Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease

The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.

开始日期2020-04-24

申办/合作机构

Janssen Pharmaceutica NV

NCT02899026

/ Withdrawn临床3期

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Polymyalgia Rheumatica

Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine with high affinity that may have therapeutic benefit in the treatment of polymyalgia rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 52-week extension phase with no study drug administration and a 16-week follow-up phase if applicable.
Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study who are in clinical remission will be eligible to enter Part B, the 52-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable for those who have withdrawn prematurely from the study or who have completed Part A but are not eligible for Part B.

开始日期2018-03-15

申办/合作机构

GSK Plc

NCT02794519

/ Withdrawn临床2期

205076: A Phase II, Multicenter, Randomized, Double-blind (Sponsor-unblind), Placebo- Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Severe, Poorly Controlled Asthma

Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The continuing unmet need in subjects with asthma refractory to corticosteroid therapy and increased understanding of asthma pathogenesis have stimulated the development of targeted biologics based on predictive biomarkers. The majority of approaches to date have targeted T Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma represents an unprecedented approach that has potential to address non-Th2 drivers of severe asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled, parallel group study will investigate the efficacy of sirukumab compared to placebo in subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable treatment period for individual subjects. Dosing will continue every 4 weeks until week 44 (inclusive), or until 24 weeks after the final subject has been randomized, whichever the sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16 week Follow Up period. Overall, the duration of participation for subjects who complete the full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175 subjects will be randomized such that 140 evaluable subjects complete the study.

开始日期2016-09-23

申办/合作机构

GSK Plc

100 项与 Sirukumab 相关的临床结果

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100 项与 Sirukumab 相关的转化医学

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100 项与 Sirukumab 相关的专利（医药）

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项与 Sirukumab 相关的文献（医药）

2024-12-01·JOURNAL OF INFECTION

Corrigendum to “The IL-6 hypothesis in COVID-19: A phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of free IL-6 sequestration by the monoclonal antibody sirukumab in severe and critical COVID-19” [J Infect 89 (2024) 106241]

作者: Foong, Kap Sum

2024-10-01·JOURNAL OF INFECTION

The IL-6 hypothesis in COVID-19: A phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of free IL-6 sequestration by the monoclonal antibody sirukumab in severe and critical COVID-19

Article

作者: Buelens, Annemie ; Verbrugge, Inge ; De Meyer, Sandra ; Robinson, Philip ; Spak, Cedric W ; Chien, Jason W. ; Opsomer, Magda ; Slim, Jihad ; Chien, Jason W ; Cook, Paul ; Van Wesenbeeck, Liesbeth ; Van Landuyt, Erika ; Deveikis, Audra ; Callewaert, Katleen ; Mo, Wai Ling ; Clement, Meredith ; Zhuang, Yanli ; Gottlieb, Robert L ; Gottlieb, Robert L. ; Foong, Kap Sum ; Spak, Cedric W.

BACKGROUND:

Upregulation of IL-6 has been associated with worse prognosis in COVID-19 patients. Impact on IL-6 signalling has mostly been limited to clinical outcomes in IL-6 receptor antagonist trials.

METHODS:

We performed a phase 2, randomised, double-blind, placebo-controlled trial (NCT04380961) of US-based hospitalised adults (<85 years) with laboratory-confirmed SARS-CoV-2 infection and severe (low levels of supplemental oxygen) or critical disease (high levels of oxygen supplementation). Patients received sirukumab 5 mg/kg or placebo single dose IV on Day 1 plus standard of care. The primary endpoint was time to sustained clinical improvement up to Day 28 based on an ordinal scale. Secondary endpoints included clinical improvement, all-cause mortality, and safety. Following an interim analysis, the protocol was amended to only recruit patients with critical COVID-19.

FINDINGS:

From May 2020 to March 2021, 209 patients were randomised; 112 had critical disease (72 sirukumab, 40 placebo) at baseline. Median time to sustained clinical improvement in critical patients was 17 and 23 days in the sirukumab and placebo groups (HR, 1∙1; 95% CI, 0∙66-1∙88; p > 0∙05). At Day 28, 59∙4% versus 55∙0% of patients achieved clinical improvement with sirukumab versus placebo and rates of all-cause mortality were 24∙6% versus 30∙0%, respectively. Rates of grade ≥3 adverse events were comparable between the sirukumab and placebo groups (25∙9% vs 32∙9%; all patients).

INTERPRETATION:

In critical COVID-19 patients who received sirukumab, there was no statistically significant difference in time to sustained clinical improvement versus placebo despite objective sequestration of circulating IL-6, questioning IL-6 as a key therapeutic target in COVID-19.

2024-01-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?

Review

作者: Burmester, Gerd R ; Feist, Eugen ; Avci, Ali Berkant

The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of treatment-resistant patients. In this context, interleukin (IL)-6 inhibition has filled an important gap in rheumatoid arthritis treatment with its effectiveness and safety in both monotherapy and combinations. The process of IL-6 inhibition initiated with IL-6 receptor blockers has prompted questions regarding the potential impact and safety of different inhibitions of this pathway, such as the direct blockade of IL-6. Following the termination of the development of sirukumab because of mortality data in early studies, the investigation of olokizumab, which targets a different region of the IL-6 cytokine, has renewed the hope in this area and the safety concerns have been largely alleviated by the open-label extension data. In addition, the efficacy and safety of tocilizumab and sarilumab have led to a rapid investigation of biosimilars and new potent IL-6 receptor blockers. A comprehensive understanding of mechanisms of this pathway with further long-term clinical data and basic research may provide a decisive impact on selecting the appropriate mechanism as the first choice in personalized treatments.

项与 Sirukumab 相关的新闻（医药）

2023-12-01

·SYNAPSE

Deciphering IL-6 Inhibitors: Your Guide to Rapidly Accessing the Newest Advances

IL-6, or Interleukin-6, is a cytokine that plays a crucial role in the human body's immune response and inflammation regulation. It is produced by various cells, including immune cells, and acts as a signaling molecule to stimulate the immune system during infection or injury. IL-6 also plays a role in the development and differentiation of immune cells, such as B cells and T cells. However, excessive or prolonged IL-6 production can lead to chronic inflammation and contribute to the pathogenesis of various diseases, including autoimmune disorders and certain cancers. Therefore, understanding and regulating IL-6 levels is of great importance in the pharmaceutical industry for the development of targeted therapies. IL-6 Inhibitors is relevant to many inflammatory diseases and cancers. The first approved medication in this class was tocilizumab (Actemra), an antibody directed against the IL-6 receptor. This was followed by siltuximab (Sylvant), which is directed against IL-6 itself. Sarilumab was approved by the US FDA in 2017 for rheumatoid arthritis. Several other agents are in clinical trials, including olokizumab (CDP6038), elsilimomab, clazakizumab (BMS-945429, ALD518), sirukumab (CNTO 136), levilimab (BCD-089), and CPSI-2364. Looking ahead, IL-6 inhibitors are expected to continue to play a significant role in the treatment of various diseases. They have shown promising results in treating serious COVID-19 cases2 and are also used widely for the treatment of rheumatoid arthritis2. The IL-6 inhibitors market is projected to grow at a CAGR of 10.9%, increasing from US$ 33.3 Billion in 2023 to US$ 93.3 Billion by 20333. However, the emergence of resistance and the lack of an effective reversal drug when bleeding occurs are challenges that need to be addressed. Ongoing research and development efforts are focused on addressing these issues and expanding the clinical applications of IL-6 inhibitors. Based on the analysis of the data, the current competitive landscape for target IL-6 is characterized by the presence of multiple companies with varying stages of development and a wide range of indications. Bristol Myers Squibb Co. stands out as the company with the highest stage of development, with multiple approved drugs and ongoing clinical trials. Small molecule drugs, molecular glues, and monoclonal antibodies are the most rapidly progressing drug types under the target IL-6. The United States, European Union, and China are the leading countries/locations in terms of development, with China showing significant progress. Overall, the target IL-6 presents a competitive landscape with diverse players and promising future development potential. How do they work?IL-6 inhibitors are a type of medication that target and inhibit the activity of interleukin-6 (IL-6), a cytokine involved in the immune response and inflammation. From a biomedical perspective, IL-6 inhibitors are used in the treatment of various inflammatory conditions such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, and Castleman's disease. These inhibitors work by blocking the binding of IL-6 to its receptor, thereby reducing the inflammatory response mediated by IL-6. By inhibiting IL-6, these medications help alleviate symptoms and reduce disease progression in patients with IL-6-mediated inflammatory disorders List of IL-6 InhibitorsThe currently marketed IL-6 inhibitors include: SiltuximabPomalidomidePirfenidoneLenalidomideOlokizumabSirukumabSodium PyruvateClazakizumabRO-7200220ZiltivekimabFor more information, please click on the image below. What are IL-6 inhibitors used for?IL-6 inhibitors are used in the treatment of various inflammatory conditions such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, and Castleman's disease. For more information, please click on the image below to log in and search. How to obtain the latest development progress of IL-6 inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of IL-6 inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

2021-02-04

·佰傲谷BioValley

靶向IL-6疗法的十年

细胞因子抑制剂已经改变了许多慢性炎症疾病的结果。自批准抗IL-6受体(anti-IL-6R)疗法以来，已经过去了十年。目前在世界范围内广泛应用于各种风湿性疾病，如类风湿关节炎(RA)、幼年特发性关节炎(JIA)、成人起病性Still’s病(AOSD)、巨细胞动脉炎(GCA)和高山动脉炎，以及其他疾病，如Castleman病和细胞因子释放综合征(CRS)。此外，还确定了可能扩展到其他几种适应症的途径，如葡萄膜炎、视神经脊髓炎以及最近的COVID-19肺炎。从信号传递到药物发现自40多年前被发现以来，IL-6通路已成为参与健康免疫调节和多种疾病失调的关键通路。 1973年，大阪大学由Kishimoto tadmitsu领导的研究人员首次报道了T细胞分泌的一种可溶性因子对B细胞产生抗体很重要，随后，这种可溶性因子被克隆为IL-6，它在多种自身免疫性疾病中发挥着不同的作用。与此同时，中外制药的研究人员正在探索治疗自身免疫性疾病药物开发的新途径。 20世纪80年代末，两组开始合作，进一步加深对IL-6在各种自身免疫性疾病中的生物学作用的认识，并开发IL-6抑制剂作为治疗选择。为了增加他们合作的可能，两个研究小组甚至搬到了大阪大学毗邻的实验室。该大学的研究人员负责识别IL-6信号机制和IL-6的生物学效应，而该公司则专注于开发IL-6抑制剂，作为自身免疫性疾病潜在的新疗法。发现IL-6和IL-6靶向治疗的时间表当研究小组发现IL-6信号转导是通过IL-6、IL-6R和糖蛋白130的六聚体高亲和力复合物发生时，寻找小分子抑制剂的传统方法被证明具有挑战性。此外，可溶性IL-6R (sIL-6R)和膜结合的IL-6R (mIL-6R)都可以成为六聚体复合物的一部分；因此，认为IL-6 - IL - 6r - gp130的结合区域过于复杂和广泛，不足以作为小分子化合物抑制IL-6信号通路。后随着生物技术的同步发展，两组决定开发一种靶向IL-6R的人源化单克隆抗体。所得到的IL-6R人源化抗体tocilizumab与IL-6R和sIL-6R结合，并通过阻止IL-6与IL-6R结合来抑制IL-6信号转导。这种抗体对IL-6R的治疗益处加速了几种IL-6抗体(sirukumab, olokizumab 和 clazakizumab)的发展。 IL-6在疾病中的细胞信号通路和生理作用初始治疗应用众所周知，IL-6具有多种生理作用，在将IL-6作为治疗靶点时，其在各种自身免疫性疾病中的稳态作用与致病作用之间存在着广泛的争论。然而，利用基于细胞的分析、动物模型和体外血清和组织分析，科学家发现了几种可能受益于IL-6抑制的候选疾病。 IL-6抑制对疾病影响的证据除上述适应症，IL-6通路抑制在不同治疗领域的治疗潜力正在进行临床研究。这些疾病包括葡萄膜炎、甲状腺眼病、视神经脊髓炎、移植物抗宿主病、侵蚀性手部骨关节炎、各种肿瘤指征、抑郁症、精神分裂症、心肌梗死、家族性地中海热和COVID-19肺炎(由新型冠状病毒SARS-CoV-2引起)等。其中，一项II期临床试验正在意大利进行，FDA于2020年3月批准的一项III期临床试验，以评估tocilizumab治疗重症COVID-19肺炎的效果。希望这些研究中的一些发现将在未来扩大IL-6通路抑制在其他疾病中的应用和医学价值。安全性方面，IL-6通路抑制剂治疗与转氨酶血清浓度升高有关。在临床试验中，这些升高似乎不会导致永久性或临床明显的肝损伤。当潜在的肝毒性药物(如甲氨蝶呤)与IL-6途径抑制剂联合使用时，转氨酶升高的频率和幅度增加。此外，胰腺炎是使用tocilizumab和sarilumab的不良反应之一。胃肠道穿孔也与这些药物的使用有关。长期暴露人群胃肠道穿孔的总发生率与类风湿关节炎一致。生物疗法的另一个安全问题是抗药物抗体的开发，其可导致功效丧失和/或免疫介导的不良反应。一项评估tocilizumab在类风湿关节炎患者中的免疫原性的研究发现，无论tocilizumab作为单药治疗或与csDMARDs联合使用，tocilizumab抗体的发生率都很低；此外，抗tocilizumab 的抗体大多是暂时性的，其发展与药代动力学、安全性事件或疗效丧失无关。对于sirukumab，FDA拒绝批准该药物用于RA，原因是考虑到在III期研究中sirukumab和安慰剂组的全因死亡率不平衡，尽管尚不清楚这种不平衡是真正的安全信号还是研究设计的结果。需要更多的研究来进一步确定sirukumab的安全性。以IL-6 信号通路为靶点的药物研究进展目前，以 IL-6 信号通路为靶点的生物技术药物已成为研发热点。国际市场方面，FDA已经批准了三款，FDA批准上市的分别为Tocilizumab（托珠单抗，商品名：Actemra /RoActemra）、Siltuximab（商品名：Sylvant）、Sarilumab（商品名：Kevzara）。其中，托珠单抗由日本公司Chugai（日本中外制药）与罗氏共同开发，是一款靶向IL-6R的人源化单抗，2010年在美国上市，是全球首款上市的IL-6信号通路单抗。用于治疗中度到重度，且之前接受过一种或多种效果不佳抗风湿性治疗的活动性类风湿性关节炎（以下简称RA）。目前的适应症，除了RA，还包括巨细胞动脉炎（Giant Cell Arteritis）、SJIA（全身性幼年特发性关节炎）、PJIA（幼年特发性关节炎）、以及Cart疗法引发的CRS（细胞因子释放综合征）。不过特别要注意一点，2019年5月，加拿大卫生部发布信息，报道了患者在使用托珠单抗中的严重药物性肝损伤，提示了其的肝毒性风险。罕见病药物 Siltuximab 靶向IL-6 ，由强生公司研发，是一款嵌合型抗体。2014年由FDA批准上市，用于治疗多中心型巨大淋巴结增生症（Mlticentric Castleman’s Disease, 以下简称MCD），且HIV和HHV-8都是阴性。 MCD是一种非常罕见的血液疾病，根据预测，美国和欧洲大约有3600名患者。Sylvant是FDA批准的首个MCD领域的药物。 Sarilumab 靶向IL-6Rα，是一款全人源单抗，由再生元和赛诺菲研发，是RA领域第二款上市的的IL-6信号通路为靶点的单抗。2017年5月在美国获批用于治疗中度到重度的活性RA（之前接受过一次或者多次的抗风湿疗法）。此外，Sarilumab有着不错的前景。除全人源单抗更好的安全性外，自体免疫领域有巨大市场，以及部分患者对于TNF单抗的不耐受和效果不佳，Global Data预测其在2026年能达到7亿美金的销量。国内方面，上市的仅有托珠单抗一款。此外，据2019 年1月24日 CDE 网站数据显示，药品审评中心（CDE）受理的相关品种共有11个，其中7个处于临床研究阶段。结语在将IL-6的生物学转化为自身免疫性疾病患者的治疗方面已经取得了重大进展。IL-6途径抑制剂安全性数据的积累为临床医生提供了评估使用这些药物风险的必要知识。IL-6通路抑制剂已显示对RA、JIA、AOSD、GCA、Castleman病和CRS患者有益，并可能对其他自身免疫性疾病甚至更严重的患者有益。然而，预测患者临床成功的临床前研究的局限性是一个主要障碍，需要进行早期的人体概念验证研究。此外，与IL-6生物学有关的几个问题仍未得到解答。例如，为什么会发生IL-6过量产生?为什么IL-6信号抑制对一些与IL-6过量产生相关的疾病(如RA)的患者有临床意义的益处，但不是所有疾病(如RA)的患者有意义? 回答这些问题将有助于我们进一步了解各种自身免疫性疾病是如何在IL-6通路生物学背景下调控的，并有助于为个别患者或患者亚群开发额外的、个性化的治疗方案。由此看来，探索IL-6通路抑制的治疗潜力之旅还远未结束。参考资料： 1. Choy EH, De Benedetti F, Takeuchi T, Hashizume M, John MR, Kishimoto T. Translating IL-6 biology into effective treatments. Nat Rev Rheumatol. 2020 Jun;16(6):335-345. 3. Hashizume M, Tan SL, Takano J, et al, Nishida KInt Rev Immunol. 2015 May; 34(3):265-79. 4. 贾春翠,饶春明.以白细胞介素-6信号通路为靶点的生物技术药物研究进展[J].中国生物制品学杂志,2019,32(9):1048-1053. 版权声明：本文转自佰傲谷BioValley，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈围绕我国生物医药产业链，针对生物医药大数据、技术和资本投资、药融园(产业园)等开展系列系统性工作，促进我国生物医药产业健康发展，完善产业链，共同面对全球合作和竞争。点分享点点赞点在看

抗体免疫疗法合作小分子药物基因疗法

2017-10-17

·BioSpace

J&J Terminates Two Drugs From Pipeline

J&J Terminates RA and Leukemia Drug From Pipeline Buried in its third-quarter financial announcement, J&J indicated it was dropping two of its pipeline drugs with little or no explanation. Buried in its third-quarter financial announcement , Johnson & Johnson indicated it was dropping two of its pipeline drugs with little or no explanation. The company otherwise had plenty of good news. J&J announced sales of $19.7 billion for the quarter, up 10.3 percent compared to the same period last year. Operational sales increased 9.5 percent and domestic sales increased 9.7 percent. International sales grew 10.9 percent. When you exclude acquisitions and divestures, domestic and international sales each grew 3.8 percent. Deeper into the statement were two sentences: “The Company has made a decision not to pursue global approvals of sirukumab for the treatment of moderately to severely active rheumatoid arthritis. In addition, the clinical trial for talacotuzumab, an investigational compound being studied in patients with acute myeloid leukemia, has been discontinued.” John Carroll, writing for Endpoints News , said , “The writing was already on the wall months ago for sirukumab, once a top prospect for rheumatoid arthritis until its partners at GlaxoSmithKline suddenly walked out. Earlier this year, though, a panel of outside experts voted down the marketing application, fretting over an unexplained imbalance in deaths in the study. The inevitable formal rejection followed.” However, J&J dropping talacotuzumab (JNJ-56022473/CSL362) wasn’t expected. There’s no explanation for why the company gave up on it. Carroll notes that this news is undoubtedly unwelcome, because J&J “has been struggling on the revenue side, leaving some prominent analysts wondering if it can continue to grow pharma sales.” Joaquin Duato , J&J’s global chairman for pharmaceuticals, said in May that the company planned for its branded drug market to continue with a 5 percent annual growth rate through 2020, despite what executives always refer to as “stiff headwinds” on prices. It expected three drugs to be approved this year and four more next year. Carroll writes, “These new drugs were part of one leg of the company’s three-leg strategy for growing revenue, with a promise that it can improve significantly on existing drugs—like Stelara, Invokana and Xarelto—while beefing up on a new core focus on pulmonary arterial hypertension through the Actelion buyout.” J&J also revised its full-year forecast, largely on the basis of strong sales for new cancer drugs. The drugs, specifically Darzalex and Imbruvica, as well as high-margin drugs for rare diseases from its acquisition of Actelion, are expected to be the impetus for future growth. “We are convinced that the pharma pipeline remains robust and more meaningful contributions will kick in beyond 2017,” Joshua Jennings , an analyst with Cowen & Co. wrote in a note to clients. Although those areas are going strong, sales of Remicade for rheumatoid arthritis slowed as biosimilars for the drug hit the market. For its projections for 2017, it increased its profit forecast of $7.12 to $7.22 per share to $7.25 to $7.30 per share. It increased its revenue forecast from $75.8 billion to $76.1 billion to between $76.1 billion and $76.5 billion. HealthBlogger, with Seeking Alpha , writes , “I believe Johnson & Johnson is one of the best positioned companies in the pharmaceuticals space and worthy of long-term investment. However, I think some profit taking on the name would make sense at this time. In fact, after the strong performance in the last two months and a 19 percent move up year-to-date, a valuation check suggests that the risk/reward is much less compelling than a few months ago.”

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100 项与 Sirukumab 相关的药物交易

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D10080	Sirukumab	L04AC15	DB11803

研发状态

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
风湿性多肌痛	临床3期	-	GSK Plc	2018-03-15
巨细胞动脉炎	临床3期	美国	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	澳大利亚	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	比利时	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	保加利亚	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	法国	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	德国	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	匈牙利	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	意大利	GSK Plc	2015-10-16
巨细胞动脉炎	临床3期	荷兰	GSK Plc	2015-10-16

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临床结果

适应症

分期

评价

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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


NCT04380961 (CTgov)	临床2期	新型冠状病毒感染	212	Sirukumab (Sirukumab + SOC)	鹹壓範鹹鬱積繭淵鑰鹽(製鬱鏇顧網鬱蓋淵製蓋) = 築觸鏇壓鏇艱膚網憲簾鹹艱鹹積膚廠糧衊夢鏇 (醖範觸齋築齋衊鏇繭繭, 衊餘餘衊鹹繭淵鏇積醖 ~ 夢繭願餘糧餘壓窪鹹糧) 更多	-	2022-06-21
				Placebo (Placebo + SOC)	鹹壓範鹹鬱積繭淵鑰鹽(製鬱鏇顧網鬱蓋淵製蓋) = 獵糧製廠醖憲積繭鑰壓鹹艱鹹積膚廠糧衊夢鏇 (醖範觸齋築齋衊鏇繭繭, 選鏇鬱網齋簾顧鏇夢繭 ~ 構膚獵艱範鏇觸鏇構艱) 更多
NCT02531633 (Pubmed \| Rheumatol Ther) 人工标引	临床3期	巨细胞动脉炎	161	Sirukumab	繭鹹願簾鑰鏇蓋醖蓋網(齋艱艱餘鹽衊壓艱窪壓) = 憲憲構願願網艱顧簾窪鏇廠壓觸鏇夢壓範鑰願 (築餘築簾鹹廠觸顧積願 )	积极	2020-12-01
				Placebo	繭鹹願簾鑰鏇蓋醖蓋網(齋艱艱餘鹽衊壓艱窪壓) = 簾築積醖鹽鹹顧鑰鑰簾鏇廠壓觸鏇夢壓範鑰願 (築餘築簾鹹廠觸顧積願 )
NCT02473289 (CTgov)	临床2期	重度抑郁症	193	Placebo	壓鬱鹹淵壓齋夢鬱齋衊(網糧鬱觸醖製膚餘窪製) = 鏇廠糧醖衊蓋願餘餘淵糧範網壓獵窪鹹願齋範 (糧齋膚網觸襯糧糧醖鏇, 1.43) 更多	-	2019-06-11
NCT01856309 (SIRROUND-LTE, CTgov)	临床3期	类风湿关节炎	1,820	Placebo (Placebo to 50 mg q4w Due to EE/LE/CO)	糧衊網窪網艱選鹽繭積 = 餘襯鑰齋觸鏇鏇醖遞淵鹹窪簾蓋鏇衊構選觸繭 (憲窪築餘簾範繭壓餘獵, 繭餘鹽衊夢願鏇顧艱鑰 ~ 鏇醖壓積積鏇鏇築艱蓋) 更多	-	2019-05-06
				Placebo (Placebo to 100 mg q2w Due to EE/LE/CO)	糧衊網窪網艱選鹽繭積 = 餘簾構膚齋獵鹹築願網鹹窪簾蓋鏇衊構選觸繭 (憲窪築餘簾範繭壓餘獵, 觸範鑰遞窪窪窪鹽廠夢 ~ 夢鏇襯襯簾鹽鏇鑰糧鹹) 更多
NCT02019472 (SIRROUND-H, Pubmed \| Ann Rheum Dis)	临床3期	类风湿关节炎	-	Sirukumab 100mg every 2 weeks	醖選範醖鏇遞願網鬱鏇(製窪醖壓淵膚遞醖鏇衊) = 構鏇窪選窪憲醖齋鹹壓鏇範顧壓鹽積鏇鬱簾憲 (鏇製積簾觸夢觸觸淵憲 )	积极	2018-05-01
				Sirukumab 50mg every 4 weeks	醖選範醖鏇遞願網鬱鏇(製窪醖壓淵膚遞醖鏇衊) = 築願衊顧觸繭餘觸構簾鏇範顧壓鹽積鏇鬱簾憲 (鏇製積簾觸夢觸觸淵憲 )
NCT01689532 (Pubmed \| J Rheumatol \| Arthritis Res Ther) 人工标引	临床3期	类风湿关节炎	122	Sirukumab (50 mg once every 4 weeks)	齋製選鹽鹹壓積築積願(淵積餘範鬱鏇窪遞構鏇) = 蓋顧遞壓鬱選窪夢積鹹窪齋獵糧憲積壓蓋鏇鹽 (積簾積觸醖襯壓簾壓夢 )	积极	2018-03-07
				Sirukumab (100 mg once every 2 weeks)	齋製選鹽鹹壓積築積願(淵積餘範鬱鏇窪遞構鏇) = 膚觸鹽選繭齋糧製網鏇窪齋獵糧憲積壓蓋鏇鹽 (積簾積觸醖襯壓簾壓夢 )
NCT01604343 (SIRROUND-D, CTgov)	临床3期	类风湿关节炎	1,670	Sirukumab	選築廠網窪壓餘淵鑰壓 = 窪憲餘衊憲鑰艱遞鬱顧壓憲網製糧鹹膚齋憲醖 (觸範膚觸襯獵襯餘廠構, 餘糧願糧製蓋艱顧齋廠 ~ 壓壓鏇憲選壓艱簾蓋積) 更多	-	2018-01-11
NCT01604343 (SIRROUND-D, Pubmed)	临床3期	类风湿关节炎	1,670	Sirukumab 100mg every 2 weeks	鏇壓選範憲願選淵蓋淵(範願鏇鬱築衊簾醖獵壓) = 繭遞鬱夢廠壓顧製構衊鹽願憲構淵鑰鹽範鏇鹹 (繭製積壓積鑰憲簾醖構 )	积极	2017-12-01
				Sirukumab 50mg every 4 weeks	鏇壓選範憲願選淵蓋淵(範願鏇鬱築衊簾醖獵壓) = 構壓鏇艱憲憲構選餘糧鹽願憲構淵鑰鹽範鏇鹹 (繭製積壓積鑰憲簾醖構 )
ACR2017	N/A	关节炎	-	Biological DMARDs	壓窪膚淵簾衊鏇選襯淵(壓齋願鏇願觸淵壓鑰壓) = 積簾簾鏇獵齋網網顧餘繭遞觸選夢遞構廠齋網 (鏇遞夢壓鹹築衊構繭膚, [-0.6 ~ -0.08])	积极	2017-11-06
NCT02019472 (SIRROUND-H, CTgov)	临床3期	类风湿关节炎	559	Adalimumab (Adalimumab 40 mg)	鹹壓觸壓壓築簾構獵獵(憲淵鏇淵願襯蓋衊遞簾) = 襯鹹繭襯鏇積艱窪鬱鏇範鏇築衊憲繭壓範觸範 (憲獵選糧築鬱積淵齋蓋, 0.851) 更多	-	2017-09-14
				Sirukumab (Sirukumab 50 mg)	鹹壓觸壓壓築簾構獵獵(憲淵鏇淵願襯蓋衊遞簾) = 遞憲鏇醖窪蓋積顧廠窪範鏇築衊憲繭壓範觸範 (憲獵選糧築鬱積淵齋蓋, 0.881) 更多