NCT03562195

A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mepolizumab 100 milligrams	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.
DRUG	Placebo	Placebo will be given as 0.9 percent sodium chloride solution.
DRUG	Salbutamol	Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.

Timeline

• Start date: 2018-08-29
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2018-06-19
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

42 sites across 1 country: China