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

Brief 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 Type: Interventional  (Clinical Trial)
Estimated Enrollment: 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy during the treatment period.
Masking: Double (Participant, Investigator)
Masking Description: This will be a double blind study. Subjects and investigator will be masked.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: September 13, 2018
Estimated Primary Completion Date: March 31, 2021
Estimated Study Completion Date: April 2, 2021

Arms:
- Experimental: Subjects receiving Docetaxel
- Placebo Comparator: Subjects receiving Placebo