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    Summary
    EudraCT Number:2019-003406-27
    Sponsor's Protocol Code Number:SL0043
    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:2021-01-21
    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 number2019-003406-27
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, per valutare l’efficacia e la sicurezza di dapirolizumab pegol in partecipanti allo studio affetti da lupus eritematoso sistemico da moderatamente a gravemente attivo.
    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 dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus
    Studio per valutare l’efficacia e la sicurezza di dapirolizumab pegol in partecipanti allo studio affetti da lupus eritematoso sistemico da moderatamente a gravemente attivo.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberSL0043
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameDapirolizumab pegol
    D.3.2Product code [CDP7657]
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapirolizumab pegol
    D.3.9.2Current sponsor codeDZP
    D.3.9.4EV Substance CodeSUB30739
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolution 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
    Systemic lupus erythematosus (SLE)
    Lupus eritematoso sistemico (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus is a chronic autoimmune inflammatory disease which can present with a chronic disease course but has more often a relapsing-remitting disease course.
    Il lupus eritematoso sistemico è una malattia cronica infiammatoria autoimmune che può avere un decorso di malattia cronica, ma che ha più spesso un decorso di malattia recidivante-remittente.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
    Valutare la capacità di dapirolizumab pegol (DZP) come trattamento aggiuntivo al farmaco della terapia standarc (SOC) di ottenere un miglioramento a lungo termine clinicamente rilevante dell’attività della malattia da moderata a grave.
    E.2.2Secondary objectives of the trial
    Evaluate the ability of DZP as an add-on treatment to SOC medication:
    - to achieve fast, clinically relevant improvement of moderate to severe disease activity
    - to achieve long term control of disease activity
    - to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time
    - to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice
    - to achieve components of the composite primary endpoints
    - to achieve alternative responder endpoint
    - to achieve endpoints supporting other key secondary endpoints

    To evaluate the safety and tolerability of DZP as add-on treatment to SOC medication.
    Valutare la capacità di DZP come trattamento aggiuntivo al farmaco della SOC di:
    - ottenere un rapido miglioramento clinicamente rilevante dell’attività della malattia da moderata a grave;
    - ottenere un controllo a lungo termine dell’attività della malattia;
    - raggiungere e mantenere l’obiettivo treat-to-target: bassa attività della malattia con dose di corticosteroidi bassa/accettabile nel tempo;
    - ottenere un miglioramento dell’attività della malattia misurata in base al punteggio numerico dello stato della malattia comunemente utilizzato nella pratica clinica;
    - raggiungere i componenti dell’endpoint primario composito;
    - raggiungere l’endpoint alternativo relativo ai soggetti rispondenti al trattamento;
    - raggiungere gli endpoint a supporto di altri endpoint secondari principali.

    Valutare la sicurezza e la tollerabilità di DZP come trattamento aggiuntivo al farmaco della SOC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Study participant must be > or = 16 years of age - Study participants who have moderate to severe disease activity due toeither persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC)medication defined as: a. Diagnosed with SLE at least 24 weeks before study entry by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)classification criteria for SLE c. With serological evidence for SLE as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies: 1. Anti-Smith (anti-Sm) antibodies (central laboratory) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
    3. Historic evidence for anti-dsDNA antibodies d. Moderately to severely active defined as -British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in > or = 2 organ systems and/or a BILAG 2004 Grade A in > or = 1 organ systems at Screening and Baseline Visit AND -Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) > or = 6 at Screening Visit AND -SLEDAI-2K without labs > or = 4 at Baseline Visit
    e. Receiving the following SOC mediation at stable dose: ¿ Anti-malarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR ¿ Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible
    - Il partecipante allo studio deve essere di età > o = 16 anni
    - Partecipanti allo studio che presentano un’attività della malattia da moderata a grave dovuta a LES persistente in fase attiva o dovuta a un peggioramento acuto di LES nell’ambito di un lupus eritematoso sistemico (LES) con frequenti riacutizzazioni/recidivante-remittente, nonostante una dose stabile di farmaco appartenente allo standard di cura (SOC), definita come:
    a. Diagnosi di LES almeno 24 settimane prima dell’ingresso nello studio da parte di un medico abilitato
    b. Classificata in base ai criteri di classificazione del 2019 della Lega europea contro le malattie reumatiche/Collegio americano di reumatologia
    (EULAR/ACR) per LES
    c. Con evidenza sierologica di LES dimostrata da almeno 1 delle seguenti opzioni:
    i) Evidenza di anticorpi anti-DNA a doppia elica (anti-dsDNA) (presso il laboratorio centrale allo screening);
    ii) Livelli di frazione C3 del complemento < limite inferiore della norma (LLN), livelli di frazione C4 del complemento < LLN o livelli elevati di frazione C4d del complemento fissata ai globuli rossi, misurati dal laboratorio centrale;
    iii) Livelli di anticorpi anti-nucleo con titolo pari ad almeno 1:80 confermati dal laboratorio centrale in combinazione con evidenza di almeno 1 dei seguenti autoanticorpi tipici del LES:
    1. Anticorpi anti-Smith (anticorpi anti-Sm) (laboratorio centrale)
    2. Autoanticorpi A specifici della sindrome di Sjögren (anti-SSA) (Ro)/Autoanticorpi B specifici della sindrome di Sjögren (anti-SSB) (La) (laboratorio centrale)
    3. Evidenza in anamnesi di anticorpi anti-dsDNA
    d. Malattia moderatamente o gravemente attiva, definita da:
    - Indice di attività della malattia, secondo il Gruppo di valutazione del lupus delle Isole Britanniche 2004 (BILAG 2004), di grado B in > o = 2 sistemi d’organo e/o BILAG 2004 di grado A in > o = 1 sistema d’organo allo screening e alla visita basale
    E
    - Indice di attività della malattia nel lupus eritematoso sistemico 2000 (SLEDAI-2K) > o = 6 alla visita di screening
    E
    - SLEDAI-2K senza esami di laboratorio > o = 4 alla visita basale
    e. In trattamento con la seguente terapia farmacologica SOC a dose stabile:
    ¿ Trattamento antimalarico combinato con corticosteroidi e/o immunosoppressori o da solo, se giustificato
    OPPURE
    ¿ Trattamento con corticosteroidi e/o immunosoppressori se il trattamento antimalarico non è possibile
    E.4Principal exclusion criteria
    - Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life threatening condition
    - Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma - Study participants with a history of thromboembolic events within 52 weeks of Screening or with a history of catastrophic antiphospholipid syndrome (APS) or saddle pulmonary embolism or with a vascular graft, valvular heart disease, atrial fibrillation, or any other heart rhythm disorder associated with an increased risk for thromboembolic events
    - Study participant has evidence of human immunodeficiency virus (HIV)infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection - Study participant had an opportunistic infection within 12 weeks prior to the first study medication infusion. - Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion - Study participant has clinically significant active or latent infection - Study participant has a mixed connective tissue disease, scleroderma and/or overlap syndrome of these diseases with SLE - Study participant takes any protocol defined prohibited concomitant medication or has active lupus that, in the opinion of the Investigator or according to local or international guidances, requires prohibited concomitant medications - Study participant has previously been assigned to treatment with DZP in a study evaluating dapirolizumab pegol (DZP) - Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP - Study participant has chronic kidney failure, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2, or serum creatinine >2.5 mg/dL, or proteinuria >3 g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit
    - Il partecipante allo studio presenta un qualsiasi disturbo medico o psichiatrico (ivi compresi disturbi dovuti al lupus eritematoso sistemico (LES) neuropsichiatrico) che, secondo l’opinione dello Sperimentatore, potrebbe pregiudicare o compromettere la capacità del partecipante allo studio di partecipare a questo studio. Ciò include partecipanti allo studio con una patologia potenzialmente letale
    - Il partecipante allo studio presenta un’anamnesi di reazione anafilattica alla somministrazione parenterale di mezzi di contrasto, proteine umane o murine o anticorpi monoclonali
    - Il partecipante allo studio presenta un’anamnesi di tumore maligno, fatta eccezione per i seguenti tumori trattati: carcinoma della cervice in situ, carcinoma basocellulare o carcinoma cutaneo a cellule squamose
    - I partecipanti allo studio con anamnesi di eventi tromboembolici entro le 52 settimane precedenti allo screening o con anamnesi di sindrome da anticorpi anti-fosfolipidi (APS) catastrofica o embolia polmonare a sella o con innesto vascolare, cardiopatia valvolare, fibrillazione atriale o qualsiasi altro disturbo del ritmo cardiaco associato ad un aumentato rischio di eventi tromboembolici
    - Il partecipante allo studio presenta evidenza di infezione da virus dell’immunodeficienza umana (HIV), agammaglobulinemia, deficit di cellule T o infezione da virus linfotropo delle cellule T umane di tipo 1
    - Il partecipante allo studio ha avuto un’infezione opportunistica entro le 12 settimane precedenti alla prima infusione del farmaco in studio.
    - Partecipanti allo studio che hanno ricevuto vaccini vivi/vivi attenuati nelle 6 settimane precedenti alla prima infusione di farmaco in studio
    - Il partecipante allo studio presenta un’infezione attiva o latente clinicamente significativa
    - Il partecipante allo studio presenta una malattia mista del tessuto connettivo, sclerodermia e/o una sindrome da sovrapposizione di queste malattie con il LES
    - Il partecipante allo studio assume qualsiasi farmaco concomitante proibito indicato nel protocollo o presenta lupus in fase attiva che, secondo l’opinione dello sperimentatore o in base alle linee guida locali o internazionali, necessita di farmaci concomitanti proibiti
    - Il partecipante allo studio è stato assegnato in precedenza a trattamento con dapirolizumab pegol (DZP) in uno studio che valuta quest’ultimo
    - Il partecipante allo studio ha partecipato a un altro studio su un farmaco sperimentale (IMP) nelle 12 settimane o 5 emivite precedenti all’IMP, a seconda di quale sia il periodo più lungo, oppure sta attualmente partecipando a un altro studio su un IMP
    - Il partecipante allo studio presenta un’insufficienza renale cronica, che si manifesta con una velocità di filtrazione glomerulare stimata (eGFR) < 30 ml/min/1,73 m^2, creatinina sierica > 2,5 mg/dl, proteinuria > 3 g/die oppure rapporto proteine:creatinina > 340 mg/mmol alla visita di screening
    E.5 End points
    E.5.1Primary end point(s)
    Achievement of BICLA response at Week 48.
    Raggiungimento di risposta BICLA alla settimana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Settimana 48
    E.5.2Secondary end point(s)
    1. Achievement of BICLA response at Week 24
    2. Achievement of BICLA response at Week 12
    3. Achievement of prevention of severe BILAG flares through Week 48
    4. Achievement of LLDAS in =50% of post-Baseline visits through Week 48
    5. Change from Baseline in SLEDAI-2K at Week 48
    6. Achievement of BILAG improvement without worsening at Week 48
    7. Change from Baseline in PGA at Week 48
    8. Achievement of SRI4 response at Week 48
    9. Achievement of prevention of moderate/severe BILAG flares through Week 48
    10. Time to severe BILAG Flare through Week 48
    11. Time to moderate/severe BILAG flare through Week 48
    12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    13. Percentage of participants with serious treatment-emergent adverse events during the study
    14. Percentage of participants with treatment-emergent adverse events of special interest during the study
    15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study
    1. Raggiungimento della risposta alla valutazione del lupus combinata basata su BILAG (BICLA) alla Settimana 24
    2. Raggiungimento della risposta BICLA alla Settimana 12
    3. Raggiungimento della prevenzione di riacutizzazioni BILAG gravi fino alla Settimana 48
    4. Raggiungimento di uno stato di attività della malattia basso nel lupus (LLDAS) in = 50% delle visite post-basale fino alla Settimana 48
    5. Variazione rispetto al basale dell’indice SLEDAI-2K alla Settimana 48
    6. Raggiungimento del miglioramento BILAG senza peggioramento alla Settimana 48
    7. Variazione rispetto al basale nella valutazione globale del medico (PGA) alla Settimana 48
    8. Raggiungimento dell’Indice di risposta 4 nel LES (SRI4) alla Settimana 48
    9. Raggiungimento della prevenzione di riacutizzazioni BILAG moderate/gravi fino alla Settimana 48
    10. Tempo alla riacutizzazione BILAG grave fino alla Settimana 48
    11. Tempo alla riacutizzazione BILAG moderata/grave fino alla Settimana 48
    12. Percentuale di partecipanti con eventi avversi emergenti dal trattamento (TEAE) durante lo studio
    13. Percentuale di partecipanti con eventi avversi emergenti dal trattamento gravi durante lo studio
    14. Percentuale di partecipanti con eventi avversi emergenti dal trattamento di speciale interesse durante lo studio
    15. Percentuale di partecipanti con eventi avversi emergenti dal trattamento che necessitano di monitoraggio speciale durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Week 24
    2: Week 12
    3, 4, 5, 6, 8, 9: Week 48
    7: From Baseline (Day 1) to Week 48
    10, 11: During Treatment Period up to Week 48
    12, 13, 14, 15: From Baseline (Day 1) until Safety Follow-Up (up to Week54)
    1: Settimana 24
    2: Settimana 12
    3, 4, 5, 6, 8, 9: Settimana 48
    7: Dal Basale (Giorno1) alla Settimana 48
    10, 11: Durante il periodo di trattamento fino alla settimana 48
    12, 13, 14, 15: Dal Basale (Giorno 1) fino al Follow-Up di sicurezza (fino alla settimana 54)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity
    Tollerabilità, 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Canada
    Chile
    Colombia
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Serbia
    Singapore
    Taiwan
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Estonia
    France
    Germany
    Greece
    Hungary
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days10
    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: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 450
    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)
    Study participants who complete the 48-week Treatment Period may be eligible to participate in an open label extension (OLE) study. Study participants who withdraw early from the 48-week Treatment Period or choose not to enter the OLE will be followed up for at least 10 weeks. Safety Follow-up (SFU) after their final dose of study medication.
    I partecipanti allo studio che completano il periodo di trattamento di 48 settimane potrà partecipare in uno studio di estensione in aperto (OLE). I partecipanti allo studio che si ritireranno prima del periodo di trattamento di 48 settimane o che scelgono di non prendere parte all'OLE saranno seguiti per almeno 10 settimane. Il follow-up di sicurezza (SFU) dopo la loro dose finale del farmaco in 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 Decision2020-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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