Subjects with life-threatening HES MedDRA version: 20.0 Level: PT Classification code 10048643 Term: Hypereosinophilic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In accordance with local procedures, written informed consent/assent can be obtained from the subject or legally authorized representative 2. = 12 years of age at the time of signing the informed consent/assent 3. Meets the diagnostic criteria for HES as defined by: - Eosinophilia >1500 cells/µl for at least 6 months with evidence of symptoms and signs of organ system involvement or dysfunction that can be directly related to eosinophilia (with no evidence of parasitic, allergic or other recognised causes of eosinophilia such as connective tissues disease, malignancy) or - Eosinophilia of >1500 cells/µl for less than 6 months and meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion of secondary causes of eosinophilia as above. 4. Subjects meeting all three of the following criteria will be eligible: - The indication, HES, is a seriously debilitating or life-threatening disease; - There is no satisfactory alternative treatment: documented failure (lack of efficacy or a contra-indication) to at least 3 standard therapies (corticosteroids, cytotoxic agents, immunomodulatory therapy, and Imatinib mesylate) at the appropriate duration and dose or demonstrated clinical benefit from prior treatment with mepolizumab; and - There is reason to believe that the benefit:risk ratio for mepolizumab in the indication is positive. Are the trial subjects under 18? yes Number of subjects for this age range: 23 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects without HES but with other conditions associated with eosinophilic pathological processes such as Eosinophilic Granulomatosis with Polyangiitis [EGPA], Wegener's Granulomatosis, atopic disorders, parasitic infections, eosinophilic gastroenteropathies. 2. Female subjects of childbearing potential who are not using a highly effective method of contraception: Consistent and correct use of an acceptable method of birth control for one month prior to the start of the investigational product and until 16 weeks after the last dose (see Section 12.2 of the protocol for a list of acceptable methods of contraception). 3. Pregnant or lactating females 4. Subjects with severe/life-threatening underlying disease unrelated to HES where life expectancy is estimated to be less than 3 months 5. Subjects with a history of or current malignancy: - Subjects with a history of or current lymphoma - Subjects with current malignancy or previous history of cancer in remission for less than 12 months prior to the first dose. Subjects that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded. 6. Subjects with history of serious allergic reaction (hypersensitivity/anaphylaxis) to anti-IL5 or other antibody therapy or known or suspected hypersensitivity to any component of mepolizumab, leading to treatment discontinuation 7. Subjects with current drug or alcohol abuse where uncertain compliance with the protocol and/or with the medical management instruction of the investigator may cause safety risk. 8. Subjects who have received treatment with an investigational agent (biologic or nonbiologic, excluding mepolizumab) within the past 30 days or 5 drug half-lives whichever is longer, prior to the administration of mepolizumab under this protocol.The term "investigational" applies to any drug not approved for sale in the country in which it is being used or investigational formulations of marketed products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: To assess the long-term AE profile associated with mepolizumab therapy. Efficacy: To characterize individual dosing requirements for control of disease.;Secondary Objective: ;Primary end point(s): Serious AEs (SAEs). Non-serious AEs related to mepolizumab as assessed by the investigator;Timepoint(s) of evaluation of this end point: Each clinic visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Mean 28-day SC dose (mg) for the last 3 administrations;Timepoint(s) of evaluation of this end point: Each clinic visit | — |
Countries
Belgium, France, Germany, Norway, Poland, Spain, United Kingdom
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed