Expanded access program for mepolizumab in subjects with HES

GlaxoSmithKline, S.A.0 sites200 target enrollmentApril 26, 2018

Overview

No summary available.

Registry

who.int

Start Date

April 26, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 recognized 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

•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.