E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with severe asthma |
Soggetti con asma grave |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSK-sponsored mepolizumab study. |
Mettere a disposizione un metodo per la fornitura di mepolizumab, su base individuale, ai soggetti eleggibili, affetti da asma, che hanno preso parte a uno studio su mepolizumab sponsorizzato da GSK. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 CLINICAL STUDY PARTICIPATION: Subject participated in GSK-sponsored asthma clinical study with mepolizumab as specified in Appendix 2 del protocollo. 2 STUDY COMPLETION: Subject has either: completed the treatment period in the mepolizumab asthma clinical study to which they were originally enrolled or if the subject was withdrawn from study treatment prematurely during the mepolizumab asthma clinical study to which they were originally enrolled but the subject has completed the study assessments at the study visit that would have been the end of the respective treatment period. 3 PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT: 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: 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 del protocollo, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration. 5 INFORMED CONSENT: The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme. In the case of a paediatric subject being eligible a parent(s)/guardian will give written informed consent prior to the child's participation in the study. If applicable, the subject must be able and willing to give assent to take part in the study according to the local requirement. |
1 PARTECIPAZIONE A UNO STUDIO CLINICO: Soggetti che hanno preso parte a uno studio clinico sull’asma con mepolizumab sponsorizzato da GSK, come specificato nell’Appendice 2 del protocollo. 2 COMPLETAMENTO DELLO STUDIO: Il soggetto: ha completato il periodo di trattamento previsto dallo studio clinico sull’asma con mepolizumab nel quale era stato inizialmente arruolato oppure ha interrotto anticipatamente il trattamento durante lo studio clinico sull’asma con mepolizumab nel quale era stato inizialmente arruolato, ma ha completato le valutazioni previste dallo studio in occasione della visita che sarebbe coincisa con la fine del relativo periodo di trattamento. 3 LA VALUTAZIONE DEL MEDICO È A FAVORE DEL TRATTAMENTO CON MEPOLIZUMAB: Il medico sperimentatore, che richiede il trattamento con mepolizumab nell’ambito del presente programma di accesso a lungo termine, ritiene che i benefici del trattamento per il singolo soggetto superino i rischi. 4 SOGGETTI DI SESSO FEMMINILE: Per essere eleggibili al trattamento con mepolizumab nell’ambito del presente programma di accesso a lungo termine, le donne potenzialmente fertili devono impegnarsi all’uso costante e corretto di un metodo contraccettivo accettabile, come riepilogato nell’Appendice 4 del protocollo, a partire dalla firma del consenso, per la durata del trattamento con mepolizumab e per 4 mesi dopo l’ultima somministrazione del farmaco. 5 CONSENSO INFORMATO: Il soggetto acconsente al trattamento con mepolizumab nell’ambito del presente Programma di accesso a lungo termine. Nel caso di un soggetto pediatrico eleggibile, sarà il genitore/tutore a dover fornire il consenso informato scritto prima di iniziare la partecipazione allo studio. Se opportuno, il soggetto dovrà essere in grado di dare il proprio assenso a partecipare allo studio e disposto a fornirlo in conformità ai requisiti locali. |
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E.4 | Principal exclusion criteria |
1 MALIGNANCY: 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: 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: 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: Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab. 5 PREMATURE WITHDRAWAL OF STUDY TREATMENT: 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: 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: Subject is currently participating in any other interventional clinical study. |
1 NEOPLASIA MALIGNA: Neoplasia maligna in atto o anamnesi positiva per cancro in remissione da meno di 12 mesi (non saranno esclusi i soggetti che hanno avuto un carcinoma localizzato della cute, ossia baso- o squamocellulare, sottoposti a resezione terapeutica). 2 ALTRE CONDIZIONI CLINICAMENTE SIGNIFICATIVE: Il soggetto presenta altre condizioni clinicamente significative non controllate con la terapia standard e non associate all’asma, quali epatopatia instabile, patologie cardiovascolari non controllate, malattie infettive in atto che richiedono un trattamento sistemico. 3 GRAVIDANZA: Il soggetto è in gravidanza o in allattamento. Non si devono prendere in considerazione per la prosecuzione del trattamento i soggetti che pianificano una gravidanza nel periodo di trattamento con mepolizumab. 4 IPERSENSIBILITÀ: Il soggetto ha un’allergia/intolleranza nota a un anticorpo monoclonale o a una terapia biologica incluso il mepolizumab. 5 INTERRUZIONE ANTICIPATA DEL TRATTAMENTO IN STUDIO: Durante la partecipazione a uno studio clinico con mepolizumab, il soggetto ha presentato un evento avverso (serio o non serio) ritenuto correlato al trattamento in studio e che ha portato all’interruzione permanente del trattamento in studio. 6 ALTRE TERAPIE BIOLOGICHE: Il soggetto è sottoposto a un’altra terapia biologica, ad es. una terapia con un anticorpo monoclonale o una terapia con immunoglobuline (Ig) per via endovenosa (ev). 7 ALTRI PRODOTTI SPERIMENTALI: Soggetti trattati con un farmaco sperimentale nei 30 giorni o nelle 5 emivite in fase terminale del farmaco (in base al periodo più lungo) precedenti l’inizio del trattamento con mepolizumab nell’ambito del presente programma di accesso a lungo termine (sono incluse anche formulazioni sperimentali di prodotti in commercio). 8 ALTRI STUDI CLINICI: Il soggetto attualmente partecipa a un qualsiasi altro studio clinico interventistico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Not applicable since this study is a long term access programme (no endpoints included in the protocol) |
Non applicabile in quanto Programma di accesso a lungo termine (non sono presenti endpoint nel protocollo) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Not applicable since this study is a long term access programme (no endpoints included in the protocol) |
Non applicabile in quanto Programma di accesso a lungo termine (non sono presenti endpoint nel protocollo) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Pharmacovigilance |
Farmacovigilanza |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Japan |
Peru |
Russian Federation |
Ukraine |
United States |
Argentina |
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E.8.7 | Trial 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
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Supply of mepolizumab under the LAP will continue until mepolizumab is commercially available in the relevant country. Treating physicians are responsible for the individual benefit versus risk assessments and safety monitoring in support of continued mepolizumab treatment. |
La fornitura di mepolizumab nell’ambito del LAP proseguirà fino a che mepolizumab non sarà disponibile in commercio nel Paese interessato. I medici sperimentatori sono responsabili delle valutazioni del rapporto di rischio/beneficio e del monitoraggio della sicurezza dei soggetti per la prosecuzione del trattamento con mepolizumab. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |