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    Summary
    EudraCT Number:2020-004006-54
    Sponsor's Protocol Code Number:PDY16744
    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:2021-06-08
    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 number2020-004006-54
    A.3Full title of the trial
    A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
    Studio di fase 2, multicentrico, in aperto, non randomizzato, di verifica concettuale per valutare l’efficacia, la sicurezza e la tollerabilità di BIVV020 in adulti affetti da polineuropatia demielinizzante infiammatoria cronica (CIDP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)
    Studio di verifica concettuale di BIVV020 nella polineuropatia demielinizzante infiammatoria cronica (CIDP)
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberPDY16744
    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 number800226343
    B.5.5Fax number0239394168
    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 nameBIVV020
    D.3.2Product code [BIVV020]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBIVV020
    D.3.9.3Other descriptive nameBIVV020
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic inflammatory demyelinating polyneuropathy
    Polineuropatia demielinizzante infiammatoria cronica
    E.1.1.1Medical condition in easily understood language
    Nervous system diseases
    Malattie del Sistema Nervoro
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077384
    E.1.2Term Chronic inflammatory demyelinating polyneuropathy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: Efficacy of BIVV020 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive.
    Part B:Long-term safety and tolerability of BIVV020 in CIDP.
    Parte A: Efficacia di BIVV020 in tre sottopopolazioni di pazienti affetti da CIDP: trattati con terapie standard (SOC), refrattari alle SOC e naïve alle SOC.
    Parte B: Sicurezza e tollerabilità a lungo termine di BIVV020 nella CIDP.
    E.2.2Secondary objectives of the trial
    Part A:
    - Safety and tolerability of BIVV020 in CIDP
    - Immunogenicity of BIVV020
    - Efficacy of BIVV020 with overlapping SOC (SOC-Treated group)
    • Part B:
    - Durability of efficacy during long-term treatment with BIVV020 in CIDP
    - Long-term immunogenicity of BIVV020 in CIDP
    Parte A:
    • Sicurezza e tollerabilità di BIVV020 nella CIDP
    • Immunogenicità di BIVV020
    • Efficacia di BIVV020 con SOC sovrapposto (gruppo trattato con SOC)
    Parte B:
    • Durata dell’efficacia durante il trattamento a lungo termine con BIVV020 nella CIDP
    • Immunogenicità a lungo termine di BIVV020 nella CIDP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adults>/=18yrs of age at the time of signing informed consent.
    -Documented definite or probable diagnosis of CIDP(typicalCIDP,pure motorCIDP,Lewis-Sumner Syndrome)according to EFNS/PNS Task Force first revision
    -Belonging to 1 of the following 3 groups:standard-of-care(SOC)-Treated,SOC-Refractory,SOC-Naïve,as defined below
    -SOC-Treated(all criteria a-c must be met):
    a)Documented evidence of objective response to SOC,with clinically meaningful improv. Clinically meaningful improv is defined as one of the following:>/=1-point decrease in adj INCAT score,>/=4points increase in RODS total score,>/=3points increase in MRC Sum score,>/=8kilopascal improv in mean grip strength(one hand),or an equivalent improv based on information documented in medical records and per the PI's judgement
    b)Must be on stable SOC therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or CS within 8wks prior to screen,remaining at stable SOC therapy until the time of first BIVV020 dosing
    c)Evidence of clinically meaningful deteriorat on interruption or dose reduct of SOC therapy within 24mths prior to screen,determined by clinical examination or medical records.Clinically meaningful deterioration is defined as one of the following:>/=1-point increase in adj INCAT score, decrease in RODS total score>/=4points, decrease in MRC Sum score>/=3,mean grip strength worsening of>/=8kilopascals(one hand),or an equivalent deterioration based on information from medical records and at the PI's judgement
    -SOC-Refractory(all criteria a-d must be met):
    a)Evidence of failure or inadequate response to SOC defined as no clinically meaningful improv and persistent INCAT score>/=2after treatment for a min of 12wks on SOC prior to screen. A clinically meaningful improv is defined as one of the following:>/=1-point decrease in adj INCAT score, increase in RODS total score>/=4points, increase in MRC Sum score>/=3,mean grip strength improv of>/=8kilopascals(one hand), or equivalent improv based on information from medical records and at the PI's judgement.Or Unable to receive or continue treatment with immunoglobulins or CS due to side effects
    b)Patient has not received IGs(IVIg or SCIg)within12wks prior to screen
    c)Certain immunosuppressant drugs are allowed in this group if taken for>/=6mths and at a stable dose for>/=3mths prior to screen: azathioprine,methotrexate,mycophenolate mofetil,cyclosporine.Oral CS are allowed if on a stable dose of<20mg/day of prednisone(or equivalent dose for other oral CS) fo =3mths prior to screen
    d)INCAT score:2-9(a score of 2 should be exclusively from leg disability component of INCAT)
    -SOC-Naïve(all criteria a-c must be met):
    a)Participants without previous treatment for CIDP or participants who received IGs(IVIg or SCIg) or CS but were stopped for reasons other than lack of response or side effects
    b)Not treated with immunoglobulins (IVIg or SCIg) or CS for at least 6mths prior to screen
    c)INCAT score:2-9(a score of 2 should be exclusively from leg disability component of INCAT
    -Documented vaccin against encapsule bacterial pathogens given within 5yrs of enrollment or initiated a min of 14days prior to first dose
    -Female participant must use a double contracept method including a highly effective method of birth control from inclusion and up to 52wks plus 30days after the last study dose and agree not to donate eggs,ova,oocytes during this period
    -Female participant must have a negative highly sensitive pregnancy test(urine or serum)as required by local regulations within 24hrs before the first dose of study intervent
    -Male participants,whose partners are of childbearing potential must accept to use,during sexual intercourse,a double contraceptive method according to the following:condom plus an additional highly effective contracept
    -Male participants must have agreed not to donate sperm during the intervention and up to 52wks after the last dose
    -Capable of giving signed informed consent
    Adulti>/=18aa al momento firma consenso
    Diagnosi probabile o definita documentata di CIDP(CIDP tipica,CIDP motoria pura,sindrome di Lewis-Sumner)secondo prima rev di Task Force EFNS/PNS
    Appartenente a 1 di 3 gruppi seguenti:trattati con terapia standard(SOC),refrattari a SOC o naïve a SOC,come definito di seguito
    -Trattato con SOC(tutti i criteri a-c devono essere soddisfatti):
    a)Evidenza document di risp obiett a SOC,con miglioram clinic signific.Miglioram clinic significat è definito come uno dei seguenti:riduz>/=1punto punteg INCAT corretto,aumento>/= 4punti punteg totale I-RODS,aumento>/=3punti tot del punteg MRC,miglioram>/=8kilopascal in forza media presa(con una mano)o miglioram equivalente su base di informaz documentate in cartelle cliniche e secondo giudizio PI
    b)Deve essere in SOC stabile,definita come nessuna variaz >10% in frequenza o dose di IG o CS in 8 sett precedenti screen,rimanendo a SOC stabile fino al momento prima somministraz BIVV020
    c)Evidenza di deterioram clinic significativo a interruz o riduz di dose di SOC in 24 mesi precedenti screen,determinata mediante esame clinico o cartelle cliniche.Deterioram clinic significativo è definito come uno di seguenti:aumento>/=1punto punteg INCAT corretto,riduz punteg totale I-RODS>/=4punti,riduz totale punteg MRC>/=3,peggioram forza media presa>/=8kilopascal(con una mano)o deterioram equivalente su base di informaz ottenute da cartelle cliniche e secondo giudizio PI
    -Refrattari a SOC(tutti i criteri a-d devono essere soddisfatti):
    a)Evidenza fallim o risposta inadeguata a SOC definita come nessun miglioram clinic significativo e punteg INCAT persistente>/=2dopo trattam per min di 12 sett con SOC prima di screen.Un miglioram clinic significativo è definito come uno di seguenti:riduz>/=1punto punteg INCAT corretto,aumento punteggio tot I-RODS>/=4punti,aumento tot punteg MRC>/=3,miglioram forza media presa>/=8kilopascal(con una mano)o miglioram equivalente su base informaz ottenute da cartelle cliniche e secondo giudizio PI. Oppure impossibilità di ricevere o continuare il tratt con IG o CS a causa effetti collaterali
    b)paz non ha ricevuto Ig (IVIg o SCIg) in 12 sett precedenti screen
    c)Alcuni farmaci immunosoppressori sono consentiti in questo gruppo se assunti per>/=6mesi e a dose stabile per>/=3mesi prima di screen:azatioprina,metotrexato,micofenolato mofetile e ciclosporina.I CS orali sono consentiti se somministr a dose stabile <20 mg/die prednisone(o dose equivalente per altri CS orali)per>/=3mesi prima screen
    d)Punteg INCAT:2-9(punteg di 2 deve essere riferito esclusivam a componente disabilità delle gambe di INCAT)
    - naïve a SOC(tutti i criteri a-c devono essere soddisfatti):
    a)Partecip senza tratt precedente per CIDP o partecip che hanno ricevuto Ig(IVIg o SCIg)o CS ma con tratt interrotto per motivi diversi da mancata risposta o effetti collaterali
    b)Non trattati/e con Ig(IVIg o SCIg)o CS da almeno 6 mesi prima screen
    c)Punteg INCAT: 2-9(punteg di 2 deve essere riferito esclusivam a componente di disabilità delle gambe di INCAT
    Vaccinaz documentate contro patog batterici incapsulati somministr in 5aa precedenti arruolam o avviate almeno 14gg prima di prima dose
    Partecip sesso femm:
    - accettare utiliz metodo contraccett doppio,compreso uno altam efficace durante periodo tratt e per almeno 52 sett più 30 gg dopo ultima dose tratt e accetta di non donare cellule uovo(ovuli, ovociti)durante qs periodo
    -presentare risult neg a test gravid altamente sensibile(urina o siero)come richiesto da normat locali in 24h precedenti prima dose tratt
    Partecip sesso masc
    -accettare utiliz, quando rapporti sessuali con donna età fertile,doppio metodo contraccett ossia preservativo più metodo contraccett aggiuntivo altam efficace
    -accettare astenersi da donaz sperma per almeno52 sett dopo ultima dose tratt
    Partecipanti in grado di fornire consenso firmato
    E.4Principal exclusion criteria
    1. Polyneuropathy of other causes, including but not limited to hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, monoclonal gammopathy of uncertain significance, lumbosacral radiculoplexus neuropathy, pure sensory CIDP and acquired demyelinating symmetric (DADS) neuropathy (also known as distal CIDP).
    2. Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.
    3. Poorly controlled diabetes (HbA1c >7%).
    4. Serious infections requiring hospitalization within 30 days prior to screening and any active infection requiring treatment during screening.
    5. Clinical diagnosis of SLE.
    6. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to BIVV020 or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
    7. Presence of conditions (medical history or laboratory assessments) that may predispose the participant to excessive bleeding or increased risk of infection.
    8. A history of CIDP relapse after prior vaccination.
    9. Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.
    10. Treatment with plasma exchange within 12 weeks prior to screening.
    11. Prior treatment with rituximab or ocrelizumab in the 6 months prior to BIVV020 dosing or until return of B-cell counts to normal levels, whichever is longer.
    12. Immunosuppressive/chemotherapeutic medications such as azathioprine, methotrexate, cyclophosphamide, cyclosporine, mycophenolate mofetil, tacrolimus, interferon, TNF-alpha inhibitor: within 6 months prior to dosing (except for some cases as indicated in the SOC-Refractory group).
    13. Treatment (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine.
    14. Treatment (any time) with total lymphoid irradiation or bone marrow transplantation.
    15. Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer, prio to screening.
    16. Pregnant (defined as positive ß-HCG blood test) or lactating females.
    17. Positive result on any of the following tests: hepatitis B surface (HBsAg) antigen,antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 antibodies).
    18. Evidence of IgG4 autoantibodies against paranodal proteins (NF155And CNTN1).
    1. Polineuropatia dovuta ad altre cause, tra cui, a titolo esemplificativo ma non esaustivo, neuropatie demielinizzanti ereditarie, neuropatie secondarie a infezioni o malattie sistemiche, neuropatia diabetica, neuropatie indotte da farmaci o tossine, neuropatia motoria multifocale, gammopatia monoclonale di significato incerto, neuropatia radicolare lombosacrale, CIDP sensitiva pura e neuropatia simmetrica demielinizzante distale acquisita (DADS) (nota anche come CIDP distale).
    2. Qualsiasi altra malattia neurologica o sistemica che può causare sintomi e segni che interferiscono con il trattamento o le valutazioni degli esiti.
    3. Diabete scarsamente controllato (HbA1c >7%).
    4. Infezioni serie che richiedono il ricovero ospedaliero nei 30 giorni precedenti lo screening e qualsiasi infezione attiva che richieda un trattamento durante lo screening.
    5. Diagnosi clinica di LES.
    6. Sensibilità a uno qualsiasi dei trattamenti dello studio o a componenti dello stesso, o al farmaco o altre allergie che, nell’opinione dello sperimentatore, rappresentano una controindicazione alla partecipazione al presente studio. Nello specifico, anamnesi di qualsiasi reazione di ipersensibilità a BIVV020 o ai suoi componenti o di una grave reazione allergica o anafilattica a qualsiasi anticorpo monoclonale umanizzato o murino.
    7. Presenza di condizioni (anamnesi medica o valutazioni di laboratorio) che possono predisporre il/la partecipante a un sanguinamento eccessivo o a un aumento del rischio di infezione.
    8. Anamnesi di recidiva di CIDP dopo precedente vaccinazione.
    9. Intervento chirurgico importante recente o pianificato che potrebbe confondere i risultati della sperimentazione o mettere il/la partecipante a rischio ingiustificato.
    10. Trattamento con scambio plasmatico nelle 12 settimane prima dello screening.
    11. Precedente trattamento con rituximab o ocrelizumab nei 6 mesi precedenti la somministrazione di BIVV020 o fino al ritorno della conta dei linfociti B ai livelli normali, a seconda di quale sia il periodo più lungo.
    12. Farmaci immunosoppressori/chemioterapici come azatioprina, metotrexato, ciclofosfamide, ciclosporina, micofenolato mofetile, tacrolimus, interferone, inibitore del TNF-alfa: entro i 6 mesi precedenti la somministrazione (eccetto per alcuni casi come indicato nel gruppo dei refrattari alle SOC).
    13. Trattamento (in qualsiasi momento) con farmaci altamente immunosoppressori/chemioterapici con effetti sostenuti, per es., mitoxantrone, alemtuzumab, cladribina.
    14. Trattamento (in qualsiasi momento) con irradiazione linfonodale totale o trapianto di midollo osseo.
    15. L’utilizzo di qualsiasi inibitore del sistema del complemento specifico (per es., eculizumab) entro 12 settimane o 5 volte l’emivita del prodotto, a seconda di quale periodo sia più lungo, prima dello screening.
    16. Donne in gravidanza (definita come positività alle analisi del sangue per ß-hCG) o in allattamento.
    17. Risultato positivo a uno qualsiasi dei seguenti test: antigene di superficie del virus dell’epatite B (HBsAg), anticorpi anti-core dell’epatite B (anti-HBc Ab), anticorpi anti-virus dell’epatite C (anti-HCV), anticorpi anti-virus dell’immunodeficienza umana 1 e 2 (anticorpi anti-HIV1 e anti-HIV2).
    18. Evidenza di autoanticorpi IgG4 contro le proteine paranodali (NF155 e CNTN1).
    E.5 End points
    E.5.1Primary end point(s)
    1) Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the BIVV020 treatment period:
    Relapse will be defined as >/=1-point increase in adjusted Inflammatory neuropathy cause and treatment (INCAT) disability score.
    2) Part A, SOC-Refractory and SOC-Naïve: Percentage of participants responding during the BIVV020 treatment period: Response will be defined as >/=1-point decrease in adjusted INCAT disability score.
    3)Part B: Number of participants reported with adverse Events:Number of participants reported with adverse events during 76 weeks of treatment and 22 weeks of follow-up.
    1) Parte A, trattati con SOC: Percentuale di partecipanti recidivanti dopo l’interruzione delle SOC e durante il periodo di trattamento con BIVV020
    La recidiva sarà definita come aumento >/=1 punto nel punteggio di disabilità della scala Causa e trattamento della neuropatia infiammatoria (INCAT) corretto
    2) Parte A, Refrattari alle SOC e Naïve alle SOC: Percentuale di partecipanti rispondenti durante il periodo di trattamento con BIVV020. La risposta sarà definita come riduzione >/=1 punto nel punteggio di disabilità INCAT corretto
    3) Parte B:Numero di partecipanti che riportano Eventi avversi: numero di partecipanti che riportano eventi avversi durante le 76 settimane di trattamento e nelle 22 settimane di follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    1)Day 1 up to 24 weeks
    2) Day 1 up to 24 weeks
    3) Day 1 up to Week 98
    1) dal giorno 1 fino a 24 settimane
    2) dal giorno 1 fino a 24 settimane
    3) dal giorno 1 fino alla settimana 98
    E.5.2Secondary end point(s)
    1)Part A: Number of participants reported with adverse Events:Number of participants reported with adverse events during 24 weeks of treatment period and if not enrolled to Part B, 22 weeks of follow-up
    period.
    2)Part A: Number of participants with incidence and titer of anti-BIVV020 antibodies (ADA):Incidence and titer of anti- BIVV020 antibodies (ADA) will be assessed during the 24 weeks of treatment period and if not enrolled to Part B, 22 weeks of follow-up period.
    3)Part A: Percentage of participants in the SOC Treated group improving during the overlap treatment period: Improvement will
    be defined as >/=1 point decrease in adjusted INCAT disability score.
    4)Part B, SOC-Treated: Percentage of participants relapse-free during the treatment extension period:Relapse-free will be defined as no increase in adjusted INCAT disability score >/=2 points.
    5)Part B, SOC-Refractory and SOC-Naive: Percentage of participants with sustained response during the treatment extension period:Maintenance of
    response will be defined as no increase in adjusted INCAT disability score >/=2 points.
    6)Part B: Long-term immunogenicity:Incidence and titer of anti-BIVV020 antibodies during the entire BIVV020 treatment period and follow-up period.
    1) Parte A: Numero di partecipanti che riportano Eventi avversi: numero di partecipanti che riportano eventi avversi durante le 24 settimane di trattamento e, se non arruolati nella parte B, nelle 22 settimane di follow-up
    2) Parte A: Numero di partecipanti con incidenza e titolo degli anticorpi anti-BIVV020 (ADA): Incidenza e titolo degli anticorpi anti-BIVV020 (ADA) sarà valutato durante le 24 settimane nel periodo di trattamento e, se non arruolati nella parte B, nelle 22 settimane di follow-up
    3) Parte A: Percentuale di partecipanti nel gruppo trattato con SOC che migliorano durante il periodo di trattamento in sovrapposizione Il miglioramento sarà definito come una riduzione >/=1 punto nel punteggio di disabilità INCAT corretto
    4) Parte B, Trattati con SOC: Percentuale di partecipanti con assenza di recidive durante il periodo di estensione del trattamento: l’assenza di recidive sarà definita come nessun aumento >/=2 punti nel punteggio di disabilità INCAT corretto
    5) Parte B, refrattari alle SOC e Naïve alle SOC: Percentuale di partecipanti con risposta sostenuta durante il periodo di estensione del trattamento: la risposta sostenuta sarà definita come nessun aumento >/=2 punti nel punteggio di disabilità INCAT corretto
    6) Parte B: Immunogenicità a lungo termine: Incidenza e titolo degli anticorpi anti-BIVV020 durante l’intero periodo di trattamento con BIVV020 e il periodo di follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)-2) Day 1 up to 46 weeks
    3)Day 1 up to 12 weeks
    4)-5)Week 24 up to Week 76
    6)Day 1 Up to Week 98
    1) e 2) dal giorno 1 fino a 46 settimane
    3) dal giorno 1 fino a 12 settimane
    4) e 5) dalla settimana 24 fino alla settimana 76
    6) dal giorno 1 fino alla settimana 98
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    studio in aperto
    open label study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Canada
    China
    France
    Germany
    Italy
    Netherlands
    Poland
    Serbia
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days17
    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: 98
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 90
    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)
    Post trial access: In addition to the 18 months of BIVV020 treatment in Parts A and B of this trial, a separate open-label extension study may be proposed in which case participants will be offered the opportunity to enroll in that study. Details will be provided under a separate protocol.
    Proseguimento del trattamento alla fine della sperimentazione: In aggiunta ai 18 mesi di trattamento con BIVV020 nella Parte A e Parte B di questo studio, verrà proposto uno studio in aperto di estensione. In tal caso ai pazienti sarà data la possibilità di partecipare a questo studio. I dettagli saranno forniti in un 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 Decision2021-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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