Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial
Abstract Introduction Atopic dermatitis (AD) is a chronic inflammatory skin disease. 611, a humanized monoclonal antibody, selectively targets the interleukin (IL)-4 receptor alpha, thereby inhibiting the signaling of both interleukin (IL)-4 and IL-13. This phase 2 study aimed to evaluate the effica...
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Adis, Springer Healthcare
2025-03-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-025-01368-4 |
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| author | Yan Zhao Litao Zhang Liming Wu Xinsuo Duan Chao Ji Rong Xiao Mingkai Ji Lunfei Liu Bin Yang Guohong Hu Yanyan Feng Jianjian Zhu Jianguo Li Yangfeng Ding Haomin Huang Qinghong Zhou Yuyu Xu Jianzhong Zhang |
| author_facet | Yan Zhao Litao Zhang Liming Wu Xinsuo Duan Chao Ji Rong Xiao Mingkai Ji Lunfei Liu Bin Yang Guohong Hu Yanyan Feng Jianjian Zhu Jianguo Li Yangfeng Ding Haomin Huang Qinghong Zhou Yuyu Xu Jianzhong Zhang |
| author_sort | Yan Zhao |
| collection | DOAJ |
| description | Abstract Introduction Atopic dermatitis (AD) is a chronic inflammatory skin disease. 611, a humanized monoclonal antibody, selectively targets the interleukin (IL)-4 receptor alpha, thereby inhibiting the signaling of both interleukin (IL)-4 and IL-13. This phase 2 study aimed to evaluate the efficacy and safety of 611 in Chinese adults with moderate-to-severe AD. Methods This randomized, double-blind, placebo-controlled phase 2 study was conducted between October 2022 and September 2023. Eligible patients with moderate-to-severe AD were randomly assigned in a 1:1:1 ratio to receive 611 at a dose of either 300 mg (loading dose of 600 mg) every 2 weeks (Group A) or 300 mg (loading dose of 600 mg) every 4 weeks (Group B), or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary efficacy endpoint was the proportion of patients achieving at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) score at week 16. The safety and pharmacodynamics were also assessed. Results After 16 weeks of treatment, 60.0% of patients in Group A and 48.8% in Group B achieved EASI-75, both significantly higher than the placebo group (15.6%, p < 0.01). Additionally, 611 at both doses significantly improved the Investigator’s Global Assessment (IGA) scores, peak pruritus numerical rating scale (NRS), and other efficacy endpoints. Patients receiving 611 demonstrated significant reductions in serum thymus activation-regulated chemokine (TARC) and total serum immunoglobulin E (IgE) levels. The incidence of treatment-emergent adverse events (TEAEs) was similar across all dosage groups. The most common 611-related TEAE is upper respiratory tract infections. No new safety concerns were identified. Conclusion 611 demonstrated a high efficacy and a favorable safety profile in patients with moderate-to-severe AD. Trial Registration ClinicalTrials.gov, NCT05544591. |
| format | Article |
| id | doaj-art-cd4a7d5931a4473f94c48667b4ba12f5 |
| institution | OA Journals |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Adis, Springer Healthcare |
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| series | Dermatology and Therapy |
| spelling | doaj-art-cd4a7d5931a4473f94c48667b4ba12f52025-08-20T01:53:00ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722025-03-0115485786710.1007/s13555-025-01368-4Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II TrialYan Zhao0Litao Zhang1Liming Wu2Xinsuo Duan3Chao Ji4Rong Xiao5Mingkai Ji6Lunfei Liu7Bin Yang8Guohong Hu9Yanyan Feng10Jianjian Zhu11Jianguo Li12Yangfeng Ding13Haomin Huang14Qinghong Zhou15Yuyu Xu16Jianzhong Zhang17Department of Dermatology, Peking University People’s HospitalDepartment of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalDepartment of Dermatology, The First People’S Hospital of HangzhouDepartment of Dermatology, The Affiliated Hospital of Chengde Medical CollegeDepartment of Dermatology, The First Affiliated Hospital of Fujian Medical UniversityDepartment of Dermatology, The Second Xiangya Hospital of Central South UniversityDepartment of Dermatology, The Second Affiliated Hospital of Xiamen Medical UniversityDepartment of Dermatology, The Fourth Affiliated Hospital of Zhejiang University School of MedicineDermatology Hospital, Southern Medical UniversityDermatology Hospital of Jiangxi ProvinceDepartment of Dermatology, The Second People’S Hospital of ChengduDepartment of Dermatology, The First People’S Hospital of Changde CityDepartment of Dermatology, Henan Provincial People’s HospitalShanghai Skin Disease Hospital (Skin Disease Hospital of Tongji University)Sunshine Guojian Pharmaceutical (Shanghai) Co.,Ltd.Sunshine Guojian Pharmaceutical (Shanghai) Co.,Ltd.Sunshine Guojian Pharmaceutical (Shanghai) Co.,Ltd.Department of Dermatology, Peking University People’s HospitalAbstract Introduction Atopic dermatitis (AD) is a chronic inflammatory skin disease. 611, a humanized monoclonal antibody, selectively targets the interleukin (IL)-4 receptor alpha, thereby inhibiting the signaling of both interleukin (IL)-4 and IL-13. This phase 2 study aimed to evaluate the efficacy and safety of 611 in Chinese adults with moderate-to-severe AD. Methods This randomized, double-blind, placebo-controlled phase 2 study was conducted between October 2022 and September 2023. Eligible patients with moderate-to-severe AD were randomly assigned in a 1:1:1 ratio to receive 611 at a dose of either 300 mg (loading dose of 600 mg) every 2 weeks (Group A) or 300 mg (loading dose of 600 mg) every 4 weeks (Group B), or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary efficacy endpoint was the proportion of patients achieving at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) score at week 16. The safety and pharmacodynamics were also assessed. Results After 16 weeks of treatment, 60.0% of patients in Group A and 48.8% in Group B achieved EASI-75, both significantly higher than the placebo group (15.6%, p < 0.01). Additionally, 611 at both doses significantly improved the Investigator’s Global Assessment (IGA) scores, peak pruritus numerical rating scale (NRS), and other efficacy endpoints. Patients receiving 611 demonstrated significant reductions in serum thymus activation-regulated chemokine (TARC) and total serum immunoglobulin E (IgE) levels. The incidence of treatment-emergent adverse events (TEAEs) was similar across all dosage groups. The most common 611-related TEAE is upper respiratory tract infections. No new safety concerns were identified. Conclusion 611 demonstrated a high efficacy and a favorable safety profile in patients with moderate-to-severe AD. Trial Registration ClinicalTrials.gov, NCT05544591.https://doi.org/10.1007/s13555-025-01368-4Atopic dermatitisChinese patients611Interleukin-4 receptor alphaEczema areaSeverity index |
| spellingShingle | Yan Zhao Litao Zhang Liming Wu Xinsuo Duan Chao Ji Rong Xiao Mingkai Ji Lunfei Liu Bin Yang Guohong Hu Yanyan Feng Jianjian Zhu Jianguo Li Yangfeng Ding Haomin Huang Qinghong Zhou Yuyu Xu Jianzhong Zhang Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial Dermatology and Therapy Atopic dermatitis Chinese patients 611 Interleukin-4 receptor alpha Eczema area Severity index |
| title | Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial |
| title_full | Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial |
| title_fullStr | Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial |
| title_full_unstemmed | Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial |
| title_short | Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial |
| title_sort | efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis results from a phase ii trial |
| topic | Atopic dermatitis Chinese patients 611 Interleukin-4 receptor alpha Eczema area Severity index |
| url | https://doi.org/10.1007/s13555-025-01368-4 |
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