Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of
mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects
with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase
(Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase
(Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase
(Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS
(prednisone/prednisolone) dose according to the Optimisation titration schedule based on a
review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase
subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100
mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing
maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction
Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to
achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the
Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks
and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule
based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation
history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance
Phase subjects will be maintained without any further OCS dose adjustment. Subjects who
complete the 24 week double-blind period and meet the eligibility criteria, will be offered
the opportunity to participate in an open label extension (OLE) study otherwise they will
return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment.
At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations
will be assessed. The pharmacokinetic samples will be collected in the beginning of the
treatment, prior to last dose, at the end of study (exit visit) and the follow up.