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    Summary
    EudraCT Number:2017-000184-32
    Sponsor's Protocol Code Number:205203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-03
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio sulla sicurezza, multicentrico, di estensione, in aperto volto a descrivere gli effetti clinici di mepolizumab a lungo termine in pazienti con sindrome ipereosinofila (HES) che hanno partecipato allo Studio 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
    Studio con mepolizumab in pazienti con sindrome ipereosinofila (HES) che hanno partecipato allo Studio 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.
    Studio sulla sicurezza, multicentrico, di estensione, in aperto volto a descrivere gli effetti clini
    A.4.1Sponsor's protocol code number205203
    A.5.4Other Identifiers
    Name:205203Number:205203
    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 RESEARCH AND DEVELOPMENT
    B.1.3.4CountryUnited Kingdom
    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 Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004408007839733
    B.5.5Fax number0000000
    B.5.6E-mailGSKClinicalSupportHD@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 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/3/04/213
    D.3 Description of the IMP
    D.3.1Product nameMEPOLIZUMAB
    D.3.2Product code [SB-240563]
    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 codeSB-240563
    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 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
    Hypereosinophilic syndrome (HES)
    Sindrome ipereosinofila grave (HES)
    E.1.1.1Medical condition in easily understood language
    Hypereosinophilic syndrome (HES)
    Sindrome ipereosinofila grave (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.
    Descrivere il profilo di sicurezza a lungo termine di mepolizumab in pazienti con HES che hanno partecipato allo Studio 200622.
    E.2.2Secondary objectives of the trial
    Not Applicable
    non applicabile
    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.
    I partecipanti sono idonei ad essere arruolati nello studio solo se soddisfano tutti i seguenti criteri:
    Requisiti dello studio 200622
    1. Partecipanti di almeno 12 anni che hanno partecipato allo studio 200622. Per essere considerati per lo studio 205203, i partecipanti dello studio 200622 devono aver completato le valutazioni fino alla 32esima settimana dalla randomizzazione:
    (i) Completamento delle 32 settimane di trattamento nello Studio 200622
    Oppure
    (ii) Se il partecipante è stato ritirato prematuramente durante lo studio 200622, ma ha continuato nello studio secondo protocollo (includendo le valutazioni del flare di HES) fino alla 32esima settimana dalla randomizzazione
    Sesso
    2. Maschi o Femmine
    Una paziente femmina che soddisfi una delle seguenti condizioni:
    (i) Non si tratta di una donna in età fertile (Woman Of Childbearing Potential, WOCBP) secondo la definizione presente nell’Appendice 5 del protocollo
    Oppure
    (ii) Si tratta di una WOCBP che acconsente a seguire le linee guida sulla contraccezione riportate nell’Appendice 5 del protocollo almeno 30 giorni prima dalla prima dose del trattamento di studio e fino a 16 settimane dopo dall’ultima dose del trattamento dello studio
    Rapporto rischio/beneficio positivo
    3. Il medico curante deve confermare un rapporto rischio/beneficio positivo. Il vantaggio clinico previsto da mepolizumab deve avere più peso di ogni possibile rischio di sicurezza o tollerabilità nello studio 205203.
    Consenso Informato
    4. Un paziente capace di firmare il Consenso Informato come descritto nell’Appendice 3 del protocollo, che comprende il rispetto dei requisiti e delle restrizioni elencati nel modulo di Consenso Informato (ICF) ed in questo protocollo.
    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.
    I partecipanti sono esclusi dallo studio se si verifica uno qualsiasi dei seguenti criteri:
    Condizioni mediche
    1. Pazienti con ipersensibilità a qualunque anticorpo monoclonale (compreso mepolizumab)
    2. Pazienti con neoplasia maligna o che hanno sviluppato neoplasia maligna durante lo studio 200622. NOTA: Pazienti che hanno avuto neoplasie maligne localizzate della pelle (ad esempio a cellule basali o squamose) rimosse chirurgicamente per terapia, non saranno esclusi dallo studio.
    3. Paziente in gravidanza o allattamento. NOTA: Le pazienti non dovrebbero essere considerate per l’estensione del trattamento se hanno in programma una gravidanza durante il corso del trattamento con mepolizumab.
    4. Pazienti che hanno altre condizioni mediche clinicamente significative e non controllate dalla terapia SoC e non legate a HES, come ad esempio, malattia epatica instabile, malattia cardiovascolare incontrollata, malattia infettiva in corso. NOTA: Pazienti con infezioni parassitarie (elmintiche) recenti saranno esclusi dallo studio oppure sarà richiesto un trattamento adeguato per le infezioni elmintiche, prima dell’inizio del trattamento con mepolizumab.
    5. Partecipanti con QTc>450 msec o QTc>480 msec in pazienti con blocco di branca, basato sulla lettura di un ECG locale. NOTA: • Il QTc è l’intervallo QT corretto per la frequenza cardiaca, in accordo con la formula di Bazett (QTcB), la formula Fridericia (QTcF), e/o un altro metodo. E’ letto dalla macchina oppure letto manualmente.
    • La formula specifica usata per determinare l’ammissibilità e l’interruzione per un individuo partecipante, dovrebbe essere determinata prima dell’inizio dello studio. In altre parole, non possono essere usate diverse formule per calcolare il QTc per un individuo partecipante e quindi il valore più basso di QTc non può essere usato per includere o rimuovere il paziente dallo studio clinico.
    6. Anomalia/Malattia epatica:
    • I partecipanti che interrompono il trattamento sperimentale nello studio 200622, sulla base dei criteri di interruzione legati alla chimica epatica,
    • Malattie del fegato e delle vie biliari in corso (ad eccezione della sindrome di Gilbert o calcoli biliari asintomatici o epatopatia cronica stabile in base alla valutazione dello sperimentatore). NOTA: L’epatopatia cronica stabile deve generalmente essere definita da assenza di ascite, encefalopatia, coagulopatia, ipoalbuminemia, varici esofagee o gastriche, ittero persistente o cirrosi.
    Esperienza di studi clinici precedenti/paralleli
    7. Altro farmaco sperimentale/studio clinico:
    • Assunzione di un farmaco sperimentale (biologico o non biologico) nei 30 giorni o nelle 5 emivite del farmaco (in base al periodo più lungo) precedenti la prima dose, eccezion fatta per il farmaco sperimentale dello studio 200622. Il termine “sperimentale” si riferisce a qualunque farmaco non approvato per la vendita per una certa patologia/indicazione nel Paese in cui viene utilizzato o a formulazioni sperimentali di prodotti in commercio.
    • Pazienti che attualmente partecipano ad un qualsiasi altro studio clinico interventistico
    8. Partecipanti che hanno avuto un evento avverso (grave o non grave) considerato legato al trattamento dello studio 200622, che ha comportato un ritiro permanente del trattamento di studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events (AEs) [serious and non- serious]
    • Anti-drug antibody
    -Eventi avversi (AEs) gravi e non gravi
    -Anticorpi anti-mepolizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    During 20 weeks starting randomization
    nelle 20 settimane successive alla randomizzazione
    E.5.2Secondary end point(s)
    No secondary endpoints
    Nessun endpoint secondario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    na
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    nessun comparatore
    no comparator
    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 concerned6
    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 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
    Brazil
    Mexico
    Russian Federation
    United States
    Argentina
    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 months7
    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.1.1.1In 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 state10
    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 mepolizumab HES expanded access (e.g., MHE104317, MHE112562), where local regulation permits. Participants who prematurely discontinue mepolizumab during Study 205203 will be considered for mepolizumab HES expanded access, if available, 20 weeks after the first dose.
    I partecipanti che completano la valutazione della Visita 6 (20sima settimana) saranno valutati per continuare il trattamento con mepolizumab tramite il programma di HES expanded access (MHE112562).
    I partecipanti che interrompono prematuramente mepolizumab durante lo studio 205203, saranno valutati per l'HES expanded access con mepolizumab, se disponibile, 20 settimane dopo la prima dose.
    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 Decision2018-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    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.

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