This Record Contains Information About the Mepolizumab Compassionate Use Product Activities: 104317: An Open-Label Compassionate Use and Long-Term Access Study of Mepolizumab in HES 201956: A Long-term Access Programme for Subjects With Severe Asthma



Status:Available
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:8/19/2017
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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104317: An Open-Label Compassionate Use Access and Long-Term Access Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome 201956: A Long-term Access Programme for Subjects With Severe Asthma Who Participated in a GSK-sponsored Mepolizumab Clinical Study

104317: The market authorisation application for mepolizumab for the indication of
hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to
outstanding questions from regulator's raised from the application. On the basis of sponsor's
evaluation, participants with life-threatening HES who have documented failure (lack of
efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and
participants who have participated in a previous GSK sponsored study in HES (long-term
access) can be consider for mepolizumab treatment where the country regulation permits. In
this study, participants will receive mepolizumab in an open-labelled manner, and limited
data will be collected to evaluate the long-term safety and efficacy of mepolizumab.

201956: This is a Long-term Access Programme (LAP) which aims to support provision of
mepolizumab, until it is commercially available, to eligible subjects with severe asthma who
participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible
subjects will initiate mepolizumab within a 6-month period following the individual subject's
last scheduled visit in their preceding clinical study. For each subject benefit versus risk
will be assessed throughout the study to support continued treatment with mepolizumab.


104317 Inclusion criteria:

- ≥ 12 years of age

- Has life-threatening HES as defined by the treating physician's documented view that
likelihood of death is high unless the course of the disease is interrupted.

- Meets the diagnostic criteria for Hyper Eosinophilic Syndrome as defined by:

Eosinophilia >1500cells/ul 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 >1500cells/ul for less than 6
months who meet the other criteria for HES accompanied by clear evidence of eosinophil
tissue infiltration and with exclusion for secondary causes of eosinophilia as above.

- Compassionate use: 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

- Long-term access: Entry of subjects who participated in a previous GSK HES study to
this study must be supported by the following: Subjects who received mepolizumab (if
study treatment is known) in a previous GSK HES study: Documented improvement in
symptoms and/or signs of HES following treatment with mepolizumab or Subjects who
received mepolizumab or placebo in a previous GSK HES study: The treating physician
must confirm a positive benefit/risk ratio, and the anticipated clinical benefit from
mepolizumab must outweigh any potential safety or tolerability risk in this study or
Subjects who participated in Study 200622 should complete the protocol required
assessments for the duration of 32 weeks after randomization. Subsequently, subjects
should complete the 20-week assessments in Study 205203, open-label extension (OLE) to
Study 200622, prior to being considered for this protocol (MHE104317). In addition,
subjects should not have had an adverse event (serious or non-serious) considered
related to study treatment while participating in Study 200622 or Study 205203 which
resulted in permanent withdrawal of study treatment.

104317 Exclusion Criteria:

- Subjects without HES but with other conditions associated with eosinophilic
pathological process such as Churg-Strauss, Wegner's Granulomatosis, atopic disorders,
hypersensitivity reactions to parasitic infections, eosinophilic gastroenteropathies,
will not be eligible for this compassionate use program which is restricted to
life-threatening HES.

- Female subjects of child -bearing potential who are not using an effective method of
contraception:

Consistent and correct use of one of the following acceptable methods of birth control for
one month prior to the start of the investigation product and 16 weeks after the last dose.

- Pregnant or lactating females

- Subjects with severe/life-threatening underlying disease unrelated to HES unrelated to
HES where life expectancy is estimated to be less than 3 months.

- Subjects with a history of or current malignancy: Subjects with a history of or
current lymphoma or 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.

- 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

- Subjects with current drug or alcohol abuse where uncertain compliance with medication
causes safety risk.

- subject currently receiving any other investigational product or other investigational
intervention.

201956 Inclusion criteria:

- Subject participated in GSK-sponsored asthma clinical study with mepolizumab.

- Subject has either: completed the treatment period in the mepolizumab asthma clinical
study to which they were originally enrolled or if the subject was withdrawn from
study treatment prematurely during the mepolizumab asthma clinical study to which they
were originally enrolled but the subject has completed the study assessments at the
study visit that would have been the end of the respective treatment period.

- The treating physician requesting mepolizumab under this Long-term Access Programme
considers the benefits of treatment with mepolizumab outweigh the risks for the
individual subject.

- To be eligible for mepolizumab treatment under this Long-term Access Programme,
females of childbearing potential (FCBP) must commit to consistent and correct use of
an acceptable method of birth control, beginning with consent, for the duration of the
treatment with mepolizumab and for 4 months after the last mepolizumab administration.

- The subject consents to receiving treatment with mepolizumab under this Long-term
Access Programme. In the case of a paediatric subject being eligible a
parent(s)/guardian will give written informed consent prior to the child's
participation in the study. If applicable, the subject must be able and willing to
give assent to take part in the study according to the local requirement.

201956 Exclusion criteria:

- A current malignancy or history of cancer in remission for less than 12 months
(Subjects who had localized carcinoma (i.e., basal or squamous cell) of the skin which
was resected for cure will not be excluded).

- Subject has other clinically significant medical conditions uncontrolled with
standard-of-care therapy not associated with asthma, e.g., unstable liver disease,
uncontrolled cardiovascular disease, ongoing active infectious disease requiring
systemic treatment.

- Subject is pregnant or breastfeeding. Subjects should not be considered for continued
treatment if they plan to become pregnant during the course of treatment with
mepolizumab.

- Subject has a known allergy or intolerance to a monoclonal antibody or biologic
therapy including mepolizumab.

- Subject had an adverse event (serious or non-serious) considered related to study
treatment whilst participating in a clinical study with mepolizumab which resulted in
permanent withdrawal of study treatment.

- Subject is receiving treatment with another biological therapy such as a monoclonal
antibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.

- Subjects who have received treatment with an investigational drug within the past 30
days or 5 terminal phase half-lives of the drug whichever is longer, prior to
initiation of mepolizumab treatment under this Long-term Access Programme (this also
includes investigational formulations of marketed products).

- Subject is currently participating in any other interventional clinical study.
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