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    Summary
    EudraCT Number:2015-001152-29
    Sponsor's Protocol Code Number:201956
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-001152-29
    A.3Full title of the trial
    A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study
    Program dlugoterminowego dostepu do leczenia dla pacjentow z ciezka astma, ktorzy uczestniczyli w sponsorowanym przez firme GSK badaniu klinicznym nad mepolizumabem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-term Access Programme for Asthmatic Subjects who Participated in a Clinical Study with Mepolizumab
    Program dlugoterminowego dostepu dla pacjentow z astma ktorzy uczestniczyli w badaniu klinicznym z mepolizumabem
    A.4.1Sponsor's protocol code number201956
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02543112
    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 & Development Ltd
    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 pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron 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 number+44 0208 990 44 66
    B.5.5Fax number+44 0208 990 12 34
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNucala
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody (IgG1, kappa), which targets human interleukin 5 (IL 5) with high affinity and specificity
    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
    Subjects with severe asthma
    ciężka astma
    E.1.1.1Medical condition in easily understood language
    severe asthma
    ciężka astma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSKsponsored mepolizumab study.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for the LAP only if all of the following criteria apply:

    [1] CLINICAL STUDY PARTICIPATION
    Subject participated in GSK-sponsored asthma clinical study with mepolizumab as specified in Appendix 2 of the study protocol

    [2] STUDY COMPLETION
    2. Subject has either:
    i. completed the preceding mepolizumab asthma clinical study
    or
    ii. the subject was withdrawn from study treatment prematurely during the preceding mepolizumab asthma clinical study due to study closure prior to commercial availability

    [3] PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT
    3. The treating physician requesting mepolizumab under this Long-term Access Programme considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.

    [4] FEMALE SUBJECTS
    4. To be eligible for mepolizumab treatment under this Long-term Access Programme, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control, as summarised in Appendix 4 of the study protocol, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.

    [5] INFORMED CONSENT
    5. The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme.
    Or for paediatrics: parent(s)/guardian able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. If applicable, the subject must be able and willing to give assent to take part in the study according to the local requirement.
    1) UCZESTNICTWO W BADANIU KLINICZNYM
    Pacjent uczestniczył w sponsorowanym przez GSK badaniu klinicznym Mepolizumabu w leczeniu astmy zgodnie z Załącznikiem 2 (Protokołu badania)
    2) ZAKOŃCZENIE BADANIA
    Pacjent:
    i. ukończył wcześniejsze badanie kliniczne mepolizumabu w leczeniu astmy lub też
    ii. leczenie pacjenta w ramach badania klinicznego mepolizumabu w leczeniu astmy zostało przedterminowo przerwane z powodu zakończenia tego badania zanim lek stał się dostępny na rynku.
    3) OCENA LEKARZA PROWADZĄCEGO PRZEMAWIAJĄCA ZA LECZENIEM MEPOLIZUMABEM
    Lekarz prowadzący składający zapotrzebowanie na Mepolizumab w ramach niniejszego Programu Długofalowego Dostępu uznaje, że w przypadku danego pacjenta korzyści z podawania mepolizumabu przewyższają zagrożenia wynikające z takiego leczenia.
    4) KOBIETY BIORĄCE UDZIAŁ W BADANIU
    Aby kwalifikować się do leczenia mepolizumabem w ramach niniejszego Programu Długofalowego Dostępu, kobiety zdolne do posiadania potomstwa (FCBP) muszą zobowiązać się do stałego i prawidłowego stosowania akceptowanej metody kontroli urodzeń, zgodnie z podsumowaniem w Załączniku 4 (Protokołu badania), od chwili wyrażenia zgody, przez cały okres leczenia mepolizumabem oraz przez 4 miesiące po przyjęciu jego ostatniej dawki.
    5) ŚWIADOMA ZGODA
    Pacjent wyraża zgodę na leczenie mepolizumabem w ramach niniejszego Programu Długofalowego Dostępu. W przypadku pacjentów pediatrycznych: Rodzic(-e)/opiekun muszą wyrazić pisemną świadomą zgodę przed rozpoczęciem udziału dziecka w badaniu, jak też muszą być w stanie przestrzegać wszystkich wymagań i ograniczeń opisanych w formularzu zgody. Jeżeli dotyczy, pacjent musi być w stanie i musi chcieć udzielić świadomej zgody na wzięcie udziału w omawianym badaniu, odpowiednio do miejscowych wymagań.
    E.4Principal exclusion criteria
    A subject will not be eligible for the LAP if any of the following criteria apply:

    [1] MALIGNANCY
    1. A current malignancy or history of cancer in remission for less than 12 months (Subjects who had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded).

    [2] OTHER CLINICALLY SIGNIFICANT MEDICAL CONDITIONS
    2. Subject has other clinically significant medical conditions uncontrolled with standard of-care therapy not associated with asthma, e.g., unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease requiring systemic treatment.

    [3] PREGNANCY
    3. Subject is pregnant or breastfeeding. Subjects should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.

    [4] HYPERSENSITIVITY
    4. Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab.

    [5] PREMATURE WITHDRAWAL OF STUDY TREATMENT
    5. Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in a clinical study with mepolizumab which resulted in permanent withdrawal of study treatment.

    [6] OTHER BIOLOGICAL THERAPY
    6. Subject is receiving treatment with another biological therapy such as a monoclonal antibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.

    [7] OTHER INVESTIGATIONAL PRODUCTS
    7. Subjects who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to initiation of mepolizumab treatment under this Long-term Access Programme (this also includes investigational formulations of marketed products).

    [8] OTHER CLINICAL STUDY
    8. Subject is currently participating in any other interventional clinical study.

    Do omawianego badania nie kwalifikują się pacjenci spełniający KTÓREKOLWIEK z poniższych kryteriów:
    1) NOWOTWÓR ZŁOŚLIWY
    Występujący aktualnie lub w przeszłości nowotwór złośliwy w remisji trwającej mniej niż 12 lat (zlokalizowany rak skóry (podstawnokomórkowy lub kolczystokomórkowy) po resekcji z zamiarem wyleczenia nie stanowi kryterium wyłączenia z badania).
    2) INNE KLINICZNIE ISTOTNE CHOROBY
    Pacjent cierpi na inne klinicznie istotne choroby niezwiązane z astmą, których nie można kontrolować przy zastosowaniu standardów leczenia, takie jak np. niewyrównana choroba wątroby, niekontrolowana choroba układu krążenia, trwająca aktywna choroba zakaźna wymagająca leczenia ogólnoustrojowego.
    3) CIĄŻA
    Pacjentka jest w ciąży lub karmi piersią. Do kontynuacji leczenia nie należy włączać pacjentek, które planują zajść w ciążę w czasie cyklu leczenia mepolizumabem.
    4) NADWRAŻLIWOŚĆ
    U pacjenta stwierdzono uczulenie na przeciwciała monoklonalne lub leczenie biologiczne mepolizumabem albo ich nietolerancję.
    5) PRZEDTERMINOWE PRZERWANIE LECZENIA W RAMACH BADANIA
    Podczas uczestnictwa pacjenta w badaniu klinicznym mepolizumabu miało miejsce zdarzenie niepożądane (ciężkie lub niesklasyfikowane jako ciężkie) uznane za związane z badaniem, na skutek którego nastąpiło trwałe przerwanie leczenia.
    6) INNY RODZAJ TERAPII BIOLOGICZNEJ
    Pacjent uczestniczy aktualnie w innego rodzaju terapii biologicznej jak np. terapia przeciwciałem monoklonalnym czy stosowanie immunoglobulin podawanych dożylnie.
    7) INNE BADANE PRODUKTY
    Pacjenci, którzy otrzymywali leczenie z zastosowaniem leku o charakterze eksperymentalnym w okresie ostatnich 30 dni lub pięciu okresów półtrwania tego leku w fazie końcowej (w zależności od tego, który okres jest dłuższy) przed rozpoczęciem leczenia mepolizumabem w ramach omawianego Programu Długofalowego Dostępu (dotyczy to również eksperymentalnych postaci produktów już dopuszczonych do obrotu).
    8) INNE BADANIE KLINICZNE
    Pacjent aktualnie uczestniczy w jakimkolwiek innym interwencyjnym badaniu klinicznym.
    E.5 End points
    E.5.1Primary end point(s)
    Not applicable since this study is a long term access programme (no endpoints included in the protocol)
    • Nie dotyczy ponieważ niniejsze badanie jest Programem Długofalowego Dostępu (bez punktów końcowych zawartych w Protokole)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable since this study is a long term access programme.
    Nie dotyczy ponieważ niniejsze badanie jest Programem Długofalowego Dostępu
    E.5.2Secondary end point(s)
    Not applicable since this study is a long term access programme.
    • Nie dotyczy ponieważ niniejsze badanie jest Programem Długofalowego Dostępu
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable since this study is a long term access programme.
    • Nie dotyczy ponieważ niniejsze badanie jest Programem Długofalowego Dostępu
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pharmacovigilance
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Greece
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Peru
    Poland
    Russian Federation
    Slovakia
    Spain
    Ukraine
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days25
    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: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    English Written informed consent must be obtained from ALL patients/legally
    authorized representative(s); in the case of paediatric subjects, a parent(s)/guardian will give written informed consent prior to the child’s participation in the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 550
    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)
    The investigator is responsible for ensuring that consideration has been given to the post study care of the subject's medical condition whether or not GSK is providing specific post study treatment. At the end of the study, Mepolizumab (SB-240563) will be commercialised; subjects could either continue the treatment or either be prescribed appropriate alternative asthma therapy if needed and as determined by the study Investigator.
    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 Decision2017-06-22
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-31
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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
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