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    Summary
    EudraCT Number:2021-000352-19
    Sponsor's Protocol Code Number:MOG001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000352-19
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)
    Studio pivotal di fase 3, randomizzato, in doppio cieco, controllato con placebo, multicentrico, con un periodo di estensione in aperto per valutare l’efficacia e la sicurezza di rozanolixizumab in partecipanti adulti affetti da malattia associata ad anticorpi antiglicoproteina oligodendrocitaria della mielina (MOG) (MOG-AD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of rozanolixizumab in adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD)
    Studio per valutare l’efficacia e la sicurezza di rozanolixizumab in partecipanti adulti affetti da malattia associata ad anticorpi antiglicoproteina oligodendrocitaria della mielina (MOG) (MOG-AD)
    A.3.2Name or abbreviated title of the trial where available
    cosMOG
    cosMOG
    A.4.1Sponsor's protocol code numberMOG001
    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 SRL
    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.5.4Telephone number000000
    B.5.5Fax number000000
    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 injection/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.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB166282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 injection/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
    Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)
    Malattia associata ad anticorpi antiglicoproteina oligodendrocitaria della mielina (MOG) (MOG-AD)
    E.1.1.1Medical condition in easily understood language
    Myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD) is an inflammatory demyelinating condition of the central nervous system (CNS).
    Malattia associata ad anticorpi antiglicoproteina oligodendrocitaria della mielina (MOG) (MOG-AD) è una confizione infiammatoria demielinizzante del sistema nervoso centrale (CNS).
    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 10012302
    E.1.2Term Demyelinating disorders NEC
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of rozanolixizumab for treatment of participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD)
    Valutare l'efficacia di rozanolixizumab per il trattamento dei partecipanti affetti dalla malattia associata all'anticorpo per la glicoproteina mielinica oligodendrocitaria (MOG-AD)
    E.2.2Secondary objectives of the trial
    Assess the safety and tolerability of rozanolixizumab in participants withmyelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD)
    Valutare la sicurezza e la tollerabilità di rozanolixizumab per il trattamento dei partecipanti affetti dalla malattia associata all'anticorpo per la glicoproteina mielinica oligodendrocitaria (MOG-AD)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants must be >=18 to <=89 years of age, at the time of signing the informed consent
    - Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations:
    a) Optic neuritis (single, recurrent, or simultaneous bilateral)
    b) Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM))
    c) Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis
    d) Combined presentations
    - Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening
    - Participant has history of relapsing MOG-AD with at least 1 documentedrelapse over the last 12 months prior to randomization
    - Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
    - I partecipanti devono avere un'età compresa tra >=18 e <=89 anni, al momento della firma del consenso informato
    - Il partecipante deve avere una storia di malattia associata agli anticorpi della glicoproteina mielinica oligodendrocitaria (MOG-AD) con una delle seguenti presentazioni cliniche:
    a) Neurite ottica (singola, ricorrente o bilaterale simultanea)
    b) Mielite trasversa (compresa la lesione midollare estesa longitudinalmente (LETM))
    c) Encefalomielite acuta disseminata o encefalite associata agli anticorpi MOG, encefalite del tronco cerebrale
    d) Presentazioni combinate
    - Positività per gli anticorpi sierici MOG-Immunglobulina G (IgG) usando un test basato su cellule allo screening
    - Il partecipante ha una storia di MOG-AD recidivante con almeno 1 ricaduta documentata negli ultimi 12 mesi prima della randomizzazione
    - Il partecipante deve essere clinicamente stabile al momento della visita di screening e durante il periodo di screening
    E.4Principal exclusion criteria
    - Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
    - Participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess), or has 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)
    - Participant has a current or medical history of primary immunodeficiency
    - Participant has a current or medical history of IgA deficiency
    - Participant tests positive for aquaporin-4 antibodies at screening
    - Participant has a serum total IgG level <=5.5g/L
    - Al partecipante è stata diagnosticata una malattia neurologica autoimmune (compresa la sclerosi multipla (SM) e il disordine dello spettro della neuromielite ottica (NMOSD) positivo all'aquaporina-4), o una malattia sistemica autoimmune che, a giudizio dello sperimentatore, può interferire con la sicurezza del partecipante
    - Il partecipante ha un'infezione attiva clinicamente rilevante (es. sepsi, polmonite o ascesso), o ha avuto un'infezione grave (con conseguente ricovero in ospedale o che richiede un trattamento antibiotico parenterale) nelle 6 settimane precedenti la prima dose del medicinale in fase di sperimentazione (IMP)
    - Il partecipante ha una storia attuale o medica di immunodeficienza primaria
    - Il partecipante ha un'anamnesi attuale o medica di carenza di IgA
    - Il partecipante risulta positivo al test di screening per gli anticorpi all'aquaporina-4
    - Il partecipante ha un livello di IgG totali nel siero <=5,5g/l
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    1. Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period

    Part B:
    2. Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
    3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) duringOLE Treatment Period
    Parte A:
    1. Tempo dalla randomizzazione alla prima ricaduta indipendentemente giudicata a livello centrale (TTFR) durante il periodo di trattamento DB

    Parte B:
    2. Incidenza di eventi avversi emergenti dal trattamento (TEAEs) durante il periodo di trattamento OLE
    3. Incidenza di eventi avversi emergenti dal trattamento (TEAEs) che hanno portato al ritiro permanente del medicinale in fase di sperimentazione (IMP) durante il periodo di trattamento OLE
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to 132 weeks)
    2, 3: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
    1. Basale (settimana 1) alla visita EDB/EWD (fino alla conferma di ricaduta o fino alle 132 settimane)
    2, 3: Periodo di trattamento OLE (OLE settimana 1) alla visita EOS/EWD (fino alle settimana OLE 52)
    E.5.2Secondary end point(s)
    Part A
    1. Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit
    2. Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the end of the EDB/EWD Visit (with confirmation at 3 months)
    3. Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period
    4. Independently centrally adjudicated annualized relapse rate (ARR) during the DB Treatment Period
    5. Change from Baseline in Low-Contrast Monocular Visual Acuity (Least Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit (with confirmation at 3 months)
    6. Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period

    Part B
    7. Independently centrally adjudicated annualized relape rate (ARR) during the DB and OLE Treatment Period
    Parte A
    1. Cambiamento rispetto al basale nell'acuità visiva monoculare a basso contrasto (occhio peggiore interessato) misurata con il grafico ad anelli rotti di Landolt C a basso contrasto alla visita EDB/EWD
    2. Disabilità come valutata dai punteggi della Expanded Disability Status Scale (EDSS) alla fine della visita EDB/EWD (con conferma a 3 mesi)
    3. Numero di ricoveri ospedalieri correlati al MOG-AD durante il periodo di trattamento DB
    4. Tasso di ricaduta annualizzato (ARR) stabilito in modo indipendente a livello centrale durante il periodo di trattamento DB
    5. Cambiamento rispetto al basale nell'acuità visiva monoculare a basso contrasto (occhio meno colpito) misurata dal grafico ad anelli rotti di Landolt C a basso contrasto alla visita EDB/EWD (con conferma a 3 mesi)
    6. Incidenza di eventi avversi emergenti dal trattamento (TEAEs) durante il periodo di trattamento DB

    Parte B
    7. Tasso annualizzato di ricaduta (ARR) regolato in modo indipendente a livello centrale durante il periodo di trattamento DB e OLE
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Baseline (Week 1) to EDB/EWD Visit (up to 132 weeks)
    2. Baseline (Week 1), EDB/EWD Visit (up to 132 weeks)
    1. Dal basale (settimana 1) alla visita EDB/EWD (fino alle 132 settimane)
    2. Basale (settimana 1), visita EDB/EWD (fino alle 132 settimane)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and immunogenicity
    Tollerabilità e 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 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 EEA34
    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
    Australia
    Belgium
    Brazil
    China
    Czechia
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Portugal
    Spain
    Sweden
    Switzerland
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days27
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 104
    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)
    none
    nessuno
    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 Decision2022-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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