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    Summary
    EudraCT Number:2019-000968-18
    Sponsor's Protocol Code Number:MG0003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-27
    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 ConcernedItaly - Italian Medicines Agency
    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.
    Studio di fase 3, Randomizzato, in Doppio Cieco, Controllato con Placebo per Valutare l’Efficacia e la Sicurezza di Rozanolixizumab in Pazienti Adulti con Miastenia Gravis Generalizzata.
    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.
    Studio di fase 3 per valutare la sicurezza e l’efficacia di rozanolixizumab in pazienti con miastenia gravis.
    A.3.2Name or abbreviated title of the trial where available
    MycarinGstudy
    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 SRL
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 generalizzata
    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 (MG) è una malattia autoimmune che causa debolezza muscolare, è causata da problemi di comunicazione tra nervi e muscoli.
    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).
    Dimostrare l’efficacia clinica di rozanolixizumab in pazienti con MG generalizzata.
    E.2.2Secondary objectives of the trial
    Assess safety and tolerability of rozanolixizumab in myasthenia gravis (MG) patients.
    Valutare la sicurezza e la tollerabilità di rozanolixizumab in pazienti con 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

    Pharmacogenomics
    Version: -
    Date: 22/02/2019
    Title: Study participants who have consented can participate in the pharmacogenomics sub-study
    Objectives: -

    Farmacogenomica
    Versione: -
    Data: 22/02/2019
    Titolo: -
    Obiettivi: Per i partecipanti allo studio che hanno firmato il consenso per partecipare al sotto-studio di farmacogenomica
    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) at screening ( Visit 1). The presence of autoantibodies may be confirmed with repeat testing at 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 ( Visit 2);
    -Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator
    - Il partecipante allo studio deve avere un'età =18 anni al momento della firma del consenso informato
    - Il partecipante allo studio ha documentata diagnosi di miastenia generalizzata gravis (gMG) alla Visita 1, basata sulla sua storia medica e supportata da precedenti valutazioni
    - Il partecipante allo studio è risultato positivo per gli autoanticorpi contro il recettore dell'acetilcolina (AChR) o della chinasi muscolo-specifica (MuSK) allo screening (visita 1).La presenza di autoanticorpi può essere confermata con test ripetuto alla visita 1
    - Il partecipante allo studio ha una Classificazione della MGFA (Fondazione americana della miastenia gravis) da II a IVa alla visita 1
    - Il partecipante allo studio deve avere un punteggio relativo alle Attività Giornaliere in presenza di Miastenia Grave (MG-ADL) di almeno 3 e un punteggio quantitativo della miastenia grave (QMG) di almeno 11 alla Visita 1 e al Basale ( Visita 2)
    -Il partecipante allo studio è considerato per un trattamento aggiuntivo come immunoglobulina endovenosa g (IVIg) o scambio plasmatico (PEX) da parte dello sperimetatore
    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 Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis a Visit 1 or Visit 2.
    - Il partecipante allo studio ha un'infezione attiva clinicamente rilevante (ad es. Sepsi,polmonite, o ascesso) secondo il parere dello sperimentatore, o ha avuto un'infezione grave (risultante in ospedalizzazione o che ha richiesto trattamento antibiotico parenterale) entro 6 settimane prima della prima dose del medicinale sperimentale (IMP)
    - Il partecipante allo studio ha subito una reazione di ipersensibilità all'esposizione ad altri farmaci del recettore Fc antineonatale (FcRn)
    - Il partecipante allo studio con debolezza grave (definita come Grado 3 su scala delle Attività Giornaliere in presenza di Miastenia Grave (MG-ADL) che colpisce i muscoli orofaringei o respiratori o chi ha una crisi miastenica o una crisi imminente a Visita 1 o Visita 2
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Day 43 (Visit 10) in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score
    Variazione dal basale al Giorno 43 (Visita 10) del punteggio relativo alle attività giornaliere in presenza di MG (MG-ADL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Visit 10 (Day 43)
    Baseline e Visita 10 (Giorno 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 (Day 43 ) Visit 10 in the Myasthenia Gravis-Composite score
    3. Change from Baseline to (Day 43 ) 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 Muscle Weakness" score
    5. Change from Baseline to (Day 43 ) Visit 10 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' score
    6. Change from Baseline to Visit 10 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' ' score
    7. Occurrence of treatment-emergent adverse events (TEAEs)
    8. Treatment-emergent adverse events (TEAEs) leading to withdrawal of investigational medicinal product (IMP)
    1. Percentuale dei partecipanti che hanno conseguito la risposta al MG-ADL alla visita 10
    2. Variazione dal basale al Giorno 43 (Visita 10) del punteggio composito della MG
    3.Variazione dal basale al Giorno 43 (Visita 10) del punteggio quantitativo della miastenia gravis (QMG)
    4.Variazione dal basale alla Visita 10 del punteggio di “affaticabilità debolezza muscolare” degli esiti riferiti dal paziente (PRO) sui sintomi della MG
    5.Variazione dal basale al Giorno 43 (Visita 10) del punteggio di “affaticamento fisico" dei PRO sui sintomi della MG
    6.Variazione dal basale alla Visita 10 del punteggio “Sintomi bulbare” dei PRO sui sintomi della MG
    7. Eventi avversi emergenti dal trattamento (TEAE)
    8. Eventi avversi emergenti dal trattamento (TEAE) che portano alla sospensione del farmaco sperimentale (IMP)
    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 ( giorno 43)
    2 - 6 Basale e Visita 10 ( Giorno 43)
    7 e 8 Dal basale sino alla visita di fine studio ( fino a settimana 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
    Tollerabilità, Immunogenicità
    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 concerned8
    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 Information not present in EudraCT
    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
    Hong Kong
    Russian Federation
    Taiwan
    United States
    Belgium
    Czechia
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days14
    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 state30
    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.
    I pazienti eligibili potranno partecipare allo studio di estensione.
    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 Decision2019-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
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