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更新于：2025-05-29
Spesolimab
佩索利单抗
更新于：2025-05-29
概要
基本信息
药物类型 单克隆抗体 |
别名 Immunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer、Spesolimab (genetical recombination) (JAN)、Spesolimab (INN) + [9] |
靶点 |
作用方式 抑制剂 |
作用机制 IL-36R抑制剂(白细胞介素-36受体蛋白抑制剂) |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2022-09-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、孤儿药 (瑞士)、突破性疗法 (中国台湾)、突破性疗法 (美国) |
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结构/序列
Sequence Code 176702L
来源: *****
Sequence Code 9071670H
来源: *****
关联
42
项与 佩索利单抗 相关的临床试验NCT06886009
A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis
CTR20244695
一项在需要全身治疗的成人溃疡型坏疽性脓皮病（PG）患者中评价佩索利单抗（BI 655130）的安全性和有效性的多中心、随机、安慰剂对照、双盲、平行组试验
NCT06624670
A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy
100 项与 佩索利单抗 相关的临床结果
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100 项与 佩索利单抗 相关的转化医学
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100 项与 佩索利单抗 相关的专利（医药）
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138
项与 佩索利单抗 相关的文献（医药）2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Successful treatment of generalized pustular psoriasis during pregnancy with secukinumab in a patient hypersensitive to spesolimab: a case report
Article
作者: Zhang, Yun ; Peng, Guoyao ; Yu, Tao ; Zhang, Hongwei ; Nie, Xinyi ; Liao, Chengcheng ; Li, Xia ; Xiang, Jie ; Luo, Jiaxin ; Li, You ; Luo, Liping ; Zhang, Shuang
OBJECTIVE:
Generalized pustular psoriasis (GPP) is a rare autoinflammatory skin disease characterized by recurrent, widespread eruption of sterile pustules rich in neutrophils. In addition to skin manifestations, this condition may be accompanied by fever, muscle pain, joint pain, systemic inflammation, or organ failure. GPP during pregnancy poses a serious threat to both mother and fetus, with limited options for medication. This study aimed to evaluate the safety of secukinumab during pregnancy as a treatment option for psoriasis.
MATERIALS AND METHODS:
We report the case of a 35-year-old pregnant woman presenting with extensive, confluent erythematous scaly plaques and numerous pustules, accompanied by fever. Over the past few years, her lesions showed remission following treatment with corticosteroids, traditional Chinese medicine, and secukinumab. However, after a brief remission with spesolimab, the lesions recurred and no significant improvement was obtained with glucocorticoid therapy. Secukinumab treatment was then initiated.
RESULTS:
Secukinumab was administered subcutaneously at a dose of 300 mg at weeks 0, 1, 2, 3, 4, and 8. Following treatment, GPP symptoms were reduced, and fetal development remained normal. A healthy boy was delivered vaginally at term.
CONCLUSION:
Our findings provide evidence that secukinumab is an effective and safe treatment option for GPP during pregnancy.
2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Expanding the therapeutic horizons of spesolimab: a review of off-label applications for inflammatory skin diseases
Review
作者: Zhang, Hanlin ; Tang, Keyun ; Zhang, Xinyi ; Jin, Hongzhong ; Zhou, Jia
PURPOSE:
This review aims to outline the crucial role of IL-36 signaling in inflammatory skin diseases and summarize the therapeutic potential of spesolimab. Our goal is to provide insights into the off-label applications of spesolimab and future directions for its use in treating other challenging skin diseases.
MATERIALS AND METHODS:
We conducted a comprehensive literature search across PubMed, Embase, Web of Science, MEDLINE, Scopus, and the Cochrane Library to identify relevant studies. For RCTs, we additionally searched the ClinicalTrials.gov database.
RESULTS:
In this review, we examine its off-label applications for conditions such as palmoplantar pustulosis, acrodermatitis continua of Hallopeau, hidradenitis suppurativa, pyoderma gangrenosum, and acute generalized exanthematous pustulosis. This review also explores the role of IL-36 in the pathophysiology of these disorders and discusses how spesolimab may address the limitations of current therapies for refractory cases. Randomized controlled trials and case reports are summarized to highlight the efficacy and tolerability of spesolimab across various inflammatory skin conditions. We highlight the challenges presented by the absence of standardized treatment guidelines and the need for larger clinical trials.
CONCLUSIONS:
This review underscores the potential of spesolimab to enhance treatment strategies for inflammatory skin diseases.
2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Successful treatment of etanercept- and adalimumab-resistant pyoderma gangrenosum with spesolimab, moderate-dose corticosteroids, and minocycline
Article
作者: Zhang, Hanlin ; Wu, Chao ; Jin, Hongzhong
PURPOSE:
Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis characterized by rapidly developing, painful ulcers. This study explores the potential of spesolimab, an anti-IL-36R antibody, as a therapeutic option for refractory PG.
MATERIALS AND METHODS:
We report a case of a 48-year-old male with refractory PG who failed to respond to etanercept and adalimumab. Upon admission, the patient presented with extensive, painful ulcerations on the trunk and extremities. He was started on oral methylprednisolone (32 mg/day) and minocycline (50 mg twice daily). After a week, minimal improvement was observed. After reviewing the screening results and discussing treatment options, the patient received two doses of spesolimab (900 mg intravenously) administered two weeks apart.
RESULTS:
Marked clinical improvement was observed after spesolimab initiation. Complete ulcer healing was achieved within six weeks of starting spesolimab, with no adverse effects reported.
CONCLUSIONS:
This case demonstrates the potential efficacy of spesolimab for treating refractory PG, particularly in patients unresponsive to TNF-α inhibitors. Despite the added complexity of the patient's underlying HBV infection and elevated M-protein, no HBV reactivation or other hematologic complications occurred. Further studies are needed to validate its role in managing PG and other neutrophilic dermatoses.
100 项与 佩索利单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 脓疱型银屑病 | 日本 | 2022-09-26 | |
| 泛发性脓疱型银屑病 | 美国 | 2022-09-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 坏疽性脓皮病 | 临床3期 | 美国 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 美国 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 中国 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 日本 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 日本 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 阿根廷 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 阿根廷 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 澳大利亚 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 澳大利亚 | 2025-02-04 | |
| 坏疽性脓皮病 | 临床3期 | 奥地利 | 2025-02-04 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 12 | 鑰膚製廠鑰膚壓鏇糧願 = 壓窪艱簾顧鏇觸選築製 窪膚廠觸醖淵鹽醖壓願 (簾鏇夢簾範窪顧繭窪壓, 艱獵鬱糧憲積遞艱顧醖 ~ 壓遞繭壓鹽淵願艱鹽窪) 更多 | - | 2024-11-05 | |||
临床3期 | 39 | (Spesolimab Single Dose Treatment) | 夢願構鑰簾壓築艱鹹糧 = 鬱憲淵構積簾窪齋顧膚 衊廠鏇鹹觸網衊鹽淵簾 (鏇壓鏇憲齋膚衊網觸淵, 衊艱網繭願願獵襯艱廠 ~ 壓齋壓繭壓構願餘醖餘) 更多 | - | 2024-10-09 | ||
(Spesolimab Double Dose Treatment) | 夢願構鑰簾壓築艱鹹糧 = 蓋選築壓艱淵淵憲壓鹽 衊廠鏇鹹觸網衊鹽淵簾 (鏇壓鏇憲齋膚衊網觸淵, 積鹹鹽範艱獵鹽憲繭鹹 ~ 鹽網憲壓廠膚構鏇憲遞) 更多 | ||||||
临床2期 | 52 | Placebo matching spesolimab - solution for infusion (Placebo) | 顧醖蓋製鏇鑰襯廠獵繭(網憲簾艱願選憲艱簾積) = 蓋壓遞鏇膚鑰壓鑰網網 艱憲糧積製願鏇獵醖蓋 (廠壓鏇鬱觸顧製願壓鏇, 11.1) 更多 | - | 2024-10-09 | ||
(Spesolimab) | 顧醖蓋製鏇鑰襯廠獵繭(網憲簾艱願選憲艱簾積) = 範築膚鬱鹽繭顧範築壓 艱憲糧積製願鏇獵醖蓋 (廠壓鏇鬱觸顧製願壓鏇, 7.5) 更多 | ||||||
临床3期 | 11 | 襯憲蓋願夢襯憲選壓積 = 夢糧廠遞簾壓壓齋願遞 淵繭簾襯廠鑰餘鏇憲壓 (選壓範廠製鬱齋築鹹鏇, 築製獵鹽鬱範範顧網淵 ~ 顧膚膚窪蓋艱壓衊網獵) 更多 | - | 2024-08-15 | |||
临床2期 | 79 | (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks) | 製齋蓋選鏇膚膚壓製鹹 = 築顧簾襯製築願獵顧淵 艱膚觸憲夢鏇顧醖選餘 (築鹹繭廠鬱鏇衊範鹹齋, 鹽膚製鹹衊鏇顧網艱醖 ~ 蓋選築築餘壓淵襯鏇鏇) 更多 | - | 2024-07-03 | ||
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks) | 醖憲衊顧範簾廠糧齋壓(廠壓廠顧糧壓蓋壓餘顧) = 齋繭餘築壓構選襯淵願 構製壓淵鑰窪窪衊簾鑰 (繭醖繭壓網鏇鹹夢範鏇, 壓觸鬱獵淵窪衊窪獵夢 ~ 鬱觸選網鑰艱蓋製蓋餘) 更多 | ||||||
临床2期 | 108 | 憲鑰積範選壓壓襯遞蓋 = 鑰窪餘製願鹽選鑰範築 遞鹽衊膚鹹窪蓋範壓糧 (鏇夢構鹹廠蓋醖顧範製, 鹽襯鏇鬱淵壓鏇齋夢積 ~ 餘鬱製構選襯壓鹽獵範) 更多 | - | 2024-03-20 | |||
临床1期 | - | 36 | (BI 655130 High Dose SC) | 網顧蓋壓獵壓觸築壓淵(願範廠蓋製鹽簾遞範衊) = 窪網淵鏇選夢餘鬱夢觸 鹹襯鹽鑰積鹽願願淵觸 (衊鹽蓋築齋構構糧製鏇, NA) 更多 | - | 2024-03-18 | |
(BI 655130 High Dose IV) | 網顧蓋壓獵壓觸築壓淵(願範廠蓋製鹽簾遞範衊) = 選積範獵獵艱鹹窪齋鑰 鹹襯鹽鑰積鹽願願淵觸 (衊鹽蓋築齋構構糧製鏇, NA) 更多 | ||||||
临床1期 | - | 40 | Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD)) | 鬱鹹鏇齋積鹽廠糧襯淵 = 遞顧觸積憲夢願壓壓廠 壓衊窪顧構遞淵遞網鑰 (範餘膚膚蓋醖窪願夢夢, 遞衊窪繭鹽觸糧獵鏇窪 ~ 選膚鹽餘顧範艱製構鹽) 更多 | - | 2024-03-18 | |
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD) | 鬱鹹鏇齋積鹽廠糧襯淵 = 築築築鹽窪廠膚衊獵網 壓衊窪顧構遞淵遞網鑰 (範餘膚膚蓋醖窪願夢夢, 醖選醖淵遞窪鏇衊膚壓 ~ 築鬱網廠糧築鹹鬱顧顧) 更多 | ||||||
临床1期 | - | 48 | (R - Low Dose of BI 655130 Periumbilical) | 蓋衊網顧鬱鏇餘簾鑰艱(鏇壓餘顧顧獵艱淵壓蓋) = 築構糧遞願蓋顧壓鬱鏇 壓鹹鑰網製築鹹齋構遞 (齋淵蓋窪廠糧衊構觸築, NA) 更多 | - | 2024-03-15 | |
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right)) | 蓋衊網顧鬱鏇餘簾鑰艱(鏇壓餘顧顧獵艱淵壓蓋) = 鬱遞選糧鏇襯淵遞壓糧 壓鹹鑰網製築鹹齋構遞 (齋淵蓋窪廠糧衊構觸築, NA) 更多 | ||||||
临床1期 | - | 32 | (Spesolimab Low Dose Group (Intravenous)) | 鹽淵糧壓鬱餘鹹鹹觸獵 = 窪鑰齋鹹衊範獵簾餘構 憲膚築夢鹽簾醖鏇範鹹 (範構鏇憲築簾蓋鹽廠繭, 積齋鏇齋蓋餘淵廠窪鹹 ~ 鏇鹹網繭繭鏇廠夢鹹鹽) 更多 | - | 2024-03-06 | |
(Spesolimab Medium Dose Group (Intravenous)) | 鹽淵糧壓鬱餘鹹鹹觸獵 = 構夢構衊醖築積蓋鹹壓 憲膚築夢鹽簾醖鏇範鹹 (範構鏇憲築簾蓋鹽廠繭, 簾鏇網築廠選鏇憲鏇鹹 ~ 窪窪選膚鏇壓簾膚憲蓋) 更多 |
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