Status:
COMPLETED
A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypereosinophilic Syndrome
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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) f...
Eligibility Criteria
Inclusion
- 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205203, subjects from study 200622 must have completed 32-Week treatment period in the study or if the subject was withdrawn from study treatment prematurely during the 200622 study, but continued in the study per protocol (including HES flare-related assessments) until 32 Weeks from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
- 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.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03306043
Start Date
November 13 2017
End Date
December 30 2019
Last Update
June 23 2020
Active Locations (36)
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1
GSK Investigational Site
La Jolla, California, United States, 92093
2
GSK Investigational Site
New Haven, Connecticut, United States, 06520
3
GSK Investigational Site
Rochester, Minnesota, United States, 55905
4
GSK Investigational Site
Cincinnati, Ohio, United States, 45229