A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 10/11/2018 |
| Start Date: | November 13, 2017 |
| End Date: | March 5, 2020 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
A Multi-centre, Open-label Extension, Safety Study to Describe the Long-term Clinical Experience of Mepolizumab in Participants With Hypereosinophilic Syndrome (HES) From Study 200622
This is an open-label extension study to Study 200622.In this study subjects from Study
200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg)
subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments
post-randomization, while they continue with their background HES therapy per standard of
care (SoC). Subjects from study 200622 will participate in this extension study if they had
completed the 32-Week treatment period in study 200622 or if they were withdrawn from the
study pre-maturely, but were continued in the study per protocol until 32 Weeks from
randomization. Data from this study (205203) and 200622 will be combined to provide up to
52-Week exposure data to further characterize the long-term safety profile of mepolizumab and
provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration
of the study participation will be 20 Weeks for subjects who continue with mepolizumab
treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for
subjects who do not continue with MHE104317/MHE112562.
200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg)
subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments
post-randomization, while they continue with their background HES therapy per standard of
care (SoC). Subjects from study 200622 will participate in this extension study if they had
completed the 32-Week treatment period in study 200622 or if they were withdrawn from the
study pre-maturely, but were continued in the study per protocol until 32 Weeks from
randomization. Data from this study (205203) and 200622 will be combined to provide up to
52-Week exposure data to further characterize the long-term safety profile of mepolizumab and
provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration
of the study participation will be 20 Weeks for subjects who continue with mepolizumab
treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for
subjects who do not continue with MHE104317/MHE112562.
Inclusion Criteria:
- Age 12 years and older subjects who were enrolled in Study 200622.
- To be considered for Study 205203, subjects from study 200622 must have completed
32-Week treatment period in the study or if the subject was withdrawn from study
treatment prematurely during the 200622 study, but continued in the study per protocol
(including HES flare-related assessments) until 32 Weeks from randomization.
- Male or female subjects. Female subjects must be either not a woman of childbearing
potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance at least 30
days prior to the first dose of study treatment and until 16 weeks after the last dose
of study treatment.
- The treating physician must confirm a positive benefit/risk ratio. The anticipated
clinical benefit from mepolizumab must outweigh any potential safety or tolerability
risk in Study 205203.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Subjects with any history of hypersensitivity to any monoclonal antibody (including
mepolizumab).
- Subjects with current malignancy or malignancy that developed during Study 200622.
- Subjects who is pregnant or breastfeeding.
- Subjects who has other clinically significant medical conditions uncontrolled with SoC
therapy not associated with HES, example (e. g.), unstable liver disease, uncontrolled
cardiovascular disease, ongoing active infectious disease.
- Subjects with QT interval corrected (QTc) greater than 450 millisecond (msec) or QTc
greater than 480 msec in subjects with bundle branch block based on local
Electrocardiogram (EGC) reading.
- Subjects who discontinue study treatment based on liver chemistry stopping criteria
during Study 200622.
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or
asymptomatic gallstones or otherwise stable chronic liver disease per investigator
assessment).
- Subjects who have received treatment with an investigational agent (biologic or
non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior
to the first dose, other than Study 200622 study treatment. The term "investigational"
applies to any drug not approved for sale for the disease/indication to treat in the
country in which it is being used or investigational formulations of marketed
products.
- Subjects who are currently participating in any other interventional clinical study.
- Subjects had an AE (serious or non-serious) considered related to study treatment
while participating in Study 200622 which resulted in permanent withdrawal of study
treatment.
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