E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) |
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E.1.1.1 | Medical condition in easily understood language |
Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018701 |
E.1.2 | Term | Granulomatous disease |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072580 |
E.1.2 | Term | Granulomatous polyangiitis |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014956 |
E.1.2 | Term | Eosinophilic granuloma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014957 |
E.1.2 | Term | Eosinophilic granulomatous vasculitis |
E.1.2 | System Organ Class | 100000004870 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056218 |
E.1.2 | Term | Necrotising granulomatous vasculitis |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068462 |
E.1.2 | Term | Eosinophilic asthma |
E.1.2 | System Organ Class | 100000004855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036023 |
E.1.2 | Term | Polyangiitis |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible subjects who previously participated in GSKsponsored study MEA115921. |
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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] MEA115921 PARTICIPATION
1. Subject participated in study MEA115921
[2] MEA115921 COMPLETION
2. Subject has either:
i. completed study MEA115921 to Week 60, i.e., completion of follow up period,
or
ii. if the subject was withdrawn prematurely from study MEA115921, the subject has reached the date of what would have been the Week 60 if the subject had completed the study, i.e., 60 weeks from Baseline (Visit 2).
[3] SUBJECT REQUIRES PREDNISOLONE (OR EQUIVALENT)=>5 MG/DAY
3. At or up to 6 months after the MEA115921 Week 60 time- point the subject requires a dose of prednisolone (or equivalent) of =>5 mg/day for adequate control of their EGPA.
Note: Inclusion of subjects >6 months after the MEA115921 Week 60 time-point will be considered on an individual subject basis by the GSK Medical Monitor.
[4] PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT
4. 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.
[5] FEMALE SUBJECTS
5. 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 3, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.
[6] INFORMED CONSENT
6. The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme.
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E.4 | Principal exclusion criteria |
[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 standardof- care therapy not associated with EGPA, 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 IN MEA115921
5. Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in study MEA115921 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 IV immunoglobulin therapy without prior agreement from the GSK Medical Monitor.
[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.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
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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 |
Long term access programme (LAP) |
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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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | No |
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 |
France |
Germany |
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E.8.7 | Trial 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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |