MG-K10, a Long-Acting Anti-IL-4 Receptor Alpha Monoclonal Antibody in Adult Patients with Moderate-to-Severe Atopic Dermatitis
<u><b><i></i></b></u> <u><b><i>Background:</i></b></u> There remains unmet need for therapies for atopic dermatitis (AD) with favorable symptom control but less frequent dosing.<u><b><i>Objective:</i></b></u> To evaluate the benefits and safety of MG-K10, a humanized interleukin-4 receptor alpha-targeting antibody, in moderate-to-severe AD.<u><b><i>Methods:</i></b></u> In this multi-center, double-blind, randomized, phase II trial, 163 moderate-to-severe AD patients were randomized to receive 16-week treatment with MG-K10 150 mg every 4 weeks (Q4W), 300 mg every 2 weeks (Q2W) (n = 41), 300 mg Q4W (n = 41), or placebo (n = 40). Primary endpoint was the change in Eczema Area and Severity Index (EASI) scores from baseline to week 16.<u><b><i>Results:</i></b></u> The mean differences in EASI score at week 16 for the 300 mg Q4W, 300 mg Q2W, and 150 mg Q4W groups were -38.83% (95% confidence interval [CI]: -56.47% to -21.20%, <i>P</i> < 0.001), -27.06% (95% CI: -44.73% to -9.38%, <i>P</i> = 0.003), and -16.00% (95% CI: -33.66% to 1.67%, <i>P</i> = 0.076) compared with placebo group. The proportion of participants achieving EASI-75 at week 16 was 79.5%, 66.7%, 53.8%, and 28.9% in the 300 mg Q4W, 300 mg Q2W, 150 mg Q4W, and placebo groups. The incidence of adverse events was comparable across groups.<u><b><i>Conclusion:</i></b></u> MG-K10 demonstrates potential as a long-acting therapeutic option for managing symptoms of moderate-to-severe AD, with favorable safety profile. The preliminary efficacy and safety supported further validation of 300 mg Q4W in phase III trial.
Authors
- Chaoying Gu (ORCID: https://orcid.org/0000-0002-5467-4671)
- Chao Ji (ORCID: https://orcid.org/0000-0002-2282-3505)
- Kun Chen (ORCID: https://orcid.org/0000-0003-1904-5033)
- Aie Xu (ORCID: https://orcid.org/0000-0001-7255-086X)
- Chenghai Zhang (ORCID: https://orcid.org/0000-0001-6960-3019)
- Yuling Shi (ORCID: https://orcid.org/0000-0002-1273-7881)
- Litao Zhang (ORCID: https://orcid.org/0000-0003-4918-611X)
- Lunfei Liu (ORCID: https://orcid.org/0000-0003-3200-4279)
- Fang Xie (ORCID: https://orcid.org/0000-0003-2667-281X)
- Jianyun Lu (ORCID: https://orcid.org/0000-0001-7187-8871)
- Rupeng Wang (ORCID: https://orcid.org/0000-0002-4759-5852)
- Xiaohua Tao (ORCID: https://orcid.org/0000-0003-3527-2914)
- Dong Qin (ORCID: https://orcid.org/0000-0002-7877-7501)
- Zhao Yi (ORCID: https://orcid.org/0000-0002-0820-1689)
- Lingqiao Zhu
- Liming Wu (ORCID: https://orcid.org/0000-0002-4708-0883)
- Shifa Zhang (ORCID: https://orcid.org/0000-0002-8102-1318)
- Xiaoyan Chen (ORCID: https://orcid.org/0009-0004-8800-4459)
- Sen Yang (ORCID: https://orcid.org/0000-0003-3125-6626)
- Linfeng Li (ORCID: https://orcid.org/0000-0002-6580-5024)
- Jinyan Wang (ORCID: https://orcid.org/0000-0001-7440-4073)
- Yumei Li (ORCID: https://orcid.org/0009-0002-0117-7003)
- Jinhua Xu (ORCID: https://orcid.org/0000-0001-9104-1294)
- Qing Guo (ORCID: https://orcid.org/0009-0002-7578-6549)
- Jianhua Wu (ORCID: https://orcid.org/0000-0003-1515-2309)
- Yangfeng Ding (ORCID: https://orcid.org/0000-0002-0287-2190)
- Yunsheng Liang
- Jingyi Li (ORCID: https://orcid.org/0000-0003-1912-0662)
- Danqi Deng
Institutions
- Jiangsu University (CN)
- Tianjin University of Traditional Chinese Medicine (CN)
- Fujian Medical University (CN)
- Central South University (CN)
- Army Medical University (CN)
- Sun Yat-sen University (CN)
- Bengbu Medical College (CN)
- Second Military Medical University (CN)
- Capital Medical University (CN)
- Anhui Medical University (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Sichuan University (CN)
- Fudan University (CN)
- Kunming Medical University (CN)
- West China Hospital of Sichuan University (CN)
- Sun Yat-sen Memorial Hospital (CN)
- Fourth Affiliated Hospital of China Medical University (CN)
- Ningbo No. 2 Hospital (CN)
- Chinese Academy of Medical Sciences Dermatology Hospital (CN)
- Affiliated Hospital of Jiangsu University (CN)
- Hubei University of Arts and Science (CN)
- Changhai Hospital (CN)
- Xinqiao Hospital (CN)
- Xiangyang Central Hospital (CN)
- First Affiliated Hospital of Fujian Medical University (CN)
- Third People's Hospital of Hangzhou (CN)
- Zhejiang Provincial People's Hospital (CN)
- First Affiliated Hospital of Anhui Medical University (CN)
- Xian Yang Central Hospital (CN)
- Beijing Friendship Hospital (CN)
- Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN)
- First Affiliated Hospital of Bengbu Medical College (CN)
- Beijing Tsinghua Chang Gung Hospital (CN)
- Shanghai Skin Disease Hospital (CN)
- Third Xiangya Hospital (CN)
- Viva Biotech (China) (CN)
- Huashan Hospital (CN)
- Ningbo No.6 Hospital (CN)
- Southern Medical University (CN)
- Northeastern University (CN)
Publication Details
- Journal
- Dermatitis
- Published
- 2025-11-05
- DOI
- https://doi.org/10.1177/17103568251388478
- Primary Topic
- Dermatology and Skin Diseases
- Type
- article
- Field-Weighted Citation Impact
- 0.00