乌司奴单抗(Ustekinumab) - 药物靶点：IL-12 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-12 x IL-23

作用方式

抑制剂

作用机制

IL-12抑制剂(白细胞介素-12复合体抑制剂)、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+ [12]

非在研适应症

皮肌炎化脓性汗腺炎狼疮性肾炎+ [13]

原研机构

Janssen Biotech, Inc.

在研机构

Janssen Research & Development LLCJanssen-Cilag International NV

Janssen Global Services LLC

+ [8]

非在研机构

Centocor, Inc.

西安杨森制药有限公司Janssen-Cilag Ltd.

+ [3]

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

166

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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3,400

项与乌司奴单抗相关的文献（医药）

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.

2025-04-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Obesity Is Associated With Worsened Outcomes in Patients With Ulcerative Colitis on Advanced Therapies: A Propensity Matched Cohort Study From the U.S.

Article

作者: Farraye, Francis A. ; Sehgal, Priya ; Lichtenstein, Gary R. ; Lewis, James D. ; Desai, Aakash ; Khataniar, Himsikhar ; Kochhar, Gursimran S.

ABSTRACT:

Background:

Obesity has been linked to a more severe phenotype in patients with ulcerative colitis (UC).

Aim:

To evaluate the impact of obesity on outcomes of advanced therapies in UC.

Methods:

We conducted a retrospective cohort study utilising the TriNetX database comparing the composite score of corticosteroid use, change in advanced therapy or colectomy within two years between two cohorts of patients with UC—those with obesity (BMI ≥ 30 kg/m2) and those without (BMI 18.5–24.9). The risk assessment was stratified to specific advanced therapies, including tumour necrosis factor α inhibitors (TNFi), vedolizumab, ustekinumab and Janus kinase inhibitors (JAKi). We performed 1:1 propensity score matching (PSM) for demographics, co‐morbid conditions, laboratory values and IBD medications including corticosteroids.

Results:

There were 3904, 2025, 1150 and 477 patients on TNFi, vedolizumab, ustekinumab and JAKi, respectively, in the UC obesity cohort. After PSM, the UC obesity cohort was at an increased risk of the composite outcome of corticosteroid use, change in therapy and colectomy compared to the UC control cohort in patients on TNFi (aHR 1.37, 95% CI 1.29–1.49), vedolizumab (aHR 1.29, 95% CI 1.16–1.43), ustekinumab (aHR 1.1.26, 95% CI 1.10–1.44) and JAKi (aHR 1.38, 95% CI 1.13–1.69). Sub‐group analysis based on the specific TNFi also showed an increased risk of composite outcome for infliximab (aHR 1.36, 95% CI 1.22–1.52) and adalimumab (aHR 1.26, 95% CI 1.11–1.42) within 2 years.

Conclusions:

Obesity is associated with lower efficacy of several advanced therapies in patients with UC.

2025-04-01·INTERNATIONAL IMMUNOPHARMACOLOGY

The safety assessment of ustekinumab on psoriasis and psoriatic arthritis: A real-world analysis based on the FDA adverse event reporting system database

Article

作者: Zheng, Yu ; Gao, Xiao-Jing ; Liu, Jia-Min ; Shen, Er-Xia ; Zheng, Yan-Ling ; Ding, Rui-Lian ; Li, Xiao-Min ; Bu, Jin ; Liao, Yue ; Chen, Xiang-Ming ; Huang, Ji-Jun ; Zhao, Yu-Yang

OBJECTIVE:

To assess safety of ustekinumab (UST) on treatment of patients with psoriasis and psoriatic arthritis (PsA) by analyze UST related adverse drug events (ADEs).

METHODS:

Data on ADEs associated with UST on psoriasis and PsA were collected from the fourth quarter of 2009 through the third quarter of 2024 in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FEARS) database. A variety of signal quantization techniques such as reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS) are used for analysis.

RESULTS:

A total of 67,765 ADE reports with UST on psoriasis and PsA as the primary suspected agent covered 25 system organ classes (SOCs). The three most common ADEs are infections and infestations (n = 9698), general disorders and administration site conditions (n = 6336), and injury, poisoning, and procedural complications (n = 6091). Specifically, reproductive system diseases (n = 262) was identified as unique adverse reactions not mentioned in official drug labels. At the preferred term (PT) level, the most common ADEs were psoriasis exacerbation (n = 3486), lower respiratory tract infection (n = 1302) and latent tuberculosis (n = 121). Strong yet rare signals, including notalgia paraesthetica (n = 3, empirical bayesian geometric mean [EBGM] 154.7) and chronic actinic dermatitis (n = 3, EBGM 101.15), were also detected. Compared to patients with PsA, patients with psoriasis treated with UST exhibit significantly stronger associations with hepatobiliary disorders (n = 955, ROR 2.44, PRR 2.4, information component [IC] 1.26, EBGM 2.4) and neoplasms (n = 3150, ROR 2.61, PRR 2.49, IC 1.31, EBGM 2.49). Spontaneous reports consistently demonstrated higher signal strength for infections and skin disorders compared to healthcare professional (HCP) reports. In contrast, at the PT level, HCP reports tended to emphasize stronger signals for rare or specific conditions.

CONCLUSION:

This study highlights a spectrum of UST-associated ADEs covering 25 SOCs in the treatment of patients with psoriasis and PsA, which emphasizes the need for vigilant clinical monitoring, particularly for infections, hepatobiliary disorders, and rare but high-signal events such as notalgia paraesthetica, chronic actinic dermatitis and pure testicular seminoma stage I. Clinicians should combine insights from both spontaneous and HCP reports and pay special attention to infections and reproductive system disorders.

925

项与乌司奴单抗相关的新闻（医药）

2025-03-31

·PMLiVE

Johnson & Johnson’s Tremfya recommended by CHMP to treat Crohn’s disease

Johnson & Johnson (J&J) has announced that its Tremfya (guselkumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease (CD). The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be approved to treat moderately to severely active CD in adults who have had an inadequate response, lost response, or been intolerant to either conventional therapy or a biologic treatment. CD is one of the two main forms of inflammatory bowel disease, which is estimated to affect nearly two million people across Europe. CD patients can experience a range of symptoms, including abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever. Offering both subcutaneous (SC) and intravenous (IV) induction options for CD, J&J’s Tremfya is designed to block IL-23, an important driver of immune-mediated diseases, while also binding to CD64, a receptor on cells that produce IL-23. The drug is already approved in the EU to treat certain cases of plaque psoriasis and active psoriatic arthritis, and was recommended by the CHMP last month to treat moderately to severely active ulcerative colitis, the other main type of IBD. The CHMP’s latest recommendation comes just one week after the US Food and Drug Administration approved Tremfya for CD and was supported by data from the late-stage GALAXI and GRAVITI programmes. This included results from the GALAXI 2 and 3 studies, in which Tremfya demonstrated greater efficacy compared to J&J’s Stelara (ustekinumab) in endoscopic response and endoscopic remission at week 48. Mark Graham, senior director, therapeutic area lead, immunology, J&J Innovative Medicine EMEA, said: “The results from the phase 3 studies demonstrate [Tremfya] has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for CD. [This] positive opinion by the CHMP marks an important step forward in offering a potentially new and differentiated treatment option for people living with this chronic and debilitating condition…” The EC will now review the CHMP’s recommendations as it makes a final decision on Tremfya in both CD and UC.

临床3期临床结果上市批准

2025-03-28

·GlobeNewswire-Health Care

UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)

March 26, 2025 -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD $4.4 billion [1]. “This represents an important step in the development of our proposed biosimilar to Xolair, with the key goal to increase patient access to an important biologic,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “At Kashiv, we are committed to developing high-quality, cost-effective therapies. The successful acceptance by MHRA of the marketing authorization for AVT23 reflects our dedication to innovation and improving access to vital biosimilars on a global scale,” said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences. Dr Nick Warwick, Chief Medical Officer of Advanz Pharma, stated, "This achievement marks a significant step in expanding treatment options for patients and reinforces Advanz Pharma's dedication to enhancing access to specialty, hospital, and rare disease medications.” Alvotech and Advanz Pharma announced in February 2023 that the companies had entered into a commercialization agreement for AVT23. In May 2023, the partners announced an expansion of the strategic partnership, to include five additional biosimilar candidates under development by Alvotech. Alvotech and Kashiv announced in October 2023 that the companies had entered into a licensing agreement for AVT23. AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair, which contains omalizumab, is indicated for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) [2]. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Sources [1] Financial Reports from Roche Group and Novartis [2] MHRA Product Information for Xolair® Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出上市批准

2025-03-28

·瑞迪博士

百奥泰与瑞迪博士就BAT2206和BAT2506签署在东南亚市场的独家授权许可及商业化协议

瑞迪博士于3月26日宣布，瑞迪博士实验室有限公司(纽交所代码：RDY)全资子公司瑞迪博士SA，（以下简称 “瑞迪博士”）与百奥泰生物制药股份有限公司（上交所代码688177）就BAT2206（一款参照喜达诺®乌司奴单抗开发的生物类似药）和BAT2506（一款参照欣普尼®戈利木单抗开发的生物类似药）达成了商业化和许可协议。根据协议，百奥泰将负责BAT2206和BAT2506的开发、生产和供应。瑞迪博士将负责在东南亚国家柬埔寨、印度尼西亚、马来西亚、菲律宾、泰国、越南获得产品注册和商业化销售。此外，瑞迪博士还将获得BAT2206在哥伦比亚的独家商业化权利。瑞迪博士品牌市场（印度和新兴市场）首席执行官M.V. Ramana表示：“此次与百奥泰合作将进一步扩大我们生物类似药在新兴市场的布局。我们在新兴市场已有成熟的商业化网络，期待为患者提供可负担的优质药物以满足尚未被满足的医疗需求。百奥泰创始人及总经理李胜峰博士表示：“公司非常重视东南亚等新兴市场的开拓，我们相信公司与瑞迪博士就BAT2206和BAT2506的合作将加速公司产品进入全球新兴市场，惠及全球更多患者，进一步提高生物制剂的可及性。”1 关于BAT2206（乌司奴单抗）BAT2206是Jansen’s Stelara®的拟定生物类似药，Stelara®是一种人源单克隆抗体，通过阻止共享p40与免疫细胞表面表达的IL-12Rβ1受体蛋白结合来抑制人IL-12和IL-23的生物活性。IL-12和IL-23参与炎症和免疫应答，如自然杀伤细胞活化和CD4+T细胞分化和活化。IL-12和IL-23被认为是慢性炎症的重要贡献者，而慢性炎症是许多其他自身免疫性疾病中克罗恩病和溃疡性结肠炎的标志。在欧盟，Stelara®目前被批准用于治疗1）成人和6岁以上儿童的中重度斑块状银屑病，这些患者的病情在接受其他全身性（全身）银屑病治疗后仍未得到改善，或无法使用其他全身性（全身）银屑病治疗；2）成人的活动性关节炎，当接受称为疾病改良抗风湿药物（DMARD）的其他治疗后病情改善不够时，可单独使用该药或与甲氨蝶呤联合使用；3）经其他克罗恩病治疗后病情改善不够或无法接受此类治疗的成人的中重度活动性克罗恩病；4）经其他溃疡性结肠炎治疗后病情改善不够或无法接受此类治疗的成人的中重度活动性溃疡性结肠炎。2 关于BAT2506（戈利木单抗）BAT2506是由百奥泰开发的拟申报戈利木单抗生物类似药。戈利木单抗是一种人源性单克隆抗体，可抑制肿瘤坏死因子α（TNF-α）的生物活性。原研药Simponi®在美国获批用于治疗中重度类风湿性关节炎、活动性银屑病关节炎、活动性强直性脊柱炎和中重度活动性UC,并带有严重感染和恶性肿瘤黑框警告。免责声明：本新闻稿可能包含前瞻性陈述，这些陈述基于管理层当前的观点和假设，涉及已知或未知的风险和不确定性，可能导致实际结果、业绩或事件与陈述明示或暗示的内容存在重大差异。除上下文明确表明前瞻性的表述外，词语"可能"、"将"、"应"、"预期"、"计划"、"打算"、"预计"、"相信"、"估计"、"预测"、"潜在"或"继续"及类似表述均属前瞻性陈述标识。实际结果、业绩或事件可能因以下因素（包括但不限于）与陈述产生重大差异：(i) 宏观经济环境，如金融市场表现、信用违约、汇率、利率、续保率及承保损失事件发生频率/严重程度；(ii) 死亡率与发病率水平及趋势变化；(iii) 竞争程度变化及一般竞争因素；(iv) 法律法规及央行/政府政策变动；(v) 收购或重组影响（含相关整合问题）；(vi) 因自然灾害、流行病（包括冠状病毒/COVID-19）等广泛疫情导致本行业及客户产品服务所处市场的经济下行风险；(vii) 美国证监会公开备案文件中载明的其他风险与不确定性（包括截至2024年3月31日的20-F年报"风险因素"和"前瞻性陈述"章节所列内容）。公司无义务更新本文所含任何信息。百奥泰前瞻性声明：本新闻稿包含了BAT2206、BAT2506或百奥泰及其产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。1. Stelara®和Simponi®是强生公司的注册商标 2.QLETLI®是百奥泰溶液有限公司的注册商标 3. TOFIDENCETM是美国Biogen公司4的商标 4. Avzivi®是山德士公司的注册商标 5. POBEVCY®是百奥泰溶液有限公司的注册商标向下滑动查看更多关于百奥泰百奥泰是一家位于中国广州，基于科学而创新的全球性生物制药企业。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。百奥泰始终以患者的福祉作为首要核心价值，通过创新研发，为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问官网：www.bio-thera.com。关于瑞迪博士瑞迪博士成立于1984年，其产品和服务涵盖广泛的治疗领域，涉及制药服务与活性成分(PSAI)、全球仿制药、专利产品和生物类似药。我们本着加快获得经济实惠的创新药品的承诺，不断寻求进入新的治疗领域以满足世界各地患者未被满足的用药需求，因为“健康不能等待”！导的带领下，严格按照各项工作流程展开工作，恪尽职守，目标明确。

生物类似药

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

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
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

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04549792 (CTgov)	早期临床1期	Sjogren-Larsson综合征 \| 鱼鳞病	13	ustekinumab	選網顧齋願鬱鑰齋膚襯(觸繭醖窪遞夢鹽願壓襯) = 積憲觸衊簾鹽憲蓋構淵構獵糧築壓夢簾鑰選淵 (淵積鏇顧簾網膚鑰遞築, 29.9) 更多	-	2025-03-25
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)	醖遞衊淵製鑰網觸餘範(蓋鹹觸範顧壓願鏇構襯) = 窪鑰觸顧遞製壓遞築憲鑰願鬱蓋衊觸憲鬱夢鏇 (構構製鹹獵選艱積窪觸, 積積襯網鬱壓選鏇簾繭 ~ 壓蓋願簾積鹽廠艱遞鑰) 更多	-	2024-12-02
				Ustekinumab (Double-blind: Ustekinumab)	醖遞衊淵製鑰網觸餘範(蓋鹹觸範顧壓願鏇構襯) = 選艱獵簾夢鹹選鹽築繭鑰願鬱蓋衊觸憲鬱夢鏇 (構構製鹹獵選艱積窪觸, 襯餘夢遞艱築餘製網窪 ~ 鏇鬱蓋憲獵簾繭齋願夢) 更多
NCT04629196 (CTgov)	临床4期	克罗恩病	12	Ustekinumab (IV Weight-Based Induction Dose)	願鏇構顧襯築餘觸築簾(遞鑰齋鏇範壓艱壓餘繭) = 構窪鏇衊觸選齋範範選窪夢築鬱窪廠選網餘觸 (齋鹽願範願遞壓夢夢繭, 64.82) 更多	-	2024-11-05
				Ustekinumab (Standard Subcutaenous Dose)	願鏇構顧襯築餘觸築簾(遞鑰齋鏇範壓艱壓餘繭) = 遞簾積壓選願艱繭衊餘窪夢築鬱窪廠選網餘觸 (齋鹽願範願遞壓夢夢繭, 47.14) 更多
UEGW2024	N/A	克罗恩病	-	Ustekinumab as 1st line biologic treatment	憲夢選窪憲選鹽憲簾築(醖繭衊網廠蓋鹽獵鬱夢) = 63.9% (108/169) of patients experienced adverse events 鹹鬱窪淵獵鑰選糧鹹範 (壓廠廠鬱壓範淵網窪醖 ) 更多	-	2024-10-13
				Ustekinumab as 2nd line biologic treatment
NCT03942120 (K-STAR, Pubmed \| Inflamm Bowel Dis) 人工标引	N/A	克罗恩病维持 \| 诱导	464	Ustekinumab	鹽網鬱鏇鬱顧膚鏇鹹襯(膚願淵糧艱艱醖鏇願淵) = 鹹積積淵範構鹽觸醖簾餘糧醖網壓廠積獵齋顧 (膚淵鏇壓襯繭積餘鏇糧 ) 更多	积极	2024-08-03
				Ustekinumab (At week 52 to 66)	鹽網鬱鏇鬱顧膚鏇鹹襯(膚願淵糧艱艱醖鏇願淵) = 衊齋壓壓鬱鬱齋觸夢願餘糧醖網壓廠積獵齋顧 (膚淵鏇壓襯繭積餘鏇糧 ) 更多
NCT04093531 (CTgov)	临床1期	原发性干燥综合征	12	ustekinumab	鏇鏇窪壓築齋膚遞齋艱(憲願醖鹽襯夢夢鹹網憲) = 範選衊願鏇醖餘鬱艱鹹獵觸鏇選願艱製蓋網遞 (築夢繭窪積衊窪獵膚糧, 襯襯齋顧獵艱廠鑰蓋廠 ~ 遞願構繭衊餘遞衊蓋積) 更多	-	2024-06-25
DDW2024	N/A	溃疡性结肠炎	-	Ustekinumab	觸淵窪獵構襯餘製構壓(壓鹹觸蓋壓獵鏇襯範壓) = 艱糧築襯憲鏇鑰艱夢醖觸鏇網選糧糧顧淵構遞 (觸鹽鹹糧願選廠廠製遞 ) 更多	-	2024-05-21
				Vedolizumab	觸淵窪獵構襯餘製構壓(壓鹹觸蓋壓獵鏇襯範壓) = 繭範鹽顧簾網築觸餘鑰觸鏇網選糧糧顧淵構遞 (觸鹽鹹糧願選廠廠製遞 ) 更多
DDW2024	N/A	克罗恩病	-	Ustekinumab	淵齋積鏇窪廠廠衊艱憲(構願顧製構積糧膚壓窪) = 積膚獵蓋鹽積製蓋壓築餘糧繭壓網衊醖夢壓簾 (範積憲夢餘簾築襯膚夢 ) 更多	-	2024-05-20
NCT04089345 (Pubmed \| Clin Gastroenterol Hepatol) 人工标引	临床3期	隐窝炎	22	ustekinumab intravenously at baseline (∼6mg/kg)	鹽鑰範範廠膚餘網構廠(鹹糧蓋積積艱膚衊醖築) = 蓋襯鹹願製廠餘願餘獵獵鏇製構選選醖憲襯蓋 (齋顧範憲觸糧餘選蓋憲 ) 更多	积极	2024-05-14
NCT03981744 (CTgov)	临床3期	皮肌炎	51	placebo+ustekinumab (Placebo)	範繭壓憲襯襯夢觸壓願 = 鹽齋網壓艱夢遞窪壓襯窪鏇鹹築積選鬱齋顧衊 (鑰觸膚願齋壓鹹繭製衊, 構網壓廠觸鹹衊鹽夢觸 ~ 鬱憲獵範膚觸範網築蓋) 更多	-	2024-05-13
				Ustekinumab (Ustekinumab)	範繭壓憲襯襯夢觸壓願 = 壓獵繭淵繭網願製衊膚窪鏇鹹築積選鬱齋顧衊 (鑰觸膚願齋壓鹹繭製衊, 餘壓膚夢鬱鏇齋襯網醖 ~ 鏇餘網餘繭獵願蓋繭鏇) 更多