Expanded access program for mepolizumab in subjects with hypereosinophilic syndrome. - 104317

Glaxosmithkline Research & Development Limited0 sites15 target enrollmentJuly 8, 2024

ConditionsHypereosinophilic Syndrome Therapeutic area: Not possible to specify Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypereosinophilic Syndrome
Sponsor: Glaxosmithkline Research & Development Limited
Enrollment: 15
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 8, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Glaxosmithkline Research & Development Limited

Eligibility Criteria

Inclusion Criteria

•In accordance with local procedures, written informed consent/assent can be obtained from the subject or legally authorized representative., \>/\= 12 years of age at the time of signing the informed consent/assent, Meets the diagnostic criteria for HES as defined by: Eosinophilia \>1500 cells/mcl for a 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 tissue disease, malignancy) or Eosinophilia \>1500mcl 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, 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

Exclusion Criteria

•Subjects without HES but with other conditions associated with eosinophilic pathological processes such as Eosinophilic Granulomatosis with Polyangitis \[EGPA], Wegener's Granulomatosis, atopic disorders, parasitic infections, eosinophilic gastroenteropathies., 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., Pregnancy or lactating females, Subjects with severe/life\-threatening underlying disease unrelated to HES where life expectancy is estimate to be less than 3 months, Subjects with a history of or a current malignancy: Subjects with a history of or current lymphoma Subjects with current malignancy or previous history of malignancy 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., Subject 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., 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., Subjects who have received treatment with an investigational agent (biologic or non\-biologic, 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 investigation formulations of marketed products.