乌司奴单抗(Ustekinumab) - 药物靶点：IL-12p40 x IL-23_在研适应症：溃疡性结肠炎，克罗恩病，银屑病关节炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-interleukin-12 p40 monoclonal antibody、Stellara、Sterrara

+ [13]

靶点

IL-12p40 x IL-23

作用方式

抑制剂

作用机制

IL-12p40抑制剂(白细胞介素-12β亚基抑制剂)、IL-23抑制剂(白细胞介素-23复合体抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [4]

在研适应症

溃疡性结肠炎克罗恩病银屑病关节炎+ [11]

非在研适应症

显微镜下结肠炎皮肌炎手足综合症+ [18]

原研机构

Janssen Biotech, Inc.

在研机构

Janssen Research & Development LLCJanssen-Cilag International NV

Janssen Global Services LLC

+ [7]

非在研机构

Janssen-Cilag Ltd.

西安杨森制药有限公司Centocor, Inc.

+ [4]

权益机构

Janssen Pharmaceuticals, Inc.

Mitsubishi Tanabe Pharma Corp.

最高研发阶段批准上市

首次获批日期

欧盟 (2009-01-15),

银屑病关节炎活动性中度克罗恩病活动性重度克罗恩病+ [3]

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、临床急需境外新药 (中国)

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结构/序列

Sequence Code 143665H

来源: *****

Sequence Code 143874L

来源: *****

关联

165

项与乌司奴单抗相关的临床试验

NCT06807593

/ Not yet recruitingN/A

Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients

The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.

开始日期2025-06-30

申办/合作机构

Janssen Research & Development LLC

NCT06786507

/ Not yet recruitingN/AIIT

A Direct Head-to-head Comparison of Ustekinumab with Infliximab for the Treatment of Ulcerative Colitis

the goal of this study is to compare the efficacy of ustekinumab with infliximab for the treatment of ulcerative colitis aim of the study :
1. Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients.
2. Compare safety of ustekinumab therapy versus infliximab therapy in UC
3. To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.

开始日期2025-05-15

申办/合作机构

Helwan University

NCT06788340

/ Not yet recruiting临床4期IIT

MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - an Independent Randomized Controlled Trial

The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is:
Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission.
As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best.
Participants will:
Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)

开始日期2025-05-01

申办/合作机构

Odense University Hospital

100 项与乌司奴单抗相关的临床结果

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100 项与乌司奴单抗相关的转化医学

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100 项与乌司奴单抗相关的专利（医药）

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3,475

项与乌司奴单抗相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost per remission for mirikizumab versus ustekinumab for moderately to severely active ulcerative colitis treatment from the United States commercial payer perspective

Article

作者: Upadhyay, Navneet ; Creveling, Thomas ; Fisher, Deborah A. ; Mittal, Neha ; Bires, Nicholas ; Chanan, Neha ; Kane, Sunanda ; Gulati, Ankit ; Koushik, Amit Kumar

INTRODUCTION:

Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.

METHODS:

An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.

RESULTS:

The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).

CONCLUSION:

Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.

2025-12-01·Current gastroenterology reports

Interleukin-23 Inhibitors for Inflammatory Bowel Disease: Pivotal Trials and Practical Considerations

Review

作者: Jennings, William ; Fudman, David ; Rotondo-Trivette, Sarah

PURPOSE OF REVIEW:

This review summarizes the literature on IL-23 inhibitors for inflammatory bowel disease and the role of these agents in clinical practice.

RECENT FINDINGS:

The last decade has seen several pivotal trials investigating IL-23 inhibitors. These agents are effective in inducing and maintaining remission of moderate-to-severe inflammatory bowel disease, including among those with prior biologic failure, and have low adverse events. IL-23 inhibitors are safe and effective for treatment of moderate-to-severe inflammatory bowel disease and appear more effective than ustekinumab for Crohn's disease. The currently available IL-23 inhibitors likely have similar efficacy, but practical considerations may influence preferences.

2025-12-01·IMMUNOLOGIC RESEARCH

A patient with CVID-enteropathy successfully treated with ustekinumab

Article

作者: Grammatikos, Alexandros ; Marley, Fenella ; Lockett, Melanie ; Gompels, Mark

CVID (common variable immunodeficiency) is associated with a variety of gastrointestinal disorders including those mimicking Crohn's disease and ulcerative colitis. At present there is no clear trial data for the treatment of CVID enteropathy. There are no specific recommendations for treatment; however, it is commonly treated in a similar manner to inflammatory bowel disease, with corticosteroids, 5-aminosalicylates (5-ASA), azathioprine and anti-TNF therapy all being used. We describe the case of a 54-year-old with CVID-enteropathy presenting with diarrhoea and evidence of granulomatous inflammation on colonic biopsies. He was successfully treated with ustekinumab following failure/intolerance of prednisolone, 5-ASA and azathioprine. Features of CVID-enteropathy improved both clinically and histologically, with no evidence of serious treatment-related side effects.

1,054

项与乌司奴单抗相关的新闻（医药）

2025-07-24

·医药地理

强生2025H1财报发布：双引擎提速，逆风也超车

当全球医药产业仍在“专利悬崖”与“支付方压价”双重阴影下踯躅，强生（Johnson & Johnson）用一份超预期的2025Q2财报，给出了截然不同的信号：营收稳步抬升、盈利健康扩张、全年指引再度上调。这家横跨 MedTech （医疗科技）与 Innovative Medicine（创新制药）两大领域的巨舰，正在用“双引擎”证明自己不仅能穿越周期，还能在周期中加速。双引擎驱动，业绩亮眼强生公司在2025年第二季度实现了237亿美元的全球销售额，同比增长5.8%，调整汇率影响后的增长率为4.6%；稀释每股收益（EPS）达到2.29美元，同比增长18.7%，调整后的稀释每股收益为2.77美元，同比增长1.8%。其中，强生创新制药全球销售额达到152亿美元，同比增长4.9%，经营性同比增长3.8%。强生医疗科技全球销售额达到85亿美元，同比增长7.3%，经营性同比增长6.1%。强生公司董事长兼首席执行官Joaquin Duato表示：第二季度的出色业绩彰显了公司横跨医疗科技和创新制药两大领域得天独厚的综合实力。公司的产品组合与研发管线为下半年业务加速增长奠定了坚实基础，预计将在肺癌、膀胱癌、重度抑郁症、银屑病、外科和心脑血管等领域迎来多项具有突破性意义的获批和上市申请。这些创新成果将显著延长患者生命，改善其生活质量。图1 强生2025Q2业绩摘要来源：强生官网创新药业务逆势增长，肿瘤与神经科学领域表现突出在2025年第二季度，强生公司的创新药物业务取得了显著的业绩增长，全球销售额达到152亿美元美元，同比增长4.9%。尽管STELARA（喜达诺®）专利到期对业绩产生了1170个基点的负面影响，但公司在肿瘤和神经科学等领域的强劲表现推动了整体增长。其中，肿瘤领域表现尤为突出，销售额达到63亿美元，同比增长24%。这一增长主要得益DARZALEX（兆珂速®）、ERLEADA（安森珂®）、CARVYKTI等产品市场份额的持续增长。神经科学领域的销售额为20亿美元，同比增长15.1%，其中SPRAVATO（速开朗®）的增长来源于不断增加的患者需求。传染病领域的销售额为8亿美元，同比增长16.8%。免疫领域的销售额约40亿美元，同比下降15.4%，主要原因为核心产品STELARA（喜达诺®）面临生物类似药的冲击。它是由强生公司开发的全球首个可同时选择性靶向IL-12和IL-23的生物制剂，用于对传统治疗或肿瘤坏死因子a（TNFa）拮抗剂应答不足、失应答或无法耐受的成年中重度活动性克罗恩病（CD）患者。2020至2024年期间，该药在中国医院端的销售额持续攀升，2024年突破10亿大关（如图2）。图2 STELARA（喜达诺®）国内院端放大市场金额（2020-2024）数据来源：PDB药物综合数据库图3 创新制药2025Q2业务亮点来源：强生官网医疗科技业务增长迅猛，心血管领域贡献居首在2025年第二季度，强生公司的医疗技术业务增长迅猛，同比增长7.3%，主要得益于公司在心血管领域的卓越表现、有效的商业执行策略以及不断的创新推动。全球销售额高达85.41亿美元，其中心血管业务贡献了23.13亿美元，同比增长23.5%，这一显著增长得益于电生理学领域的竞争优势，包括新产品（如VARIPULSE、TRPULSE、NUVISION、QDOT）的推出。骨科业务的销售额为23.05亿美元，同比下降0.3%。受中国带量采购（VBP）政策的影响，髋关节、膝关节、脊柱等细分领域面临一定的市场压力。外科业务的销售额为25.55亿美元，同比增长2.7%。视觉业务的销售额为12.69亿美元，同比增长了6.5%。隐形眼镜业务依赖于ACUVUE OASYS 1-Day系列的强劲表现实现了高速增长。图4 医疗科技2025Q2业务亮点来源：强生官网结语强生公司2025年第二季度中展现出的强劲增长势头和卓越的业务表现，充分证明了其在医药行业中的领先地位和强大的抗风险能力。在创新制药领域，尽管面临专利到期的挑战，但公司在肿瘤、神经科学等关键领域的突破性进展，为未来的持续增长注入了强大动力。医疗科技业务的迅猛发展，尤其是心血管领域的创新成果，进一步巩固了强生在全球医疗市场的竞争力。展望未来，强生凭借其丰富的产品组合和强大的研发管线，有望在更多疾病领域取得重大突破，持续推动医疗技术的进步，为全球患者带来更多的希望和改善生活质量的解决方案。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

专利到期生物类似药财报

2025-07-24

·药事纵横

全球首创口服IL-23靶向药！强生银屑病新药Icotrokinra申报上市

7月21日，全球医疗巨头强生公司与ProtagonistTherapeutics共同宣布，已向FDA提交全球首个IL-23受体靶向口服肽类药物Icotrokinra的新药申请，用于治疗12岁及以上中重度斑块状银屑病患者。如顺利获批，Icotrokinra将成为全球首个通过口服给药方式精确靶向IL-23受体的银屑病治疗药物，打破目前以注射用生物制剂为主的市场格局。关于斑块状银屑病斑块状银屑病不仅是一种皮肤疾病，更是一种系统性炎症性疾病。患者皮肤表面形成隆起的鳞屑斑块，在浅肤色人群中呈红色，在深肤色人群中则可能表现为紫色、灰色或深棕色。这种疾病在全球影响着超过1.25亿人，其中仅美国就有约800万患者,近四分之一患者病情达到中重度程度。2021年发表在《美国医学会皮肤病学杂志》的研究确认，银屑病困扰着约3%的美国成年人口，相当于约750万人，这些患者不仅承受着皮肤的瘙痒与疼痛，还经常面临心理健康问题和社交障碍。当前治疗方法主要有两类：生物制剂和小分子药物。然而，现有疗法在给药方式、疗效持久性和安全性方面均有局限，大量患者需求仍未得到满足。关于IcotrokinraIcotrokinra（研发代号JNJ-77242113或JNJ-2113）代表着一类全新的治疗模式。作为全球首创的口服肽类药物，它能够高精度选择性阻断IL-23受体，这正是斑块状银屑病炎症反应的核心通路。这种创新药物以皮摩尔级亲和力与IL-23受体结合，在人类T细胞中表现出对IL-23信号的强效选择性抑制作用，其分子设计使其能够精确靶向疾病核心机制，同时避免影响其他无关生物通路。与传统小分子药物相比，肽类药物具有更少的脱靶效应，可以更特异性地靶向细胞受体，与生物制剂相比，口服给药方式则大大提高了治疗便利性。胰岛素和GLP-1类药物是肽类药物成功应用的典范，Icotrokinra有望将这一成功扩展到免疫介导疾病领域。临床实证此次新药申请基于ICONIC临床开发项目中四项关键III期研究的坚实数据，包括ICONIC-LEAD、ICONIC-TOTAL、ICONIC-ADVANCE1和ICONIC-ADVANCE2研究。2025年3月在美国皮肤病学会年会上公布的ICONIC-LEAD研究结果显示，治疗第16周时，Icotrokinra组65%的患者达到IGA评分0或1（皮肤完全或几乎完全清除），而安慰剂组仅为8%。在衡量银屑病严重程度的另一关键指标PASI90方面，Icotrokinra组达到50%响应率，安慰剂组仅有4%。疗效随时间持续增强，到第24周时，74%患者达到IGA0/1，65%达到PASI90。在2025年世界儿童皮肤病学大会上公布的亚组分析显示，12岁以上青少年患者群体中也观察到类似疗效，皮肤完全或几乎完全清除率显著高于安慰剂组。ICONIC-TOTAL研究特别关注了难治部位的治疗效果。在涉及头皮银屑病的患者中，66%使用Icotrokinra的患者达到头皮特异性IGA评分0/1，而安慰剂组仅11%。在生殖器银屑病患者中有效率也显著提升。最引人注目的是ICONIC-ADVANCE1和2研究结果，这两项头对头试验证明Icotrokinra在主要疗效终点上显著优于已上市药物氘可来昔替尼（百时美施贵宝的Sotyktu）。安全性与治疗优势汇总安全性数据显示，Icotrokinra组（49.1%）与安慰剂组（51.9%）出现不良事件的患者比例相近，未发现新的安全性信号。强生创新医药免疫皮肤病与呼吸疾病领域负责人LizaO’Dowd博士指出：“鉴于我们研究的广度和深度，以及迄今为止报告的强劲临床结果，我们相信Icotrokinra有潜力改变医生和患者对斑块状银屑病护理的认知，为这种免疫介导疾病的治疗建立新的标准。”ICONIC-LEAD研究负责人RobertBissonnette博士补充道：“这些研究结果充满希望，表明Icotrokinra治疗有望为患者提供独特的组合优势——皮肤完全清除、良好的安全性以及每日一次口服给药的便利性。”强生公司已启动III期ICONIC-ASCEND研究，计划将Icotrokinra与该公司现有的生物制剂Stelara进行头对头比较。该公司还启动了Icotrokinra与Sotyktu的对比研究。市场前景预测根据ProtagonistTherapeutics与强生达成的合作协议，该合作总金额高达10亿美元。Protagonist已收到3.375亿美元预付款和里程碑付款，还有资格获得6.3亿美元潜在里程碑付款以及6-10%的销售分成。业内分析人士预测，Icotrokinra的销售峰值有望超过50亿美元，这主要基于其卓越的临床数据、口服给药便利性以及在多种IL-23介导疾病中的潜在应用价值。银屑病治疗市场目前由注射用生物制剂主导，包括强生自身的Stelara（乌司他单抗）、诺华的Cosentyx（司库奇尤单抗）和礼美的Taltz（依奇珠单抗）等。Icotrokinra的口服给药方式可能重塑这一价值数百亿美元的市场格局。市场研究分析师指出：“作为一种首创的口服疗法，Icotrokinra可能颠覆当前以注射用生物制剂为主导的治疗模式。口服给药的便利性与优异的临床数据结合，使其可能成为患者和医疗专业人员的首选。”应用拓展方面Icotrokinra的潜力不止于斑块状银屑病。IL-23通路在多种免疫介导疾病中起关键作用，包括银屑病关节炎、溃疡性结肠炎和克罗恩病等。强生公司表示，ICONIC临床开发项目的长期数据，包括ICONIC-LEAD和ICONIC-TOTAL研究中至少52周的治疗数据，以及评估疗效持久性的随机撤药分析结果，正在准备在未来的医学会议上发布。目前，强生已启动III期ICONIC-ASCEND试验，这是首个旨在证明口服药物（Icotrokinra）优于注射用生物制剂（乌司他单抗）的头对头研究。同时，公司正在评估该药物在其他IL-23介导疾病中的应用潜力，有望扩大其治疗范围。参考信息：[1]强生IL-23R口服环肽抑制剂向FDA递交上市申请-多肽圈[2]Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis[3]Protagonist Therapeutics Inc (PTGX) Submits NDA for Icotrokinra to FDA | PTGX stock news药事纵横投稿须知：稿费已上调，欢迎投稿

临床3期临床1期临床2期生物类似药

2025-07-23

·GlobeNewswire-Health Care

AscellaHealth Service and Infrastructure Enhancements Support Specialty Drug Manufacturers to Protect Market Share Across Brand, Biosimilar and Generic Launches

BERWYN, Pa., July 23, 2025 (GLOBE NEWSWIRE) -- AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, announces service and infrastructure enhancements designed to help specialty and rare disease drug manufacturers respond to accelerating market disruption across the pharmaceutical landscape. From sudden formulary exclusions and loss of preferred status to the growing impact of biosimilars, generics and aggressive cost-containment measures by payers, manufacturers rely upon a strategic, flexible distribution partnership with AscellaHealth. “This is a wake-up call for biopharma manufacturers,” says Bill Oldham, chairman and president of AscellaHealth. “When preferred drug status can be lost overnight, it’s essential to have a pharmacy-first HUB partner that scales with you, minimizes disruption and delivers what’s best for patients and the product.” As the recent shift in UnitedHealthcare’s formulary status for Stelara® illustrates, biopharma companies must act quickly to prepare for sudden market access changes. With these pressures intensifying, the need for AscellaHealth’s high-touch, patient-first model is greater than ever. Combined with leading technology and data capabilities, AscellaHealth positions manufacturers to respond with agility, protect product access and ensure patient continuity of care. “AscellaHealth’s integrated HUB model ensures manufacturers maintain full control over their product, patients, and critical program data—regardless of payer shifts, employer transitions or market disruptions,” continues Oldham. “Patients benefit from a consistent, reliable support system, while manufacturers can trust in a distribution partner that scales seamlessly and prioritizes uninterrupted access and continuity of care.” Enhanced capabilities, enabling manufacturers to mitigate risk and maintain product value throughout the drug lifecycle, include: 1. Optimized Plan Design & Formulary Management AscellaHealth leverages deep expertise in formulary dynamics and cost-containment strategies to help manufacturers maintain access while navigating payer and PBM shifts. 2. Patient Engagement Technology A new mobile platform enables HIPAA-compliant messaging, document sharing and video support—ensuring personalized, multi-channel engagement that improves adherence and satisfaction. 3. Real-Time Data & Analytics Combining the power of Microsoft’s ecosystem of business intelligence through Power BI, Power Platform, CoPilot for AI and CRM, in conjunction with proprietary analytics tools, AscellaHealth offers actionable insights into program health. With real time business analytics, integrated reporting, and alert monitoring, it allows internal stakeholders and manufacturer partners to drive smarter decisions faster. 4. Alternative Distribution & Market Access Strategy With experience across exclusive, limited and open distribution models, AscellaHealth helps manufacturers choose the right channel strategy, optimize site-of-care and educate providers to support adoption. These timely advancements are supported by infrastructure investments in both technology and facilities. A phased upgrade to WellSky’s cutting edge healthcare software continues to enhance care coordination, optimize clinical and financial workflows and improve patient engagement through tailored, integrated solutions. The ongoing expansion of patient support facility, Optime Care East, increases AscellaHealth’s ability to manage high-acuity patient populations and deliver enhanced care management solutions globally. About AscellaHealth AscellaHealth is a global partner that delivers proven end-to-end solutions to both life sciences and healthcare companies to enhance the quality of life for patients with complex, chronic conditions. A dedicated team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma. Visit www.AscellaHealth.com. About Optime Care Optime Care, Inc., AscellaHealth’s Specialty Pharmacy, is a nationally recognized specialty pharmacy, distribution and patient management organization offering a suite of comprehensive services tailored to maximize therapeutic opportunities for the treatment of orphan and rare disorders. The executive team has partnered in the launch and management of over 40 orphan products and programs while consistently implementing the best brand services for the community. Optime Care has dual-accreditation from the Utilization Review Accreditation Commission (URAC) for compliance with specialty pharmacy and the Accreditation Commission for Health Care (ACHC) for specialty pharmacy services that demonstrate a commitment to providing quality care and services to consumers. Visit: https://www.optimecare.com/ *Optime Care is wholly owned by Innovative Specialty Solutions, LLC, an affiliate of AscellaHealth, LLC. This press release was published by a CLEAR® Verified individual. Media: Caroline Chambers CPR Communications cchambers@cpronline.com 201.641.1911 x 21

100 项与乌司奴单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09214	乌司奴单抗	L04AC05	DB05679

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
溃疡性结肠炎	澳大利亚	Janssen-Cilag Pty Ltd.	2009-07-28
克罗恩病	澳大利亚	Janssen-Cilag Pty Ltd.	2009-07-28
银屑病关节炎	欧盟	Janssen-Cilag International NV	2009-01-15
银屑病关节炎	冰岛	Janssen-Cilag International NV	2009-01-15
银屑病关节炎	列支敦士登	Janssen-Cilag International NV	2009-01-15
银屑病关节炎	挪威	Janssen-Cilag International NV	2009-01-15
活动性中度克罗恩病	欧盟	Janssen-Cilag International NV	2009-01-15
活动性中度克罗恩病	冰岛	Janssen-Cilag International NV	2009-01-15
活动性中度克罗恩病	列支敦士登	Janssen-Cilag International NV	2009-01-15
活动性中度克罗恩病	挪威	Janssen-Cilag International NV	2009-01-15
活动性重度克罗恩病	欧盟	Janssen-Cilag International NV	2009-01-15
活动性重度克罗恩病	冰岛	Janssen-Cilag International NV	2009-01-15
活动性重度克罗恩病	列支敦士登	Janssen-Cilag International NV	2009-01-15
活动性重度克罗恩病	挪威	Janssen-Cilag International NV	2009-01-15
斑块状银屑病	欧盟	Janssen-Cilag International NV	2009-01-15
斑块状银屑病	冰岛	Janssen-Cilag International NV	2009-01-15
斑块状银屑病	列支敦士登	Janssen-Cilag International NV	2009-01-15
斑块状银屑病	挪威	Janssen-Cilag International NV	2009-01-15
活动性中度溃疡性结肠炎	欧盟	Janssen-Cilag International NV	2009-01-15
活动性中度溃疡性结肠炎	冰岛	Janssen-Cilag International NV	2009-01-15

未上市

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适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	临床3期	美国	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	阿根廷	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	丹麦	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	法国	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	德国	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	意大利	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	波兰	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	西班牙	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	土耳其	Janssen Research & Development LLC	2022-08-30
幼年特发性关节炎	临床3期	英国	Janssen Research & Development LLC	2022-08-30

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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


NCT04882072 (Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study of ustekinumab in patients with Takayasu arteritis, Pubmed \| Rheumatol Adv Pract)	临床3期	大动脉炎	14	Ustekinumab	積蓋選簾鏇壓繭製膚鹹(鹽襯齋醖鹽鬱鹹簾鹹艱) = 獵壓繭網齋鏇鑰艱製網積醖壓廠顧餘鬱糧願積 (簾繭願餘觸繭艱壓遞積, 4.14 ~ NE)	不佳	2025-03-14
				Placebo	積蓋選簾鏇壓繭製膚鹹(鹽襯齋醖鹽鬱鹹簾鹹艱) = 襯鏇願簾製餘網簾餘顧積醖壓廠顧餘鬱糧願積 (簾繭願餘觸繭艱壓遞積, 12.14 ~ NE)
NCT04549792 (CTgov)	早期临床1期	Sjogren-Larsson综合征 \| 鱼鳞病	13	Ustekinumab	淵鏇鬱鏇壓鹽積壓憲範(選製選鬱餘襯範醖襯襯) = 衊構艱窪願鹹憲蓋製衊淵窪遞繭遞糧廠鹽餘網 (餘築鹹範遞糧獵鏇選鏇, 29.9) 更多	-	2025-02-12
NCT04882072 (Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study of ustekinumab in patients with Takayasu arteritis, CTgov)	临床3期	大动脉炎	14	placebo+ustekinumab (Double-blind: Placebo)	範夢繭鏇簾鬱鬱鏇顧齋(夢鏇顧簾繭淵壓積糧鬱) = 獵願夢鹽餘壓觸顧鹹鹽齋積願鬱艱夢鬱醖網膚 (齋網範淵選簾夢繭願鬱, 蓋壓壓鏇獵襯構獵襯鑰 ~ 鬱製蓋淵蓋築淵窪製構) 更多	-	2024-12-02
				Ustekinumab (Double-blind: Ustekinumab)	範夢繭鏇簾鬱鬱鏇顧齋(夢鏇顧簾繭淵壓積糧鬱) = 鏇淵積構膚鏇鹽餘襯鬱齋積願鬱艱夢鬱醖網膚 (齋網範淵選簾夢繭願鬱, 範襯廠夢淵積鹽範蓋蓋 ~ 網蓋鬱襯繭醖糧製鏇鏇) 更多
NCT04629196 (CTgov)	临床4期	克罗恩病	12	Ustekinumab (IV Weight-Based Induction Dose)	壓艱窪積遞積鑰獵淵醖(繭構製鹹願積觸壓淵醖) = 範鹽醖選顧鬱衊遞鬱鹽顧醖繭蓋淵餘範鏇鏇鏇 (鹽範積蓋憲憲糧顧積糧, 64.82) 更多	-	2024-11-05
				Ustekinumab (Standard Subcutaenous Dose)	壓艱窪積遞積鑰獵淵醖(繭構製鹹願積觸壓淵醖) = 觸獵壓網窪築餘築獵製顧醖繭蓋淵餘範鏇鏇鏇 (鹽範積蓋憲憲糧顧積糧, 47.14) 更多
UEGW2024	N/A	溃疡性结肠炎	-	Ustekinumab	網築蓋齋憲衊鏇齋顧遞(壓淵簾願壓鏇衊齋網鏇) = Adverse events were reported in 14.1% (18/198), with colectomies exclusively observed in bio-exposed individuals (8.6%; 17/198) 廠淵壓夢築蓋艱簾鹽遞 (蓋壓艱齋淵遞鏇觸鹹鬱 )	-	2024-10-13
				Ustekinumab (Bio-naive patients)
UEGW2024	N/A	炎症性肠病	-	Intravenous Ustekinumab 130mg/4 weeks	蓋網範範艱鏇鹹衊鹽築(鏇廠衊構餘簾膚衊鬱鏇) = 2 patients (both with CD) experienced recurrent respiratory infections as an adverse effect, without the need to discontinue UST 願繭觸鏇襯餘簾鑰顧範 (製網積衊鹹膚鏇糧繭鬱 )	-	2024-10-13
UEGW2024	N/A	溃疡性结肠炎	-	Ustekinumab 90 mg every-8-weeks	觸範願積衊壓醖衊積網(範膚鹽壓網艱憲網鏇餘) = A total of 176 patients (28%) had at least one adverse event, with infections being the most frequent (11%). No negative impact on extraintestinal manifestations and/or immunomediated diseases was seen. 鹹鏇鑰淵觸簾獵蓋鹹餘 (願糧膚齋遞觸積淵鏇築 )	-	2024-10-13
UEGW2024	N/A	-	-	Cohort 1	淵積鏇觸製製夢壓願蓋(網壓蓋窪艱簾窪積膚餘) = 艱醖醖鑰糧醖糧製鏇衊膚餘鹹醖壓醖築鏇鹽鹹 (積廠鬱衊獵觸構選鏇顧 ) 更多	-	2024-10-13
				Cohort 2	淵積鏇觸製製夢壓願蓋(網壓蓋窪艱簾窪積膚餘) = 鹽壓選積衊醖齋築窪壓膚餘鹹醖壓醖築鏇鹽鹹 (積廠鬱衊獵觸構選鏇顧 )
UEGW2024	N/A	溃疡性结肠炎	-	Ustekinumab	餘鏇鑰膚艱築鑰顧夢觸(蓋構觸膚糧築鹽構網願) = 62 adverse drug reactions were recorded in 36 patients 選醖憲範憲製蓋憲壓願 (積顧淵觸衊窪衊餘艱壓 ) 更多	-	2024-10-13
UEGW2024	N/A	-	17	Ustekinumab	醖憲鹹鹹淵壓繭願餘積(選鬱廠艱壓醖襯蓋憲範) = 鹹鏇築網顧膚遞顧築獵獵願糧夢鑰獵積選積蓋 (襯製範築齋獵襯築簾窪 )	积极	2024-10-13