At a glance
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A Randomized, Double Blind, Parallel Group Study of the Efficacy and Safety of Mepolizumab as Adjunctive Therapy in Patients With Severe Asthma With Eosinophilic Inflammation
In Brief
A Phase 3 clinical trial evaluating Mepolizumab 100 milligrams, Placebo, and 1 other intervention for Asthma. Completed, enrolled 300 participants across 42 sites.
Detailed Summary
Mepolizumab, a humanized monoclonal antibody, has been developed as an add-on treatment for subjects with severe asthma with eosinophilic inflammation. Current asthma treatment guidelines offer minimal options for the severe asthmatic subjects on intensive therapy with frequent exacerbations. There is a significant unmet medical need to provide better treatment options for this segment of the asthma population. Thus, this study is designed to evaluate the efficacy and safety of mepolizumab in Chinese severe asthmatic subjects with eosinophilic inflammation. A total number of 300 subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy. The maximum study duration will be 56 weeks.
Study Details
Timeline
Interventions
Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use.
Placebo will be given as 0.9 percent sodium chloride solution.
Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.