Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-002504-12
    Sponsor's Protocol Code Number:ARGX-113-2003
    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:2021-12-03
    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 number2021-002504-12
    A.3Full title of the trial
    A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)
    Studio di fase 3b, randomizzato, in aperto, a gruppi paralleli per valutare diversi regimi di dosaggio di efgartigimod per via endovenosa per massimizzare e mantenere il beneficio clinico in pazienti con miastenia gravis generalizzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)
    Studio di fase 3b, randomizzato, in aperto, a gruppi paralleli per valutare diversi regimi di dosaggio di efgartigimod per via endovenosa per massimizzare e mantenere il beneficio clinico in pazienti con miastenia gravis generalizzata
    A.3.2Name or abbreviated title of the trial where available
    ADAPT NXT
    ADAPT NXT
    A.4.1Sponsor's protocol code numberARGX-113-2003
    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 SponsorARGENX BV
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BV
    B.5.2Functional name of contact pointAntonio Guglietta
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.6E-mailregulatory@argenx.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/245/17
    D.3 Description of the IMP
    D.3.1Product nameEfgartigimod
    D.3.2Product code [ARGX-113]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNEfgartigimod
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.4EV Substance CodeSUB198780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Generalized Myasthenia Gravis (gMG)
    Miastenia Gravis Generalizzata (MGG)
    E.1.1.1Medical condition in easily understood language
    Generalized Myasthenia Gravis (gMG)
    Miastenia Gravis Generalizzata (MGG)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10071942
    E.1.2Term Myasthenia gravis and related conditions
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical efficacy of efgartigimod IV 10 mg/kg administered
    in a q2w continuous regimen compared to that administered in a cyclic
    regimen
    Per valutare l'efficacia clinica di efgartigimod IV 10 mg/kg somministrato
    in regime q2w continuo rispetto a quello somministrato in regime ciclico
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of both treatment regimens
    used throughout the study
    • To assess the clinical efficacy of efgartigimod IV in both treatment
    regimens over time
    • To compare the number of participants who achieve maximal clinical
    effect during different treatment regimens
    valutare la sicurezza e la tollerabilità di entrambi i regimi di trattamento
    utilizzato durante lo studio
    • Valutare l'efficacia clinica di efgartigimod IV in entrambi i trattamenti
    regimi nel tempo
    • Per confrontare il numero di partecipanti che raggiungono il massimo clinico
    effetto durante diversi regimi di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent as described in Section
    10.1.3 of the protocol, which includes compliance with the requirements
    and restrictions listed in the informed consent form (ICF) and in this
    protocol
    2. At least 18 years of age, at the time of signing the informed consent
    3. Diagnosed with gMG with confirmed documentation and supported by
    a physical exam and confirmed seropositivity for AChR-Abs
    4. Meets the clinical criteria as defined by the Myasthenia Gravis
    Foundation of America (MFGA) class II, III, or IV
    5. Has an MG-ADL total score =5 at screening and the day 1 visit, with
    more than 50% of the score due to nonocular symptoms
    6. Concomitant gMG treatment is permitted. Permitted concomitant gMG
    treatment includes nonsteroidal immunosuppressive drugs (NSIDs),
    steroids, and/or acetylcholinesterase (AChE) inhibitors. If receiving
    corticosteroids and/or NSIDs, must be on a stable dose for at least 1
    month before screening.
    7. Contraceptive use by men and women should be consistent with local
    regulations regarding the methods of contraception for those participating in clinical studies and:
    a. Male participants:
    - Male participants are not allowed to donate sperm from signing the
    ICF until the end of the study.
    b. Female participants:
    - WOCBP (defined in Section 10.4.1 of protocol) must have a negative
    serum pregnancy test at screening and a negative urine pregnancy test
    at baseline before IMP can be administered.
    - The contraception requirements for WOCBP are described in Section
    10.4.2.1 of the protocol.
    1. In grado di fornire il consenso informato firmato come descritto nella Sezione
    10.1.3 del protocollo, che prevede il rispetto dei requisiti
    e restrizioni elencate nel modulo di consenso informato (ICF) e in questo
    protocollo
    2. Almeno 18 anni di età, al momento della sottoscrizione del consenso informato
    3. Diagnosticato con gMG con documentazione confermata e supportato da
    un esame fisico e confermata sieropositività per AChR-Abs
    4. Soddisfa i criteri clinici definiti dalla Miastenia Gravis
    Foundation of America (MFGA) classe II, III o IV
    5. Ha un punteggio totale MG-ADL =5 allo screening e alla visita del giorno 1, con
    più del 50% del punteggio a causa di sintomi non oculari
    6. È consentito il trattamento concomitante con gMG. GMG concomitant concomitante consentita
    il trattamento comprende farmaci immunosoppressori non steroidei (NSID),
    steroidi e/o inibitori dell'acetilcolinesterasi (AChE). Se si riceve
    corticosteroidi e/o NSID, devono essere a una dose stabile per almeno 1
    mese prima dello screening.
    7. L'uso di contraccettivi da parte di uomini e donne dovrebbe essere coerente con le norme locali
    regolamenti riguardanti i metodi di contraccezione per coloro che partecipano a studi clinici e:
    a. Partecipanti maschi:
    - I partecipanti di sesso maschile non sono autorizzati a donare sperma dalla firma del
    ICF fino alla fine dello studio.
    B. Partecipanti donne:
    - WOCBP (definito nella Sezione 10.4.1 del protocollo) deve avere un negativo
    test di gravidanza sul siero allo screening e test di gravidanza sulle urine negativo
    al basale prima che IMP possa essere somministrato.
    - I requisiti di contraccezione per WOCBP sono descritti nella Sezione
    10.4.2.1 del protocollo.
    E.4Principal exclusion criteria
    1. Clinically significant uncontrolled active or chronic bacterial, viral, or
    fungal infection at screening
    2. A positive test for SARS-CoV-2 at screening
    3. Any other known autoimmune disease that, in the opinion of the
    investigator, would interfere with an accurate assessment of the clinical
    symptoms of gMG and/or put the participant at undue risk
    4. History of malignancy unless deemed cured by adequate treatment
    with no evidence of reoccurrence for =3 years before the first
    administration of the IMP. Participants with the following cancers can be
    included at any time, provided they are adequately treated at screening:
    a. Basal cell or squamous cell skin cancer
    b. Carcinoma in situ of the cervix
    c. Carcinoma in situ of the breast
    d. Incidental histological finding of prostate cancer (TNM stage T1a or
    T1b)
    5. Clinical evidence of other significant serious diseases, a recent (<3
    months) major surgery, or any other condition that, in the opinion of the
    investigator, could confound the results of the study or put the
    participant at undue risk
    6. A thymectomy within 3 months of screening
    7. Pregnant or lactating females and those who intend to become
    pregnant during the study or within 90 days of the last dose of IMP
    8. Use of the following prior or concomitant therapies:
    a. IVIg or subcutaneous (SC)Ig within 14 days of day 1
    b. Rituximab within 6 months of day 1
    c. Eculizumab within 1 month of day 1
    d. Other monoclonal antibodies (eg, adalimumab, tocilizumab,
    ixekizumab) within 5 half-lives of the monoclonal antibodies before day
    1
    e. Use of any other investigational product within 3 months or 5 halflives,
    whichever is longer, before day 1
    f. Receipt of a live or live-attenuated vaccine within 4 weeks of
    screening. The receipt of any inactivated, subunit, polysaccharide,
    conjugate vaccine at any time before screening is not considered
    exclusionary.
    9. Previous participation in a clinical study or patient access program
    during which they were treated with efgartigimod
    10. Positive serum test at screening for an active viral infection with any
    of the following conditions:
    a. Hepatitis B virus (HBV) that is indictive of an acute or chronic
    infection
    b. Hepatitis C virus (HCV) based on HCV antibody assay (unless
    associated with a negative HCV RNA test)
    c. HIV based on test results that are associated with an AIDS-defining
    condition or a CD4 count =200 cells/mm3
    11. Total IgG <6 g/L at screening
    12. Known hypersensitivity reaction to efgartigimod or any of its excipients
    13. The participant stands in any relationship of dependency with the
    sponsor.
    14. The participant has been institutionalized due to an official or judicial
    order.
    1. infezione fungina,batterica, virale o cronica attiva o cronica non controllata clinicamente significativa
    allo screening
    2. Un test positivo per SARS-CoV-2 allo screening
    3. Qualsiasi altra malattia autoimmune nota che, a giudizio del
    ricercatore, interferirebbe con un'accurata valutazione del quadro clinico
    sintomi di gMG e/o esporre il partecipante a un rischio eccessivo
    4. Storia di malignità a meno che non sia ritenuto guarito da un trattamento adeguato
    senza evidenza di recidiva per =3 anni prima del primo
    amministrazione dell'IMP. I partecipanti con i seguenti tumori possono essere
    inclusi in qualsiasi momento, a condizione che siano adeguatamente trattati allo screening:
    un. Cancro della pelle a cellule basali o squamose
    B. Carcinoma in situ della cervice
    C. Carcinoma in situ del seno
    D. Reperto istologico incidentale di cancro alla prostata (stadio TNM T1a o
    T1b)
    5. Evidenza clinica di altre malattie gravi significative, un recente (<3
    mesi) intervento chirurgico maggiore, o qualsiasi altra condizione che, a giudizio del
    ricercatore, potrebbe confondere i risultati dello studio o mettere il
    partecipante a rischio indebito
    6. Una timectomia entro 3 mesi dallo screening
    7. Donne in gravidanza o in allattamento e coloro che intendono diventarlo
    incinta durante lo studio o entro 90 giorni dall'ultima dose di IMP
    8. Utilizzo delle seguenti terapie precedenti o concomitanti:
    un. IVIg o Ig sottocutanea (SC) entro 14 giorni dal giorno 1
    B. Rituximab entro 6 mesi dal giorno 1
    C. Eculizumab entro 1 mese dal giorno 1
    D. Altri anticorpi monoclonali (p. es., adalimumab, tocilizumab,
    ixekizumab) entro 5 emivite degli anticorpi monoclonali prima del giorno
    1
    e. Uso di qualsiasi altro prodotto sperimentale entro 3 mesi o 5 emivite,
    qualunque sia più lungo, prima del giorno 1
    F. Ricezione di un vaccino vivo o attenuato entro 4 settimane dal
    selezione. La ricezione di qualsiasi subunità inattivata, polisaccaride,
    vaccino coniugato in qualsiasi momento prima che lo screening non sia considerato
    escludente.
    9. Partecipazione precedente a uno studio clinico o a un programma di accesso dei pazienti
    durante il quale sono stati trattati con efgartigimod
    10. Test siero positivo allo screening per un'infezione virale attiva con qualsiasi
    delle seguenti condizioni:
    un. Virus dell'epatite B (HBV) che è indicativo di un'infezione acuta o cronica
    infezione
    B. Virus dell'epatite C (HCV) basato sul dosaggio degli anticorpi HCV (a meno che
    associato a un test HCV RNA negativo)
    C. HIV in base ai risultati dei test associati a una definizione di AIDS
    condizione o una conta CD4 =200 cellule/mm3
    11. IgG totali <6 g/L allo screening
    12. Reazione nota di ipersensibilità a efgartigimod o ad uno qualsiasi dei suoi eccipienti
    13. Il partecipante si trova in qualsiasi rapporto di dipendenza con il
    sponsor.
    14. Il partecipante è stato istituzionalizzato a causa di un funzionario o giudiziario
    ordine.
    E.5 End points
    E.5.1Primary end point(s)
    Mean of the average MG-ADL total score change from baseline during the
    visit of week (W)1 through W21 by regimen arm
    Media della variazione media del punteggio totale MG-ADL rispetto al basale durante il
    visita della settimana (W)1 fino a W21 per braccio regime
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 weeks
    21 settimane
    E.5.2Secondary end point(s)
    1: Incidence and severity of adverse events (AEs), serious adverse
    events (SAEs) and AEs of special interest (AESIs) Time point: 126 weeks
    2: Incidence of serious adverse events (SAEs) and AEs of special interest
    (AESIs) Time point: 126 weeks
    3: Change from baseline in the Myasthenia Gravis – Activities of Daily
    Living (MG-ADL) total score over time. A higher total score indicates
    more impairment. Time point: 128 weeks
    4: Normalized area under the effect curve (AUEC) of MG-ADL total score
    improvement from baseline during following intervals: Day 1 through
    Week7, Week 7 through Week 14, Week 14 trough Week 21 and Week 7
    through Week 21. Time point: 21 weeks
    5: Characterization of MG-ADL total score change from baseline during
    the following 5 intervals using mean and standard deviation: Week 1
    through Week 7, Week 8 through Week 14, Week 15 through Week 21,
    Week 8 through Week 21 and Week 1 through Week 21. Time point: 21
    weeks
    6: Number of participants who have a =2, 3, 4, or 5 points improvement
    in MG-ADL total score from baseline. during the following 5 intervals:
    Week 1 through Week 7, Week 8 through Week 14, Week 15 through
    Week 21, Week 8 through Week 21 and Week 1 through Week 21. Time
    point: 21 weeks
    7: percentage of participants who have a =2, 3, 4, or 5 points
    improvement in MG-ADL total score from baseline during the following 5
    intervals: Week 1 through Week 7, Week 8 through Week 14, Week 15
    through Week 21, Week 8 through Week 21 and Week 1 through Week
    21. Time point: 21 weeks
    8: Percentage of time, participants have a change in MG-ADL total score
    of at least 2 points from baseline during Week 4 through Week 21. Time
    point: 21 weeks
    9: Number of participants who achieve minimal symptom expression
    (MSE), defined as a MG-ADL total score of 0 or 1. Time point: 21 weeks
    10: Percentage of participants who achieve minimal symptom expression
    (MSE), defined as a MG-ADL total score of 0 or 1 in the following 5
    intervals: Week 1 through Week 7, Week 8 through Week 14, Week 15
    through Week 21, Week 8 through Week 21 and Week 1 through Week
    21. Time point: 21 weeks
    1: Incidenza e gravità degli eventi avversi (EA), eventi avversi gravi
    eventi (SAE) e AE di particolare interesse (AESI) Punto temporale: 126 settimane
    2: Incidenza di eventi avversi gravi (SAE) e AE di particolare interesse
    (AESI) Punto temporale: 126 settimane
    3: Cambiamento dalla linea di base nella Miastenia Gravis – Attività di Daily
    Punteggio totale vivente (MG-ADL) nel tempo. Un punteggio totale più alto indica
    più compromissione. Punto temporale: 128 settimane
    4: Area normalizzata sotto la curva degli effetti (AUEC) del punteggio totale MG-ADL
    miglioramento rispetto al basale durante i seguenti intervalli: dal giorno 1 al
    Dalla settimana 7, dalla settimana 7 alla settimana 14, dalla settimana 14 alla settimana 21 e dalla settimana 7
    fino alla settimana 21. Punto temporale: 21 settimane
    5: Caratterizzazione della variazione del punteggio totale di MG-ADL rispetto al basale durante
    i seguenti 5 intervalli utilizzando media e deviazione standard: Settimana 1
    dalla settimana 7, dalla settimana 8 alla settimana 14, dalla settimana 15 alla settimana 21,
    Dalla settimana 8 alla settimana 21 e dalla settimana 1 alla settimana 21. Punto temporale: 21
    settimane
    6: Numero di partecipanti che hanno ottenuto un miglioramento =2, 3, 4 o 5 punti
    nel punteggio totale di MG-ADL dal basale. durante i seguenti 5 intervalli:
    Dalla settimana 1 alla settimana 7, dalla settimana 8 alla settimana 14, dalla settimana 15 alla
    Settimana 21, dalla settimana 8 alla settimana 21 e dalla settimana 1 alla settimana 21. Ora
    punto: 21 settimane
    7: percentuale di partecipanti con =2, 3, 4 o 5 punti
    miglioramento del punteggio totale MG-ADL rispetto al basale durante i successivi 5
    intervalli: dalla settimana 1 alla settimana 7, dalla settimana 8 alla settimana 14, settimana 15
    dalla settimana 21, dalla settimana 8 alla settimana 21 e dalla settimana 1 alla settimana
    21. Punto temporale: 21 settimane
    8: Percentuale di tempo, i partecipanti hanno un cambiamento nel punteggio totale MG-ADL
    di almeno 2 punti dalla linea di base durante la settimana 4 fino alla settimana 21. Tempo
    punto: 21 settimane
    9: Numero di partecipanti che raggiungono la minima espressione dei sintomi
    (MSE), definito come un punteggio totale MG-ADL di 0 o 1. Punto temporale: 21 settimane
    10: Percentuale di partecipanti che raggiungono la minima espressione dei sintomi
    (MSE), definito come un punteggio totale MG-ADL di 0 o 1 nei seguenti 5
    intervalli: dalla settimana 1 alla settimana 7, dalla settimana 8 alla settimana 14, settimana 15
    dalla settimana 21, dalla settimana 8 alla settimana 21 e dalla settimana 1 alla settimana
    E.5.2.1Timepoint(s) of evaluation of this end point
    21 weeks
    21 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity and tolerability
    immunogeneticità e tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    efgartigimod somministrato in regime continuo vs efgartigimod in regime ciclico
    efgartigimod administered in a continuous regimen vs efgartigimod in a cyclic regimen
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Georgia
    Austria
    Belgium
    Canada
    Germany
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    France
    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 years3
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 72
    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)
    At the end of the study, argenx will comply with all local regulations for
    ensuring continued access to IMP medically identified as essential.
    Al termine dello studio, argenx rispetterà tutte le normative locali per
    garantire l'accesso continuo all'IMP identificato dal punto di vista medico come essenziale.
    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 Decision2022-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-Fri Apr 26 04:41:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA