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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42771   clinical trials with a EudraCT protocol, of which   7044   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).


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    Summary
    EudraCT Number:2018-003243-39
    Sponsor's Protocol Code Number:ALXN1210-MG-306
    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:2019-05-27
    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 number2018-003243-39
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
    Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la seguridad y la eficacia de ravulizumab en pacientes adultos sin tratamiento previo con inhibidores del complemento con miastenia gravis generalizada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.
    Estudio de seguridad y eficacia de ravulizumab en adultos con miastenia gravis generalizada
    A.4.1Sponsor's protocol code numberALXN1210-MG-306
    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 Incorporated
    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 Incorporated
    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 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 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 INNFc- and CDR-modified humanised monoclonal antibody against C5
    D.3.9.2Current sponsor codeALXN1210
    D.3.9.3Other descriptive nameFc- and CDR-modified humanised monoclonal antibody against C5
    D.3.9.4EV Substance CodeSUB172162
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution 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
    Generalized Myasthenia Gravis
    Miastenia gravis generalizada
    E.1.1.1Medical condition in easily understood language
    Generalized Myasthenia Gravis
    Miastenia gravis generalizada
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10071942
    E.1.2Term Myasthenia gravis and related conditions
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) profile.
    Evaluar la eficacia de ravulizumab en comparación con el placebo en el tratamiento de la MGg basándose en la mejora del perfil de miastenia gravis-actividades de la vida diaria (MG-AVD).
    E.2.2Secondary objectives of the trial
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Quantitative Myasthenia Gravis (QMG) total score.
    Evaluar la eficacia de ravulizumab en comparación con el placebo en el tratamiento de la MgG basándose en la mejora de la puntuación total de miastenia gravis cuantitativa (MGC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients ≥ 18 years of age
    • Diagnosed with MG at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by protocol-specific criteria
    • Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening
    • MG-ADL profile must be ≥ 6 at screening and randomization (Day 1)
    • Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).
    • Body weight ≥ 40 kg at the time of screening
    • Patients of childbearing potential and patients with partners of childbearing potential must follow protocol-specified contraception guidance for avoiding pregnancy while on treatment and for 8 months after last dose of study drug
    • Hombres y mujeres deben tener ≥18 años de edad
    • Diagnóstico de miastenia gravis (MG) al menos 6 meses (180 días) antes de la fecha de la visita de selección, según lo confirmen los criterios específicos del protocolo (ver a continuación).
    • Clase II a IV en la selección según la clasificación clínica de la Myasthenia Gravis Foundation of America (Fundación de América para la Miastenia Grave).
    • El perfil de MG-ADL debe ser ≥ 6 en la selección y la aleatorización (día 1).
    • Para reducir el riesgo de infección meningocócica (N meningitidis), todos los pacientes se deben haber vacunado contra infecciones meningocócicas en los 3 años previos al inicio del medicamento del estudio o en dicho momento. Los pacientes que inicien tratamiento con el medicamento del estudio menos de 2 semanas después de recibir una vacuna antimeningocócica deben recibir tratamiento con antibióticos profilácticos adecuados hasta 2 semanas después de la vacunación.
    • Las pacientes con capacidad para tener hijos y los pacientes con parejas con capacidad para tener hijos deben seguir la guía sobre anticoncepción especificada en el protocolo para evitar el embarazo mientras reciban el tratamiento y durante 8 meses después de la última dosis del medicamento del estudio.
    E.4Principal exclusion criteria
    Medical Conditions:
    • Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before Screening
    • History of thymectomy within the 12 months prior to screening
    • History of N meningitidis infection
    • Human immunodeficiency virus (HIV) infection
    • History of hospitalization for ≥ 24 hours, for any reason, within the 4 weeks (28 days) prior to screening
    • Females who plan to become pregnant during the study, or are currently pregnant or breastfeeding, or who have a positive pregnancy test result at screening or on Day 1

    Prior/Concomitant Therapy
    •Use of the following within the time period specified below:
    - IVIg within the 4 weeks (28 days) prior to randomization (Day 1)
    - Use of PE within the 4 weeks (28 days) prior to randomization (Day 1)
    - Use of rituximab within the 6 months (180 days) prior to screening
    • Patients who have received previous treatment with complement-inhibitors (eg, eculizumab)
    Afecciones médicas
    • Cualquier timoma activo o sin tratar. Antecedentes de carcinoma tímico o neoplasia tímica a menos que se considere curada por un tratamiento adecuado sin evidencia de recidiva durante ≥ 5 años antes de la selección.
    • Antecedentes de timectomía en los 12 meses anteriores a la selección.
    • Antecedentes de infección por N meningitidis.
    • Infección por el virus de inmunodeficiencia humana (VIH) (que se pone de manifiesto mediante valoración de anticuerpos contra el VIH-1 o VIH-2).
    • Antecedentes de hospitalización durante ≥ 24 horas, por cualquier motivo en las 4 semanas (28 días) anteriores a la selección.
    • Pacientes de sexo femenino que planean quedarse embarazadas o que están actualmente embarazadas o en período de lactancia.
    • Pacientes de sexo femenino que han obtenido un resultado positivo en una prueba de embarazo en la selección o el día 1.

    • Pacientes que hayan recibido tratamiento previo con inhibidores del sistema del complemento (p. ej., eculizumab).
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in MG-ADL total score
    Cambio respecto al inicio en la puntuación total de MG-AVD en la semana 26 del período aleatorizado-controlado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 26 of the Randomized-Controlled Period.
    Variación respecto al inicio de la puntuación de MGC en la semana 26
    E.5.2Secondary end point(s)
    Change from Baseline in QMG total score
    Variación respecto al inicio de la puntuación de MGC
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Week 26
    En la semana 26
    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 No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Austria
    Canada
    Denmark
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Spain
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee No
    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 in the study or last scheduled procedure shown in the Schedule of Activities for the last patient in the study globally
    Última visita del último paciente o el último procedimiento programado indicado en el Programa de actividades.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 35
    F.4.2.2In the whole clinical trial 160
    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 will return to the care of their treating physician at the completion of study participation.
    Los pacientes retomarán su tratamiento habitual con su médico tras finalizar su participación en el estudio.
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-17
    P. End of Trial
    P.End of Trial StatusOngoing
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