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    Summary
    EudraCT Number:2020-003230-20
    Sponsor's Protocol Code Number:MG0007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 number2020-003230-20
    A.3Full title of the trial
    An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
    Studio di estensione in aperto per valutare Rozanolixizumab in soggetti in studio con miastenia gravis generalizzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis
    Studio per valutare Rozanolixizumab in soggetti in studio con miastenia gravis generalizzata
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberMG0007
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2272
    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.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB187374
    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
    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 è una malattia autoimmune che causa debolezza muscolare; è causata da un problema di comunicazione tra i nervi e i 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
    Assess the safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).
    Valutare la sicurezza e la tollerabilità di ulteriori cicli di trattamento di 6 settimane con rozanolixizumab in partecipanti allo studio affetti da miastenia gravis generalizzata (gMG)
    E.2.2Secondary objectives of the trial
    Assess the efficacy of 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG)
    Valutare l’efficacia di cicli di trattamento di 6 settimane con rozanolixizumab in partecipanti allo studio affetti da miastenia gravis generalizzata (gMG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Study participant must meet one of the following:
    a) completed MG0003 [NCT03971422],
    b) required rescue therapy during the Observation Period in MG0003, or
    c) completed at least 6 visits in MG0004 [NCT04124965]
    - Body weight > or = 35 kg at Baseline (Day 1)
    - Study participants may be male or female
    - Il partecipante allo studio deve soddisfare uno dei seguenti criteri:
    a) aver completato MG0003 [NCT03971422],
    b) aver avuto bisogno di una "rescue therapy" durante il periodo di osservazione in MG0003, o
    c) aver completato almeno 6 visite in MG0004 [NCT04124965]
    - Peso corporeo > o = 35 Kg al basale (Giorno 1)
    - I partecipanti allo studio possono essere maschi o femmine
    E.4Principal exclusion criteria
    - Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal FC receptor (FcRn) medications
    - Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
    - Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
    - Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab
    - Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
    - Il partecipante allo studio ha una nota ipersensibilità a qualsiasi dei componenti del farmaco in studio o ad altri farmaci anti-FcRn (neonatal FC receptor)
    - Il partecipante allo studio ha una nota infezione da tubercolosi (TB), un alto rischio di contrarre una infezione TB, o una infezione latente da rubercolosi (LTBI), o una attuale/pregressa infezione micobatterica non tubercolosi (NTMBI)
    - Il partecipante allo studio ha riscontrato una qualsiasi interruzione obbligatoria o è rientrato nei criteri di interruzione del farmaco in studio in MG0003, o MG0004 o ha definitivamente sospeso il trattamento con il farmaco in qualsiasi degli studi citati
    - Il partecipante allo studio intende sottoporsi a vaccinazione durante lo svolgimento dello studio o nelle 8 settimane seguenti la dose finale di rozanolixizumab
    - Il partecipante allo studio con grave debolezza (definita come grado 3 della scala delle attività della miastenia gravis, MG-ADL) che colpisce i muscoli oro-faringei o respiratori, o chi ha una crisi miastenica o una crisi imminente
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with treatment-emergent adverse events (TEAEs)
    2. Percentage of participants with TEAEs leading to permanent withdrawal of investigational medicinal product (IMP)
    1. Percentuale di partecipanti che manifestano eventi avversi emergenti dal trattamento (TEAE)
    2. Percentuale di partecipanti che manifestano TEAE con conseguente ritiro del prodotto medicinale sperimentale (IMP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.; 2. From Baseline (Day 1) to End of Study (average of 20 months)
    1.; 2. dal basale (Giorno 1) fino alla fine dello studio (circa 20 mesi)
    E.5.2Secondary end point(s)
    1. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score within one treatment cycle
    2. Change from Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) score within one treatment cycle
    3. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) score within one treatment cycle
    4. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within one treatment cycle
    5. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' score within one treatment cycle
    6. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar symptoms' score within one treatment cycle
    7. MG-ADL responder (> or = 2.0-point improvement from Baseline [Day 1] to end of Day 43) within one treatment cycle
    8. Time to MG-ADL response (> or = 2.0-point improvement from Baseline [Day 1]) within one treatment cycle
    9. Time between consecutive treatment cycles
    1. Variazione dal basale (Giorno 1) al Giorno 43 in termini di Punteggio relativo alle attività giornaliere (ADL) entro un ciclo di trattamento
    2. Variazione dal basale (Giorno 1) al Giorno 43 in termini di Punteggio quantitativo della miastenia gravis (QMG) entro un ciclo di trattamento
    3. Variazione dal basale (Giorno 1) al Giorno 43 in termini di Punteggio composito della miastenia gravis (MG-C) entro un ciclo di trattamento
    4. Variazione dal basale (Giorno 1) al Giorno 43 in termini di Punteggio di “affaticamento da debolezza muscolare” degli esiti riferiti dal paziente (PRO) sui sintomi della miastenia gravis (MG) entro un ciclo di trattamento
    5. Variazione dal basale (Giorno 1) al Giorno 43 in termini di Punteggio di “affaticamento fisico” dei PRO sui sintomi della MG entro un ciclo di trattamento
    6. Variazione dal basale (Giorno 1) al Giorno 43 in termini di Punteggio dei “sintomi bulbari” dei PRO sui sintomi della MG entro un ciclo di trattamento
    7. Soggetti responsivi alla MG-ADL (> o = 2,0 punti dal basale [Giorno 1] al Giorno 43) entro un ciclo di trattamento
    8. Tempo alla risposta MG-ADL (> o = 2,0 punti dal basale [Giorno 1] al Giorno 43) entro un ciclo di trattamento
    9. Tempo tra cicli di trattamento consecutivi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. - 8. From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
    9. From end of the previous treatment cycle (Day 43) to the next treatment cycle (Day 1)
    1. - 8. Dal basale (Giorno 1) fino alla fine del ciclo di trattamento (fino a 6 settimane)
    9. Dalla fine del precedente ciclo di trattamento (Giorno 43) al ciclo di trattamento successivo (Giorno 1)
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    -
    -
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    China
    Georgia
    Japan
    Russian Federation
    Serbia
    United States
    Belgium
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days24
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 200
    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 participants will be allowed to receive expanded access.
    I partecipanti considerati idonei potranno ricevere un accesso più ampio.
    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 Decision2020-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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