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    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2019-004619-30
    Sponsor's Protocol Code Number:ALXN1210-ALS-308
    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:2020-03-06
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-004619-30
    A.3Full title of the trial
    A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
    Estudio multicéntrico fase III, doble ciego, aleatorizado, controlado con placebo y de grupos paralelos con una extensión abierta para evaluar la eficacia y la seguridad de ravulizumab en pacientes con esclerosis lateral amiotrófica (ELA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Ravulizumab in ALS Patients
    Estudio sobre la eficacia y la seguridad de ravulizumab en pacientes con ELA
    A.3.2Name or abbreviated title of the trial where available
    An Efficacy and Safety Study of Ravulizumab in ALS Patients
    Estudio sobre la eficacia y la seguridad de ravulizumab en pacientes con ELA
    A.4.1Sponsor's protocol code numberALXN1210-ALS-308
    A.5.4Other Identifiers
    Name:IND NumberNumber:145660
    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 SponsorAlexion Pharmaceuticals
    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
    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.5.4Telephone number+34932723127
    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. name Ultomiris
    D. 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 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 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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
    La esclerosis lateral amiotrófica (ELA) es una enfermedad neurodegenerativa debilitante
    E.1.1.1Medical condition in easily understood language
    ALS, motor neuron disease
    ELA, enfermedad neurodegenerativa debilitante
    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 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    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 effect of ravulizumab compared with
    placebo on amyotrophic lateral sclerosis functional rating
    scale-revised (ALSFRS-R) score in adult patients with
    amyotrophic lateral sclerosis (ALS)
    Evaluar el efecto de ravulizumab comparado con placebo sobre la puntuación de la escala revisada de valoración funcional de la esclerosis lateral amiotrófica (ALSFRS-R) en pacientes adultos con esclerosis lateral amiotrófica (ELA)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of ravulizumab compared with
    placebo on ventilation assistance-free survival (VAFS) in
    adult patients with ALS

    To evaluate the effect of ravulizumab compared with
    placebo on respiratory function in adult patients with

    To evaluate the safety of ravulizumab compared with
    placebo in adult patients with ALS

    To evaluate the effect of ravulizumab compared with
    placebo on muscle strength in adult patients with ALS

    To evaluate the effect of ravulizumab compared with
    placebo on neurofilament light chain (NfL)
    concentrations in adult patients with ALS

    To characterize the pharmacokinetics (PK) of
    ravulizumab in adult patients with ALS

    To characterize the pharmacodynamics (PD) of
    ravulizumab in adult patients with ALS

    To characterize the immunogenicity of ravulizumab in
    adult patients with ALS
    Evaluar el efecto de ravulizumab comparado con placebo sobre la supervivencia sin ventilación asistida (SSVA) en pacientes adultos con ELA

    Evaluar el efecto de ravulizumab comparado con placebo sobre la función respiratoria en pacientes adultos con ELA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years of age or older, at the time of signing the informed consent.
    2. A diagnosis of ALS, defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the revised World Federation of Neurology El Escorial criteria. Patients diagnosed with either sporadic or familial ALS are eligible for enrollment.
    3. ALS onset, defined as time of onset of first muscle weakness (eg, limb weakness, dysarthria, dysphagia, shortness of breath), ≤ 36 months from the Screening Visit.
    4. Prestudy ALSFRS-R progression between disease onset and screening of -0.3 points per month or worse (calculated by ALSFRS-R total score decline from 48 divided by the months since onset of ALS symptoms).
    5. Upright SVC ≥ 65% predicted at Screening.
    6. Vaccinated against N. meningitidis within 3 years prior to, or at the time of, initiating ravulizumab. 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.
    7. Patients who enter the trial receiving standard of care for ALS (ie, riluzole and/or edaravone), either in combination or monotherapy, must be on a stable dosing regimen of adequate duration prior to screening with no plan to discontinue or to change the dose during the study period as follows:
    -If a patient who enters the study is receiving riluzole, the patient must have been on a stable dose of riluzole for ≥ 30 days prior to Day 1.
    -If a patient who enters the study is receiving edaravone, the patient must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1.
    Note: Patients not on riluzole and/or edaravone at the time of screening are permitted in the study.
    8. Body weight ≥ 40 kg at Screening.
    9. Male and/or female
    -Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    10. Capable of giving written or verbal informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    1.Tener como mínimo 18 años de edad en el momento de firmar el formulario de consentimiento informado.
    2.Diagnóstico de ELA, lo que se define como cumplir los criterios posibles, probables respaldados por pruebas analíticas, probables o definitivos de diagnóstico de ELA según los criterios de El Escorial revisados de la Federación Mundial de Neurología. Los pacientes con diagnóstico de ELA esporádica o familiar serán aptos para su inscripción.
    3.Inicio de la ELA, que se define como el momento de aparición de la primera debilidad muscular (p. ej., debilidad en las extremidades, disartria, disfagia, disnea), ≤ 36 meses antes de la visita de selección.
    4.Progresión según la ALSFRS-R previa al estudio entre la aparición de la enfermedad y la selección de -0,3 puntos al mes o peor (calculada mediante el declive de la puntuación total en la ALSFRS-R desde 48, dividido por los meses transcurridos desde la aparición de los síntomas de la ELA).
    5.CVL vertical ≥ 65 % del valor previsto en la selección.
    6.Vacunado contra N. meningitidis en los 3 años anteriores al tratamiento o en el momento de iniciar el tratamiento con ravulizumab. Los pacientes que comiencen el tratamiento con el fármaco del estudio menos de 2 semanas después de recibir una vacuna antimeningocócica recibirán una antibioterapia profiláctica adecuada hasta 2 semanas después de la vacunación.
    7.Los pacientes que entren en el ensayo recibiendo un tratamiento según la práctica clínica habitual para la ELA (es decir, riluzol o edaravona), ya sea en combinación o en monoterapia, deben tener una pauta posológica estable de una duración adecuada antes de la selección sin que esté previsto interrumpirla o modificar la dosis durante el periodo del estudio, como se indica a continuación:
    •Si un paciente entra en el estudio recibiendo riluzol, debe llevar ≥ 30 días con una dosis estable de riluzol antes del día 1.
    •Si un paciente entra en el estudio recibiendo edaravona, debe haber empezado con ella ≥ 60 días (2 ciclos de tratamiento) antes del día 1.
    Nota: Los pacientes que no estén recibiendo riluzol o edaravona en el momento de la selección podrán participar en el estudio.
    8.Peso corporal ≥ 40 kg en la selección.
    9.Hombre o mujer:
    •El uso de anticonceptivos por parte de mujeres y hombres debe ser coherente con las normativas locales relativas a los métodos anticonceptivos para los participantes en estudios clínicos.
    10.Ser capaz de otorgar su consentimiento informado por escrito o de palabra, según lo establecido en la Sección 10.1.3, lo que incluye el cumplimiento de los requisitos y restricciones enumerados en el formulario de consentimiento informado (FCI) y en este protocolo.
    E.4Principal exclusion criteria
    1. History of N. meningitidis infection.
    2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
    3. History of unexplained infections.
    4. Active systemic bacterial, viral, or fungal infection within 14 days prior to study drug administration on Day 1.
    5. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration on Day 1.
    6. Hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab.
    7. Dependence on invasive or non-invasive mechanical ventilation. Dependence on mechanical ventilation is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use > 6 hours per day for > 3 days per week. Non-invasive ventilation for sleep apnea is allowed subject to discussion with Medical Monitor.
    8. Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial, poses any added risk for the patient, or confounds the assessment of the patient.
    9. The presence of unstable psychiatric disease or dementia that might interfere with the patient’s participation in the trial, poses any added risk for the patient, or confounds the assessment of the patient.
    10. History of drug and/or alcohol abuse (according to Diagnostic and Statistical Manual of Mental Disorders) within 1 year of screening that would limit patient participation in the study as determined by the Investigator.
    11. History of Parkinson’s disease, myasthenia gravis, multiple sclerosis, or any other neurological disorder that may confound the diagnosis or assessment of the patient as determined by the Investigator.
    12. Previously or currently treated with a complement inhibitor.
    13. Use of IV immunoglobulin (IVIg) within 3 weeks prior to screening.
    14. Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during the course of the study.
    15. Participation in any other investigational product study or exposure to an investigational drug or device within 30 days of screening or 5 half-lives of the study drug, whichever is greater or any prior exposure to gene therapy.
    16. Pregnant, breastfeeding, or intending to conceive during the course of the study.
    1.Antecedentes de infección por N. meningitidis.
    2.Infección por el virus de la inmunodeficiencia humana (VIH) (demostrada mediante el título de anticuerpos anti-VIH-1 o anti-VIH-2).
    3.Antecedentes de infecciones de origen desconocido.
    4.Infección bacteriana, vírica o fúngica sistémica activa en los 14 días previos a la administración del fármaco del estudio del día 1.
    5.Presencia de fiebre ≥ 38 °C (100,4 °F) en los 7 días previos a la administración del fármaco del estudio del día 1.
    6.Hipersensibilidad a las proteínas murinas o a alguno de los excipientes de ravulizumab.
    7.Dependencia de ventilación mecánica invasiva o no invasiva. La dependencia de ventilación mecánica se define como no ser capaz de permanecer tumbado (en decúbito supino) sin ella, no poder dormir sin ella o un uso diurno > 6 horas al día durante > 3 días a la semana. Se permite la ventilación no invasiva para la apnea del sueño previa consulta con el supervisor médico.
    8.Cualquier afección médica que, en opinión del investigador, pueda interferir en la participación del paciente en el ensayo, suponga algún riesgo adicional para el paciente o genere confusión en la evaluación del paciente.
    9.Presencia de enfermedad psiquiátrica o demencia inestable que pueda interferir en la participación del paciente en el ensayo, suponga algún riesgo adicional para el paciente o genere confusión en la evaluación de la paciente.
    10.Antecedentes de toxicomanía o alcoholismo (según la clasificación del Manual diagnóstico y estadístico de los trastornos mentales) en el año anterior a la selección que puedan limitar la participación del paciente en el estudio, según el criterio del investigador.
    11.Antecedentes de enfermedad de Parkinson, miastenia grave, esclerosis múltiple o cualquier otro trastorno neurológico que pueda generar confusión en el diagnóstico o la evaluación del paciente según el criterio del investigador.
    12.Tratamiento previo o en curso con inhibidores del complemento.
    13.Uso de inmunoglobulina i.v. (IgIV) en las 3 semanas anteriores a la selección.
    14.Tener un sistema de electroestimulación diafragmática (SED) al entrar en el estudio o tener prevista la colocación de un SED durante el estudio
    15.Participación en cualquier otro estudio de productos en investigación o exposición a fármacos o dispositivos en investigación en los 30 días anteriores a la selección o las 5 semividas del fármaco del estudio, lo que sea mayor, o cualquier exposición anterior a terapia génica.
    16.Mujeres embarazadas, en periodo de lactancia o que tengan intención de quedarse embarazadas durante el transcurso del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in ALSFRS-R total score
    Cambio con respecto al inicio en la puntuación total
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 50 visit
    Semana 50
    E.5.2Secondary end point(s)
    Time to the earliest occurrence of 1 of the following events during the 50-week Randomized Controlled Period:
    • All-cause mortality
    • First use of non-invasive ventilation (NIV) for
    ≥ 22 hours per day for ≥ 10 consecutive days
    • First use of permanent assisted ventilation (PAV) for
    ≥ 22 hours per day for ≥ 7 consecutive days
    • Change from baseline in percent (%) predicted slow vital capacity (SVC) at Week 50
    • Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation
    • Percent change in combined muscle megascore from baseline at Week 50 as assessed by handheld dynamometry (HHD)
    • Change from baseline in NfL concentrations in serum at Week 50
    • Change in serum ravulizumab concentration over the study duration
    • Change in serum free complement component 5 (C5) concentration over the study duration
    • Presence and titer of antidrug antibodies (ADAs)
    Tiempo hasta la primera aparición de uno de los siguientes acontecimientos durante el periodo controlado aleatorizado de 50 semanas:
    •Mortalidad por cualquier causa
    •Primer uso de ventilación no invasiva (VNI) durante ≥ 22 horas al día durante ≥ 10 días consecutivos
    •Primer uso de ventilación asistida permanente (VAP) durante ≥ 22 horas al día durante ≥ 7 días consecutivos
    •Cambio con respecto al inicio en el porcentaje (%) previsto de la capacidad vital lenta (CVL) en la semana 50
    •Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST), acontecimientos adversos graves surgidos durante el tratamiento (AAGST) y AAST que provocan la interrupción del fármaco del estudio
    • Cambio porcentual en la puntuación muscular máxima combinada con respecto al inicio en la semana 50 medida mediante dinamometría manual (DM)
    • Cambio con respecto al inicio en las concentraciones de NfL en suero en la semana 50
    • Cambio en la concentración en suero de ravulizumab a lo largo del estudio
    • Cambio en la concentración en suero del componente 5 (C5) del complemento libre a lo largo del estudio
    • Presencia y título de anticuerpos antifármaco (AAF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 50; throughout the study
    Semana 50, a través del ensayo
    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
    Biomarker characterization, immunogenicity
    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. 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 Yes
    E. trial design description
    Open Label Extension
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Korea, Republic of
    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
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 284
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 177
    F.4.2.2In the whole clinical trial 354
    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)
    Ravulizumab will not be provided to patients after the last scheduled dosing. Patients will be followed for an additional 8 weeks after the last dose of study drug and will return to the care of their regular dotctor.
    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 Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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