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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2022-003870-21
    Sponsor's Protocol Code Number:MG0020
    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:2023-01-24
    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 number2022-003870-21
    A.3Full title of the trial
    An open-label, crossover study to evaluate rozanolixizumab self-administration by study participants with generalized Myasthenia Gravis
    Studio crossover in aperto per valutare l’auto-somministrazione di rozanolixizumab da parte di partecipanti allo studio con miastenia gravis generalizzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, open-label, crossover study to evaluate self-administration of rozanolixizumab by study participants with generalized Myasthenia Gravis (gMG)
    Studio crossover in aperto di fase 3 per valutare l’auto-somministrazione di rozanolixizumab da parte di partecipanti allo studio con miastenia gravis generalizzata (gMG)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberMG0020
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1279-4426
    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.5.6E-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
    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 code-
    D.3.9.3Other descriptive nameUCB7665
    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 nei tuoi muscoli; 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods
    Valutare la capacità dei partecipanti allo studio con miastenia gravis generalizzata (gMG) di auto- somministrarsi con successo rozanolixizumab dopo essere stati addestrati nella tecnica di auto-somministrazione con i metodi della pompa a siringa e della spinta manuale.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of subcutaneous (SC) self-administration
    Valutare la sicurezza dell’auto-somministrazione sottocutanea (SC) di rozanolixizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
    - Study participant is willing to perform and capable of performing home self-administration
    - Study participant is considered for additional rozanolixizumab treatment with the posology proposed in this study
    - Body weight >=35 kg
    - Study participants may be male or female
    - Il partecipante allo studio deve avere una diagnosi documentata di miastenia gravis generalizzata (gMG)
    - Il partecipante allo studio è disposto ad eseguire ed è in grado di eseguire l'auto-somministrazione domiciliare
    - Il partecipante allo studio è considerato per un ulteriore trattamento con rozanolixizumab con la posologia proposta in questo studio
    - Peso corporeo >=35 kg
    - 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 or history of nontuberculous mycobacterial infection (NTMBI)
    - Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit
    - The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal or mandatory study drug discontinuation criteria
    - Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette Guérin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last 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 componente del farmaco in studio o ad altri farmaci anti-FcRn
    - Partecipante allo studio con infezione nota da tubercolosi (TB), ad alto rischio di contrarre infezione da tubercolosi, o infezione tubercolare latente (LTBI), o attuale o storia di infezione micobatterica non tubercolare (NTMBI)
    - Il partecipante allo studio ha un'infezione attiva clinicamente rilevante o una storia di infezione grave (con conseguente ospedalizzazione o che richiede un trattamento antibiotico per via endovenosa) entro 6 settimane prima della visita di base
    - Il partecipante allo studio ha precedentemente partecipato a qualsiasi studio MG con rozanolixizumab e ha soddisfatto qualsiasi criterio per il ritiro obbligatorio o sospensione obbligatoria del farmaco in studio
    - Il partecipante allo studio ha ricevuto una vaccinazione viva entro 4 settimane prima di iniziare il trattamento o un vaccino contro il Bacillus Calmette Guérin (BCG) entro 1 anno prima di iniziare il trattamento; o intende sottoporsi a una vaccinazione viva nel corso dello studio o entro 8 settimane dall'ultima dose di rozanolixizumab
    - Il partecipante allo studio ha grave debolezza (definita come Grado 3 sulla scala delle attività di vita quotidiana della miastenia gravis (MG-ADL)) che colpisce i muscoli orofaringei o respiratori, o che ha crisi miasteniche o crisi imminenti
    E.5 End points
    E.5.1Primary end point(s)
    1. Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 13
    2. Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respecively) during the Self-administration Period at Visit 19
    1. Efficacia dell’auto-somministrazione di rozanolixizumab (con uso corretto rispettivamente della pompa a siringa e della spinta manuale) durante il periodo di auto-somministrazione alla Visita 13
    2. Efficacia dell’auto-somministrazione di rozanolixizumab (con uso corretto rispettivamente della pompa a siringa e della spinta manuale) durante il periodo di auto-somministrazione alla Visita 19
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Visit 13 (Week 12; last dose of Self-administration Period 1)
    2. Visit 19 (Week 18; last dose of Self-administration Period 2)
    1. Visita 13 (Settimana 12; ultima dose del periodo di auto-somministrazione 1)
    2. Visita 19 (Settimana 18; ultima dose del periodo di auto- somministrazione 2)
    E.5.2Secondary end point(s)
    1. Occurrence of Treatment-Emergent Adverse Events (TEAEs) after syringe driver or manual push self-administration from Visit 2 up to the End of Study Visit
    2. Occurrence of local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods
    3. Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study
    1. Frequenza di eventi avversi emergenti dal trattamento (TEAE) dopo l’auto-somministrazione con pompa a siringa o mediante spinta manuale dalla Visita 2 fino alla Visita di fine studio
    2. Frequenza di reazioni locali nel sito di iniezione fino a 24 ore dopo ciascuna somministrazione durante il Periodo di formazione e i periodi di auto-somministrazione.
    3. Frequenza di errori terapeutici associati a reazioni avverse durante i 2 periodi di auto-somministrazione dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 (Week 26))
    2. Up to 24 hours after each administration during the Training Period (Baseline to Visit 7 (Week 6) and Self-administration Periods (Visit 8 (Week 7) to Visit 19 (Week 18))
    3. During the Self-administration Periods (Visit 8 (Week 7) to Visit 19 (Week 18))
    1. Dalla Visita 2 (Settimana 1) fino alla Visita di fine studio (Visita 21 [Settimana 26])
    2. Fino a 24 ore dopo ciascuna somministrazione durante il Periodo di formazione (dalla visita base alla Visita 7 (Settimana 6) e i periodi di auto-somministrazione (dalla Visita 8 (Settimana 7) alla Visita 19 (Settimana 18)).
    3. Durante i periodi di auto-somministrazione (dalla Visita 8 (Settimana 7) alla Visita 19 (Settimana 18)).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Japan
    United States
    Poland
    Spain
    Germany
    Italy
    Georgia
    United Kingdom
    Serbia
    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 months0
    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 months1
    E.8.9.2In all countries concerned by the trial days20
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 30
    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)
    Following participation in MG0020, study participants who have completed the study (End of Study Visit performed) will have the option of a post-trial access to rozanolixizumab at the discretion of the investigator, if available according to local guidance.
    Dopo la partecipazione allo studio MG0020, i partecipanti che hanno completato lo studio (visita di fine studio eseguita) avranno la possibilità di un accesso post-studio a rozanolixizumab a discrezione dello sperimentatore, se disponibile secondo le linee guida locali.
    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 Decision2023-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-07
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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