Expanded access program for mepolizumab in subjects with HES

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety:<br>To assess the long-term AE profile<br>associated with mepolizumab therapy.<br><br>Efficacy:<br>To characterize individual dosing<br>requirements for control of disease.;Secondary Objective: ;Primary end point(s): Serious AEs (SAEs).<br>Non-serious AEs related to mepolizumab as<br>assessed by the investigator;Timepoint(s) of evaluation of this end point: Each clinic visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Mean 28-day SC dose (mg) for the last<br>3 administrations;Timepoint(s) of evaluation of this end point: Each clinic visit

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