A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
Status:
Completed
Trial end date:
2017-10-05
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered
mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic
asthma. This study will enroll a subset of subjects from Study MEA115661 who have
demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy
are individuals at greatest risk of serious deterioration of their health status. In order to
target individuals at greatest risk for serious deterioration of their health status, only
subjects from the MEA115661 study with a history of life-threatening or seriously
debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility
criteria for the study will be offered the opportunity to consent for this study of up to 128
weeks in length (including the Follow-Up Visit). This study will give opportunity to extend
the collection of clinical data for long-term use and further assess the sustainability of
efficacy in a population likely to experience significant loss of asthma control and the need
for higher doses of systemic steroids if returned to SOC only.