento di 156 settimane con i trattamenti dello studio assegnati saranno incoraggiati a entrare nel follow-up di sicurezza (SFU) di 24 settimane. I partecipanti che interrompono i trattamenti dello studio assegnati prima della Settimana 152 saranno incoraggiati a completare tutte le valutazioni dello studio per la visita di fine trattamento (ET) il prima possibile, ma entro 4 settimane dall’interruzione del trattamento dello studio.
    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 Decision2023-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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