MG-K10（一种靶向IL-4Rα的人源化单克隆抗体）在中国成年哮喘患者中的初步疗效、安全性和药效学特征的Ib/Ⅱ期研究
2026/06/30
摘要
背景 ：MG-K10是一种长效、人源化的抗白细胞介素-4受体α（IL-4Rα）单克隆抗体，通过抑制IL-4和IL-13介导的信号传导，减轻哮喘中的2型炎症。
目的：本Ib/Ⅱ期研究旨在评估MG-K10在中国哮喘患者中的初步疗效、安全性和药效学特征。
方法：本研究包括初始的Ib期（评估安全性和耐受性）和随后的Ⅱ期研究。在Ⅱ期研究中，符合条件的中度至重度哮喘患者按1:1:1随机分组，分别接受MG-K10 300 mg每2周一次（Q2W）、MG-K10 300 mg每4周一次（Q4W）或匹配的安慰剂（2 mL）Q2W皮下注射，共治疗24周。主要终点为第12周时支气管舒张前用力呼气容积（FEV1）较基线的绝对变化。次要疗效终点包括哮喘控制、严重急性发作率和安全性评估。本试验已在ClinicalTrials.gov注册（NCT05382910）。
结果：共有64名、60名和63名患者分别随机分配到MG-K10 Q2W组、MG-K10 Q4W组和安慰剂组。在第12周时，两个MG-K10治疗组的支气管舒张前FEV1的最小二乘均值改善均显著优于安慰剂组[Q2W组 vs. 安慰剂组：0.35升（95% CI, 0.208-0.490）；Q4W组 vs. 安慰剂组：0.30升（95% CI, 0.156-0.441），两组p值均<0.0001]。基线血嗜酸性粒细胞计数≥0.3×10⁹/L的患者观察到更显著的FEV1改善。各组不良事件发生率相似[MG-K10 300 mg Q2W组（79.7%）、MG-K10 300 mg Q4W组（85.0%）和安慰剂组（79.4%）]。MG-K10安全且耐受性良好，与其已知的安全性特征一致。
结论：MG-K10在改善哮喘患者肺功能、增强哮喘控制和减少严重急性发作方面优于安慰剂。每4周一次的给药方案提供了更长的给药间隔，可能有助于提高用药依从性。
Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Rα, in Adult Chinese Patients With Asthma
Xian M, Shi X, Li RR, Zhao L, Zhuan B, Chen B, et al.
Abstract
BACKGROUND:MG-K10 is a long-acting, humanised monoclonal antibody against interleukin-4 receptor alpha (IL-4R alpha), which inhibits IL-4 and IL-13-mediated signalling to reduce type 2 inflammation in asthma.
OBJECTIVES:This Phase Ib/II study aimed to evaluate the preliminary efficacy, safety and pharmacodynamic characteristics of MG-K10 in Chinese patients with asthma.
METHODS:This study included an initial phase Ib to evaluate safety and tolerability, followed by a phase II study in which eligible patients with moderate-to-severe asthma were randomised 1:1:1 to receive MG-K10 300 mg every 2 weeks (Q2W), MG-K10 300 mg every 4 weeks (Q4W), or a matched placebo (2 mL) Q2W subcutaneously for 24 weeks. The primary endpoint was the absolute change from baseline in the prebronchodilator forced expiratory volume in 1 s (FEV1) at week 12. Secondary efficacy endpoints, including asthma control, the rate of severe exacerbations and safety, were assessed. This trial is registered with ClinicalTrials.gov (NCT05382910).
RESULTS:A total of 64, 60 and 63 patients were randomised to the MG-K10 Q2W, MG-K10 Q4W and placebo groups respectively. At week 12, the least squares mean improvements in prebronchodilator FEV1 were significantly greater in both MG-K10 groups than in the placebo group [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]. Greater FEV1 improvements were observed in patients with baseline blood eosinophils >= 0.3 × 10(9)/L. The incidence of adverse events was similar across groups [MG-K10 300 mg, Q2W (79.7%), MG-K10 300 mg Q4W (85.0%) and placebo groups (79.4%)]. MG-K10 was safe and well-tolerated, and consistent with the known safety signals.
CONCLUSIONS:MG-K10 was superior to placebo in improving lung function, enhancing asthma control and reducing severe exacerbations in patients with asthma. The once-every-4-week regimen offers extended dosing intervals that may enhance medication adherence.
背景 ：MG-K10是一种长效、人源化的抗白细胞介素-4受体α（IL-4Rα）单克隆抗体，通过抑制IL-4和IL-13介导的信号传导，减轻哮喘中的2型炎症。
目的：本Ib/Ⅱ期研究旨在评估MG-K10在中国哮喘患者中的初步疗效、安全性和药效学特征。
方法：本研究包括初始的Ib期（评估安全性和耐受性）和随后的Ⅱ期研究。在Ⅱ期研究中，符合条件的中度至重度哮喘患者按1:1:1随机分组，分别接受MG-K10 300 mg每2周一次（Q2W）、MG-K10 300 mg每4周一次（Q4W）或匹配的安慰剂（2 mL）Q2W皮下注射，共治疗24周。主要终点为第12周时支气管舒张前用力呼气容积（FEV1）较基线的绝对变化。次要疗效终点包括哮喘控制、严重急性发作率和安全性评估。本试验已在ClinicalTrials.gov注册（NCT05382910）。
结果：共有64名、60名和63名患者分别随机分配到MG-K10 Q2W组、MG-K10 Q4W组和安慰剂组。在第12周时，两个MG-K10治疗组的支气管舒张前FEV1的最小二乘均值改善均显著优于安慰剂组[Q2W组 vs. 安慰剂组：0.35升（95% CI, 0.208-0.490）；Q4W组 vs. 安慰剂组：0.30升（95% CI, 0.156-0.441），两组p值均<0.0001]。基线血嗜酸性粒细胞计数≥0.3×10⁹/L的患者观察到更显著的FEV1改善。各组不良事件发生率相似[MG-K10 300 mg Q2W组（79.7%）、MG-K10 300 mg Q4W组（85.0%）和安慰剂组（79.4%）]。MG-K10安全且耐受性良好，与其已知的安全性特征一致。
结论：MG-K10在改善哮喘患者肺功能、增强哮喘控制和减少严重急性发作方面优于安慰剂。每4周一次的给药方案提供了更长的给药间隔，可能有助于提高用药依从性。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（Clin Exp Allergy. 2026.DOI: 10.1111/cea.70345）
（Clin Exp Allergy. 2026.DOI: 10.1111/cea.70345）
Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Rα, in Adult Chinese Patients With Asthma
Xian M, Shi X, Li RR, Zhao L, Zhuan B, Chen B, et al.
Abstract
BACKGROUND:MG-K10 is a long-acting, humanised monoclonal antibody against interleukin-4 receptor alpha (IL-4R alpha), which inhibits IL-4 and IL-13-mediated signalling to reduce type 2 inflammation in asthma.
OBJECTIVES:This Phase Ib/II study aimed to evaluate the preliminary efficacy, safety and pharmacodynamic characteristics of MG-K10 in Chinese patients with asthma.
METHODS:This study included an initial phase Ib to evaluate safety and tolerability, followed by a phase II study in which eligible patients with moderate-to-severe asthma were randomised 1:1:1 to receive MG-K10 300 mg every 2 weeks (Q2W), MG-K10 300 mg every 4 weeks (Q4W), or a matched placebo (2 mL) Q2W subcutaneously for 24 weeks. The primary endpoint was the absolute change from baseline in the prebronchodilator forced expiratory volume in 1 s (FEV1) at week 12. Secondary efficacy endpoints, including asthma control, the rate of severe exacerbations and safety, were assessed. This trial is registered with ClinicalTrials.gov (NCT05382910).
RESULTS:A total of 64, 60 and 63 patients were randomised to the MG-K10 Q2W, MG-K10 Q4W and placebo groups respectively. At week 12, the least squares mean improvements in prebronchodilator FEV1 were significantly greater in both MG-K10 groups than in the placebo group [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]. Greater FEV1 improvements were observed in patients with baseline blood eosinophils >= 0.3 × 10(9)/L. The incidence of adverse events was similar across groups [MG-K10 300 mg, Q2W (79.7%), MG-K10 300 mg Q4W (85.0%) and placebo groups (79.4%)]. MG-K10 was safe and well-tolerated, and consistent with the known safety signals.
CONCLUSIONS:MG-K10 was superior to placebo in improving lung function, enhancing asthma control and reducing severe exacerbations in patients with asthma. The once-every-4-week regimen offers extended dosing intervals that may enhance medication adherence.
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薯蓣皂苷通过IL-4R相关的上皮-免疫反应调节减轻过敏性气道炎症
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呼吸道生物制剂引入后哮喘急性加重的群体趋势
