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    Summary
    EudraCT Number:2019-003107-35
    Sponsor's Protocol Code Number:ARGX-113-1902
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-05-28
    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 number2019-003107-35
    A.3Full title of the trial
    Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
    Extensión abierta del ensayo ARGX-113-1802 para investigar la seguridad, la tolerabilidad y la eficacia a largo plazo de efgartigimod PH20 SC en pacientes con polineuropatía desmielinizante inflamatoria crónica (PDIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)
    Estudio para evaluar la seguridad y la eficacia a largo plazo de una formulación subcutánea de efgartigimod en adultos con polineuropatía desmielinizante inflamatoria crónica (un trastorno autoinmune que afecta los nervios periféricos)
    A.3.2Name or abbreviated title of the trial where available
    ADHERE+
    ADHERE+
    A.4.1Sponsor's protocol code numberARGX-113-1902
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04280718
    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 BVBA
    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 BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BVBA
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number0034900834223
    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 nameEfgartigimod PH20 SC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEfgartigimod alfa
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.3Other descriptive nameARGX-113
    D.3.9.4EV Substance CodeSUB180001
    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 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
    Polineuropatía desmielinizante inflamatoria crónica
    E.1.1.1Medical condition in easily understood language
    Inflammation of peripheral nervous system
    Inflamación del sistema nervioso periférico.
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co-formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration)
    Evaluar la seguridad y la tolerabilidad a largo plazo de efgartigimod PH20 SC (efgartigimod formulado conjuntamente con hialuronidasa PH20 humana recombinante [rHuPH20] para administración subcutánea [SC]).
    E.2.2Secondary objectives of the trial
    - To determine the long-term efficacy
    - To evaluate the immunogenicity (anti-drug antibodies [ADA]) of efgartigimod and rHuPH20
    - To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC
    - To evaluate the pharmacodynamic (PD) effect of efgartigimod PH20 SC (ie, immunoglobulin G [IgG] levels)
    - To evaluate additional patient-reported outcomes (PROs) (including patient-reported quality of life and satisfaction with treatment)
    - To explore self-administration of the treatment
    - Determinar la eficacia a largo plazo.
    - Evaluar la inmunogenicidad (anticuerpos contra el fármaco [ACF]) de efgartigimod y rHuPH20.
    - Evaluar la farmacocinética (FC) de efgartigimod PH20 SC.
    - Evaluar el efecto farmacodinámico (FD) de efgartigimod PH20 SC (es decir, concentraciones de inmunoglobulina G [IgG]).
    - Evaluar otros resultados comunicados por los pacientes (RCP) (como la calidad de vida y la satisfacción con el tratamiento comunicadas por los pacientes).
    - Investigar la autoadministración del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.

    2. Male or female patient with one of the following options:
    - Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
    - Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
    - Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
    - Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.

    3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.

    4. Women of childbearing potential must use a highly effective method of contraception (failure rate of less than 1% per year) from baseline to 90 days after the last administration of IMP

    5. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom and his partner must use a highly effective method of contraception (failure rate of less than 1% per year) from baseline to 90 days after the last administration of IMP. Male patients practicing true sexual abstinence (when this is in line with the preferred and usual life style of the participant) can be included. Sterilized male patients who have had vasectomy with documented aspermia post-procedure can be included. In addition, male patients are not allowed to donate sperm from baseline to 90 days after the last administration of IMP.
    1. Capacidad para comprender los requisitos del ensayo y otorgar el consentimiento informado por escrito (incluido el consentimiento para el uso y la divulgación de información médica relacionada con la investigación), así como disposición y capacidad para cumplir los procedimientos del protocolo del ensayo (incluidas las visitas del ensayo exigidas).

    2. Paciente de cualquier sexo en el que se aplica una de las opciones siguientes:
    - Ha completado la visita de la semana 48 de la etapa B del ensayo ARGX-113-1802 y se le considera apto para recibir tratamiento con efgartigimod PH20 SC, ó
    - Ha presentado deterioro durante la etapa B del ensayo ARGX-113-1802 y se le considera apto para recibir tratamiento con efgartigimod PH20 SC, ó
    - Se le ha ofrecido participar en la extensión abierta debido a la finalización prematura del ensayo ARGX 113 1802 (porque se ha alcanzado un número suficiente de episodios para el análisis del criterio de valoración principal de dicho ensayo y se ha interrumpido) y se le considera apto para recibir tratamiento con efgartigimod PH20 SC, ó
    - Ha completado la visita de la semana 48 del ciclo previo de la extensión abierta y se le considera apto para continuar con efgartigimod PH20 SC.

    3. Las mujeres en edad fértil deberán tener una prueba de embarazo en orina negativa en el momento basal antes de la administración del PEI.

    4. Las mujeres en edad fértil deberán utilizar un método anticonceptivo muy eficaz (índice de fallos inferior al 1% anual) desde la selección hasta 90 días después de la última administración del PEI.

    5. Los varones no esterilizados que mantengan relaciones sexuales con una pareja en edad fértil deberán utilizar preservativo y su pareja deberá utilizar un método anticonceptivo muy eficaz (índice de fallos inferior al 1% anual) desde la selección hasta 90 días después de la última administración del PEI. Podrán participar varones que practiquen una abstinencia sexual real (cuando esté en consonancia con el modo de vida preferido y habitual del participante). Podrán participar pacientes varones esterilizados que se hayan sometido a una vasectomía con aspermia documentada después del procedimiento. Además, los varones no podrán donar semen desde la selección hasta 90 días después de la última administración del PEI.
    E.4Principal exclusion criteria
    1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.

    2. Pregnant and lactating women and those intending to become pregnant during the trial or within 90 days after last IMP administration.

    3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or any other reason which could confound the results of the trial or put the patient at undue risk.
    1. La visita de la semana 48/retirada prematura (RP) del ensayo ARGX-113-1802 o la visita de la semana 48 de la participación previa en la extensión abierta tuvo lugar más de 14 días antes del D1E de la extensión abierta o del inicio de un nuevo ciclo de tratamiento en la extensión abierta y más de 21 días después de la última dosis del PEI.

    2. Mujeres embarazadas y lactantes y mujeres que pretendan quedarse embarazadas durante el ensayo o en los 90 días siguientes a la última administración del PEI.

    3. Pacientes con signos clínicos de otra enfermedad grave importante o pacientes que se hayan sometido recientemente o tengan programada una intervención de cirugía mayor, o cualquier otro motivo que pueda confundir los resultados del ensayo o suponer un riesgo indebido para el paciente.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of TEAEs and SAEs by system organ class (SOC) and preferred term (PT).
    - Incidence of clinically significant laboratory abnormalities.
    - Incidencia de acontecimientos adversos aparecidos durante el tratamiento (AAAT) y acontecimientos adversos graves (AAG) según la categoría SOC (clase de órgano y sistema) y el término preferente.
    - Incidencia de anomalías analíticas clínicamente significativas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    TEAEs and SAEs are monitored throughout the entire study duration
    Blood sampling for laboratory analysis is taken at every study visit
    AAAT y AAG se monitorizan durante toda la duración del estudio.
    Se toman muestras de sangre para pruebas de laboratorio en cada visita del estudio.
    E.5.2Secondary end point(s)
    Efficacy;
    Change from baseline over time in the following scores and measurements:
    − Adjusted INCAT score;
    − MRC Sum score;
    − 24-item I-RODS disability scores;
    − Mean grip strength assessed by Martin vigorimeter;
    − TUG score.
    Percentage of patients without clinical deterioration over time, defined by adjusted INCAT increase ≥1 point compared to baseline.

    Immunogenicity;
    - Percentage of patients with and titers of binding antibodies (BAb) towards efgartigimod and/or rHuPH20; and the presence of neutralizing antibodies (NAb) against efgartigimod and titers of NAb against rHuPH20.

    Pharmacokinetics;
    - Efgartigimod serum concentrations over time during the trial.

    Pharmacodynamics;
    - Changes from baseline over time of serum IgG levels (total and IgG subtypes)

    Additional Patient-reported Outcome;
    Change from baseline over time in:
    − Health-related quality-of-life questionnaire (EQ-5D-5L);
    − Brief Pain Inventory – Short Form (BPI-SF);
    − 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9);
    − Rasch-transformed-Fatigue Severity Scale (RT-FSS);
    − Hospital Anxiety and Depression Scale (HADS).
    Eficacia:
    •Variación con respecto al momento basal a lo largo del tiempo de las siguientes puntuaciones y determinaciones:
    - Puntuación INCAT ajustada.
    - Puntuación de Suma del Medical Research Council (MRC).
    - Puntuaciones de discapacidad en la escala I-RODS (Escala de discapacidad global de Rasch-origen inflamatorio) de 24 apartados.
    - Fuerza media de prensión evaluada con un vigorímetro de Martin.
    - Puntuación en la prueba TUG (Prueba cronometrada de levantarse y caminar).

    • Porcentaje de pacientes sin deterioro clínico a lo largo del tiempo, definido por un deterioro de la puntuación INCAT ajustada ≥ 1 punto en comparación con el D1E de la extensión abierta.

    Inmunogenicidad:
    • Porcentaje de pacientes con títulos de anticuerpos fijadores (AcF) contra efgartigimod o rHuPH20, así como presencia de anticuerpos neutralizantes (AcN) contra efgartigimod y títulos de AcN contra rHuPH20.

    Farmacocinética:
    • Concentraciones séricas de efgartigimod a lo largo del tiempo durante el ensayo.

    Farmacodinámica:
    • Variaciones con respecto al momento basal a lo largo del tiempo de las concentraciones séricas de IgG (total y subtipos de IgG).

    Resultados adicionales informados por el paciente:
    •Variación con respecto al momento basal a lo largo del tiempo de:
    - Cuestionario EQ-5D-5L (Cuestionario de calidad de vida relacionada con la salud EuroQol de 5 dimensiones y 5 niveles).
    - Cuestionario BPI SF (Inventario breve del dolor-cuestionario abreviado).
    - Cuestionario TSQM-9 (Cuestionario de satisfacción con el tratamiento referente a la medicación de 9 apartados).
    - Escala RT-FSS (Escala de intensidad del cansancio con transformación de Rasch).
    - Escala HADS (Escala de ansiedad y depresión hospitalarias).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy, immunogenicity, pharmacokinetic and pharmacodynamic endpoints are assessed at every study visit
    Patient report outcomes are assessed at every study visit with the exception of visit 2 (week 4)
    La eficacia, la inmunogenicidad, los criterios de valoración farmacocinéticos y farmacodinámicos se evalúan en cada visita de estudio.
    Los resultados informados por el paciente se evalúan en cada visita de estudio con la excepción de la visita 2 (semana 4)
    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
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    France
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Japan
    Latvia
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    UVUP
    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 months0
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 360
    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)
    After the end of the trial, patients will no longer receive IMP and will be treated as considered appropriate by the investigator
    Después del final del ensayo, los pacientes ya no recibirán IMP y serán tratados como lo considere apropiado el investigador.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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