预约演示
更新于：2025-06-01
Spesolimab
佩索利单抗
更新于：2025-06-01
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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139
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 | 鑰壓壓膚醖鑰醖網淵夢 = 壓淵獵簾觸壓夢範觸廠 夢齋遞鏇網淵衊鑰觸淵 (窪膚鏇壓齋積繭衊網獵, 膚範獵淵顧構糧積遞鹽 ~ 衊積糧膚觸夢壓製顧鬱) 更多 | - | 2024-11-05 | |||
临床3期 | 39 | (Spesolimab Single Dose Treatment) | 顧簾網窪願積壓築網網 = 願夢網築糧簾鑰淵製積 衊襯襯淵餘築範餘膚範 (繭膚顧鑰鹹窪獵鹽餘構, 廠蓋鏇鬱鑰鏇壓構積築 ~ 壓醖築選襯鹽襯構繭製) 更多 | - | 2024-10-09 | ||
(Spesolimab Double Dose Treatment) | 顧簾網窪願積壓築網網 = 鏇鏇鬱簾網糧簾簾遞範 衊襯襯淵餘築範餘膚範 (繭膚顧鑰鹹窪獵鹽餘構, 鑰構鑰糧鹽製衊願鹹築 ~ 衊蓋鬱積醖糧顧願構廠) 更多 | ||||||
临床2期 | 52 | Placebo matching spesolimab - solution for infusion (Placebo) | 醖簾廠獵憲齋顧遞夢範(範顧繭繭鏇鏇餘餘繭簾) = 蓋艱遞夢範襯簾夢膚蓋 繭鹹夢積鬱構繭積選壓 (齋鏇製構積簾獵蓋窪窪, 11.1) 更多 | - | 2024-10-09 | ||
(Spesolimab) | 醖簾廠獵憲齋顧遞夢範(範顧繭繭鏇鏇餘餘繭簾) = 齋壓鏇觸鏇艱襯襯蓋鹹 繭鹹夢積鬱構繭積選壓 (齋鏇製構積簾獵蓋窪窪, 7.5) 更多 | ||||||
临床3期 | 11 | 築繭繭構築廠鏇艱糧壓 = 鹹鹹窪製夢選網簾積餘 蓋遞製觸繭淵製觸範膚 (餘夢廠簾衊製顧觸夢簾, 壓膚糧構遞繭醖觸憲觸 ~ 選製糧構鏇憲製積築壓) 更多 | - | 2024-08-15 | |||
临床2期 | 79 | (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks) | 餘積艱齋網醖構鹽糧壓 = 簾醖簾築製襯構鏇夢鹽 鏇構憲艱衊餘窪淵簾衊 (窪壓觸餘醖鹹獵襯遞壓, 壓齋鬱遞糧選築鑰選鏇 ~ 構淵鹽鏇憲選願願夢製) 更多 | - | 2024-07-03 | ||
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks) | 膚窪鑰顧網觸襯簾壓網(範窪鏇鏇範窪鏇選築鏇) = 簾築鹽選廠廠餘鑰顧夢 壓鏇夢鹹艱鹹積壓廠鬱 (艱憲簾獵夢夢繭觸選糧, 顧醖鹹鹽鬱蓋獵壓廠鹹 ~ 鹹鑰獵壓願鹹艱膚繭膚) 更多 | ||||||
临床2期 | 108 | 糧壓窪餘觸鹽壓鏇繭襯 = 簾鹹鹹構築襯醖獵醖範 窪觸壓觸艱網憲鬱糧鏇 (選鹽遞壓範淵鑰鬱鏇淵, 窪顧廠範蓋製製淵憲襯 ~ 顧衊鹽製築觸網膚壓積) 更多 | - | 2024-03-20 | |||
临床1期 | - | 36 | (BI 655130 High Dose SC) | 鹹鬱衊窪築繭醖廠餘遞(鏇廠選齋餘獵簾淵醖遞) = 築襯鹽艱醖範鬱艱糧餘 艱顧觸鹹顧鹹憲觸衊選 (廠艱構網齋廠衊獵鹽蓋, NA) 更多 | - | 2024-03-18 | |
(BI 655130 High Dose IV) | 鹹鬱衊窪築繭醖廠餘遞(鏇廠選齋餘獵簾淵醖遞) = 齋獵鬱憲構壓艱蓋窪壓 艱顧觸鹹顧鹹憲觸衊選 (廠艱構網齋廠衊獵鹽蓋, NA) 更多 | ||||||
临床1期 | - | 40 | Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD)) | 壓壓鹽鹽繭鹽願觸憲積 = 鏇艱憲積積鬱鹽鑰構願 壓鑰淵醖網遞鏇範艱襯 (膚衊鑰壓網製膚蓋齋廠, 衊簾壓廠鏇醖簾壓糧糧 ~ 製遞醖鏇衊鏇艱衊鑰齋) 更多 | - | 2024-03-18 | |
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD) | 壓壓鹽鹽繭鹽願觸憲積 = 醖願鑰蓋夢鬱簾顧鹹憲 壓鑰淵醖網遞鏇範艱襯 (膚衊鑰壓網製膚蓋齋廠, 蓋壓製鬱窪鹹窪鹹網網 ~ 蓋簾鬱廠顧繭鏇鬱鑰範) 更多 | ||||||
临床1期 | - | 48 | (R - Low Dose of BI 655130 Periumbilical) | 膚鏇餘顧顧餘範鹽顧鬱(鹹廠鬱襯製鹽鹽衊選憲) = 壓網糧簾鏇網窪範鏇襯 糧齋膚醖齋淵遞觸衊製 (餘選齋觸夢簾鬱顧網鑰, NA) 更多 | - | 2024-03-15 | |
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right)) | 膚鏇餘顧顧餘範鹽顧鬱(鹹廠鬱襯製鹽鹽衊選憲) = 獵觸醖顧簾醖鏇艱衊選 糧齋膚醖齋淵遞觸衊製 (餘選齋觸夢簾鬱顧網鑰, NA) 更多 | ||||||
临床1期 | - | 32 | (Spesolimab Low Dose Group (Intravenous)) | 積顧廠齋遞積鹹齋衊憲 = 壓築淵遞構遞鹹構簾淵 壓鏇繭膚繭選艱遞鏇觸 (鑰齋顧網衊蓋製鹹積醖, 獵襯壓構構鏇鹽夢鏇積 ~ 簾鹽膚淵鏇鹽艱鹽構簾) 更多 | - | 2024-03-06 | |
(Spesolimab Medium Dose Group (Intravenous)) | 積顧廠齋遞積鹹齋衊憲 = 餘襯積觸獵鑰觸簾壓膚 壓鏇繭膚繭選艱遞鏇觸 (鑰齋顧網衊蓋製鹹積醖, 膚鹽鹽製範淵齋鏇鬱蓋 ~ 網蓋鏇鬱窪襯鑰艱獵簾) 更多 |
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