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    Summary
    EudraCT Number:2022-003870-21
    Sponsor's Protocol Code Number:MG0020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 ConcernedSpain - AEMPS
    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​
    Estudio abierto y cruzado para evaluar la autoadministración del
    rozanolixizumab por los participantes en el estudio con miastenia gravis generalizada.
    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)
    Estudio de fase 3, abierto y cruzado, para evaluar la autoadministración del
    rozanolixizumab por los participantes en el estudio con gMG.
    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.3.9.3Other 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 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
    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 autoinmunitaria
    que causa debilidad en los músculos; Es causada por un problema de comunicación entre los nervios y los 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 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​
    Evaluar la capacidad de los
    participantes en el estudio con gMG para autoadministrarse con éxito el rozanolixizumab, tras su formación en la técnica de autoadministración, utilizando los métodos de syringe driver y manual push
    E.2.2Secondary objectives of the trial
    ​​To evaluate the safety of subcutaneous (SC) self-administration​
    Evaluar la seguridad de la
    autoadministración SC del
    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​
    - Los participantes en el estudio deben tener un diagnóstico documentado de
    Miastenia gravis (gMG)
    - El participante del estudio está dispuesto a realizar y es capaz de realizar la autoadministración domiciliaria
    - Se considera que el participante del estudio recibe rozanolixizumab adicional
    Tratamiento con la posología propuesta en este estudio
    - Peso corporal >=35 kg
    - Los participantes del estudio pueden ser hombres o mujeres
    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
    - El participante del estudio tiene una hipersensibilidad conocida a cualquiera de los componentes del medicamento del estudio u otros medicamentos anti-receptor Fc neonatal (FcRn).
    - Participante del estudio con una infección de tuberculosis (TB) conocida, con alto riesgo de contraer una infección de TB o una infección de tuberculosis latente (LTBI), o una infección por micobacterias no tuberculosas actual o anterior (NTMBI)
    - El participante del estudio tiene una infección activa clínicamente relevante o antecedentes de infección grave (que resultó en hospitalización o requirió tratamiento con antibióticos por vía intravenosa) dentro de las 6 semanas anteriores a la visita inicial
    - El participante del estudio participó previamente en cualquier estudio de rozanolixizumab MG y cumplió con los criterios obligatorios de retiro o interrupción obligatoria del fármaco del estudio.
    - El participante del estudio ha recibido una vacuna viva dentro de las 4 semanas antes de comenzar el tratamiento, o una vacuna de Bacillus Calmette Guérin (BCG) dentro de 1 año antes de comenzar el tratamiento; o tiene la intención de recibir una vacuna viva durante el curso del estudio o dentro de las 8 semanas posteriores a la última dosis de rozanolixizumab
    - Participante del estudio con debilidad grave (definida como grado 3 en la escala de actividades de la vida diaria (MG-ADL) de miastenia gravis) que afecta los músculos orofaríngeos o respiratorios, o que tiene una crisis miasténica o una crisis inminente
    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.Autoadministración con éxito de rozanolixizumab
    (con uso correcto del syringe driver y del manual
    push, respectivamente) durante los Períodos de
    Autoadministración, en la Visita 13.
    2. Autoadministración con éxito de rozanolixizumab
    (con uso correcto del syringe driver y del manual
    push, respectivamente) durante los Períodos de
    Autoadministración, en la 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
    (Semana 12; última dosis Período de
    Autoadministración 1)
    2. la Visita 19 (Semana 18;
    última dosis del Período de Autoadministración 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. Presentación de acontecimientos adversos surgidos
    durante el tratamiento (treatment-emergent adverse
    events [TEAEs]) tras la autoadministración mediante
    syringe driver o manual push desde la Visita 2
    hasta la Visita de Fin del Estudio
    2. Presentación de reacciones locales en la zona de
    administración en las 24 horas siguientes a cada
    administración durante el Periodo de Formación y
    los Periodos de Autoadministración.

    3. Producción de errores de medicación que cursen con reacciones adversas durante los 2 Periodos de
    Autoadministración del estudio.
    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. Desde la Visita 2 (Semana 1) hasta la Visita de Fin de Estudio (Visita 21 (Semana 26))
    2. Hasta 24 horas después de cada administración durante el Período de Formación (Línea base hasta la Visita 7 (Semana 6) y Períodos de Autoadministración (Visita 8 (Semana 7) hasta la Visita 19 (Semana 18))
    3. Durante los Períodos de Autoadministración (Visita 8 (Semana 7) a Visita 19 (Semana 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 No
    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 Information not present in EudraCT
    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 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 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 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
    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/ Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    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.
    Tras su participación en MG0020, los participantes en el estudio que lo hayan completado (con práctica de la Visita de Fin del Estudio) tendrán la opción, a criterio del investigador, de acceder después de dicho ensayo al rozanolixizumab, si se encuentra disponible por las directrices
    locales.
    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 Decision2023-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-10
    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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