A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Adult and Adolescent Patients With Moderate To-Severe Atopic Dermatitis

Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation.
The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population.
Objectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it.
Check how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10

开始日期2026-05-01

申办/合作机构

湖南麦济生物技术股份有限公司

NCT07540442

/ Not yet recruiting临床3期

Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)

开始日期2026-04-17

申办/合作机构

湖南麦济生物技术股份有限公司

NCT07546487

/ Not yet recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor control of second-generation H1 antihistamines.

开始日期2026-04-14

申办/合作机构

湖南麦济生物技术股份有限公司

100 项与柯美奇拜单抗相关的临床结果

登录后查看更多信息

100 项与柯美奇拜单抗相关的转化医学

登录后查看更多信息

100 项与柯美奇拜单抗相关的专利（医药）

登录后查看更多信息

项与柯美奇拜单抗相关的文献（医药）

Journal of Clinical Medicine

A Comprehensive Review of Biologics in Phase III and IV Clinical Trials for Atopic Dermatitis

Review

作者: Jenerowicz, Dorota ; Dańczak-Pazdrowska, Aleksandra ; Waligóra-Dziwak, Katarzyna

Atopic dermatitis (AD) is a skin condition characterized by significant challenges and a substantial deterioration in the life quality for affected patients. The therapeutic landscape for AD has witnessed a transformative shift with the emergence of biologic therapies. Our focus centers on biologics currently undergoing phase III and IV clinical trials, deeming them to hold the highest potential for significant clinical relevance. To identify biologic drugs under development in phase III and IV clinical trials, we searched ClinicalTrials.gov. Additional relevant trials were identified through JapicCTI/ Japan Registry of Clinical Trials (jRCT) with a citation search. A search in MEDLINE and EMBASE was performed. There have been 76 clinical trials identified concerning biologic drugs: dupilumab (34 trials), lebrikizumab (14 trials), tralokinumab (10 trials), rocatinlimab (7 trials), amlitelimab (2 trials), nemolizumab (6 trials), MG-K10 (1 trial), CM310 (1 trial), 611 (1 trial). A search in MEDLINE revealed 132 articles concerning phase III and IV clinical trials for AD treatment. A total of 39 articles concerned biologic drugs covering 23 clinical trials. A search in EMBASE revealed 268 relevant articles, allowing us to identify results of an additional six clinical trials. The safety and efficacy of these biologics are comprehensively addressed in this review. This comprehensive review aims to explore the current landscape of biologic therapies for AD, delving into the latest research findings, clinical trial outcomes, and the diverse mechanisms of action employed by these novel interventions.

CLINICAL AND EXPERIMENTAL ALLERGY

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

Article

作者: Guo, Jian ; Guo, Jinlin ; Zhong, Nanshan ; Chen, Bi ; Dang, Wei ; Wang, Zaiyi ; Li, Ruoran ; Zhao, Li ; Chen, Yousheng ; Wu, Feng ; Zhang, Chenghai ; Zhuan, Bing ; Li, Jing ; Xian, Mo ; Shi, Hanbing ; Qin, Di ; Shi, Xu

ABSTRACT:

Background:

MG‐K10 is a long‐acting, humanised monoclonal antibody against interleukin‐4 receptor alpha (IL‐4Rα), which inhibits IL‐4 and IL‐13‐mediated signalling to reduce type 2 inflammation in asthma.

Objective:

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 (FEV 1 ) 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 FEV 1 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 FEV 1 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.

231

项与柯美奇拜单抗相关的新闻（医药）

2026-07-15

·雨泽皮康驿站

慢性自发性荨麻疹等来了长效新药 MG-K10，III 期临床已全国启动！！

慢性自发性荨麻疹长效新药MG-K10 III期已全国启动 MG-K10 Clinical Trial Launch 点击蓝色关注我们慢性自发性荨麻疹有多折磨人，只有亲身经历过的人才懂：身上无缘无故就冒出一片片风团，钻心地痒，晚上痒得整宿整宿睡不着觉，吃了抗过敏药也压不住，反反复复一得就是好几年，工作生活全被打乱。最近，国内自主研发的长效抗IL-4Rα人源化单抗MG-K10（通用名：柯美奇拜单抗），它的慢性自发性荨麻疹适应症已经正式进入全国多中心III期临床试验。这对于吃抗组胺药效果不好的中重度患者来说，又多了一个更长效、更省事的新选择。 01 [ 为什么 IL-4Rα 是荨麻疹治疗的核心靶点？ ] 很多人一提到荨麻疹，只知道是“过敏”，却不清楚背后的炎症机制。慢性自发性荨麻疹的核心发病机制，是 2 型炎症通路过度激活，而 IL-4 和 IL-13 作为推动炎症的两个关键细胞因子会促进组胺释放、增加皮肤血管的通透性，最终让人不停长风团、剧烈瘙痒，还会让皮肤变得越来越敏感。 IL-4Rα 是 IL-4 和 IL-13 受体共用的一个亚基，相当于这两条炎症通路的“总开关”。MG-K10 能精准地结合 IL-4Rα，同时阻断 IL-4 和 IL-13 两条下游炎症信号，从上游就把 2 型炎症的级联反应压下去，从根源上减少风团发作、缓解瘙痒，而不像抗组胺药那样，只是堵在末端去拦组胺。图片来源于网络 02 [ 每4 周 1 针长效给药，治疗负担减半 ] 对多数患者来说，二代抗组胺药是首选的一线治疗，但对于难治性慢性自发性荨麻疹患者来说只能去用生物制剂，每 2 周就得打一次针，动不动就要跑医院，既耗费时间又耗费精力。而 MG-K10 通过优化分子结构，把药物半衰期拉长了，只需要每 4 周打一次。相当于半年只用去 6 次医院，大幅降低了长期治疗的时间成本，对上班族、异地就医患者都非常友好。图片来源于网络小结其实这些年慢性自发性荨麻疹的治疗一直在往前走：从第一代抗组胺药到高选择性二代药物，从每两周跑一次医院的生物制剂，到如今 4 周一针的长效方案，咱们对待这种慢性病，目标越来越精准，方法也越来越省心。不用总硬扛着，多了解一些新疗法，总能找到最适合自己的治疗方案。目前有慢性自发性荨麻疹临床新药正在招募患者，符合条件即可免费三甲医院用药一年，入组前全面体检以及入组用药不收取任何费用，就近安排三甲医院，名额有限，点击下方免费申请用药⬇⬇⬇ 关注慢性自发性荨麻疹，关注雨泽皮康驿站，了解更多医药资讯！如果有需要可以转发给身边的朋友，感谢您的支持~我们下期再见！ END

2026-07-15

·麦济生物

柯美奇拜单抗每八周给药潜力初显

近日，麦济生物完成一项探索柯美奇拜单抗（MG-K10）每八周给药一次治疗中重度特应性皮炎（AD）的II期临床研究，结果提示MG-K10每八周一次给药方案的巨大临床应用潜力。研究方法这是一项多中心、随机、双盲、平行对照的II期研究。共60例中重度AD患者按1:1随机分配至MG-K10 300mg Q4W组（首剂600mg）和MG-K10 600mg Q8W组。主要终点为治疗24周时达到EASI-75（EASI 评分较基线降低≥75%）的受试者百分比和治疗24周时IGA评分达到0或1分且较基线下降≥2分的受试者百分比；其他疗效终点包括各访视点EASI-75、EASI-50、EASI-90、瘙痒NRS评分及生活质量评分改善。研究结果主要终点方面，第24周，MG-K10 300mg Q4W组和MG-K10 600mg Q8W组达到EASI-75的受试者比例分别为83.3%和88.5%，达到IGA评分达到0或1分且较基线下降≥2分的受试者比例分别为70.0%和73.1%。次要终点方面，随着用药时间延长，MG-K10 300mg Q4W组和MG-K10 600mg Q8W组各访视点EASI-75、EASI-50、EASI-90、IGA改善、DLQI改善、POEM改善，以及各周NRS改善均持续提升且两组疗效相当，提示MG-K10 两个剂量组均可持续缓解和改善中重度 AD 患者的临床症状和生活质量。安全性结果提示MG-K10两个剂量组的安全性和耐受性均良好。结论 MG-K10 特应性皮炎适应症（300mg Q4W，首剂600mg）已处于中国新药上市申请审评阶段。本次针对更长给药间隔的探索性研究，为MG-K10每八周一次给药方案的临床应用提供了初步且有力的循证依据。同时，麦济将进一步开发每三月给药一次的方案，以期为患者带来更大获益。

2026-07-14

·知乎专栏

每月一针94%患者皮损改善超75%，特应性皮炎长效新选择柯美奇拜单抗

伊顿健康前言：对于中重度特应性皮炎患者，生物制剂是重要的治疗选择，然而常规每两周一次的注射频率，仍让不少人对频繁往返医院、自行注射感到身心俱疲。在2026年的中华医学会第三十一次皮肤性病学术年会（CSD 2026）上，一款可实现每月一针的人源化抗IL-4Rα单抗——柯美奇拜单抗（MG-K10）公布了52周临床数据，为AD的长效便捷管理提供了新的依据。一、从源头掐断两条炎症通路AD是典型的2型炎症性疾病，IL-4和IL-13是其中关键的促炎因子。柯美奇拜单抗直接结合它们共同的受体亚基IL-4Rα，同时阻断这两条信号通路。这种作用能从源头抑制2型炎症，进而控制瘙痒与皮损。二、长效机制：半衰期达32天常规的IL-4Rα单抗半衰期较短，需要每2周给药。柯美奇拜单抗通过Fc突变技术，将亲和力提高至现有IL-4Rα单抗的10倍左右，半衰期延长到32天。首次注射后4周，血药浓度就能达到稳态并维持在有效水平。从两周一次（Q2W）变为四周一次（Q4W），在保证疗效的同时大幅提升治疗便利性，也降低了长期管理中的就诊负担。三、52周皮损清除与瘙痒控制持久这项Ⅲ期研究纳入中重度成人AD患者，主要终点第16周即显示出优效。到第52周时，EASI-75（皮损面积和严重程度指数改善75%）应答率升至94.3%，EASI-90达79.1%，IGA 0/1且下降≥2分（研究者评估皮损清除或几乎清除）的比例为76.6%。瘙痒控制同样扎实。PP-NRS（瘙痒峰值数字评分）较基线改善≥3分的患者占84.6%，改善≥4分的占71.7%。反映生活质量的DLQI改善≥4分者达81.9%。并且治疗第4周皮损和瘙痒指标就开始与安慰剂拉开差距，起效并不慢。这些数据表明，每月一针的方案能够持续实现深度皮损清除与瘙痒缓解。四、柯美奇拜单抗安全性与耐受性整个52周里，柯美奇拜单抗300mg每4周一次的不良事件多为轻中度，未出现特别关注的不良事件，无死亡病例。双盲治疗期结膜炎发生率为3.0%，维持期降至2.4%；注射部位反应发生率分别为1.8%和0.9%，且均为1级。长期安全性特征与前期一致，未发现新信号。这款由麦济生物研发、康哲药业/德镁医药合作开发的创新长效单抗，上市申请已于2025年10月获国家药监局受理。若顺利获批，将为中重度AD的长期管理提供一个更便捷的选择。你在AD治疗中最在意的是什么？皮损消退速度、止痒效果还是打针频率？欢迎在评论区聊聊。多项跟柯美奇拜单抗同靶点IL-4Rα的新药正在开展临床招募，包含上市药。符合条件，体检用药费用均由项目组承担，享多项补贴及就近三甲专业随访。参考文献1. Gu C, et al. MG-K10, a Long-Acting Anti-IL-4 Receptor Alpha Monoclonal Antibody in Adult Patients with Moderate-to-Severe Atopic Dermatitis. Dermatitis. 2026 Feb 28:17103568251388478.2. Jianzhong Zhang,et al. Long-Term Efficacy and Safety of MG-K10 for Moderate-to-Severe Atopic Dermatitis: 52-Week Results from a Pivotal Phase 3 Trial. 2026 AAD.

100 项与柯美奇拜单抗相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
季节性过敏性鼻炎	申请上市	中国	上海麦济医药有限公司	2026-04-23
季节性过敏性鼻炎	申请上市	中国	鼎康（武汉）生物医药有限公司	2026-04-23
中度特应性皮炎	申请上市	中国	上海麦济医药有限公司	2025-10-30
中度特应性皮炎	申请上市	中国	鼎康（武汉）生物医药有限公司	2025-10-30
重度特应性皮炎	申请上市	中国	上海麦济医药有限公司	2025-10-30
重度特应性皮炎	申请上市	中国	鼎康（武汉）生物医药有限公司	2025-10-30
慢性荨麻疹	临床3期	-	湖南麦济生物技术股份有限公司	2026-04-14
结节性痒疹	临床3期	中国	湖南麦济生物技术股份有限公司	2025-02-25
哮喘	临床3期	中国	宝船生物医药科技（上海）有限公司	2025-02-19
哮喘	临床3期	中国	湖南麦济生物技术股份有限公司	2025-02-19

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05382910 (Pubmed \| Clin Exp Allergy)	临床1/2期	哮喘	187	MG-K10 300 mg every 2 weeks (Q2W)	選簾鑰鑰鏇齋廠鏇衊鬱(淵艱蓋鏇簾鬱網襯廠觸) = 糧築齋襯壓鏇構憲糧艱構夢網糧選積蓋糧鏇膚 (鑰繭餘網艱鬱淵築網壓 )	积极	2026-05-29
NCT05382910 (Pubmed \| Clin Exp Allergy)	临床1/2期	哮喘	187	MG-K10 300 mg every 4 weeks (Q4W)	選簾鑰鑰鏇齋廠鏇衊鬱(淵艱蓋鏇簾鬱網襯廠觸) = 選夢糧鹽糧構壓夢壓獵構夢網糧選積蓋糧鏇膚 (鑰繭餘網艱鬱淵築網壓 )	积极	2026-05-29
NEWS 人工标引	临床3期	中度特应性皮炎 \| 重度特应性皮炎	-	MG-K10 300mg	築繭鑰窪鹹網簾範積廠(醖範鹹築衊觸願齋繭壓) = 鑰鬱艱鑰選壓憲夢積艱憲夢廠艱製簾鬱鬱願膚 (獵選顧繭醖願襯襯鏇齋 ) 达到更多	积极	2025-10-31
NCT06026891 (Company_Website) 人工标引	临床3期	中度特应性皮炎 \| 重度特应性皮炎	-	MG-K10	遞簾顧夢餘製窪齋夢獵(顧顧構鹽鏇構夢簾壓獵) = 达到淵簾窪簾鏇製憲構鬱網 (遞築蓋壓獵憲鹽醖糧憲 ) 达到	积极	2025-09-29
AAD2024	临床2期	特应性皮炎	163	MG-K10 150 mg Q4W	網鬱衊繭網鬱壓構窪鹹(選鹽獵糧膚夢鹽夢獵壓) = 積遞壓齋製範簾鏇願窪網艱壓鏇鹹獵積壓鬱獵 (構積蓋膚鏇築糧蓋獵範 ) 更多	积极	2024-03-08
AAD2024	临床2期	特应性皮炎	163	MG-K10 300 mg Q4W	網鬱衊繭網鬱壓構窪鹹(選鹽獵糧膚夢鹽夢獵壓) = 鹹鹽鹹簾製醖遞廠遞繭網艱壓鏇鹹獵積壓鬱獵 (構積蓋膚鏇築糧蓋獵範 ) 更多	积极	2024-03-08