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    Summary
    EudraCT Number:2021-001567-25
    Sponsor's Protocol Code Number:ACT17010
    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:2021-10-12
    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 number2021-001567-25
    A.3Full title of the trial
    Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study
    Efficacia e sicurezza di SAR441344 nel trattamento del lupus eritematoso sistemico: Studio di fase 2, proof of concept, randomizzato, in doppio cieco, controllato con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus
    Efficacia e sicurezza di SAR441344 nel trattamento del lupus eritematoso sistemico
    A.3.2Name or abbreviated title of the trial where available
    APATURA
    APATURA
    A.4.1Sponsor's protocol code numberACT17010
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.r.l
    B.5.2Functional name of contact pointContact Point
    B.5.3 Address:
    B.5.3.1Street AddressViale Luigi Bodio 37/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800536389
    B.5.5Fax number000000
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 nameSAR441344
    D.3.2Product code [SAR441344]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNON APPLICABILE
    D.3.9.2Current sponsor codeSAR441344
    D.3.9.3Other descriptive nameSAR441344
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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
    Lupus eritematoso sistemico
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus
    Lupus eritematoso sistemico
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    To evaluate the efficacy of SAR441344 in comparison with placebo and in addition to standard of care (SOC), over a 24-week period, on disease activity in participants with active SLE
    Valutare l’efficacia di SAR441344 rispetto al placebo e in aggiunta allo standard di cura (SOC), nell’arco di un periodo di 24 settimane, sull’attività della malattia nei/nelle partecipanti con LES attivo.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of SAR441344 in comparison with placebo and in addition to SOC, over a 24-week period, on disease activity in all participants and biomarker (BM) subgroups of participants with active SLE.
    • To evaluate the efficacy of SAR441344 in comparison with placebo and in addition to SOC, over a 24-week period, in all participants and BM subgroups of participants with active SLE, on oral corticosteroid (OCS) reduction, skin manifestations, and joints manifestations.
    • To evaluate the safety profile of SAR441344 in comparison with placebo and in addition to SOC, over a 24-week period, in participants with active SLE
    • To evaluate the potential for immunogenicity of SAR441344 in participants with active SLE
    • To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 24 weeks in adult participants with SLE
    -Valutare l’efficacia di SAR441344 rispetto al placebo e in aggiunta alla SOC, nell’arco di un periodo di 24 settimane, sull’attività della malattia in tutti/e i/le partecipanti e in partecipanti con sottogruppi di biomarcatori (BM) con LES attivo.
    -Valutare l’efficacia di SAR441344 rispetto al placebo e in aggiunta alla SOC, nell’arco di un periodo di 24 settimane, in tutti/e i/le partecipanti e in partecipanti con sottogruppi di BM con LES attivo, sulla riduzione dei corticosteroidi orali (OCS), sulle manifestazioni cutanee e sulle manifestazioni articolari.
    -Valutare il profilo di sicurezza di SAR441344 rispetto al placebo e in aggiunta alla SOC, nell’arco di un periodo di 24 settimane, in partecipanti con LES attivo.
    -Valutare il potenziale di immunogenicità di SAR441344 in partecipanti con LES attivo
    -Valutare l’esposizione farmacocinetica (PK) di un regime di dosaggio di SAR441344 nell’arco di 24 settimane in partecipanti adulti/e affetti/e da LES.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria
    - Positive ANA (titer >/=1:80) during screening
    - Positivity for at least one serological characteristic
    - Total hSELENA-SLEDAI score >/=6 (including points attributed from arthritis and rash) during screening and at randomization as confirmed by a Sponsor-selected independent reviewer(s)
    - At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
    - Receiving at least one of the SOC for SLE (combination is possible)
    - Body weight within 45 kg to 120 kg (inclusive) at screening
    - Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    -Diagnosi di LES da almeno 6 mesi prima dello screening soddisfacendo i criteri rivisti per la classificazione del LES in base all’aggiornamento del 1997 dei criteri ACR del 1982.
    -ANA positivo (titolo >/=1:80) durante lo screening
    -Positività per almeno una caratteristica sierologica
    -Punteggio hSELENA-SLEDAI totale >/=6 (compresi i punti attribuiti da artrite ed eruzione cutanea) durante lo screening e alla randomizzazione, in base a quanto confermato da uno o più revisori indipendenti selezionati dallo sponsor
    -Almeno 1 punteggio BILAG A o 2 punteggi BILAG B durante lo screening, in base a quanto confermato da uno o più revisori indipendenti selezionati dallo sponsor
    -Ricevere almeno uno dei SOC per il LES (è possibile la combinazione)
    -Peso corporeo compreso tra 45 kg e 120 kg (compresi) allo screening.
    -L’uso di contraccettivi da parte di uomini o donne deve essere in linea con le normative locali riguardanti i metodi di contraccezione per coloro che partecipano agli studi clinici.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments
    - Active and severe lupus nephritis
    - Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis
    - Known or suspected drug-induced lupus
    - History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment
    - History or current hypogammaglobulinemia
    - Serious systemic viral, bacterial or fungal infection
    - Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution
    - Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest X rays) and examination, and tuberculosis testing
    - High dose of steroids, or a change in dose within 4 weeks prior to randomization
    - High dose of antimalarial, or a change in dose within 12 weeks prior to randomization
    - High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
    - Use of cyclophosphamide within 3 months prior to screening
    - Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
    - Participants likely to require multiple courses of OCS during the study for chronic diseases other than SLE
    - Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies)
    - Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization
    In presenza di uno dei seguenti criteri, i/le partecipanti saranno esclusi/e dallo studio:
    -Diagnosi primaria di una malattia reumatica oltre al LES o di una malattia infiammatoria articolare o cutanea diversa dal LES che potrebbe confondere le valutazioni dell’attività della malattia.
    -Nefrite lupica attiva e grave
    -LES neuropsichiatrico grave o instabile attivo, con eventi quali, a titolo esemplificativo ma non esaustivo: crisi convulsive, psicosi, stato confusionale acuto, mielite trasversa, vasculite del SNC e neurite ottica.
    -Lupus indotto da farmaci noto o sospetto.
    -Anamnesi, evidenza clinica, sospetto o rischio significativo di eventi tromboembolici, nonché infarto del miocardio, ictus e/o sindrome da antifosfolipidi e qualsiasi partecipante che richieda un trattamento antitrombotico.
    -Ipogammaglobulinemia pregressa o attuale
    -Infezione sistemica seria di origine virale, batterica o fungina
    -Partecipanti con anamnesi di infezioni opportunistiche invasive quali, a titolo esemplificativo ma non esaustivo, istoplasmosi, listeriosi, coccidioidomicosi, candidiasi, Pneumocystis jirovecii e aspergillosi, indipendentemente dalla risoluzione
    -Evidenza di tubercolosi latente attiva o non trattata, in base a quanto documentato dall’anamnesi medica (per es., radiografie del torace) e dall’esame obiettivo, nonché dal test della tubercolosi
    -Dose elevata di steroidi o variazione della dose nelle 4 settimane precedenti la randomizzazione
    -Dose elevata di antimalarici o variazione della dose nelle 12 settimane precedenti la randomizzazione
    -Dose elevata di immunosoppressori o una variazione della dose nelle 12 settimane precedenti la randomizzazione.
    -Uso di ciclofosfamide nei 3 mesi precedenti lo screening.
    -Precedente somministrazione parenterale (EV), intramuscolare (IM) o intrarticolare di steroidi nelle 4 settimane precedenti la randomizzazione.
    -Partecipanti che probabilmente richiederanno cicli multipli di OCS durante lo studio per malattie croniche diverse dal LES.
    -Somministrazione di qualsiasi vaccino vivo (attenuato) nei 3 mesi precedenti la randomizzazione (per es., vaccino per varicella-zoster, poliomielite orale, rabbia).
    -Somministrazione di qualsiasi vaccino non vivo (per es., influenza stagionale, COVID-19) nelle 4 settimane precedenti la randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    English Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24:
    A composite endpoint, with SRI-4 response requiring a >/= 4-point improvement (reduction) from baseline in Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (hSELENA-SLEDAI), no new British Isles Lupus Assessment Group (BILAG-2004) A organ domain scores, or >/= 2 new BILAG-2004 B organ domain scores compared with baseline, no worsening from baseline in lupus disease activity, and no permanent discontinuation of study drug or use of new or increased medication for SLE other than defined per protocol.
    Percentuale di partecipanti che hanno ottenuto una risposta valutata mediante il Systemic Lupus Erythematosus Responder Index (SRI-4) alla Settimana 24:
    un endpoint composito, con risposta SRI-4 che richiede un miglioramento (riduzione) >/= 4 punti rispetto al basale, all’interno del Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (hSELENA-SLEDAI),
    Nessun nuovo punteggio nel British Isles Lupus Assessment Group (BILAG-2004) A organ domain scores, oppure un punteggio >/=2 rispetto al basale nel nuovo BILAG-2004 B organ domain scores, nessun peggioramento rispetto al basale nell'attività della malattia da lupus e nessuna interruzione permanente del farmaco in studio o uso di nuovi farmaci o aumento di farmaci per il SLE diversi da quelli definiti dal protocollo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 24
    Alla settimana 24
    E.5.2Secondary end point(s)
    1-Percentage of participants who achieved an SRI-4 response in prespecified BM subgroups at Week 24
    2-Percentage of participants who achieved a BILAG–based Composite Lupus Assessment (BICLA) response in prespecified BM subgroups
    3-Percentage of participants who achieved a BICLA response
    4-Percentage of participants whose prednisone dose was </= 7.5 mg at Week 16 and maintained through Week 24 in the subgroup with baseline prednisone >/=10 mg/day
    5-Total cumulative corticosteroid dose
    6-Percentage of participants achieving an SRI-4 response at week 24 with sustained reduction of oral corticosteroids
    7-Percent change from baseline in percentage in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A at Week 24 in the subgroup of participants with baseline CLASI-A score >/=8
    8-Percentage of participants with >/=50% improvement in CLASI-A at Week 24 in the subgroup of participants with baseline CLASI-A score >/=8
    9-Percentage of participants with >/=50% improvement in the number of tender and swollen joints at Week 24 (among participants with at least 4 joints affected at baseline)
    10-Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) from Baseline to Week 36 End of Study (EoS)
    11-Incidence of study investigational medicinal product permanent discontinuations and study withdrawals due to TEAEs from Baseline to Week 36 (EoS)
    12-Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
    13-Measurement of anti-drug antibodies (ADA) (before administration at Week 0, 4, 8, 12, 16, 20, 24 and after treatment discontinuation at Week 36)
    14-SAR441344 concentrations over time
    15-Pharmacokinetic (PK) parameters: maximum concentration (Cmax)
    16-PK parameters: time to Cmax (tmax)
    17-PK parameters: area under the curve over the dosing interval (AUC0- tau)
    18-PK parameters: terminal half-life (t1/2z).
    1. Percentuale di partecipanti con sottogruppi di BM predefiniti che hanno ottenuto una risposta SRI-4 alla Settimana 24.
    2. Percentuale di partecipanti che hanno ottenuto una risposta BILAG-based Composite Lupus Assessment (BICLA) in sottogruppi di BM predefiniti.
    3. Percentuale di partecipanti che hanno ottenuto una risposta BICLA.
    4. Percentuale di partecipanti la cui dose di prednisone era </=7,5 mg alla Settimana 16 ed è stata mantenuta fino alla Settimana 24 nel sottogruppo con prednisone al basale >/=10 mg/die.
    5. Dose cumulativa totale di corticosteroidi.
    6. Percentuale di partecipanti che ottiene una risposta SRI-4 alla Settimana 24 con riduzione sostenuta dei corticosteroidi orali.
    7. Variazione percentuale rispetto al basale nella percentuale Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A alla Settimana 24 nel sottogruppo di partecipanti con punteggio CLASI-A al basale >/=8.
    8. Percentuale di partecipanti con miglioramento >/=50% nel CLASI-A alla Settimana 24 nel sottogruppo di partecipanti con punteggio CLASI-A al basale >/=8.
    9. Percentuale di partecipanti con miglioramento >/=50% nel numero di articolazioni dolenti e tumefatte alla Settimana 24 (tra i/le partecipanti con almeno 4 articolazioni interessate al basale).
    10. Incidenza di EA emergenti dal trattamento (TEAE), EA seri (SAE) ed EA di particolare interesse (AESI) dal basale alla Settimana 36 (fine dello studio EoS)
    11. Incidenza delle interruzioni permanenti del prodotto medicinale sperimentale dello studio e dei ritiri dallo studio a causa di TEAE dal basale alla Settimana 36 (EoS).
    12. Partecipanti con variazioni clinicamente significative nei parametri vitali, nell’elettrocardiogramma (ECG) e/o nella valutazione di laboratorio.
    13. Misurazione degli anticorpi antifarmaco (ADA) (prima della somministrazione alle Settimane 0, 4, 8, 12, 16, 20 e 24 e dopo l’interruzione del trattamento alla Settimana 36).
    14. Concentrazioni di SAR441344 nel tempo.
    15. Parametri farmacocinetici (PK): concentrazione massima (Cmax);
    16. Parametri PK: tempo alla Cmax (tmax);
    17. Parametri PK: area sotto la curva nell’intervallo di somministrazione (AUC0-tau)
    18. Parametri PK: emivita terminale (t1/2z).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 6, 7, 8, 9: At Week 24
    4, ,5: Until Week 24
    10, 11, 12, 13, 14, 15, 16, 17, 18: Until Week 36
    1, 2, 3, 6, 7, 8, 9: alla settimana 24
    4, ,5: fino alla settimana 24
    10, 11, 12, 13, 14, 15, 16, 17, 18: fino alla settimana 36
    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 Yes
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Chile
    Mexico
    Russian Federation
    Turkey
    Ukraine
    United States
    Germany
    Italy
    Spain
    Argentina
    Greece
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months19
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 166
    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)
    expected normal treatment of the condition
    previsto trattamento normale della condizione
    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 Decision2021-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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