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   43857   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:2020-004436-21
    Sponsor's Protocol Code Number:WN42636
    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:2021-09-02
    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 number2020-004436-21
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS
    ESTUDIO MULTICENTRO DE FASE III, ALEATORIZADO, DOBLE CIEGO, CONTROLADO POR PLACEBO, PARA EVALUAR LA EFICACIA, LA SEGURIDAD, LA FARMACOCINÉTICA Y LA FARMACODINÁMICA DE SATRALIZUMAB EN PACIENTES CON MIASTENIA GRAVIS GENERALIZADA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis
    Estudio para Evaluar la Eficacia, Seguridad, Farmacocinética y Farmacodinamia de Satralizumab en Pacientes con Miastenia Gravis Generalizada
    A.4.1Sponsor's protocol code numberWN42636
    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 SponsorRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@roche.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 nameSatralizumab
    D.3.2Product code RO5333787
    D.3.4Pharmaceutical form 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 INNSATRALIZUMAB
    D.3.9.2Current sponsor codeRO5333787
    D.3.9.4EV Substance CodeSUB195082
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    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 Grave Generalizada (MGg)
    E.1.1.1Medical condition in easily understood language
    Myasthenia gravis is a rare neuromuscular disorder that causes weakness in the skeletal muscles. Myasthenia gravis affecting multiple muscle groups throughout the body is called gMG.
    La miastenia gravis es trastorno raro neuromuscular que provoca debilidad en los músculos esqueléticos. La miastenia gravis que afecta a múltiples grupos musculares de todo el cuerpo se denomina MGg.
    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 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of satralizumab versus placebo on function in daily life in the acetylcholine receptor antibody seropositive (AChR+) population
    •Evaluar la eficacia de satralizumab en comparación con un placebo sobre la funcionalidad en la vida diaria en la población positiva para AChR.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of satralizumab versus placebo on function in daily life in the overall population (OP)
    • To evaluate the efficacy of satralizumab versus placebo in the AChR+ and OP on QMG, QoL, Fatigue, Clinical status and Disease severity
    • To evaluate the durability of the efficacy of satralizumab versus placebo in the AChR+ population and the OP
    • To evaluate the safety of satralizumab versus placebo
    • To confirm target engagement and pathway inhibition in response to satralizumab
    • To investigate the pharmacokinetics (PK) of satralizumab
    • To evaluate the immune response to satralizumab
    - Evaluar la eficacia de satralizumab en comparación con placebo en la funcionalidad en la vida diaria en la población total (PT).
    - Evaluar la eficacia de satralizumab en comparación con placebo en la población AChR y en la PT en: QMG, QoL, cansancio, estado clínico y gravedad de la enfermedad
    - Evaluar la durabilidad de la eficacia de satralizumab en comparación con el placebo en la población AChR y en la PT
    - Evaluar la seguridad de satralizumab en comparación con placebo
    - Confirmar la actuación sobre la diana y la inhibición de la vía en respuesta a satralizumab
    - Investigar la farmacocinética de satralizumab
    - Evaluar la respuesta inmunitaria a satralizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=12 years at time of signing Informed Consent Form
    • Confirmed diagnosis of gMG
    • MGFA class II, III or IV at screening
    • A total MG-ADL score of >=5 points at screening with more than 50% of this score attributed to non-ocular items
    • Ongoing gMG treatment at a stable dose
    • For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
    - Edad 12 años en el momento de firmar el documento de consentimiento informado.
    - Diagnóstico confirmado de MGg
    - MGFA clases II, III o IV en la selección
    - Puntuación total de las actividades cotidianas en la miastenia grave (MG ADL) >= 5 puntos en la selección con más del 50 % de esta puntuación atribuidos a apartados no oculares
    - Tratamiento activo para la MGg en una dosis estable
    - Para mujeres en edad fértil: compromiso de practicar la abstinencia (abstenerse de mantener relaciones heterosexuales) o de utilizar métodos anticonceptivos adecuados durante el período de tratamiento y hasta al menos 3 meses después de la última dosis de satralizumab
    E.4Principal exclusion criteria
    Exclusion Criteria Related to Myasthenia Gravis (MG):
    • History of thymic cysts, thymoma, thymic carcinoma or other neoplasm of the thymus as defined by the 2015 WHO classification of tumors of the thymus unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
    • History of thymectomy within 12 months prior to screening
    • Ocular MG (Myasthenia Gravis Foundation of America [MGFA] Class I)
    • Myasthenic crisis within the last 3 months prior to screening (MGFA Class V)
    • Known disease other than gMG that would interfere with the course and conduct of the study

    Exclusion Criteria Related to Previous or Concomitant Therapy:
    • Use of IVIg within 8 weeks prior to randomization (Day 1)
    • Use of PE within 8 weeks prior to randomization (Day 1)
    • Treatment with IL-6 inhibitory therapy (e.g., tocilizumab) at any time,
    • Treatment with total body irradiation, or bone marrow transplantation at any time
    • Treatment with B and/or T cell-depleting agents
    • For patients with prior exposure to anti-CD20 agents, CD19 counts below the normal range, as assessed by the central laboratory at screening, or <6 months since last anti-CD20 treatment till screening
    • Treatment with eculizumab within 6 months prior to screening
    • Treatment with neonatal Fc receptor antagonists, or anti-B-lymphocyte stimulator monoclonal antibody at any time
    • Treatment with cyclophosphamide IV within 6 months prior to screening
    • Treatment with oral cyclophosphamide at any time
    • Treatment with methotrexate within 8 weeks prior to screening
    • Treatment with any investigational agent within 24 weeks prior to screening or 5 drug-elimination half-lives of the investigational drug (whichever is longer)
    • Use of more than one IST as background therapy except for the combination of an oral corticosteroids (OCS) with another permitted IST drug

    General Safety Exclusion Criteria:
    • Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
    • Planned surgical procedure (except minor surgeries) during the study
    • Evidence of progressive multifocal leukoencephalopathy
    • Evidence of serious uncontrolled concomitant diseases that may preclude patient participation
    • Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
    • Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds or dental caries
    • Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit or oral anti-infective agents within 2 weeks prior to baseline visit
    • Positive screening tests for hepatitis B and C
    • History of drug or alcohol abuse within 1 year prior to baseline
    • History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator’s opinion, may lead to increased risk of complications such as GI perforation
    • Evidence of latent or active tuberculosis
    • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
    • History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening and Day 1
    • History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma
    • History of severe allergic reaction to a biologic agent
    • Active suicidal ideation within 6 months prior to screening or history of suicide attempt within 3 years prior to screening
    • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab

    Laboratory Exclusion Criteria (at Screening):
    • White blood cells (WBC) <3.0*10^3/microliter
    • Absolute neutrophil count (ANC) <2.0*10^3/microliter
    • Absolute lymphocyte count <0.5*10^3/microliter
    • Platelet count <10*10^4/microliter
    • Aspartate aminotransferase (AST) or alanine transaminase (ALT) >1.5*upper limit of normal (ULN)
    • Thyroid stimulating hormone (TSH) level <0.9*lower limit of normal or >1.1*ULN and symptoms associated with hyperthyroidism or hypothyroidism
    Criterios de exclusión relacionados con la miastenia grave:
    - Antecedentes de quistes tímicos, timoma, carcinoma tímico u otra neoplasia del timo según la clasificación de la OMS de 2015 de tumores del timo, a menos que se consideren curados con un tratamiento adecuado sin signos de recidiva durante >=5 años antes de la selección
    - Antecedentes de timectomía en los 12 meses previos a la selección.
    - MG ocular (clase I de la MGFA).
    - Crisis miasténica en los 3 meses previos a la selección (clase V de la MGFA).
    - Enfermedad conocida distinta de la MGg que pudiera interferir en el curso
    Criterios de exclusión relacionados con un tratamiento previo o concomitante
    - Uso de IgIV en las 8 semanas previas a la aleatorización (día 1).
    - Uso de plasmaféresis en las 8 semanas previas a la aleatorización (día 1).
    - Tratamiento inhibidor de la interleucina 6 (IL 6) (p. ej., tocilizumab) en cualquier momento.
    - Tratamiento con irradiación corporal total o trasplante de médula ósea en cualquier momento.
    - Tratamiento con fármacos reductores de los linfocitos B y/o T
    - En los pacientes con exposición previa a fármacos anti-CD20, recuentos de CD19 por debajo del intervalo normal, evaluados por el laboratorio central en la selección o 6 meses desde el último tratamiento anti-CD20 hasta la selección.
    - Tratamiento con eculizumab en los 6 meses previos a la selección.
    - Tratamiento con antagonistas del receptor Fc neonatal o anticuerpo monoclonal estimulante anti linfocitos B en cualquier momento.
    - Tratamiento con ciclofosfamida IV en los 6 meses previos a la selección.
    - Tratamiento con metotrexato en las 8 semanas previas a la selección
    - Tratamiento con cualquier fármaco en investigación en las 24 semanas previas a la selección o el tiempo equivalente a 5 semividas de eliminación del fármaco en investigación, lo que suponga más tiempo.
    - Uso de más de un IMD como tratamiento de base, excepto la combinación de un CO con otro IMD
    Criterios de exclusión generales relacionados con la seguridad
    - Cualquier intervención quirúrgica (excepto intervenciones de cirugía menor) en las 4 semanas previas al momento basal.
    - Intervención quirúrgica programada (excepto intervenciones de cirugía menor) durante el estudio.
    - Signos de leucoencefalopatía multifocal progresiva.
    - Signos de enfermedades concomitantes graves no controladas que puedan impedir la participación del paciente
    - Inmunodeficiencia congénita o adquirida, incluida la infección por el virus de la inmunodeficiencia humana.
    - Presencia activa o presencia recurrente de infecciones bacterianas, víricas, micóticas, micobacterianas o de otro tipo, excluida la micosis de los lechos ungueales o las caries dentales.
    - Infección con necesidad de hospitalización o tratamiento con antiinfecciosos IV en las 4 semanas previas a la visita basal o con antiinfecciosos orales en las 2 semanas previas a la visita basal.
    - Pruebas positivas de cribado de hepatitis B y C
    - Antecedentes de alcoholismo o toxicomanía en el año previo al momento basal.
    - Antecedentes de diverticulitis o trastornos digestivos graves concomitantes que, en opinión del investigador, puedan aumentar el riesgo de complicaciones, como perforación digestiva.
    - Signos de tuberculosis latente o activa
    - Recepción de una vacuna de microorganismos vivos o atenuados en las 6 semanas previas al momento basal.
    - Recepción de una vacuna de microorganismos vivos o atenuados en las 6 semanas previas al momento basal.
    - Antecedentes de donación de sangre (1 unidad o más), donación de plasma o donación de plaquetas en los 90 días previos a la selección y el día 1.
    - Antecedentes de neoplasia maligna en los últimos 5 años, como tumores sólidos, neoplasias malignas hemáticas y carcinoma in situ
    - Antecedentes de reacción alérgica grave a un producto
    - Ideas suicidas activas en los 6 meses previos a la selección o antecedentes de intento de suicidio en los 3 años previos a la selección.
    - Cualquier enfermedad grave o anomalía en las pruebas analíticas que, a criterio del investigador, impida la participación segura del paciente y la realización del estudio.
    - Embarazo o lactancia, o intención de quedarse embarazada durante el estudio o en los 3 meses siguientes a la última dosis de satralizumab.
    Criterios analíticos de exclusión (en la selección):
    • Leucocitos <3,0 x 103/microl
    • RAN <2,0x 103/microl
    • Recuento absoluto de linfocitos <0,5 x 103/microl
    • Recuento de plaquetas <10 x104/microl
    • AST o ALT > 1,5 veces el límite superior de la normalidad (LSN)
    • Concentración de TSH < 0,9 veces el límite inferior de la normalidad >1,1 veces el LSN y síntomas asociados a hipertiroidismo o hipotiroidismo
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean change from baseline in total MG-ADL score (AChR+ population) Week 24
    1. Variación media de la puntuación total de la escala MG ADL (población positiva para AChR) entre el momento basal y la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From baseline to Week 24
    1. Entre el momento basal a semana 24
    E.5.2Secondary end point(s)
    1. Mean change from baseline in total MG-ADL score (OP population)
    2. Mean change from baseline in QMG score, MG-QOL 15r total score and Neuro-QoL Fatigue Subscale total score
    3. Mean change from baseline in total Myasthenia Gravis Composite (MGC) score
    4. Percentage of patients with a >=2-point reduction from baseline in total MG-ADL score
    5. Percentage of patients with a >=3-point reduction from baseline in QMG score
    6. Percentage of patients with a >=3-point reduction from baseline in total MGC score
    7. Proportion of patients who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1)
    8. Proportion of patients with at least one gMG-related exacerbation and receiving rescue therapy between baseline and Week 24
    9. Annualized rate of gMG-related exacerbations
    10. Duration (average number of consecutive months) of meaningful improvement, defined as >=2-point reduction from baseline in total MG-ADL score
    11. Absolute values of biomarkers interleukin-6 (IL-6) and soluble interleukin-6 receptor (sIL-6R)
    12. Serum concentrations of satralizumab at specified timepoints
    13. Apparent clearance (CL/F) of satralizumab at specified timepoints
    14. Volume of distribution (V/F) of satralizumab at specified timepoints
    15. Area under the concentration-time curve (AUC) of satralizumab at specified timepoints
    16. Incidence of ADAs against satralizumab during the study
    17. Prevalence of anti-drug antibodies (ADAs) against satralizumab at baseline
    18. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading
    19. Change from baseline in targeted vital signs, ECG results, physical examination findings, targeted clinical laboratory test results, and suicidality
    1. Variación media respecto al valor basal de la puntuación total de la escala MG ADL (PT)
    2. Variación media respecto al valor basal de la puntuación QMG, la puntuación total de MG QOL 15r y la puntuación total de la subescala de cansancio NeuroQoL
    3. Variación media respecto al valor basal de la puntuación total de MGC
    4. Porcentaje de pacientes con una reducción 2 puntos en la puntuación total de la escala MG ADL respecto al valor basal
    5. Porcentaje de pacientes con una reducción 3 puntos de la puntuación QMG respecto al valor basal
    6. Porcentaje de pacientes con una reducción 3 puntos de la puntuación total de MGC respecto al valor basal
    7. Proporción de pacientes que hayan alcanzado una manifestación mínima de la enfermedad (puntuación total de la escala MG ADL de 0 o 1)
    8. Proporción de pacientes con al menos una exacerbación relacionada con la MGg entre el momento basal y la semana 24
    9. Tasa anualizada de exacerbaciones relacionadas con la MGg.
    10. Duración (promedio de meses consecutivos) de la mejoría significativa, definida como una reducción 2 puntos de la puntuación total de la escala MG ADL con respecto al momento basal
    11. Valores absolutos de los biomarcadores IL 6 y sIL 6R.
    12. Concentraciones séricas de satralizumab en los momentos especificados.
    13. Aclaramiento aparente (CL/F) de satralizumab en momentos específicos
    14. Volumen de distribución /V/F) de satralizumab en momentos específicos
    15. Area bajo la curva de concentración-tiempo (AUC) de satralizumab en momentos específicos
    16. Incidencia de ACF contra satralizumab durante el estudio
    17. Prevalencia de anticuerpos anti fármaco (ACF) en el momento basal
    18. Incidencia e intensidad de los acontecimientos adversos, con determinación de la intensidad según los criterios CTCAE del NCI v5.0.
    19. Variación con respecto al momento basal de las constantes vitales de interés, los resultados del ECG, los hallazgos de la exploración física, los resultados de las pruebas analíticas de interés y las tendencias suicidas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Baseline and Week 24
    4-8. At Week 24
    9. Baseline to Week 24
    10-11. Baseline to Week 24
    12-16. At Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24
    17. Predefined timepoints
    18-19. Baseline to 24 weeks
    1-3. Momento basal y semana 24
    4-8. En la semana 24
    9. Del momento basal a la semana 24
    10-11. Del momento basal a la semana 24
    12-16. En el día 1, semanas 2, 4, 8, 12, 16, 20 y 24
    17. Momentos predefinidos
    18-19. Del momento basal a la semana 24
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Australia
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Russian Federation
    Turkey
    United States
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV, or the date at which the last data point required for statistical analysis or SFU is received from the last patient, whichever occurs later.
    LPLV, o la fecha en que se reciba el último punto de datos requerido para el análisis estadístico o SFU del último paciente, lo que ocurra más tarde.
    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 months2
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 208
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 240
    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)
    Patients can continue to receive treatment with satralizumab in the OLE period until commercial availability of satralizumab in patients with gMG, the availability of satralizumab as post-trial access in accordance with local regulation, or until the Sponsor decides to discontinue the development program.
    Los pacientes pueden seguir recibiendo el tratamiento con satralizumab en el periodo de OLE hasta la disponibilidad comercial de satralizumab en pacientes con gMG, la disponibilidad de satralizumab como acceso post ensayo de acuerdo con la regulación local, o hasta que el Promotor decida interrumpir el programa de desarrollo.
    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 Decision2021-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-12
    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-Wed Apr 24 00:26:02 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA