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    Summary
    EudraCT Number:2021-004998-32
    Sponsor's Protocol Code Number:ARGX-117-2003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-004998-32
    A.3Full title of the trial
    A Long-Term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerabillity, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy
    Extensión a largo plazo del ensayo ARGX-117-2002 para evaluar la seguridad y la tolerabilidad, la eficacia, la farmacodinámica, la farmacocinética y la inmunogenicidad a largo plazo de ARGX-117 en adultos con neuropatía motora multifocal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
    Ensayo clínico para investigar a largo plazo la seguridad, tolerabilidad, eficacia, farmacodinámica, farmacocinética y la inmunogenicidad de ARGX-117 en adultos con neuropatía motora multifocal
    A.3.2Name or abbreviated title of the trial where available
    ARDA+
    ARDA+
    A.4.1Sponsor's protocol code numberARGX-117-2003
    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 supportargenx BV
    B.4.2CountryBelgium
    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 pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde (Ghent)
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameARGX-117 IV
    D.3.2Product code ARGX-117 IV
    D.3.4Pharmaceutical form Concentrate 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 INNnot defined
    D.3.9.3Other descriptive nameARGX-117
    D.3.9.4EV Substance CodeSUB206651
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 2
    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 nameARGX-117 IV
    D.3.2Product code ARGX-117 IV
    D.3.4Pharmaceutical form Concentrate 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 INNnot defined
    D.3.9.3Other descriptive nameARGX-117
    D.3.9.4EV Substance CodeSUB206651
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number165
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboConcentrate for solution 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
    Multifocal Motor Neuropathy
    Neuropatía motora multifocal
    E.1.1.1Medical condition in easily understood language
    Multifocal Motor Neuropathy
    Neuropatía motora multifocal
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10065579
    E.1.2Term Multifocal motor neuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of ARGX-117 in adult participants with MMN
    Evaluar la seguridad y la tolerabilidad a largo plazo de ARGX-117 en adultos con neuropatía motora multifocal
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term efficacy of ARGX-117 on muscle strength and/or motor function in adult participants with MMN
    • To evaluate the long-term efficacy of ARGX-117 on functional ability, arm and hand function, quality of life (QOL), and fatigue in adult participants with MMN
    • To evaluate the long-term effect of ARGX-117 on health-related productivity and work productivity
    • To assess the PK, PD, and immunogenicity of ARGX-117
    •Evaluar la eficacia a largo plazo de ARGX-117 sobre la fuerza muscular y/o la función motora en participantes adultos con NMM
    •Evaluar la eficacia a largo plazo de ARGX-117 sobre la capacidad funcional, la función de los brazos y las manos, la calidad de vida (Cdv) y la fatiga en participantes adultos con NMM.
    •Evaluar el efecto a largo plazo de ARGX 117 sobre la productividad relacionada con la salud y la productividad laboral
    •Evaluar la FC, la FD y la inmunogenicidad de ARGX-117.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the trial only if all of the following criteria apply:
    1. Capable of providing signed informed consent, and complying with protocol requirements. Participants must be able to read and write.
    2. Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117
    3. Agrees to use contraceptive measures consistent with local regulations and the following:
    a. Male participants: must use an acceptable contraceptive method that should be maintained at minimum until 12 months after last dose of Investigational Medicinal Product (IMP).
    b. Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before IMP can be administered.
    Solo podrán ser incluidos en el ensayo los participantes que cumplan todos los criterios siguientes:
    1. Capacidad para otorgar el consentimiento informado firmado, y cumplimiento de los requisitos del protocolo. Los participantes deben ser capaces de leer y escribir.
    2. Deben haber completado el período de tratamiento doble ciego del ensayo ARGX 117 2002 y ser considerados elegibles para el tratamiento con ARGX-117
    3. Se comprometa a utilizar métodos anticonceptivos compatibles con la normativa local y lo siguiente:
    a.Participantes Varones: deberán usar un métoco anticonceptivo adecuado durante al menos 12 meses tras la última dosis den producto en investigación (PEI).
    b. Participantes mujeres con capacidad reproductiva deberán tener una prueba de embarazo en orina negativa en el momento basal antes de que pueda administrarse el PEI.
    E.4Principal exclusion criteria
    Participants will be excluded from the trial if any of the following criteria apply:
    1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection
    2. Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
    a. Germany only: A SARS-CoV-2 rapid antigen test must be completed or a negative rapid antigen test not older than 48 hours (depending on local requirements) must be presented upon site entry during DV1 while COVID-19 is considered an epidemic. Rapid antigen testing will only be mandatory while required by local regulations.
    3. Currently participating in another interventional clinical study
    4. Pregnant or lactating or intend to become pregnant during the trial or within 12 months after last dose of the IMP.
    Se excluirá del ensayo a los participantes que cumplan alguno de los criterios siguientes:
    1.Infección bacteriana, vírica o micótica activa o crónica, clínicamente significativa y no controlada.
    2.Evidencia clínica de otras enfermedades graves significativas, haberse sometido recientemente a una intervención de cirugía mayor, o presencia de cualquier otro proceso que, en opinión del investigador, podría confundir los resultados del ensayo o suponer un riesgo excesivo para el participante.
    a.Solo en Alemania: deberá realizarse una prueba rápida de detección de antígenos del SARS-CoV-2 o presentarse una prueba rápida de detección de antígenos negativa no superior a 48 horas (dependiendo de los requisitos locales) a la entrada en el centro durante la VD1 mientras que la COVID-19 se considere una epidemia. El análisis rápido de antígenos solo será obligatorio cuando así lo exija la normativa local.
    3.Participación en curso en otro estudio clínico de intervención.
    4.Embarazo, lactancia o intención de quedarse embarazada durante el ensayo o en los 12 meses siguientes a la última dosis del PEI
    E.5 End points
    E.5.1Primary end point(s)
    • Safety outcomes based on AE monitoring and other safety assessments
    •Variables de seguridad basadas en la vigilancia de acontecimientos adversos (AA) y otras evaluaciones de la seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuously
    De manera continuada
    E.5.2Secondary end point(s)
    • Modified Medical Research Council (mMRC)
    1.Value and change from baseline in the mMRC-10 sum score
    2.Proportion of participants showing a deterioration of at least 2 points in mMRC-10 sum score
    3.Value and change from baseline in the mMRC-14 sum score
    4.Proportion of participants showing a deterioration of at least 2 points in the mMRC-14 sum score
    5.Proportion of participants showing a deterioration of 1 or more points in at least 2 muscle groups as assessed by the mMRC-14 sum score
    6.Proportion of participants with no deterioration in 2 or more muscle groups as assessed by mMRC-14 sum score
    7.Value and change from baseline in the 2 most important muscle groups as assessed by the mMRC-14 sum score

    • Grip strength (GS)
    8.Values, change, and percent change from baseline in GS
    9.Proportion of participants with a decline of >30% in GS
    10. Proportion of participants with a GS decrease of 8 kilopascals (kPa) or more

    11.Values and change from baseline in the Rasch-built overall disability scale for MMN (MMN‐RODS)
    12.Values and change from baseline in the average time for the upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed pegboard test)
    13.Proportion of participants by level of severity on each dimension of EQ-5D-5L
    14.Value and change from baseline in EQ-5D-5L visual analog scale (VAS)
    15.Values and change from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI)
    16.Values and change from baseline in the 9-item Fatigue Severity Scale (FSS)
    17.Proportion of participants by level of change as assessed by the Patient Global Impression of Change (PGIC)
    18.Proportion of participants by level of severity of MMN as assessed by the Patient Global Impression of Severity (PGIS)
    19.Values for work-related and household chore activities of the Health-Related Productivity Questionnaire (HRPQ)
    20.Serum concentrations and PK parameters for ARGX-117
    21.Values and change from baseline in free C2, total C2, and functional complement activity (CH50) over time
    22.Incidence and prevalence of antidrug antibodies (ADA) against ARGX-117
    •Escala del Medical Research Council modificada (mMRC)
    1.Valor y variación con respecto al momento basal de la puntuación acumulada de la escala mMRC 10.
    2.Proporción de participantes que presenten un deterioro de al menos 2 puntos en la puntuación acumulada de la escala mMRC 10.
    3.Valor y variación con respecto al momento basal de la puntuación acumulada de la escala mMRC 14.
    4.Proporción de participantes que presenten un deterioro de al menos 2 puntos en la puntuación acumulada de la escala mMRC-14.
    5.Proporción de participantes que presenten un deterioro de 1 o más puntos en al menos 2 grupos musculares, evaluados mediante la puntuación acumulada de la escala mMRC-14.
    6.Proporción de participantes sin deterioro en 2 o más grupos musculares, evaluados mediante la puntuación acumulada de la escala mMRC 14.
    7.Valor y variación con respecto al momento basal en los 2 grupos musculares más importantes, evaluados mediante la puntuación acumulada de la escala mMRC-14.

    •Fuerza de prensión (FP)
    8.Valores, variación y variación porcentual de la FP con respecto al valor basal.
    9.Proporción de participantes con una disminución >30% de la FP
    10.Proporción de participantes con una disminución de la FP de 8 kilopascales (kPa) o más

    11.Valores y variación con respecto al momento basal de la escala de discapacidad global basada en el modelo de Rasch para la NMM (MMN‐RODS).
    12.Valores y variación con respecto al momento basal del tiempo medio para la función de las extremidades superiores (brazo y mano) (prueba del tablero con 9 orificios [9-HPT] o prueba del tablero cronometrada).
    13.Proporción de participantes por nivel de intensidad en cada dimensión del EQ-5D-5L.
    14.Valor y variación con respecto al momento basal de la escala visual analógica (EVA) del cuestionario EQ-5D-5L.
    15.Valores y variación con respecto al valor basal del Índice de polineuropatía adquirida crónica comunicado por el paciente (CAP-PRI, Chronic acquired polyneuropathy patient-reported index).
    16.Valores y variación con respecto al momento basal de la Escala de intensidad de la fatiga de 9 apartados (FSS, Fatigue Severity Scale).
    17.Proporción de participantes por grado de variación, evaluado mediante la escala de Impresión global de cambio por el paciente (PGIC, Patient Global Impression of Change).
    18.Proporción de participantes por grado de intensidad de la NMM evaluada mediante la Impresión global de gravedad por el paciente (PGIS, Patient Global Impression of Severity).
    19.Valores de las actividades laborales y domésticas del Cuestionario de productividad relacionada con la salud (HRPQ, Health-Related Productivity Questionnaire) en cada visita
    20.Concentraciones séricas y parámetros FC de ARGX 117
    21.Valores y variación con respecto al momento basal de C2 libre, C2 total y actividad funcional del complemento (CH50).
    22.Incidencia y prevalencia de anticuerpos contra el fármaco (ACF) dirigidos contra ARGX 117
    E.5.2.1Timepoint(s) of evaluation of this end point
    - For Endpoints 1 to 12, 18, 20, 21: On day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117 or treatment discontinuation
    - For Endpoints 13 to 16, 19 : On day 1 and 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117 or treatment discontinuation
    - For Endpoint 17: On day 15 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of ARGX-117 or treatment discontinuation
    - For Endpoint 22: On day 1, 15, 29, 113 followed by every 8 weeks until market authorization of ARGX-117 or treatment discontinuation
    - Para los criterios nº 1 a 12, 18, 20, 21: días 1, 8, 15 y 22 seguidos de cada 4 semanas durante 12 semanas, y después cada 8 semanas hasta la autorización de comercialización de ARGX-117 o la suspensión del tratamiento.
    - Para los criterios 13 a 16, 19: días 1 y 15, seguidos de cada 4 semanas durante 12 semanas, y después cada 8 semanas hasta la autorización de comercialización de ARGX-117 o la suspensión del tratamiento
    -Para el criterio 17: el día 15 seguido de cada 4 semanas durante 12 semanas y después cada 8 semanas hasta la autorización de comercialización de ARGX-117 o la suspensión del tratamiento
    - Para el criterio 22: días 1, 15, 29, y 113, seguidos de cada 8 semanas hasta la autorización de comercialización de ARGX-117 o la suspensión del tratamiento
    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
    tolerability, immunogenicity
    tolerabilidad, inmunogenicidad
    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 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
    Double - blinded rollover treatment (DTP) followed by Open - label treatment period (OTP)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 No
    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
    United States
    Austria
    France
    Poland
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    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
    The end of trial is defined as the date of the last participant’s last visit.
    El fin del ensayo se define como la última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 29
    F.4.2.2In the whole clinical trial 48
    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)
    The trial will continue until marketing authorisation of ARGX-117 or until the trial is discontinued by the sponsor.
    El ensayo continuará hasta que haya una autorización de comercialización de ARGX-117 o hasta que se interrumpa por parte del promotor
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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