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

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.

Timeline

Start

2018-08-29

Primary completion

2022-09-07

Completion

2022-09-07

Publications

• Background Chen R, Wei L, Dai Y, Wang Z, Yang D, Jin M, Xiong C, Li T, Hu S, Song J, Chan R, Kumar S, Abdelkarim A, Zhong N. Efficacy and safety of mepolizumab in a Chinese population with severe asthma: a phase III, randomised, double-blind, placebo-controlled trial. ERJ Open Res. 2024 May 20;10(3):00750-2023. doi: 10.1183/23120541.00750-2023. eCollection 2024 May.
• Shi C, Wang Y, Tan C, Zeng X, Liu Q. Cost-effectiveness analysis of mepolizumab among patients with severe asthma from the Chinese societal perspective. PLoS One. 2026 May 13;21(5):e0348955. doi: 10.1371/journal.pone.0348955. eCollection 2026.
• Chen R, Dai Y, Yang D, Liu C, Han W, Gu W, Cao J, Zhou Q, Howarth P, Weng S, Xiong C, Huang J, Liang P, Zhong N; 201536 Study Group. Clinical Remission Outcome in Chinese Patients With Severe Asthma With an Eosinophilic Phenotype Receiving Mepolizumab: A Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. Allergy Asthma Immunol Res. 2025 Jul;17(4):473-485. doi: 10.4168/aair.2025.17.4.473.

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