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    The EU Clinical Trials Register currently displays   38958   clinical trials with a EudraCT protocol, of which   6398   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-002698-36
    Sponsor's Protocol Code Number:MG0002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002698-36
    A.3Full title of the trial
    A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis.
    Estudio multicéntrico, aleatorizado y controlado con placebo, de secuencias de tratamiento, con enmascaramiento para el investigador y el sujeto, a fin de evaluar la seguridad, la tolerabilidad y la eficacia de UCB7665 en sujetos con Miastenia Gravis de grado moderado o severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.
    Estudio para evaluar la seguridad, la tolerabilidad y la eficacia de UCB7665 en sujetos con Miastenia Gravis de grado moderado o severo
    A.4.1Sponsor's protocol code numberMG0002
    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 SPRL
    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-Str. 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number3491 391 3443
    B.5.5Fax number492173 481572
    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 nameUCB7665
    D.3.2Product code UCB7665
    D.3.4Pharmaceutical form Powder for 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 INNUCB7665
    D.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.3Other descriptive nameUCB7665
    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 number100
    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
    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
    Moderate to severe myasthenia gravis
    Miastenia Gravis de grado moderado o severo
    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 autoimmune que causa debilidad en los músculos; esta causada por problemas de comunicación entre nervios y músculos.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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
    Evaluate the clinical efficacy of UCB7665 as an chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe
    Evaluar la eficacia clínica del UCB7665 como tratamiento a largo plazo intermitente en sujetos con Miastenia Gravis (MG) generalizada de carácter moderado o severo
    E.2.2Secondary objectives of the trial
    - Gather data for future study planning, whether for chronic-intermittent treatment or a longer therapy option by evaluating the general concept that UCB7665 has a clinical effect in patients with generalized myasthenia gravis (MG)
    - Evaluate the safety and tolerability of UCB7665 administered by subcutaneous (sc) infusion in subjects with MG
    - Assess the effect of UCB7665 as measured by total immunoglobulin G (IgG) concentrations in serum
    - Recoger datos para un futuro plan de estudio, tanto para el tratamiento a largo plazo intermitente como para opciones de tratamiento más prolongadas, mediante la evaluando del concepto general de que el UCB7665 es clínicamente eficaz en pacientes con MG generalizada.
    - Evaluar la seguridad y la tolerabilidad del UCB7665 administrado en infusión subcutanea (sc) a sujetos con MG
    - Evaluar el efecto del UCB7665 según la medición de la concentración sérica de IgG total
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
    - Subject would currently be considered for treatment with immunological therapy such as intravenous
    immunoglobulin/plasma exchange (IVIG/PLEX) by the investigator
    - Subject has documented evidence in his/her medical history or at Screening of detectable autoantibodies (anti-acetylcholine receptor+ve (Anti-AChR+ve) or anti-muscle specific kinase+ve (Anti-
    MuSK+ve)
    - Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
    - Male subjects must be willing to use a method of contraception
    - Sujeto con diagnóstico bien documentado de miastenia gravis (MG) en la Visita 1 (Selección), de acuerdo a sus antecedentes y con respaldo por evaluaciones previas
    - Sujeto que puede estar actualmente considerado por el investigador para posible tratamiento inmunológico, como inmunoglobulina intravenosa/plasmaféresis (IVIG/PLEX)
    - Sujeto con evidencia documentada en su historia médica o en la Selección de autoanticuerpos detectables [positividad de anti-receptor de acetilcolina (anti-AChR positivo) o positividad de anti-cinasa músculo-específica (anti-MuSK positivo)]
    - Si se trata de una mujer: en posmenopausia, sometida a esterilización permanente o, si es potencialmente fértil, que va a utilizar un método anticonceptivo altamente eficaz
    - Si se trata de un varón: conformidad en utilizar un método anticonceptivo
    E.4Principal exclusion criteria
    - Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
    - Subject has participated in another study of an investigational medicinal product (IMP; or a medical device) within the previous 30 days of Screening or is currently participating in another study of an
    investigational medicinal product (IMP; or a medical device)
    - Subject has a known hypersensitivity to any components of the IMP
    - Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
    - Subjects with MG only affecting the ocular muscles
    - Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
    - Subject has quantitative myasthenia gravis (QMG) score of <11 at Baseline
    - Subject has a serum total immunoglobulin G (IgG) level <= 6g/L at Screening
    - Absolute neutrophil count <1500 cells/mm^3
    - Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study
    - Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject’s ability to participate in this study
    - Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
    - Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
    - Sujeto que ha recibido tratamiento previamente en este estudio o que ha recibido previamente UCB7665
    - Sujeto que ha participado en otro estudio con un producto en fase de investigación (medicamento o producto sanitario) en el plazo de los 30 días anteriores a la Selección o que está participando actualmente en otro estudio con un producto en fase de investigación (medicamento o producto sanitario)
    - Sujeto con hipersensibilidad conocida a cualquier componente del medicamento en investigación
    - Sujeto con historia de hiperprolinemia (ya que la L-prolina es un componente del medicamento en investigación UCB7665)
    - Sujeto con MG que sólo afecta a musculatura ocular
    - Sujeto con debilidad severa que afecta a músculos orofaríngeos o respiratorios, o con crisis miasténicas en la Selección o con amenaza de crisis
    - Sujeto con una puntuación de la escala cuantitativa de miastenia gravis (QMG) <11 en el Basal
    - Sujeto con una concentración sérica de inmunoglobulina G (IgG) total < =6 g/L en la Selección
    - Recuento absoluto de neutrófilos <1.500 /mm^3
    - Sujeto con cualquier proceso médico (agudo o crónico) o psiquiátrico que, en opinión del investigador, podría poner en riesgo o comprometer su capacidad de participar en el estudio
    - Sujeto con una anomalía de laboratorio que, en opinión del investigador, es clínicamente importante, no se ha resuelto en la aleatorización o podría poner en riesgo o comprometer su capacidad de participar en el estudio
    - Sujeto que ha recibido una vacuna con gérmenes vivos en el plazo de las 8 semanas previas a la Visita Basal; o programado para recibir una vacuna con gérmenes vivos durante el curso del estudio o en el plazo de las 7 semanas siguientes a la última dosis del medicamento en investigación
    - Sujeto que ha recibido cualquier agente biológico experimental, dentro o fuera de un estudio clínico, en los 3 últimos meses o en el plazo de 5 semividas del agente antes del momento basal (eligiéndose el más prolongado de estos plazos)
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in Quantitative Myasthenia Gravis (QMG)
    score to Visit 9
    Variación respecto al momento basal de la puntuación de la escala cuantitativa de MG (QMG) en la visita 9
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Visit 9 (Day 29)
    Basal y Visita 9 (Día 29)
    E.5.2Secondary end point(s)
    Change from Baseline in Myasthenia Gravis-Composite score to
    Visit 9
    Change from Baseline in Myasthenia Gravis-Activities of Daily
    Living (MGADL) score to Visit 9
    Variación respecto al momento basal de la puntuación de la escala compuesta de MG (MG Composite) en la visita 9
    Variación respecto al momento basal del cuestionario de actividades cotidianas con MG (MGADL) en la visita 9
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Visit 9 (Day 29)
    Basal y Visita 9 (Día 29)
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    Germany
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last subject last visit (LSLV)
    Ultima Visita del Ultimo Sujeto (LSLV)
    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 months3
    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 months6
    E.8.9.2In all countries concerned by the trial days15
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 42
    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)
    No post-trial medication will be provided
    No se facilitará medicación post-ensayo.
    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 Decision2017-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-06
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