Asthma Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)
Primary objective of the study is to evaluate whether patients with severe eosinophilic
asthma who have received long-term treatment with mepolizumab (at least 3 years) need to
maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated
in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with
mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of
mepolizumab treatment will be eligible to participate in this study. This study will be
conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in
(for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year
exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8
weeks). During Part A and B subjects will be administered Open-label mepolizumab (100
milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded
part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg
SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.
Subjects discontinuing investigational product (IP) due to a clinically significant asthma
exacerbation will then enter optional Part D of the study. During Part D, subjects receive
open-label mepolizumab in addition to their standard of care therapy for the remainder of the
study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52
weeks after randomization in order to assess subject's efficacy parameters, immunogenicity
status, and to conduct additional safety assessments. Eligible subjects will participate in
the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks)
and Part B (4 to 8 weeks).
n/a
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