Safety and efficacy of stapokibart, an anti-IL-4Rα monoclonal antibody, in children aged 6-11 years with moderate-to-severe atopic dermatitis: An open-label, single-arm phase 1b/2a trial

Mutong Zhao; Zigang Xu; Liming Wu; Zhu Wei; Bin Yang; Zhimiao Lin; Yangfeng Ding; Guohong Hu; Hua Wang; Qiufang Qian; Qin Ran; Xu Li; Yayun Xu; Yufeng Xu; Yanqiu Huang; Yingmin Jia; Bo Chen; Lin Ma

doi:10.1093/bjd/ljaf455

Safety and efficacy of stapokibart, an anti-IL-4Rα monoclonal antibody, in children aged 6-11 years with moderate-to-severe atopic dermatitis: An open-label, single-arm phase 1b/2a trial

Br J Dermatol. 2025 Nov 24:ljaf455. doi: 10.1093/bjd/ljaf455. Online ahead of print.

Authors

Mutong Zhao¹, Zigang Xu¹, Liming Wu², Zhu Wei³, Bin Yang⁴, Zhimiao Lin⁴, Yangfeng Ding⁵, Guohong Hu⁶, Hua Wang⁷, Qiufang Qian⁸, Qin Ran⁹, Xu Li¹⁰, Yayun Xu¹¹, Yufeng Xu¹¹, Yanqiu Huang¹¹, Yingmin Jia¹¹, Bo Chen¹¹, Lin Ma¹

Affiliations

¹ Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Key Discipline of Pediatrics, Key Laboratory of Major Diseases in Children, Ministry of Education, National Center for Children's Health, Beijing, China.
² Department of Dermatology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China.
³ Department of Dermatology, Hunan Children's Hospital, Changsha, Hunan, China.
⁴ Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.
⁵ Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China.
⁶ Department of Dermatology, Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, China.
⁷ Department of Dermatology, Children's Hospital of Chongqing Medical University, Chongqing, China.
⁸ Department of Dermatology, Shanghai Children's Hospital, Shanghai, China.
⁹ Department of Dermatology, Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China.
¹⁰ Department of Allergy, The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Shandong Institute of Respiratory Diseases, Jinan, Shandong, China.
¹¹ Keymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.

PMID: 41284735
DOI: 10.1093/bjd/ljaf455

Abstract

Background: Stapokibart is a novel anti-IL-4Rα monoclonal antibody approved for treating adults with moderate-to-severe AD.

Objectives: To assess the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of stapokibart in children with moderate-to-severe AD.

Methods: Multicenter, open-label, single-arm phase 1b/2a trial (NCT06162507) involving eight-week treatment and eight-week follow-up. Children aged 6-11 years received subcutaneous stapokibart based on a body weight-tiered regimen (30-60 kg: 300 mg Q3W for a total of three doses, including a 600 mg loading dose; 15-30 kg: 150 mg Q2W for a total of four doses, including a 300 mg loading dose).

Results: Twenty-five patients (30-60 kg: 13, 15-30 kg: 12) received stapokibart; 68.0% reported mild or moderate adverse events. At week 8, 53.8% of the 30-60 kg group and 75.0% of the 15-30 kg group achieved EASI-75. Stapokibart concentrations increased rapidly following the first dose, further climbed with repeated dosing, and gradually declined after treatment discontinuation. Stapokibart reduced inflammatory biomarkers in both groups. No treatment-related anti-drug antibodies were detected. No new safety signals emerged.

Conclusions: Stapokibart showed potential for improving disease outcomes and appeared to be well tolerated in children aged 6-11 years with moderate-to-severe AD. Larger controlled studies are needed to confirm long-term benefits.