Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000184-32
    Sponsor's Protocol Code Number:205203
    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:2017-07-21
    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 number2017-000184-32
    A.3Full title of the trial
    A multi-centre, open-label extension, safety study to describe the longterm
    clinical experience of mepolizumab in participants with hypereosinophilic syndrome (HES) from Study 200622
    Estudio multicéntrico, de extensión abierto y de seguridad, para describir la experiencia clínica a largo plazo con mepolizumab en pacientes con síndrome hipereosinofílico (HES) procedentes del estudio 200622.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of mepolizumab in patients with HES from Study 200622
    Estudio con mepolizumab en pacientes con síndrome hipereosinofílico (HES) procedentes del estudio 200622.
    A.3.2Name or abbreviated title of the trial where available
    A multi-centre, open-label, long term safety study of mepolizumab in subjects with HSE.
    A.4.1Sponsor's protocol code number205203
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.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 Yes
    D.2.1.1.1Trade name Nucala
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Trading Services Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/04/213
    D.3 Description of the IMP
    D.3.1Product nameNucala
    D.3.2Product code SB240563
    D.3.4Pharmaceutical form Lyophilisate for 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 INNMEPOLIZUMAB
    D.3.9.1CAS number 196078-29-2
    D.3.9.2Current sponsor codeSB240563
    D.3.9.3Other descriptive nameMEPOLIZUMAB
    D.3.9.4EV Substance CodeSUB21650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypereosinophilic syndrome (HES)
    Síndrome hipereosinofílico (HES)
    E.1.1.1Medical condition in easily understood language
    Hypereosinophilic syndrome (HES)
    Síndrome hipereosinofílico (HES)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048643
    E.1.2Term Hypereosinophilic syndrome
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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
    To describe the long-term safety profile of mepolizumab in participants with HES who took part in Study 200622.
    Describir el perfil de seguridad a largo plazo de mepolizumab en sujetos con HES que participaron en el Estudio 200622.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Study 200622 requirements
    1. Age 12 years and older participants who were enrolled in Study 200622.
    To be considered for Study 205203, Study 200622 participants must have completed 32-week assessments since randomization:
    (i) Completion of the 32-week treatment period in Study 200622
    OR
    (ii) If the participant was withdrawn from study treatment prematurely during the 200622 study, but continued in the study per protocol(including HES flare related assessments) until 32 weeks from randomization.
    Sex
    2. Male or female
    Female participants:
    A female participant who meets one of the following conditions:
    (i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5
    OR
    (ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 at least 30 days prior to the first dose of study treatment and until 16 weeks after the last dose of study treatment.

    Positive benefit: risk ratio
    3. The treating physician must confirm a positive benefit/risk ratio. The anticipated clinical benefit from mepolizumab must outweigh any potential safety or tolerability risk in Study 205203.

    Informed consent
    4. Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    El paciente podrá participar en este estudio únicamente si satisface todos los criterios siguientes:

    Requerimientos del estudio 200622:
    1. 12 o más años de edad cuando fueron aleatorizados en el estudio 200622. Para entrar en el Estudio 205203, los pacientes del Estudio 200622 tienen que haber completado las evaluaciones del periodo de 32 semanas desde aleatorización:
    (i) Periodo de 32 semanas de tratamiento en el Estudio 200622
    O
    (ii) Si el paciente suspendió prematuramente el tratamiento en el estudio 200622, pero continuó en el estudio conforme al protocolo (incluidas las evaluaciones relacionadas con los brotes de HES) hasta la semana 32 desde la aleatorización.

    Sexo:
    2. Varón o mujer
    Mujeres que cumplan al menos una de las condiciones siguientes:
    (i) Sin capacidad de procrear (MSCP), como se define en el Apendice 5.
    O
    (ii) Son capacidad de procrear que aceptan seguir los métodos anticonceptivos del Apéndice 5 durante al menos 30 días antes de la primera dosis de la medicación del estudio y hasta 16 semanas después de la última dosis de medicación del estudio.
    Ratio beneficio-riesgo positivo
    3. El medico tratante tiene que confirmar un coeficiente beneficio-riesgo positivo. El beneficio clínico esperado con mepolizumab tiene que compensar cualquier riesgo potencial de seguridad o tolerabilidad en el Estudio 205203.
    Consentimiento Informado:
    4. Capacidad de otorgar el consentimiento/asentimiento informado firmado, tal como se describe en el Apéndice 3, lo que incluye el cumplimiento de los requisitos y restricciones mencionados en el documento de consentimiento y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical conditions
    1. Participants with any history of hypersensitivity to any monoclonal antibody (including mepolizumab)
    2. Participants with current malignancy or malignancy that developed during Study 200622.
    NOTE:
    Participants who had localized localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
    3. Participant who is pregnant or breastfeeding.
    NOTE:
    Participants should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.
    4. Participant who has other clinically significant medical conditions uncontrolled with SoC therapy not associated with HES, e.g., unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease.
    NOTE:
    -Participants with recent parasitic (helminth) infections will be excluded from the study or required to be adequately treated for helminth infections before initiation of mepolizumab.
    5. Participants with QTc >450 msec or QTc > 480 msec in participants with bundle branch block based on local EGC reading
    NOTES:
    -The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is either machine-read or manually over-read.
    - The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.

    6. Liver abnormality/disease:
    - Participants who discontinue study treatment based on liver chemistry stopping
    criteria during Study 200622
    -Current active liver or biliary disease (with the exception of Gilbert’s syndrome
    or asymptomatic gallstones or otherwise stable chronic liver disease per
    investigator assessment).
    NOTE: Stable chronic liver disease should generally be defined by the absence
    of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or
    gastric varices, or persistent jaundice, or cirrhosis.

    Prior/concurrent clinical study experience

    7. Other investigational product/clinical study:
    -Participants who have received treatment with an investigational agent (biologic
    or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer,
    prior to the first dose, other than Study 200622 study treatment. The term “investigational” applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or
    investigational formulations of marketed products
    -Participants who are currently participating in any other interventional clinical
    study

    8. Participant had an adverse event (serious or non-serious) considered related to study treatment while participating in Study 200622 which resulted in permanent withdrawal of study treatment.
    No podrán participar en el estudio los pacientes que cumplan cualquiera de los criterios siguientes:
    Condiciones médicas:
    1. Pacientes con cualquier antecedente de hipersensibilidad a cualquier anticuerpo monoclonal (incluido mepolizumab).
    2. Pacientes con neoplasia maligna o neoplasia maligna que se desarrolló durante el Estudio 200622.
    NOTA: No se excluirá a los pacientes con carcinoma localizado (es decir, basocelular o espinocelular) de la piel que se haya resecado para curarlo.
    3. Mujeres embarazas o en periodo de lactancia.
    NOTA: No serán elegibles para recibir tratamiento continuado aquellas mujeres que planeen quedarse embarazadas durante el periodo de tratamiento con mepolizumab.
    4. Pacientes con otras afecciones concurrentes clínicamente significativas, mal controladas con corticosteroides orales, no relacionadas con el HES, como por ejemplo, enfermedad hepática inestable, enfermedad cardiovascular descontrolada, infecciones activas en curso.
    NOTA: Los pacientes con infestación parasitaria (por helmintos) reciente quedarán excluidos del estudio o tendrán que ser tratados de forma adecuada de la infestación por helmintos antes de iniciar mepolizumab.
    5. Pacientes con QTc >450 ms o QTc >480 ms en pacientes con bloqueo de rama en base a la lectura local del ECG.
    NOTAS:
    - El QTc es el intervalo QT corregido por la frecuencia cardíaca según la fórmula de Bazett (QTcB), la fórmula de Fridericia (QTcF), y/u otro método. Puede ser calculado por la máquina o leído manualmente.
    - La fórmula específica para determinar la elegibilidad y discontinuación de cada sujeto, se tiene que definir antes del inicio del estudio. Es decir, no se pueden utilizar varias fórmulas diferentes para calcular el QTc de cada paciente para después usar el valor más bajo de QTc para incluir o discontinuar a un paciente en el estudio.
    6. Alteración/enfermedad hepática:
    - Pacientes que interrumpen la medicación del estudio en base al criterio de interrupción por bioquímica hepática durante el Estudio 200622.
    - Enfermadad hepática o biliar activa actual (excepto el síndrome de Gilbert o la litiasis biliar asintomática o una hepatopatía crónica por lo demás estable según la evaluación del investigador).
    NOTA: Por lo general, la hepatopatía crónica estable deberá definirse por la ausencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices esofágicas o gástricas, o ictericia persistente o cirrosis.
    Experiencia clínica de estudios previos/concurrentes:
    7. Otro producto en investigación/estudio clínico:
    - Pacientes que hayan recibido tratamiento con un fármaco en investigación (biológico o no biológico) diferente del tratamiento del estudio 200622 en los 30 días previos o 5 semividas, lo que sea más largo, antes de la primera dosis. El término “en investigación” se aplica a todo medicamento no aprobado para la venta en el país en el que se utiliza o formulaciones experimentales de productos comercializados.
    - Pacientes que estén participando actualmente en otro estudio clínico de intervención.
    8. Pacientes que presenten un efecto adverso (grave o no) que se considere relacionado con la medicación del estudio mientras participen en el Estudio 200622, y que lleve interrupción permanente del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events (AEs) [serious and non- serious]
    - Anti-drug antibody
    - Acontecimientos adversos (AA) [graves y no graves]
    - Anticuerpo antifármaco
    E.5.1.1Timepoint(s) of evaluation of this end point
    During 20 weeks starting randomization
    E.5.2Secondary end point(s)
    No secondary endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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 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 No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Argentina
    Brazil
    Mexico
    Russian Federation
    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
    Última visita del último paciente.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 8
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    Participants who complete assessments at Visit 6 (Week 20) in Study 205203 may continue with mepolizumab treatment via MHE104317/MHE112562, where local regulation permits. Participants who prematurely discontinue mepolizumab during Study 205203 will be considered for MHE104317/MHE112562, if available, 20 weeks after the first dose.
    Los sujetos que completen las evaluaciones en la Visita 6 (Semana 20) pueden continuar recibiendo mepolizumab a través de MHE104317/MHE112562, siempre que la normativa local lo permita. Los sujetos del Estudio 205203 que no continúen en MHE104317/MHE112562 se someterán a una evaluación de seguimiento adicional en la Visita 7 (28 semanas después de la primera dosis y 12 semanas tras la última dosis de mepolizumab).
    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 Decision2017-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-30
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 07 15:37:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA