Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial.

IF 4.2 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-09 DOI:10.1007/s13555-025-01368-4

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

{"title":"Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial.","authors":"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","doi":"10.1007/s13555-025-01368-4","DOIUrl":null,"url":null,"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.","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"857-867"},"PeriodicalIF":4.2000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971068/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01368-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/9 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}

引用次数: 0

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.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

611治疗中国成人中重度特应性皮炎的疗效和安全性：一项II期试验的结果

特应性皮炎（AD）是一种慢性炎症性皮肤病。611是一种人源化单克隆抗体，选择性靶向白细胞介素(IL)-4受体α，从而抑制白细胞介素(IL)-4和IL-13的信号传导。该2期研究旨在评估611例中国成人中重度AD患者的有效性和安全性。方法：这项随机、双盲、安慰剂对照的2期研究于2022年10月至2023年9月进行。符合条件的中重度AD患者按1:1:1的比例随机分配，接受611治疗，每2周300 mg（负荷剂量为600 mg）（a组）或每4周300 mg（负荷剂量为600 mg）（B组），或每2周安慰剂治疗，持续16周，随访8周。主要疗效终点是在第16周湿疹面积和严重程度指数（EASI-75）评分至少减少75%的患者比例。并对其安全性和药效学进行了评价。结果：治疗16周后，A组60.0%和B组48.8%的患者达到EASI-75，均显著高于安慰剂组（15.6%,p）。结论：611对中重度AD患者疗效高，安全性好。试验注册：ClinicalTrials.gov, NCT05544591。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.