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    Summary
    EudraCT Number:2021-006075-42
    Sponsor's Protocol Code Number:ALXN1210-NMO-317
    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:2022-02-24
    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 number2021-006075-42
    A.3Full title of the trial
    A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of Ravulizumab in Children and Adolescents With Aquaporin-4 antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Estudio de fase II/III, abierto, con grupo de referencia histórico, de un solo grupo y multicéntrico para evaluar la eficacia, la farmacocinética, la farmacodinámica y la seguridad del ravulizumab en niños y adolescentes con trastorno del espectro de la neuromielitis óptica (TENMO) con anticuerpos anti-acuaporina 4 (Ac AQP4 [+])
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study testing the efficacy and safety of Ravulizumab in pediatric patients with NMOSD
    Estudio clínico de eficacia y seguridad del ravulizumab en participantes pediátricos con TENMO
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2/3 Efficacy and Safety Study of Ravulizumab in Pediatric Patients with NMOSD
    A.4.1Sponsor's protocol code numberALXN1210-NMO-317
    A.5.4Other Identifiers
    Name:INDNumber:144187
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/474/2021
    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 Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103-105 Rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number+33147 10 06 15
    B.5.5Fax number+33147 10 06 11
    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 ULTOMIRIS®
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRavulizumab
    D.3.2Product code ALXN1210
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNRavulizumab
    D.3.9.1CAS number 1803171-55-2
    D.3.9.2Current sponsor codeALXN1210
    D.3.9.4EV Substance CodeSUB192773
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10077875
    E.1.2Term Neuromyelitis optica spectrum disorder
    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 efficacy of ravulizumab in pediatric participants with NMOSD
    Evaluar la eficacia del ravulizumab en participantes pediátricos con TENMO
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of ravulizumab on disease-related disability in pediatric participants with NMOSD
    - To evaluate the effect of ravulizumab on neurologic function in pediatric participants with NMOSD
    - To characterize the PK of treatment with ravulizumab in pediatric participants with NMOSD
    - To characterize the PD of treatment with ravulizumab in pediatric participants with NMOSD
    - To assess quality of life based on patient-reported outcomes in pediatric participants with NMOSD based on treatment with Ravulizumab
    - To evaluate safety of ravulizumab in pediatric participants with NMOSD
    - To assess immunogenicity to ravulizumab in pediatric participants with NMOSD
    - Descriptive comparison of ravulizumab data to historical data from a NMOSD observational study (NCT 03766437) to contextualize efficacy data from this study.
    - To characterize the long-term effect of ravulizumab on efficacy, safety, PK, PD, and immunogenicity
    - Evaluar el efecto del ravulizumab en la discapacidad relacionada con la enfermedad en participantes pediátricos con TENMO
    - Eval. el efecto del ravulizumab sobre la función neurológica en particip. pediátricos con TENMO
    - Caracterizar la FC del tto. con ravulizumab en particip. pediátricos con TENMO
    - Caract. la FD del tto. con ravulizumab en particip. pediátricos con TENMO
    - Eval. la calidad de vida basada en los resultados comunicados por los pacientes en particip. pediátricos con TENMO según el tto. con ravulizumab
    - Eval. la seguridad del ravulizumab en particip. pediátricos con TENMO
    - Eval. la inmunogenicidad del ravulizumab en participantes pediátricos con TENMO
    - Comparación descriptiva de los datos del ravulizumab con los datos históricos de un estudio observacional sobre el TENMO (NCT03766437) para contextualizar los datos de eficacia de este estudio
    - Caract. el efecto a largo plazo del ravulizumab sobre la eficacia, la seguridad, la FC, la FD y la inmunogenicidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be ≥ 2 to < 18 years of age at the time of signing the informed consent/assent.

    2. Participants must be anti-AQP4 Ab-positive and have a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.

    3. Complement inhibitor treatment-naïve participants must have had at least 1 attack or relapse in the last 12 months prior to the Screening Period

    4. Expanded Disability Status Scale (EDSS) score ≤ 7

    5. Eculizumab-experienced participants must be clinically stable per Investigator for 30 days and have been treated with eculizumab in Study ECU-NMO-303 for at least 90 days prior to screening with no missed doses within 2 months prior to Day 1

    6. Participants who enter the study receiving supportive IST(s) (eg, corticosteroid, azathioprine [AZA], mycophenolate mofetil [MMF], methotrexate [MTX], tacrolimus [TAC], cyclosporin [CsA], or cyclophosphamide [CYC]) for the prevention of relapse, either in combination or monotherapy, must be on a stable dosing regimen of adequate duration prior to Screening and remain on a stable dosing regimen during the Screening Period.

    7. To reduce the risk of meningococcal infection (Neisseria meningitidis), all participants must be vaccinated against meningococcal infection from serogroups A, C, W 135, and Y within 3 years prior to, or at least 14 days prior to Day 1, according to national/local guidelines. Participants who do not meet this requirement will be vaccinated against meningococcal infection according to national/local guidelines and will receive prophylactic antibiotics for at least 2 weeks after meningococcal vaccination if Day 1 occurs < 2 weeks after initial vaccination.

    8. Documented vaccination for Hib and S pneumoniae at least 14 days prior to Day 1 according to national/local guidelines for the applicable age group.

    Please see the detailed list of inclusion criteria in the protocol.
    1. El participante debe tener de ≥2 a <18 años de edad en el momento de la firma del consentimiento informado/asentimiento.

    2. Positividad para anticuerpos anti-AQP4 y tener un diagnóstico confirmado de TENMO según la definición de los criterios de diagnóstico de consenso internacional (IPND) de 2015.

    3. En el caso de los participantes que no han recibido tratamiento previo con inhibidores del complemento, deben haber tenido al menos una crisis o recidiva en los últimos 12 meses anteriores al periodo de selección.

    4. Puntuación de la Escala expandida de estado de discapacidad (EDSS).

    5. Los participantes tratados previamente con eculizumab deben estar clínicamente estables según el investigador durante 30 días y haber sido tratados con eculizumab en el estudio ECU-NMO-303 durante al menos 90 días antes de la selección, sin haber omitido ninguna dosis en los 2 meses anteriores al día 1

    6. Los participantes que se incorporen al estudio mientras están recibiendo TIS complementario (por ejemplo, corticosteroides, azatioprina [AZA], micofenolato mofetilo [MMF], metotrexato [MTX], tacrólimus [TAC], ciclosporina [CsA] o ciclofosfamida [CYC]) para la prevención de recidivas, ya sea en combinación o en monoterapia, deben estar recibiendo una pauta posológica estable de duración adecuada antes de la selección y mantener una pauta posológica estable durante el período de selección.

    7. Para reducir el riesgo de infección meningocócica (Neisseria meningitidis), todos los participantes deben haberse vacunado contra la infección meningocócica de los serogrupos A, C, W 135 e Y en los 3 años anteriores o al menos 14 días antes del día 1, según las directrices nacionales/locales. Los participantes que no cumplan este requisito serán vacunados contra la infección meningocócica de acuerdo con las directrices nacionales/locales y recibirán antibióticos profilácticos durante al menos 2 semanas después de la vacunación antimeningocócica si el día 1 es <2 semanas después de la vacunación inicial.

    8. Vacunación documentada contra Hib y S. pneumoniae al menos 14 días antes del día 1 según las directrices nacionales/locales para el grupo de edad correspondiente.

    Ver la lista detallada de criterios de inclusión en el protocolo.
    E.4Principal exclusion criteria
    1. Known to be human immunodeficiency virus (HIV) positive

    2. History of N meningitidis infection

    3. Active systemic bacterial, viral, or fungal infection within 14 days prior to Day 1.

    4. Hypersensitivity to ravulizumab, murine proteins or to one of the excipients of ravulizumab.

    5. Use of rituximab within 6 months prior to Day 1.

    6. Currently treated with a biologic medications (other than eculizumab) that may affect immune system functioning, or has stopped treatment with a biologic medication that may affect immune system functioning, and 5 half lives of the medication have not elapsed by the time of the Screening Visit

    7. Use of intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 3 weeks prior to Screening.

    8. Participation in another investigational drug or investigational device study (other than Study ECU-NMO-303) within 5 half lives of that investigational product (if known) or 30 days before initiation of the first dose of study drug, whichever is longer.

    9. Use of immunomodulatory therapies for multiple sclerosis within 3 months prior to Screening.

    Please see the detailed list of exclusion criteria in the protocol.
    1. Positividad conocida para el virus de la inmunodeficiencia humana (VIH)

    2. Antecedentes de infección por N. meningitidis

    3. Infección sistémica activa bacteriana, vírica o fúngica en los 14 días anteriores al día 1.

    4. Hipersensibilidad al ravulizumab, a proteínas murinas o a uno de los excipientes del ravulizumab.

    5. Uso de rituximab en los 6 meses anteriores al día 1.

    6. Actualmente está en tratamiento con una medicación biológica (distinta del eculizumab) que pueda afectar al funcionamiento del sistema inmunitario, o ha interrumpido el tratamiento con una medicación biológica que pueda afectar al funcionamiento del sistema inmunitario, y no han transcurrido 5 semividas de la medicación en el momento de la visita de selección.

    7. Uso de inmunoglobulina intravenosa (Ig i.v.) o plasmaféresis (PF) en las 3 semanas previas a la selección.

    8. Participación en otro estudio de con medicamentos o productos sanitarios en investigación (distinto del estudio ECU-NMO-303) dentro de las 5 semividas de ese producto en investigación (si se conoce) o 30 días antes del inicio de la primera dosis del medicamento del estudio, el período que sea más largo.

    9. Uso de tratamientos inmunomoduladores contra la esclerorir múltiple en los 3 meses anteriores a la selección.

    Ver la lista detallada de criterios de esclusión en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    - The change from baseline in the annualized relapse rate (ARR)
    - Time to First Adjudicated On-trial Relapse (TFR)
    - La variación con respecto al inicio en la tasa de recidivas anualizada (TRA).
    - Tiempo transcurrido hasta la primera recidiva validada (TFR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary treatment period:
    On-Trial Relapses will be monitored throughout the study and at 50 weeks
    Periodo de tratamiento principal:
    Recidiva en el estudio será monitorizada durante el estudio y en la semana 50.
    E.5.2Secondary end point(s)
    Primary treatment period:

    Efficacy:
    - Change from baseline in expanded disability status scale (EDSS) score
    - Change from baseline in Hauser Ambulation Index (HAI)
    - The change from baseline in visual acuity at the end of the Primary Treatment Period
    - The change from baseline in confrontational visual fields at the end of the Primary Treatment Period
    - The change from baseline in color vision at the end of the Primary Treatment Period

    PK/PD:
    - Serum ravulizumab concentrations through the end of the Primary Treatment Period
    - Absolute values, change from baseline, and percentage change from baseline for free serum C5 concentrations over time through the end of the Primary Treatment Period

    Health-related QoL:
    - Change from baseline in PedsQL Scales at the end of the Primary Treatment Period

    Safety:
    - Incidence of AEs and SAEs
    - Change from baseline in vital signs, physical growth (weight, height, and head circumference [participants ≤ 3 years of age only]), and laboratory parameters at scheduled visits

    Extension treatment period:
    The endpoints of the Primary Treatment Period will be evaluated during the Extension Period.
    Periodo de tratamiento principal:

    Eficacia:
    - Variación con respecto al inicio en la puntuación de la EDSS
    - Variación con respecto al inicio en el Índice de deambulación de Hauser (HAI)
    - La variación con respecto al inicio en la agudeza visual al final del período de tratamiento principal
    - La variación con respecto al inicio en la agudeza visual al final del período de tratamiento principal
    - La variación con respecto al inicio en la visión del color al final del período de tratamiento principal

    FC y FD:
    - Concentraciones séricas de ravulizumab hasta el final del período de tratamiento principal
    - Valores absolutos, variación con respecto al inicio y variación porcentual con respecto al inicio para las concentraciones de C5 libre en suero a lo largo del tiempo hasta el final del periodo de tratamiento principal

    CdV relacionada con la salud:
    - Variación con respecto al inicio en las escalas básicas genéricas PedsQL 4.0 al final del período de tratamiento principal

    Seguridad:
    - Incidencia de AA y AAG
    - Variación con respecto al inicio en las constantes vitales, el crecimiento físico (peso, estatura y perímetro cefálico [participantes ≤3 años de edad solamente]) y los parámetros de laboratorio en las visitas programadas

    Periodo de extensión:
    Las estimaciones y los criterios de valoración del periodo de tratamiento principal serán evaluadas durante el periodo de extensión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary treatment period: throughout the primary treatment period and at 50 weeks
    Extension treatment period: 104 weeks
    Periodo de tratamiento principal: durante el l periodo de tratamiento principal y en la semana 50.

    Periodo de extensión: 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
    Immunogenicity Assessments and quality of life
    Evaluaciones de Inmunogenicidad y calidad de vida
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Historical-controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Historical-controlled
    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 EEA10
    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
    France
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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: 12
    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: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 12
    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 patients will return to the care of their physician for their standard treatment.
    Los pacientes volverán a ser atendidos por su doctor para el tratamiento de práctica clinica habitual.
    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 Decision2022-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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    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.

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