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    Summary
    EudraCT Number:2019-001829-26
    Sponsor's Protocol Code Number:ECU-NMO-303
    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:2019-11-06
    Trial results View 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 number2019-001829-26
    A.3Full title of the trial
    A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder
    Ensayo en fase II/III abierto, de un solo grupo para evaluar la seguridad y la actividad de eculizumab en pacientes pediátricos con trastorno del espectro de la neuromielitis óptica recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric
    Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Ensayo para evaluar la seguridad y actividad de eculizumab en pacientes pediátricos con trastorno del espectro de la neuromielitis óptica recidivante
    A.4.1Sponsor's protocol code numberECU-NMO-303
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/252/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlexion Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 supportAlexion Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Pharma Spain
    B.5.2Functional name of contact pointRosa Enrique
    B.5.3 Address:
    B.5.3.1Street AddressPº de Gracia,85
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932723019
    B.5.5Fax number+33147100611
    B.5.6E-mailclinicaltrials.eu@alexion.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 Yes
    D.2.1.1.1Trade name Soliris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1185
    D.3 Description of the IMP
    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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.3Other descriptive nameh5G1.1-mAb
    D.3.9.4EV Substance CodeSUB25187
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Trastorno del espectro de la neuromielitis óptica (TENMO)
    E.1.1.1Medical condition in easily understood language
    Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Trastorno del espectro de la neuromielitis óptica (TENMO)
    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 LLT
    E.1.2Classification code 10077879
    E.1.2Term Neuromyelitis optica spectrum disorder relapse
    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
    • Evaluate the efficacy of eculizumab in relapsing pediatric patients with
    Neuromyelitis Optica Spectrum Disorder (NMOSD) in the Primary Treatment Period.
    •Evaluar la eficacia de eculizumab en pacientes pediátricos con trastorno del espectro de la neuromielitis óptica (TENMO) recidivante en el período de tratamiento principal.
    E.2.2Secondary objectives of the trial
    Primary Treatment Period:
    • Evaluate the safety and tolerability of eculizumab treatment in relapsing pediatric patients with NMOSD.
    • Evaluate the efficacy of eculizumab by additional efficacy measures including: disease-related disability, quality of life and change in ophthalmologic examination findings.
    • Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in relapsing pediatric patients with NMOSD.
    Extension Treatment Period:
    • Characterize long-term safety of eculizumab treatment in pediatric patients with NMOSD.
    • Characterize long-term efficacy of eculizumab treatment in pediatric patients with NMOSD.
    Período de tratamiento principal:
    •Evaluar la seguridad y la tolerabilidad del tratamiento con eculizumab en pacientes pediátricos con TENMO recidivante.
    •Evaluar la eficacia de eculizumab mediante medidas de la eficacia adicionales como: Discapacidad relacionada con la enfermedad, Calidad de vida y Cambio en los resultados de las exploraciones oftalmológicas.
    •Describir la farmacocinética (FC) y la farmacodinámica (FD) de eculizumab en pacientes pediátricos con TENMO recidivante.
    Período de tratamiento de extension:
    •Caracterizar la seguridad a largo plazo del tratamiento con eculizumab en pacientes pediátricos con TENMO.
    •Caracterizar la eficacia a largo plazo del tratamiento con eculizumab en pacientes pediátricos con TENMO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients aged 2 years to < 18 years at time of assent/consent.
    • Anti-AQP4 Ab-positive and diagnosis of NMOSD as defined by the 2015 IPND criteria
    • Historical Relapse Rate of at least 2 relapses in the last 2 years, and with at least 1 relapse in the year prior to Screening.
    • Expanded Disability Status Scale score ≤ 7
    • Patients who enter the study receiving supportive immunosuppressive therapies for the prevention of relapse, either in combination or monotherapy, must be on a stable dosing regimen of adequate duration prior to Screening.
    • Vaccinated against N meningitidis within 3 years prior to, or at the time of initiating eculizumab. Patients who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics until 2 weeks after the vaccination.
    • Documented vaccination against Hib and S pneumoniae infections 2 weeks prior to dosing as per local and country-specific immunization guidelines for the appropriate age group.
    • Willing and capable to give informed assent (if applicable, as determined by the central Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) and in accordance with local requirements) and whose parent/legal guardian are willing and able to give written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
    • Pacientes de ambos sexos de 2 años a < 18 años en el momento del asentimiento/consentimiento.
    • Positivo para anticuerpos anti-AQP4 y diagnóstico de TENMO según la definición de los criterios de IPND de 2015
    • Tasa de recidivas histórica de al menos 2 recidivas en los 2 años anteriores y con al menos 1 recidiva en el año previo a la selección.
    • Puntuación de la escala del estado de discapacidad ampliada ≤ 7
    • Pacientes que entren en el estudio y reciban TIS complementario (p. ej., corticoesteroide, azatioprina [AZA], micofenolato mofetilo [MMF], metotrexato [MTX], tacrolimús [TAC], ciclosporina [CsA] o ciclofosfamida [CYC]) para la prevención de recidivas, en combinación o en monoterapia, deben recibir una pauta posológica estable durante un período suficiente previo a la selección.
    • Vacunados frente a N meningitidis en los 3 años previos o en el momento de inicio de eculizumab. Los pacientes que inicien tratamiento con el fármaco del estudio menos de 2 semanas antes de recibir una vacuna antimeningocócica, deben recibir la antibioterapia profiláctica apropiada hasta 2 semanas después de la vacunación.
    • Vacunación documentada frente a infecciones causadas por Hib y S pneumoniae al menos 2 semanas antes de la administración de la dosis, según las directrices de inmunización locales y específicas del país para el grupo de edad correspondiente.
    • Voluntad y capacidad para proporcionar un asentimiento informado (si procede, según los Comités de Revisión Institucional (CRI)/Comités de Ética Independientes (CEI) centrales y de conformidad con los requisitos locales), y cuyos padres/tutores estén dispuestos y sean capaces de dar su consentimiento informado, tal como se describe en la Sección 10.1.2; Apéndice 1, que incluye el cumplimiento con los requisitos y las restricciones enumerados en el formulario de consentimiento informado (FCI) y en este protocolo.
    E.4Principal exclusion criteria
    • Patients known to be human immunodeficiency virus (HIV) positive or with congenital immunodeficiency.
    • Unresolved meningococcal or other serious infection.
    • Any unresolved acute or chronic systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics.
    • Hypersensitivity to murine proteins or to one of the excipients of eculizumab.
    • Use of rituximab or other biologicals such as tocilizumab within 6 months prior to Screening.
    • Use of mitoxantrone within 3 months prior to Screening.
    • Use of intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 3 weeks prior to Screening.
    • Use of immunomodulatory therapies for multiple sclerosis within 3 months prior to Screening.
    • Pacientes positivos para el virus de la inmunodeficiencia humana (VIH) o con inmunodeficiencia congénita conocida.
    • Infección meningocócica u otra infección grave no resueltas.
    • Cualquier infección bacteriana sistémica crónica o aguda o de otro tipo no resueltas que sea clínicamente significativa, según criterio del investigador, y que no haya recibido tratamiento con los antibióticos adecuados.
    • Hipersensibilidad a proteínas murinas o a alguno de los excipientes de eculizumab.•
    • Uso de rituximab u otro producto biológico como tocilizumab en los 6 meses previos a la selección.
    • Uso de mitoxantrona en los 3 meses previos a la selección.
    • Uso de inmunoglobulina intravenosa (Ig i.v.) o plasmaféresis (PF) en las 3 semanas previas a la selección.
    • Uso de tratamientos inmunomoduladores para la EM en los 3 meses previos a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from Baseline in the Annualized Relapse Rate (ARR).
    • Time to First Relapse (TFR).
    •Cambio respecto al inicio en la tasa de recidivas anualizada/(TRA) a las 52/53 semanas
    •Tiempo hasta la primera recidiva (TPR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Treatment Period:
    52/53* Weeks
    * For patients who start in weight cohort 10 to <20 kg, the one-year evaluation will occur on Week 53, an odd-numbered week, because maintenance dosing, which is administered every 2 weeks, begins on Week 1. For all other cohorts the one-year evaluation will occur on Week 52, because maintenance dosing begins on an even-numbered week. Hence, the end of the Primary Treatment Period is designated as Week 52/53 throughout the study protocol.
    Período de tratamiento principal:
    52/53 semanas*
    *Para pacientes que empiecen en la cohorte de peso de 10 a < 20 kg, la evaluación al cabo de un año se realizará en la semana 53, una semana impar, puesto que la dosis de mantenimiento, que se administra cada 2 semanas, comienza en la semana 1. Para todas las demás cohortes, la evaluación al cabo de un año se realizará en la semana 52 porque la dosis de mantenimiento comienza en una semana par. Por tanto, el final del período de tratamiento principal se denomina como semana 52/53 a lo largo de todo el protocolo.
    E.5.2Secondary end point(s)
    Primary Treatment Period:

    Safety:
    • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to study drug discontinuation.
    • Incidence of antidrug antibodies (ADA).
    • Changes from Baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory assessments.
    • Change from Baseline in both weight and height.

    Efficacy:
    Disease-related disability:
    • Change from Baseline in Expanded Disability Status Scale (EDSS) score in patients ≥5 years of age.
    • Change from Baseline in the Hauser Ambulatory Index (HAI) score.
    Quality of life:
    • Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) in patients ≥5 years of age.
    • Change from Baseline in Pediatric Quality of Life Inventory Parent Proxy (PedsQL Parent Proxy) in patients < 5 years of age.
    Change in ophthalmologic examination findings:
    • Change from Baseline in Visual Acuity (VA) as measured by the Snellen or LEA symbols Eye Chart examination in all patients.
    • Change from Baseline in Confrontational Visual Fields (VF) as measured during ophthalmologic examination in all patients.
    • Change from Baseline in color vision as measured during ophthalmologic examination in all patients.

    PK/PD:
    • Changes in serum eculizumab concentration over time.
    • Changes in serum free complement protein 5 (C5) concentrations and in vitro hemolytic activity over time.

    Extension Treatment Period:
    The safety and efficacy endpoints of the Primary Treatment Period will be evaluated during the Extension Treatment Period.
    Período de tratamiento principal:
    Seguridad:
    •Incidencia de acontecimientos adversos surgidos durante el tratamiento (AADT), acontecimientos adversos graves (AAG) y acontecimientos adversos que provocaron la suspensión del fármaco del estudio.
    •Incidencia de anticuerpos antifármaco (AAF).
    •Cambios con respecto al inicio en las constantes vitales, los parámetros electrocardiográficos (ECG) y las analíticas clínicas.
    •Cambio respecto al inicio tanto en el peso como en la estatura

    Eficacia:
    -Discapacidad relacionada con la enfermedad:
    •Cambio respecto al inicio en la puntuación de la escala del estado de discapacidad ampliada (Expanded Disability Status Scale, EDSS) a las 52/53 semanas en pacientes ≥5 años.
    •Cambio respecto al inicio en el índice de deambulación de Hauser (Hauser Ambulatory Index, HAI) a las 52/53 semanas.
    -Calidad de vida:
    •Cambio respecto al inicio en el inventario de calidad de vida pediátrica (PedsQL) a las 52/53 semanas en pacientes ≥5 años.
    •Cambio respecto al inicio en el indicador indirecto para los padres del inventario de calidad de vida pediátrico (PedsQL para padres como representantes) a las 52/53 semanas en pacientes < 5 años.
    -Cambio en los resultados de las exploraciones oftalmológicas:
    •Cambio respecto al inicio en la agudeza visual (AV) determinada mediante las tablas optométricas de Snellen o los símbolos de LEA a las 52/53 semanas en todos los pacientes.
    •Cambio respecto al inicio en los campos visuales (CV) confrontacionales determinados durante la exploración oftalmológica a las 52/53 semanas en todos los pacientes.
    •Cambio respecto al inicio en la visión en color determinada durante la exploración oftalmológica a las 52/53 semanas en todos los pacientes.

    FC/FD:
    •Cambios en la concentración sérica de eculizumab a lo largo del tiempo.
    •Cambios en las concentraciones séricas de proteína del complemento 5 (C5) libre y en la actividad hemolítica in vitro a lo largo del tiempo.

    Período de tratamiento de extension:
    Los criterios de valoración de la eficacia y la seguridad del período de tratamiento principal se evaluarán durante el período de tratamiento de extensión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary Treatment Period:
    At 52/53* weeks
    * For patients who start in weight cohort 10 to <20 kg, the one-year evaluation will occur on Week 53, an odd-numbered week, because maintenance dosing, which is administered every 2 weeks, begins on Week 1. For all other cohorts the one-year evaluation will occur on Week 52, because maintenance dosing begins on an even-numbered week. Hence, the end of the Primary Treatment Period is designated as Week 52/53 throughout the study protocol.

    Extension Treatment Period:
    104 weeks
    Período de tratamiento principal:
    52/53 semanas*
    *Para pacientes que empiecen en la cohorte de peso de 10 a < 20 kg, la evaluación al cabo de un año se realizará en la semana 53, una semana impar, puesto que la dosis de mantenimiento, que se administra cada 2 semanas, comienza en la semana 1. Para todas las demás cohortes, la evaluación al cabo de un año se realizará en la semana 52 porque la dosis de mantenimiento comienza en una semana par. Por tanto, el final del período de tratamiento principal se denomina como semana 52/53 a lo largo de todo el protocolo.

    Período de tratamiento de extension:
    104 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Germany
    Italy
    Japan
    Korea, Republic of
    Spain
    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
    Ultima visita del ultimo paciente
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 15
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 15
    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)
    None
    No
    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 Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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