2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T565,Stapokibart is a novel anti-IL-4Rα monoclonal antibody approved for treating adults with moderate-to-severe AD. To assess the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of stapokibart in children with moderate-to-severe AD. 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). 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. 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.31:T88a,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. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Single-Arm Open-Label Trial: study design Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Single-Arm Open-Label Trial (study design). Clinician-written summaries and actionable practice insights. 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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.","abstract":"$30","keywords":[],"pubmed_id":"41284735","conclusions":"","publication_date":"2025-11-24T00:00:00"},"crossref":{"DOI":"10.1093/bjd/ljaf455","URL":"https://doi.org/10.1093/bjd/ljaf455","ISSN":["0007-0963","1365-2133"],"link":[{"URL":"https://academic.oup.com/bjd/advance-article-pdf/doi/10.1093/bjd/ljaf455/65492565/ljaf455.pdf","content-type":"application/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https://academic.oup.com/bjd/advance-article-pdf/doi/10.1093/bjd/ljaf455/65492565/ljaf455.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["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"],"author":[{"given":"Mutong","family":"Zhao","sequence":"first","affiliation":[{"name":"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 ,"}]},{"given":"Zigang","family":"Xu","sequence":"additional","affiliation":[{"name":"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 ,"}]},{"given":"Liming","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Affiliated Hangzhou First People’s Hospital, School of Medicine, Westlake University , Hangzhou, Zhejiang ,"}]},{"given":"Zhu","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hunan Children’s Hospital , Changsha, Hunan ,"}]},{"given":"Bin","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dermatology Hospital of Southern Medical University , Guangzhou, Guangdong ,"}]},{"given":"Zhimiao","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dermatology Hospital of Southern Medical University , Guangzhou, Guangdong ,"}]},{"given":"Yangfeng","family":"Ding","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine , Shanghai ,"}]},{"given":"Guohong","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dermatology Hospital of Jiangxi Province , Nanchang, Jiangxi ,"}]},{"given":"Hua","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Children’s Hospital of Chongqing Medical University , Chongqing ,"}]},{"given":"Qiufang","family":"Qian","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Children’s Hospital , Shanghai ,"}]},{"given":"Qin","family":"Ran","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Chengdu Women’s and Children’s Central Hospital , Chengdu, Sichuan ,"}]},{"given":"Xu","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Allergy, The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Shandong Institute of Respiratory Diseases , Jinan, Shandong ,"}]},{"given":"Yayun","family":"Xu","sequence":"additional","affiliation":[{"name":"Keymed Biosciences (Chengdu) Co., Ltd , Chengdu, Sichuan ,"}]},{"given":"Yufeng","family":"Xu","sequence":"additional","affiliation":[{"name":"Keymed Biosciences (Chengdu) Co., Ltd , Chengdu, Sichuan ,"}]},{"given":"Yanqiu","family":"Huang","sequence":"additional","affiliation":[{"name":"Keymed Biosciences (Chengdu) Co., Ltd , Chengdu, Sichuan ,"}]},{"given":"Yingmin","family":"Jia","sequence":"additional","affiliation":[{"name":"Keymed Biosciences (Chengdu) Co., Ltd , Chengdu, Sichuan ,"}]},{"given":"Bo","family":"Chen","sequence":"additional","affiliation":[{"name":"Keymed Biosciences (Chengdu) Co., Ltd , Chengdu, Sichuan ,"}]},{"given":"Lin","family":"Ma","sequence":"additional","affiliation":[{"name":"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 ,"}]}],"issued":{"date-parts":[[2025,11,24]]},"member":"286","prefix":"10.1093","source":"Crossref","volume":null,"created":{"date-time":"2025-11-23T12:48:08Z","timestamp":1763902088000,"date-parts":[[2025,11,23]]},"indexed":{"date-time":"2025-11-24T19:49:32Z","timestamp":1764013772288,"date-parts":[[2025,11,24]]},"license":[{"URL":"https://creativecommons.org/licenses/by-nc/4.0/","start":{"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000,"date-parts":[[2025,11,24]]},"delay-in-days":0,"content-version":"am"}],"subject":[],"abstract":"$31","language":"en","relation":{},"resource":{"primary":{"URL":"https://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljaf455/8341573"}},"subtitle":[],"deposited":{"date-time":"2025-11-24T18:39:02Z","timestamp":1764009542000,"date-parts":[[2025,11,24]]},"issn-type":[{"type":"print","value":"0007-0963"},{"type":"electronic","value":"1365-2133"}],"published":{"date-parts":[[2025,11,24]]},"publisher":"Oxford University Press 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trial","updated":"2025-11-27T02:22:14+00:00","published_date":"2025-11-23","best_oa_location":{"url":"https://academic.oup.com/bjd/advance-article-pdf/doi/10.1093/bjd/ljaf455/65492565/ljaf455.pdf","pmh_id":null,"url_for_pdf":"https://academic.oup.com/bjd/advance-article-pdf/doi/10.1093/bjd/ljaf455/65492565/ljaf455.pdf","url_for_landing_page":"https://doi.org/10.1093/bjd/ljaf455"}}},"created_at":"2025-12-01T07:04:09.830Z","updated_at":"2025-12-02T07:03:10.886Z","tags":[{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"age_group","value":"child","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"category","value":"Dermatology","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"condition","value":"Atopic Dermatitis","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"generic","value":"stapokibart","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"modality","value":"IL-4Rα Inhibitor","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"sample_size","value":"n=25","value_numeric":25},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"study_design","value":"Single-Arm Open-Label Trial","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"warning","value":"Follow-up was limited to 8 weeks post-treatment, which constrains assessment of durability and rare adverse events.","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"warning","value":"Responder outcomes are reported as percentages without raw counts.","value_numeric":null},{"paper_doi":"10.1093/bjd/ljaf455","tag_type":"warning","value":"Study design label is approximate; this is a phase 1b/2a single-arm, open-label study without a comparator.","value_numeric":null}],"summaries":{"what_studied":"A multicenter, open-label, single-arm phase 1b/2a trial evaluated stapokibart in children aged 6–11 years with moderate-to-severe atopic dermatitis over 8 weeks of treatment and 8 weeks of follow-up, using weight-tiered dosing (30–60 kg: 600 mg loading then 300 mg Q3W; 15–30 kg: 300 mg loading then 150 mg Q2W).","key_result":"Among 25 treated children, 68.0% experienced mild or moderate adverse events; at week 8, EASI-75 was achieved by 53.8% in the 30–60 kg group and 75.0% in the 15–30 kg group, with no treatment-related anti-drug antibodies or new safety signals. Drug concentrations rose after the first dose, accumulated with repeated dosing, declined after discontinuation, and inflammatory biomarkers decreased in both groups.","limitations":"Small sample size (n=25), short duration (8-week treatment with 8-week follow-up), and open-label single-arm design without a comparator limit efficacy interpretation and generalizability.","practice_takeaway":"Stapokibart showed early efficacy signals and was generally well tolerated over 8 weeks in 6–11-year-olds with moderate-to-severe atopic dermatitis, but evidence remains preliminary; await larger, controlled pediatric trials before changing practice."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"study_design","value":"Single-Arm Open-Label Trial"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Study Designs","href":"/hub/tag/study_design"},{"name":"Single-Arm Open-Label Trial"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"study_design","hub_tag_value":"Single-Arm Open-Label Trial"}}}]]

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