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Expanded access program for mepolizumab in subjects with hypereosinophilic syndrome.
EU CTIS ID: 2024-515247-28-00
What this study is testing
To provide expanded access for subjects that have a clear medical need and in whom the benefit to risk ratio is thought to be appropriate. It must be noted that expanded access is only permitted by regulatory authorities is some but not all countries. GSK does not solicit requests for expanded access from investigators or subjects. An investigator administering mepolizumab through expanded access is responsible for the administration and management of the supply, and for the subject's welfare. Accordingly, the investigator must refer to the Investigator's Brochure (IB) prepared for the ongoing clinical trials for mepolizumab which contain a comprehensive range of information on the drug, and then use his or her clinical judgment as to whether the drug is suitable for the relevant subject.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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"
You likely can't join if
- 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.
See the full eligibility 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"
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.