Dataset from 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

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.

美泊利珠单抗（mepolizumab）是一种人源化单克隆抗体，被开发为伴嗜酸性粒细胞性炎症的重度哮喘患者的附加治疗方案。当前哮喘治疗指南对于接受强化治疗且频繁急性加重的重度哮喘患者，可供选择的治疗方案极为有限。为此类哮喘患者群体提供更优治疗选择，存在显著的未被满足的临床需求。因此，本研究旨在评估美泊利珠单抗在中国伴嗜酸性粒细胞性炎症的重度哮喘患者中的疗效与安全性。本研究将总计纳入300名受试者，按1:1的比例随机分配至美泊利珠单抗组或安慰剂（placebo）组，同时联合现行标准治疗方案。研究最长持续时长为56周。