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    Summary
    EudraCT Number:2019-000968-18
    Sponsor's Protocol Code Number:MG0003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-09-12
    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 number2019-000968-18
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.
    Estudio en fase III, aleatorizado, con doble enmascaramiento y controlado con placebo para evaluar la eficacia y la seguridad de rozanolixizumab en pacientes adultos con miastenia gravis generalizada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.
    Estudio para evaluar la seguridad y la eficacia de rozanolixizumab en pacientes con miastenia gravis generalizada.
    A.3.2Name or abbreviated title of the trial where available
    MycarinGstudy
    A.4.1Sponsor's protocol code numberMG0003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03971422
    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 SponsorUCB Biopharma SPRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameRozanolixizumab
    D.3.2Product code UCB7665
    D.3.4Pharmaceutical form Solution for infusion
    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 INNrozanolixizumab
    D.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB166282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 placeboSolution for infusion
    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
    Miastenia gravis generalizada
    E.1.1.1Medical condition in easily understood language
    Myasthenia gravis is an autoimmune disease that causes weakness in your muscles; it is caused by a communication problem between nerves and muscles.
    La Miastenia Gravis es una enfermedad autoimmune que causa debilidad en los músculos; esta causada por problemas de comunicación entre nervios y músculos.
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the clinical efficacy of rozanolixizumab in patients with generalized myasthenia gravis (MG)
    Demostrar la eficacia clínica de rozanolixizumab en pacientes con miastenia gravis (MG) generalizada.
    E.2.2Secondary objectives of the trial
    Assess safety and tolerability of rozanolixizumab in myasthenia gravis (MG) patients
    Evaluar la seguridad y la tolerabilidad de rozanolixizumab en los pacientes con miastenia gravis (MG)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study participants who have consented can participate in the pharmacogenomics sub-study.
    Los pacientes del ensayo que hayan consentido podrán participar en el subestudio de farmacogenómica
    E.3Principal inclusion criteria
    - Study participant must be ≥18 years of age, at the time of signing the informed consent
    - Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant’s history and supported by previous evaluations
    - Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Visit 1
    - Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1
    - Study participant with a myasthenia gravis-activities of daily living (MG-ADL) score of at least 3 AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline
    - El participante del estudio debe ser ≥18 años de edad, en el momento de firmar el consentimiento informado
    - Tener documentado el diagnóstico de la miastenia gravis generalizada (MGg) en visita 1, basado en la historia clínica del participante del estudio y avalado por evaluaciones previas
    -Participante del estudio con un registro positivo confirmado de autoanticuerpos contra receptores de acetilcolina (AChR) o tirosina quinasa muscular (MuSK) antes de la visita 1
    - Participante con miastenia gravis de clase II a clase IVa en visita 1 según la Fundación de Myasthenia Gravis de América (MGFA)
    - Participante del estudio con una puntuación de al menos 3 en la escala de actividades de la vida diaria en la miastenia gravis (AVD-MG) y una puntuación en la escala cuantitativa de miastenia gravis (QMG) de al menos 11, en visita 1 y en la visita basal.
    E.4Principal exclusion criteria
    - Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
    - Study participant has experienced hypersensitivity reaction after exposure to other antineonatal Fc receptor (FcRn) drugs
    - Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis a Visit 1
    - Participante del estudio con infección activa clínicamente relevante (por ejemplo, sepsis, neumonía o absceso) en la opinión del investigador, o que tuviera una infección grave (con resultado de hospitalización o que requiera tratamiento antibiótico parenteral) en las 6 semanas previas a la primera dosis de medicamento en investigación (IMP).
    - Participante del estudio que haya experimentado reacción de hipersensibilidad después de la exposición a otras drogas contra el receptor Fc neonatal (FcRn).
    - Participante con debilidad grave (definida como grado 3 en la escala ADL MG) que afecte a los músculos orofaríngeos o respiratorios, o con crisis miasténica o inminente crisis en visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Visit 10 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score
    Cambio desde el inicio hasta la visita 10 en la puntuación de actividades de la vida diaria en la miastenia gravis (AVD-MG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Visit 10 (Day 43)
    Visita de inicio y visita 10 (día 43)
    E.5.2Secondary end point(s)
    1. Percentage of participants achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) response at Visit 10
    2. Change from Baseline to Visit 10 in the Myasthenia Gravis-Composite score
    3. Change from Baseline to Visit 10 in Quantitative Myasthenia Gravis (QMG) score to Visit 10
    4. Change from Baseline to Visit 10 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) ‘Fatigability’ score
    5. Change from Baseline to Visit 10 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) ‘Physical Fatigue, Limb and Axial Weakness’ score
    6. Change from Baseline to Visit 10 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) ‘Bulbar’ score
    7. Occurrence of treatment-emergent adverse events (TEAEs)
    8. Treatment-emergent adverse events (TEAEs) leading to withdrawal of investigational medicinal product (IMP)
    1. porcentaje de participantes que alcancen respuesta en visita 10, en la escala de actividades de la vida diaria en la miastenia gravis (AVD-MG).
    2. Cambio desde el inicio hasta la visita 10 en la puntuación compuesta de miastenia gravis.
    3. Cambio desde el inicio hasta la visita 10 en la puntuación cuantitativa de la miastenia gravis (QMG).
    4. Cambio desde el inicio hasta la visita 10 en la puntuación de “Fatigabilidad” de los resultados notificados por el paciente (RNP) de los síntomas de la miastenia gravis.
    5. Cambio desde el inicio hasta la visita 10 en la puntuación de “Fatiga física, debilidad de extremidades y axial” de los RNP de los síntomas de la miastenia gravis.
    6. Cambio desde el inicio hasta la visita 10 en la puntuación “Bulbar” de los RNP de los síntomas de miastenia gravis.
    7. Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST).
    8. AAST que provocan la retirada del producto en investigación (PEI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Visit 10 (Day 43)
    2.- 6. Baseline and Visit 10 (Day 43)
    7. and 8. From Baseline until End of Study Visit (up to Week 14)
    1. Visita 10 (día 43)
    2.- 6. Visita Inicio y visita 10 (Day 43)
    7. y 8. Desde el Inicio hasta la visita de fin de ensayo (hasta semana 14)
    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, Immunogenicity
    Tolerabilidad, 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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Spain
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days17
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 121
    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)
    Eligible subjects will be allowed to enroll in an extension study.
    Los pacientes elegibles podrán entrar en un estudio de extensión.
    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 Decision2019-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusRestarted
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