佩索利单抗(Spesolimab) - 药物靶点：IL-36R_在研适应症：脓疱型银屑病，泛发性脓疱型银屑病，坏疽性脓皮病_专利_临床

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

IL-36R

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)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病其他疾病+ [2]

在研适应症

脓疱型银屑病泛发性脓疱型银屑病坏疽性脓皮病+ [2]

非在研适应症

溃疡性结肠炎克罗恩病肠梗阻+ [4]

原研机构

Boehringer Ingelheim International GmbH

在研机构

Boehringer Ingelheim GmbHBoehringer Ingelheim España SABoehringer Ingelheim RCV GmbH & Co. KG

+ [9]

非在研机构

Boehringer Ingelheim Italia SpABoehringer Ingelheim BVBoehringer Ingelheim Ltd.

+ [2]

权益机构

Boehringer Ingelheim GmbH

LEO Pharma A/S

最高研发阶段批准上市

首次获批日期

美国 (2022-09-01),

泛发性脓疱型银屑病

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、突破性疗法 (中国台湾)、突破性疗法 (中国)、优先审评 (美国)、优先审评 (中国)、孤儿药 (瑞士)、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

38

项与佩索利单抗相关的临床试验

NCT06886009

/ Not yet recruitingN/A

A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis

The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.

开始日期2026-03-31

申办/合作机构

Boehringer Ingelheim GmbH

NCT06624670

/ Recruiting临床3期

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

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm^2 to 80 cm^2 in size.
This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.
In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.
In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.
Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

开始日期2025-02-04

申办/合作机构

Boehringer Ingelheim GmbH

NCT06520514

/ Completed临床1期

Safety, Tolerability, and Relative Bioavailability of a Single Dose of Spesolimab Via Two Subcutaneous Modes of Delivery in Healthy Subjects (Mono-centric, Randomised, Parallel Group Design)

The main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects.

开始日期2024-08-07

申办/合作机构

Boehringer Ingelheim GmbH

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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170

项与佩索利单抗相关的文献（医药）

2026-03-01·Actas Dermo-Sifiliograficas

Generalized Pustular Psoriasis: Review and Consensus of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology

Review

作者: Carrascosa, J M ; Rivera, R ; de la Cueva, P ; López-Ferrer, A ; Vilarrasa, E ; Puig, L

Generalized pustular psoriasis (GPP) is an autoinflammatory disease characterized by primarily sterile pustules, with a widespread distribution, and flares that can be associated with life-threatening complications. Spesolimab (Spevigo®) is the only drug approved for treatment and prevention of GPP flares, and there are uncertainties that justify the development by the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) of a Delphi consensus on the diagnosis and treatment of this rare disease. A panel of experts, starting from a literature search in PubMed (since 2014), designed a structured questionnaire with assertions that were evaluated (Likert scale from 1 to 7) by 38 members of the PWG with experience in GPP. Following two rounds, between October 2024 and January 2025, agreement (≥80% of participants) was reached on 50 out of 70 statements, including the definition of GPP outbreak, infection screening, medium- and long-term treatment goals, and criteria for initiation of maintenance treatment. This Delphi consensus is intended to support clinicians in the diagnosis and treatment of patients with PPG in our setting.

2026-03-01·JOURNAL OF INVESTIGATIVE DERMATOLOGY

microRNA-223 Expression during Flares in Patients with Generalized Pustular Psoriasis Is Regulated by Spesolimab Treatment

Article

作者: Thoma, Christian ; Becker, Kolja ; Delić, Denis ; Krueger, James G ; Kukreja, Anjli ; Rolser, Marcel ; Roy, Janine ; Wohnhaas, Christian T

2026-02-01·Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology

[Role and clinical significance of PD-L1⁺ neutrophils in generalized pustular psoriasis].

Article

作者: Gu, Yunfeng ; Shao, Shuai ; Wang, Gang ; Wang, Jiaqi ; Tang, Xin ; Xu, Zhongrui

Objective To characterize the distribution and functional phenotype of programmed death-ligand 1 (PD-L1) positive neutrophils in generalized pustular psoriasis (GPP) and determine their associations with disease severity and treatment response. Methods We integrated bioinformatic analyses with clinical samples to compare PD-L1 expression on neutrophils from peripheral blood and lesional skin among patients with GPP, healthy controls (HC), and psoriasis vulgaris (PV). PD-L1⁺ neutrophils were magnetically isolated from HC peripheral blood for in vitro culture, and 24 hours apoptosis was assessed by flow cytometry. The proportion of PD-L1⁺ neutrophils was quantified by flow cytometry and immunofluorescence and correlated with clinical indices -including GPPASI, high-sensitivity C-reactive protein (hsCRP), neutrophil-to-lymphocyte ratio (NLR), and relapse frequency, as well as clinical response to spesolimab. Results PD-L1 expression on neutrophils was significantly upregulated in both peripheral blood and lesional skin of patients with GPP, showing marked differences compared with HC and PV patients. PD-L1⁺ neutrophils exhibited delayed apoptosis at 24 hours and a pro-inflammatory phenotype characterized by increased release of IL-36γ-processing enzymes. PD-L1 levels correlated positively with GPPASI, hsCRP, and NLR. The proportion of lesional PD-L1⁺CD15⁺ neutrophils was positively associated with relapse frequency. Patients with higher baseline PD-L1 levels demonstrated better clinical responses to spesolimab. Conclusion PD-L1⁺ neutrophils are enriched in GPP and display delayed apoptosis and inflammatory activation. Their abundance is closely linked to disease activity, systemic inflammation, and biologic response, suggesting a role in shaping GPP immune heterogeneity. PD-L1⁺ neutrophils are merit consideration as a practical immunologic biomarker for monitoring disease activity and guiding individualized biologic therapy.

270

项与佩索利单抗相关的新闻（医药）

2026-02-18

·EndPoints

Leo Pharma says it's turned a profit for the first time in seven years

For the first time since 2018, Leo Pharma said it turned a profit last year thanks to new brands on the market and rising sales in the US. The dermatology-focused company collected 2.49 billion Danish krone ($394 million) in net profit for 2025 due to the launch of its chronic hand eczema drug Anzupgo in 10 countries, including the US. It also profited from a licensing deal with Boehringer Ingelheim. CEO Christophe Bourdon told Endpoints News last year that profitability is one of the milestones the company is tracking if it wants to go public . In an interview with Endpoints ahead of its 2025 earnings release on Wednesday, Bourdon said it will be the “shareholders’ decision on if and when to push the button on the IPO.” Currently, the Leo Foundation has a majority stake in Leo Pharma, with Nordic Capital also holding a minority stake after its investment in March 2021. Leo Pharma has been eyeing a potential IPO since at least 2022. It underwent a broad multiyear restructuring to boost its balance sheet. In a bid to boost profitability, the company reshuffled its R&D teams and made sweeping layoffs . These actions seem to be paying off: The last time it turned a profit was in 2018, when it made DKK 1.26 billion ($200 million). Leo Pharma’s profits were down for seven consecutive years due to various factors , including high R&D and restructuring costs, impairment charges, and spending on acquisitions such as the Timber Pharmaceuticals deal in 2023. Bourdon was named CEO in 2022. But Leo Pharma made efforts last year to boost its dermatology product offerings, which drove the business’ revenue up by 12% for 2025 compared to the previous year. The company launched Anzupgo in the US in September and brought Spevigo into its portfolio after inking a licensing deal with Boehringer in July. Spevigo is a monoclonal antibody used to treat generalized pustular psoriasis. Combined revenue for Anzupgo, Spevigo and Adbry increased by 48% for 2025 compared to the year before. Adbry, branded as Adtralza in Europe, is used to treat moderate-to-severe atopic dermatitis. Overall, Leo Pharma pulled in DKK 13.5 billion ($2.1 billion) in revenue for 2025, up 10% compared to 2024. The jump is mainly driven by 35% growth in the US. As for 2026, the company is expecting its revenue to grow between 8% and 11% at constant exchange rates.

IPO财报并购引进/卖出高管变更

2026-02-18

·BioSpace

LEO Pharma Delivers 10% Revenue Growth in 2025 and More Than Doubles Adjusted EBITDA Margin

BALLERUP, Denmark--(BUSINESS WIRE)--In 2025, LEO Pharma delivered a third consecutive year of double‑digit revenue growth (CER), at the upper end of guidance, and achieved a significant improvement in profitability, returning to positive net profit and free cash flow. The portfolio was strengthened by the launch of Anzupgo ® in 10 additional markets, including the U.S., as well as the addition of Spevigo ® . The pipeline was advanced through new late‑stage programs and strategic partnerships aimed at accelerating innovation. For 2026, revenue growth is expected to be 8-11% (CER), supporting further improvement in the adjusted EBITDA margin to 16-19%, alongside increased investments in innovation and LEO Pharma’s global platform. Financial highlights LEO Pharma’s revenue increased by 10% at constant exchange rates (CER) and by 8% in DKK to 13,499 million. Revenue growth was led by North America (+35% at CER), with Rest of World (+9% at CER) and Europe (+3% at CER) also contributing to the overall growth. Revenue from the Dermatology portfolio grew by 12% (CER), driven by the Strategic brands Adtralza ® /Adbry ® , Anzupgo ® , and Spevigo ® , which combined had a revenue increase of 48% (CER), in addition to growth of 2% (CER) for the Established brands. Sales in the Critical Care portfolio declined by 1% (CER), affected by a reversal of sales discounts in the same period last year. Operating profit improved sharply, with adjusted EBITDA reaching DKK 2,107 million in 2025, reflecting a margin of 16% (2024: 7%), excluding the STAT6 partnership upfront payment from Gilead Sciences received in January 2025 and other non-recurring items. The improvement in adjusted EBITDA was driven by sales growth and reduced operating expenses. Net profit for 2025 was DKK 2,489 million (2024: negative DKK 1,776 million), including non-recurring items. Free cash flow was DKK 1,875 million for 2025 (2024: negative DKK 52 million), and net interest-bearing debt was reduced to DKK 9,347 million (2024: DKK 11,115 million). Excluding M&A, free cash flow was DKK 940 million. Innovation highlights Anzupgo ® (delgocitinib) cream was launched in the U.S. in September as the first and only topical pan‑JAK inhibitor for chronic hand eczema, supported by a more than 50% increase in LEO Pharma’s U.S. sales force following FDA approval in July 2025. Spevigo ® (spesolimab), an IL-36RA biologic for generalized pustular psoriasis, joined LEO Pharma’s portfolio on 30 September as its third global, first-in-class brand following a development and commercialization license secured from Boehringer Ingelheim. In 2025, LEO Pharma entered several strategic partnerships to advance innovation, including an agreement with Gilead Sciences for the pre-clinical STAT6 program. The pipeline was expanded with new late stage trials of Anzupgo ® (delgocitinib cream) in adults with palmoplantar pustulosis and lichen sclerosus, as well as the addition of an ongoing Phase 3 trial of Spevigo ® (spesolimab) in pyoderma gangrenosum. 2026 Outlook For 2026, group revenue growth is expected at 8-11% (CER) driven by Anzupgo ® and Spevigo ® . The adjusted EBITDA margin is expected to improve to 16-19%, led by gross margin expansion, offset by higher commercial investments and R&D. "2025 was another year of strong progress for LEO Pharma and a landmark year in our strategic transformation. We expanded our portfolio, delivered strong growth with significantly improved profitability, and formed new partnerships to accelerate innovation. With the ongoing launch of Anzupgo ® and the addition of Spevigo ® , we enter 2026 with strong momentum, committed to making a fundamental difference for patients by further unlocking the potential of our global platform.” CEO Christophe Bourdon. FY 2025 Financial overview (DKK million) FY 2025 FY 2024 Growth Revenue 13,499 12,453 8% Revenue growth at CER 10% 11% N.m. Adjusted EBITDA 2,107 895 135% Adjusted EBITDA margin 16% 7% N.m. Net profit/(loss) for the period 2,489 (1,777) N.m. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin. For more information, visit Financial highlights and key figures (DKK million) FY 2025 FY 2024 Income statement Revenue 13,499 12,453 Of which dermatology revenue 10,991 10,008 Gross profit 8,240 7,518 Adjusted EBITDA 1 2,107 895 Non-recurring items 1 1,644 (295) EBITDA 1 3,751 600 Operating profit/(loss) (EBIT) 2,279 (1,143) Net financials (566) (814) Profit/(loss) before tax 1,713 (1,957) Net profit/(loss) for the period 2,489 (1,776) Balance sheet Assets 20,445 20,151 Equity 5,262 2,704 Net working capital 2 3,991 3,833 Net interest-bearing debt (NIBD) 3 9,358 11,115 Invested capital 4 14,380 13,637 Cash flow Cash flow from operating activities 1,255 265 Cash flow from investing activities 620 (317) Free cash flow 1,875 (52) Key ratios (%) Revenue growth 8% 9% Revenue growth at CER 1 10% 10% Dermatology revenue growth at CER 12% 12% Gross margin 61% 60% OPEX ratio 57% 70% Adjusted EBITDA margin 1 16% 7% EBITDA margin 1 28% 5% EBIT margin 17% (9)% Effective tax rate (45%) 9% NIBD/Adjusted EBITDA (LTM) 5 4.4 12.4 People Average number of full-time employees (FTE) 4,104 4,184 1 See Note 2 Non-IFRS measures. 2 Net working capital comprises Inventories, Trade receivables and Other receivables less Trade payables and Other payables. 3 The net interest-bearing debt (NIBD) is the interest-bearing liabilities less cash and cash equivalents. 4 Invested capital is calculated as the sum of non-current assets, net working capital and tax receivables less deferred tax liabilities and other non-interest-bearing liabilities. 5 Adjusted EBITDA (LTM) is the adjusted EBITDA in the last 12 months. Contacts For further information please contact: Investor Relations: Christian Boas Ryom, telephone +45 4494 5888 Media: Jeppe Ilkjær, telephone +45 3050 2014

引进/卖出临床3期财报上市批准生物类似药

2026-02-15

·浙大二院

仿佛被“咬”掉一块肉，溃疡“边烂边长”，警惕这种疾病！这里反复长“小脓疱”，是炎症在作怪！

近年来，随着皮肤医学界对IL-23/Th17、Th2、IL-36、IL-1等通路认识加深，生物制剂与靶向小分子药物的发展，以及“老药新用”等方法，许多过去“很难治”的脓疱/溃疡性皮肤病，正在从“反复发作”走向“长期控制”。浙江大学医学院附属第二医院（简称浙大二院）皮肤科近期的真实世界研究，改变了这类疾病的治疗结局：从原来的“控制病情”，到现在的“几乎完全清除”，治愈从遥不可及的梦，变成触手可及的光。皮肤科手掌脚底反复长“小脓疱” 是身体里这种炎症在作怪！你是否听说过“掌跖脓疱病（PPP）”？这是一种让人非常困扰的皮肤病，患者的手掌和脚底会反复长出疼痛的无菌性脓疱、红斑和脱屑，严重时连走路、握手都成问题。其炎症机制以IL-23/Th17轴、Th2轴与先天免疫（如IL-36相关炎症）为主，同时存在较强的个体异质性[1]。近期，浙大二院皮肤科的研究带来了好消息，研究成果分别在国际期刊JAAD、Allergy杂志发表：度普利尤单抗（dupilumab）在3年随访病例系列中，提示可能获得较长期的疾病控制与安全性数据，但仍需更大样本与前瞻性研究进一步验证[2]。另外，该团队通过血清蛋白组学分析发现，PPP患者体内存在显著上调的“2型炎症”。度普利尤单抗正能精准靶向并阻断这条炎症通路，从而有可能在很大程度上控制病情[3]。 IL-23、IL-17或PDE4抑制剂等药物，亦为难治PPP提供了新选择[4]。皮肤科全身突发脓疱伴高热？这类罕见皮肤病有了“精准导弹” 泛发性脓疱性银屑病（GPP）是一种少见却可能危及生命的严重皮肤病。患者全身会突然爆发大量无菌性脓疱，并伴有高热、寒战，常需紧急住院[5]。遗传学研究提示，IL36RN等基因变异与部分患者相关，而IL-36轴被认为是驱动GPP发作的关键通路之一[6]。以往治疗以激素、维A酸等传统药物为主，但效果有限且副作用较大[5]。如今，GPP的治疗已进入精准靶向时代。 GPP的关键致病通路是IL-36信号通路过度活化。针对此靶点的佩索利单抗作为全球首个IL-36R抑制剂，已在中国获批，它能像“精确制导导弹”一样阻断核心炎症。临床数据显示，超过一半的患者用药1周皮肤脓疱即可完全消退[7，8]。该药已基本实现全球同步研发和获批，真正“零时差”惠及中国患者。皮肤科腋窝、腹股沟反复肿痛？这不是普通“痘痘”！如果您的腋窝、腹股沟等“隐匿角落”反复出现疼痛性结节、脓肿、破溃流脓甚至形成瘢痕，千万别简单将其当成“火气痘”！这很可能是化脓性汗腺炎（HS）。 HS是一种慢性、复发性、炎症性皮肤病，因毛囊堵塞引发持续深在的炎症。它专攻顶泌汗腺（大汗腺）密集的部位，不仅带来剧烈疼痛和异味，破溃后形成的窦道和瘢痕还可能影响关节活动[9]。更棘手的是，它极易复发，传统手术后的复发率也较高[9]。以往的治疗以外用或口服抗生素、维A酸类药物等为主，对中重度患者往往“力不从心”。如今，随着对疾病机制的深入理解，靶向生物制剂已成为重要的治疗武器[9]。靶向IL-17A/F、TNF-α的生物制剂已被证明能显著减轻中重度HS患者的炎症和皮损，并已进入临床应用[10,11]。除此之外，研究提示IL-1家族在HS炎症放大中具有关键作用，相关靶向治疗正在加速推进[12]。皮肤科皮肤溃疡为何“边烂边长”？警惕坏疽性脓皮病！坏疽性脓皮病（PG）是一种少见的、非感染性的中性粒细胞性皮肤病。它最典型的表现是皮肤突然出现快速扩大的疼痛性溃疡，边缘呈紫红色，仿佛被“咬”掉了一块肉，疼痛剧烈。这种溃疡可以发生在任何部位，常与炎症性肠病、关节炎等全身性疾病相伴[13]。 PG的治疗曾经非常棘手，常规的抗生素无效，大剂量激素或免疫抑制剂虽有一定效果，但起效慢、副作用大，且溃疡愈合过程漫长[13]。如今，治疗局面已大为改观。随着对PG与IL-36、IL-1、TNF-α等炎症通路关联的认识加深，靶向生物制剂的应用展现出巨大潜力。值得注意的是，已成功用于GPP的IL-36R单抗（佩索利单抗），其治疗PG的潜力正在被积极探索，并已进入全球III期临床研究阶段。这为此种难治性疾病带来了全新的、机制明确的治疗希望[14]。另外，针对TNF-α、IL-1、IL-23/IL-17等通路的生物制剂，在临床个案或小型研究中也被证实能有效促进PG的溃疡愈合。这使得PG从一种令人恐惧的、病程迁延的疾病，逐渐变为可控、可愈的疾病。科室探索浙大二院皮肤科门诊就诊的掌跖脓疱病患者治疗前后的脚掌临床照片对比从掌跖脓疱病到脓疱型银屑病、化脓性汗腺炎、坏疽性脓皮病，这类饱受脓疱与疼痛困扰的疾病，正在经历一场深刻的治疗变革。治疗策略从“广谱抑制”转向“精准靶向”，越来越多的“无计可施”正变为“有的放矢”。浙大二院皮肤科于1950年建科，历经七十余年发展，集医疗、教学、科研于一体，是国内疑难重症皮肤病诊治的重要中心。科室设银屑病、特应性皮炎、白癜风、脱发、痤疮、皮肤肿瘤与皮外科等亚专科，开展生物制剂/小分子、免疫调控、激光与手术等综合治疗，并建立规范随访与多学科协作流程，擅长难治、复发与重症病例的精准评估与长期管理。依托团队与临床研究平台，提供更个体化治疗与管理。解读人介绍郑瑀心浙大二院皮肤科医师，博士研究方向：炎症性皮肤病，包括银屑病、特应性皮炎、掌跖脓疱病的发病机制。以第一作者发表SCI论文十余篇，包括J Am Acad Dermatol、Allergy、J Invest Dermatol等，参与多项国家自然科学基金重点项目、面上项目。获得 International Society of Atopic Dermatitis (ISAD) fellowship、国家留学基金委奖学金，曾赴新加坡科技研究局皮肤研究所博士联合培养。参考文献 [1] McCluskey, D. et al. Single-cell analysis implicates T(H)17-to-T(H)2 cell plasticity in the pathogenesis of palmoplantar pustulosis. J Allergy Clin Immunol 150, 882-893 (2022). https://doi.org/10.1016/j.jaci.2022.04.027 [2] Zheng, Y. X., Cai, S. Q., Man, X. Y. & Zheng, M. Real-world long-term drug survival of dupilumab in palmoplantar pustulosis: A 3-year observational follow-up. J Am Acad Dermatol (2025). https://doi.org/10.1016/j.jaad.2025.10.012 [3] Zheng, Y. X. et al. Efficacy of dupilumab in palmoplantar pustulosis treatment highlights the role of Th2 inflammation. Allergy 79, 1361-1364 (2024). https://doi.org/10.1111/all.16019 [4] Spencer, R. K. et al. Comparative efficacy of biologics and oral agents in palmoplantar psoriasis and palmoplantar pustulosis: A systematic review and network meta-analysis of randomized clinical trials. J Am Acad Dermatol 89, 423-425 (2023). https://doi.org/10.1016/j.jaad.2023.04.043 [5] Choon, S. E., Navarini, A. A. & Pinter, A. Clinical Course and Characteristics of Generalized Pustular Psoriasis. Am J Clin Dermatol 23, 21-29 (2022). https://doi.org/10.1007/s40257-021-00654-z [6] Marrakchi, S. et al. Interleukin-36-receptor antagonist deficiency and generalized pustular psoriasis. N Engl J Med 365, 620-628 (2011). https://doi.org/10.1056/NEJMoa1013068 [7] Bachelez, H. et al. Trial of Spesolimab for Generalized Pustular Psoriasis. N Engl J Med 385, 2431-2440 (2021). https://doi.org/10.1056/NEJMoa2111563 [8] Heymann, W. R. The expanding horizon of anti-IL-36 therapy. J Am Acad Dermatol 90, 714-715 (2024). https://doi.org/10.1016/j.jaad.2024.01.034 [9] Goldburg, S. R., Strober, B. E. & Payette, M. J. Hidradenitis suppurativa: Epidemiology, clinical presentation, and pathogenesis. J Am Acad Dermatol 82, 1045-1058 (2020). https://doi.org/10.1016/j.jaad.2019.08.090 [10] Kimball, A. B. et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet 403, 2504-2519 (2024). https://doi.org/10.1016/S0140-6736(24)00101-6 [11] Kimball, A. B. et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med 375, 422-434 (2016). https://doi.org/10.1056/NEJMoa1504370 [12] Charrow, A., Santiago-Soltero, K. & Porter, M. Biologics in hidradenitis suppurativa: Progress and new directions. J Am Acad Dermatol 91, S27-S30 (2024). https://doi.org/10.1016/j.jaad.2024.09.027 [13] Hadi, A. & Lebwohl, M. Clinical features of pyoderma gangrenosum and current diagnostic trends. J Am Acad Dermatol 64, 950-954 (2011). https://doi.org/10.1016/j.jaad.2010.01.049 [14] Lebwohl MG, Ortega-Loayza AG, Mostaghimi A, et al. Randomized Phase 3 trial of spesolimab in patients with ulcerative pyoderma gangrenosum: A study protocol. J Am Acad Dermatol. 2025. 广济一周第259期到这里就结束了感谢各位读者朋友的支持如有相关建议或意见欢迎在下方留言点击上方图片查看往期回顾审核 | 邓国芳满孝勇责编 | 许紫莹

100 项与佩索利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12066	-	-	DB15626

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
脓疱型银屑病	日本	Nippon Boehringer Ingelheim Co., Ltd.	2022-09-26
泛发性脓疱型银屑病	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2022-09-01

未上市

10 条进展最快的记录,

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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	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	美国	Boehringer Ingelheim GmbH	2025-02-04
坏疽性脓皮病	临床3期	中国	Boehringer Ingelheim GmbH	2025-02-04
坏疽性脓皮病	临床3期	日本	Boehringer Ingelheim GmbH	2025-02-04
坏疽性脓皮病	临床3期	日本	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	阿根廷	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	阿根廷	Boehringer Ingelheim GmbH	2025-02-04
坏疽性脓皮病	临床3期	澳大利亚	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2025-02-04
坏疽性脓皮病	临床3期	奥地利	Boehringer Ingelheim International GmbH	2025-02-04

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05819398 (CTgov)	临床2/3期	化脓性汗腺炎	209	Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo)	壓範糧憲糧襯鑰選簾簾(糧築壓遞顧築網壓鏇範) = 艱糧鏇遞鹽鬱糧簾鹹壓蓋願餘膚襯淵簾衊壓積 (蓋遞衊願網繭鹹顧淵齋, 7.7) 更多	-	2025-11-05
				Spesolimab i.v. (Spesolimab low dose group)	壓範糧憲糧襯鑰選簾簾(糧築壓遞顧築網壓鏇範) = 壓夢願積糧壓淵鏇廠窪蓋願餘膚襯淵簾衊壓積 (蓋遞衊願網繭鹹顧淵齋, 7.8) 更多
NCT04876391 (CTgov)	临床2期	化脓性汗腺炎	45	Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP))	積鹽憲鏇簾夢衊觸壓齋 = 範鏇願網觸鑰遞糧積夢鑰廠鹽憲構壓鹽構鬱遞 (淵艱醖壓鹹構襯膚顧憲, 憲膚鑰觸範獵觸鬱範壓 ~ 齋艱遞壓蓋鑰構築廠艱) 更多	-	2025-06-08
				Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS))	積鹽憲鏇簾夢衊觸壓齋 = 膚範窪糧淵糧襯網鹽淵鑰廠鹽憲構壓鹽構鬱遞 (淵艱醖壓鹹構襯膚顧憲, 築簾鹽鏇鹹鏇鹽淵餘鑰 ~ 選鹽蓋糧獵網鏇夢壓夢) 更多
NCT04362254 (CTgov)	临床2期	克罗恩病	12	Spesolimab	網醖構廠糧鑰願鏇齋憲 = 鏇願範襯鬱積選壓積鑰窪簾醖鏇遞憲糧鏇願網 (鹹憲鏇顧蓋願齋製憲鏇, 壓壓憲鹹觸製構積願構 ~ 製窪遞鹽夢顧獵範壓網) 更多	-	2024-11-05
NCT04762277 (CTgov)	临床2期	化脓性汗腺炎	52	Placebo matching spesolimab - solution for infusion (Placebo)	簾廠壓窪窪夢餘餘壓網(鹽壓鹽糧構淵齋繭窪膚) = 夢築齋積鏇襯鬱壓壓齋鑰鏇餘觸願鏇觸廠淵膚 (製衊範願網鬱鏇襯願鬱, 11.1) 更多	-	2024-10-09
				Spesolimab - solution for infusion (Spesolimab)	簾廠壓窪窪夢餘餘壓網(鹽壓鹽糧構淵齋繭窪膚) = 艱鏇壓鏇製窪願糧築鏇鑰鏇餘觸願鏇觸廠淵膚 (製衊範願網鬱鏇襯願鬱, 7.5) 更多
NCT05239039 (CTgov)	临床3期	泛发性脓疱型银屑病	39	spesolimab (Spesolimab Single Dose Treatment)	鑰積選鏇範餘構遞築選 = 糧觸範廠選廠鑰範鹽選鑰齋膚鬱製構糧願衊鹹 (窪窪糧淵齋壓遞遞積鏇, 積繭憲襯鹽願鬱積淵艱 ~ 鑰壓願壓積簾衊觸製糧) 更多	-	2024-10-09
				spesolimab (Spesolimab Double Dose Treatment)	鑰積選鏇範餘構遞築選 = 餘繭醖衊糧糧簾壓製襯鑰齋膚鬱製構糧願衊鹹 (窪窪糧淵齋壓遞遞積鏇, 網繭鹹夢製鏇構願願觸 ~ 網簾襯獵獵壓膚憲膚蓋) 更多
NCT05200247 (CTgov)	临床3期	泛发性脓疱型银屑病	11	Spesolimab	鏇窪糧壓網鑰齋築鹹鹽 = 築觸製窪糧壓夢艱鹹願範鹽襯鏇遞衊淵網餘築 (夢淵鹹鏇繭夢製襯夢艱, 窪鬱簾願網鏇願壓繭淵 ~ 鹽憲鏇憲鬱築選鹹顧醖) 更多	-	2024-08-15
NCT03648541 (CTgov)	临床2期	溃疡性结肠炎	79	Spesolimab (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)	鏇鑰壓蓋衊製網顧構壓 = 構夢衊鑰範鬱醖鹹艱壓鏇艱鹽窪獵鏇壓醖醖壓 (遞遞艱膚網淵淵繭觸糧, 餘鬱壓鬱觸窪襯願壓鹽 ~ 鹹糧築淵鹹餘範醖繭襯) 更多	-	2024-07-03
				Spesolimab (1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)	構鏇餘艱餘積夢遞窪窪(齋膚蓋網獵齋衊淵鹹簾) = 醖鏇製壓鹽願齋廠襯獵選衊淵襯願網製鬱膚壓 (顧鏇遞積膚簾觸簾遞壓, 觸齋憲繭窪積獵齋壓壓 ~ 觸選糧選製壓醖齋艱糧) 更多
NCT04493424 (CTgov)	临床2期	手掌和足底脓疱病 \| 脓疱型银屑病	108	Spesolimab	膚鹹窪鹹淵簾衊遞製蓋 = 膚淵構簾夢艱艱獵鹽網鏇網鹹醖衊製淵製鏇糧 (網窪艱獵獵願糧鹽繭網, 壓鏇廠膚願糧鬱網膚醖 ~ 蓋齋醖窪選膚選鏇構觸) 更多	-	2024-03-20
NCT02852824 (CTgov)	临床1期	-	40	Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD))	顧鏇鏇網齋膚蓋淵鬱網 = 鹽選鹹醖夢觸蓋蓋艱憲選襯衊網淵築範膚簾鹹 (鹹鹽製觸製襯觸鹽糧繭, 獵襯蓋醖鑰蓋簾醖餘廠 ~ 積簾選鏇襯醖鏇艱鬱積) 更多	-	2024-03-18
				BI 655130 (3 Milligram/Kilogram (mg/kg)] BI 655130 MD)	顧鏇鏇網齋膚蓋淵鬱網 = 鹽選淵壓夢網遞鹹觸壓選襯衊網淵築範膚簾鹹 (鹹鹽製觸製襯觸鹽糧繭, 繭鏇憲壓獵廠選遞鑰構 ~ 築鹹衊簾蓋範簾衊觸繭) 更多
NCT03100903 (CTgov)	临床1期	-	36	BI 655130 (BI 655130 High Dose SC)	淵鏇窪鬱鑰鑰製製餘觸(糧餘鹽窪蓋構顧遞壓膚) = 築憲獵餘網衊鹽鹹壓繭鹹醖鑰淵觸餘選鹹襯齋 (鬱願築醖願廠衊觸憲獵, NA) 更多	-	2024-03-18
				BI 655130 (BI 655130 High Dose IV)	淵鏇窪鬱鑰鑰製製餘觸(糧餘鹽窪蓋構顧遞壓膚) = 醖齋鏇構糧壓遞築鏇網鹹醖鑰淵觸餘選鹹襯齋 (鬱願築醖願廠衊觸憲獵, NA) 更多