A Study of MG-K10 in Subjects With Asthma

Summary

This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.

Timeline

Start

2022-07-05

Primary completion

2023-12-20

Completion

2024-06-20

Outcome

Met primary endpoint

paper At week 12, the least squares mean improvements in prebronchodilator FEV1 were significantly greater in both MG-K10 groups than in the placebo group PMID 42212541 ↗

paper [Q2W vs. placebo: 0.35 L (95% CI, 0.208-0.490), Q4W vs. placebo: 0.30 L (95% CI, 0.156 to 0.441), both p < 0.0001]. PMID 42212541 ↗

release “成人哮喘受试者中的安全性、药代动力学和初步有效性的Ib/ II期临床试验 （方案编号：MG-K10-AS-2），完成受试者入组，且期中分析显示，主要疗效 终点治疗12周时 支气管扩张剂 使用前FEV 1 较基线的绝对值变化，MG-K10 300mg Q4W组和MG-K10 300mg Q2W组与安慰剂组差异均达到统计学显著差异” mabgeek.com ↗

Publications

• Xian M, Shi X, Li R, Zhao L, Zhuan B, Chen B, Shi H, Wang Z, Wu F, Guo J, Chen Y, Dang W, Guo J, Qin D, Zhang C, Li J, Zhong N. Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Ralpha, in Adult Chinese Patients With Asthma. Clin Exp Allergy. 2026 May 29. doi: 10.1111/cea.70345. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	COMEKIBART	Monoclonal antibody	300 mg	Subcutaneous

Indications