A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab When Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects With Active Rheumatoid Arthritis

This is a two-stage study of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of various doses of levilimab when administered intravenously and subcutaneously to healthy subjects and subjects with active rheumatoid arthritis resistant to methotrexate monotherapy.
Aim of the Stage 1 is to study the tolerability, safety, immunogenicity, and main pharmacokinetic and pharmacodynamic parameters of levilimab after its single subcutaneous or intravenous administration at ascending doses to healthy subjects.
Aim of the Stage 2 is to confirm the efficacy and safety of levilimab 648 mg IV Q4W in combination with methotrexate and levilimab 324 mg SC Q2W in combination with methotrexate in subjects with active rheumatoid arthritis, resistant to methotrexate monotherapy.

开始日期2022-12-07

申办/合作机构

Biocad CJSC

NCT04397562 / Completed临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptively Designed Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.

开始日期2020-04-29

申办/合作机构

Biocad CJSC

NCT04227366 / Completed临床3期

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor.
The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

开始日期2019-11-19

申办/合作机构

Biocad CJSC

100 项与乐维利单抗相关的临床结果

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100 项与乐维利单抗相关的转化医学

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100 项与乐维利单抗相关的专利（医药）

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项与乐维利单抗相关的文献（医药）

2023-01-01·Annals of the Rheumatic Diseases

Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Review

作者: Edwards, Christopher John ; van der Heijde, Désirée ; de Souza, Savia ; Stamm, Tanja A ; Caporali, Roberto ; Verschueren, Patrick ; Schoones, Jan W ; Sepriano, Alexandre ; Smolen, Josef S ; Hyrich, Kimme L ; Aletaha, Daniel ; Winthrop, Kevin L ; Pope, Janet E ; Takeuchi, Tsutomu ; Kerschbaumer, Andreas ; Bergstra, Sytske Anne ; Landewé, Robert B M

ObjectivesTo update the evidence on efficacy of DMARDs (disease-modifying antirheumatic drugs) and inform the taskforce of the 2022 update of the European Alliance of Associations for Rheumatology (EULAR) recommendations for management of rheumatoid arthritis (RA).MethodsThis systematic literature review (SLR) investigated the efficacy of conventional synthetic (cs), biological (b), biosimilar and targeted synthetic (ts)DMARDs in patients with RA. Medline, EMBASE, Cochrane CENTRAL and Web of Science were used to identify all relevant articles published since the previous update in 2019 to 14 January 2022.ResultsOf 8969 search results, 169 articles were selected for detailed review and 47 were finally included. Trials investigated the efficacy of csDMARDs, bDMARDs and tsDMARDs, DMARD switching, tapering and trials investigating different treatment strategies. The compounds investigated were csDMARDs (methotrexate (MTX), leflunomide, sulfasalazine, hydroxychloroquine), bDMARDs (abatacept, adalimumab, certolizumab-pegol, denosumab, etanercept, infliximab, levilimab, olokizumab, opineracept, rituximab, sarilumab, tocilizumab) and tsDMARDs (baricitinib, filgotinib, tofacitinib, upadacitinib). The efficacy of csDMARDs+ short-term glucocorticoids in early RA was confirmed and similar to bDMARD+MTX combination therapy. Interleukin-6 pathway inhibition was effective in trials on olokizumab and levilimab. Janus kinase inhibitor (JAKi) was efficacious in different patient populations. After insufficient response to JAKi, patients could respond to TNFi treatment. Tapering of DMARDs was feasible for a proportion of patients, who were able to taper therapy while remaining in low disease activity or remission.ConclusionThe results of this SLR, together with one SLR on safety of DMARD and one on glucocorticoids, informed the taskforce of the 2022 update of the EULAR recommendations for pharmacological management of RA.

2021-12-01·Inflammation Research3区 · 医学

The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study

3区 · 医学

Article

作者: Gordeev, Ivan G ; Mazurov, Vadim I ; Pasechnik, Elena S ; Dokukina, Ekaterina A ; Eremeeva, Anna V ; Bakirov, Bulat A ; Lomakin, Nikita V ; Lutckii, Anton A ; Linkova, Yulia N ; Smolyarchuk, Elena A ; Fomina, Darya S ; Gilyarov, Mikhail Yu ; Seleznev, Anton I ; Morozova, Maria A ; Musaev, Gaziyavdibir H ; Popov, Vladimir V ; Zinkina-Orikhan, Arina V ; Protsenko, Denis N ; Moiseeva, Olga M ; Pukhtinskaia, Polina S

AbstractObjective and designThe aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19.SubjectsThe study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.Treatment206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy.MethodsThe primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missing data were considered non-responders.Results63.1% and 42.7% of patients in the LVL and in the placebo groups, respectively, achieved sustained clinical improvement on Day 14 (P = .0017). The frequency of adverse drug reactions was comparable between the groups.ConclusionIn patients with radiologically confirmed SARS-CoV-2 pneumonia, requiring or not oxygen therapy (but not ventilation) with no signs of other active infection administration of LVL + SOC results in an increase of sustained clinical improvement rate.Trail registrationThe trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).

2021-03-18·The Cochrane database of systematic reviews

Interleukin-6 blocking agents for treating COVID-19: a living systematic review.

Review

作者: Boutron, Isabelle ; Davidson, Mauricia ; Ferrand, Gabriel ; Sguassero, Yanina ; Riveros, Carolina ; Henschke, Nicholas ; Ghosn, Lina ; Schmucker, Christine ; Nguyen, Thu Van ; Kapp, Philipp ; Tovey, David ; Rada, Gabriel ; Ravaud, Philippe ; Ávila, Camila ; Hróbjartsson, Asbjørn ; Grasselli, Giacomo ; Chaimani, Anna ; Bollig, Claudia ; Devane, Declan ; Nejstgaard, Camilla Hansen ; Graña, Carolina ; Menon, Sonia ; Evrenoglou, Theodoros ; Meerpohl, Joerg J

BACKGROUNDInterleukin 6 (IL-6) blocking agents have been used for treating severe coronavirus disease 2019 (COVID-19). Their immunosuppressive effect might be valuable in patients with COVID-19 characterised by substantial immune system dysfunction by controlling inflammation and promoting disease tolerance.OBJECTIVESTo assess the effect of IL-6 blocking agents compared to standard care alone or with placebo on efficacy and safety outcomes in COVID-19. We will update this assessment regularly.SEARCH METHODSWe searched the World Health Organization (WHO) International Clinical Trials Registry Platform (up to 11 February 2021) and the L-OVE platform, and Cochrane COVID-19 Study Register to identify trials up to 26 February 2021.SELECTION CRITERIAWe included randomised controlled trials (RCTs) evaluating IL-6 blocking agents compared with standard care alone or with placebo for people with COVID-19, regardless of disease severity.DATA COLLECTION AND ANALYSISWe followed standard Cochrane methodology. The protocol was amended to reduce the number of outcomes considered. Two review authors independently collected data and assessed the risk of bias with the Cochrane Risk of Bias 2 tool. We rated the certainty of evidence with the GRADE approach for the critical outcomes such as clinical improvement (defined as hospital discharge or improvement on the scale used by trialists to evaluate clinical progression or recovery) (day (D) 28 / ≥ D60); WHO Clinical Progression Score of level 7 or above (i.e. the proportion of participants with mechanical ventilation +/- additional organ support OR death) (D28 / ≥ D60); all-cause mortality (D28 / ≥ D60); incidence of any adverse events; and incidence of serious adverse events.MAIN RESULTSWe identified 10 RCTs with available data including one platform trial comparing tocilizumab and sarilumab with standard of care. These trials evaluated tocilizumab (nine RCTs including two platform trials; seven were reported as peer-reviewed articles, two as preprints; 6428 randomised participants); and two sarilumab (one platform trial reported as peer reviewed article, one reported as preprint, 880 randomised participants). All trials included were multicentre trials. They were conducted in Brazil, China, France, Italy, UK, USA, and four were multi-country trials. The mean age range of participants ranged from 56 to 65 years; 4572 (66.3%) of trial participants were male. Disease severity ranged from mild to critical disease. The reported proportion of participants on oxygen at baseline but not intubated varied from 56% to 100% where reported. Five trials reported the inclusion of intubated patients at baseline. We identified a further 20 registered RCTs of tocilizumab compared to placebo/standard care (five completed without available results, five terminated without available results, eight ongoing, two not recruiting); 11 RCTs of sarilumab (two completed without results, three terminated without available results, six ongoing); six RCTs of clazakisumab (five ongoing, one not recruiting); two RCTs of olokizumab (one completed, one not recruiting); one of siltuximab (ongoing) and one RCT of levilimab (completed without available results). Of note, three were cancelled (2 tocilizumab, 1 clazakisumab). One multiple-arm RCT evaluated both tocilizumab and sarilumab compared to standard of care, one three-arm RCT evaluated tocilizumab and siltuximab compared to standard of care and consequently they appear in each respective comparison. Tocilizumab versus standard care alone or with placebo a. Effectiveness of tocilizumab for patients with COVID-19 Tocilizumab probably results in little or no increase in the outcome of clinical improvement at D28 (RR 1.06, 95% CI 1.00 to 1.13; I² = 40.9%; 7 RCTs, 5585 participants; absolute effect: 31 more with clinical improvement per 1000 (from 0 fewer to 67 more); moderate-certainty evidence). However, we cannot exclude that some subgroups of patients could benefit from the treatment. We did not obtain data for longer-term follow-up (≥ D60). The effect of tocilizumab on the proportion of participants with a WHO Clinical Progression Score of level of 7 or above is uncertain at D28 (RR 0.99, 95% CI 0.56 to 1.74; I² = 64.4%; 3 RCTs, 712 participants; low-certainty evidence). We did not obtain data for longer-term follow-up (≥ D60). Tocilizumab reduces all-cause mortality at D28 compared to standard care alone or placebo (RR 0.89, 95% CI 0.82 to 0.97; I² = 0.0%; 8 RCTs, 6363 participants; absolute effect: 32 fewer deaths per 1000 (from 52 fewer to 9 fewer); high-certainty evidence). The evidence suggests uncertainty around the effect on mortality at ≥ D60 (RR 0.86, 95% CI 0.53 to 1.40; I² = 0.0%; 2 RCTs, 519 participants; low-certainty evidence). b. Safety of tocilizumab for patients with COVID-19 The evidence is very uncertain about the effect of tocilizumab on adverse events (RR 1.23, 95% CI 0.87 to 1.72; I² = 86.4%; 7 RCTs, 1534 participants; very low-certainty evidence). Nevertheless, tocilizumab probably results in slightly fewer serious adverse events than standard care alone or placebo (RR 0.89, 95% CI 0.75 to 1.06; I² = 0.0%; 8 RCTs, 2312 participants; moderate-certainty evidence). Sarilumab versus standard care alone or with placebo The evidence is uncertain about the effect of sarilumab on all-cause mortality at D28 (RR 0.77, 95% CI 0.43 to 1.36; 2 RCTs, 880 participants; low certainty), on all-cause mortality at ≥ D60 (RR 1.00, 95% CI 0.50 to 2.0; 1 RCT, 420 participants; low certainty), and serious adverse events (RR 1.17, 95% CI 0.77 to 1.77; 2 RCTs, 880 participants; low certainty). It is unlikely that sarilumab results in an important increase of adverse events (RR 1.05, 95% CI 0.88 to 1.25; 1 RCT, 420 participants; moderate certainty). However, an increase cannot be excluded No data were available for other critical outcomes.AUTHORS' CONCLUSIONSOn average, tocilizumab reduces all-cause mortality at D28 compared to standard care alone or placebo and probably results in slightly fewer serious adverse events than standard care alone or placebo. Nevertheless, tocilizumab probably results in little or no increase in the outcome clinical improvement (defined as hospital discharge or improvement measured by trialist-defined scales) at D28. The impact of tocilizumab on other outcomes is uncertain or very uncertain. With the data available, we were not able to explore heterogeneity. Individual patient data meta-analyses are needed to be able to identify which patients are more likely to benefit from this treatment. Evidence for an effect of sarilumab is uncertain and evidence for other anti-IL6 agents is unavailable. Thirty-nine RCTs of IL-6 blocking agents with no results are currently registered, of which nine are completed and seven trials were terminated with no results available. The findings of this review will be updated as new data are made available on the COVID-NMA platform (covid-nma.com).

项与乐维利单抗相关的新闻（医药）

2024-01-29

·BioBAY

资本市场丨艾视雅：完成千万级Pre A轮融资

近日，BioBAY园内企业艾视雅成功完成Pre A轮融资，本轮融资由国内知名的风险投资机构聚明创投领投。艾视雅成立于2021年6月, 是一家聚焦眼科领域多产品布局的创新型医疗器械公司。截至2023.12.31累计提交42个专利，其中已授权10个，2023年新增申请9个, 2024年拟新增申请23个，获得商标及著作权18件，艾视雅公司产品获第四届中国医疗器械创新创业大赛获二等奖, 公司创始人姜皓天获评第十七届苏州工业园区领军人才。姜皓天毕业于美国罗切斯特大学光学工程专业，已在眼视光及眼科器械研发领域深耕7年，2020年起与资深医疗器械研发专家、公司共同创始人于林一起构建了艾视雅强大的多管线研发团队, 与多名眼科专家及医疗机构合作，持续加大研发投入陆续推出近视防控、视力保护、干眼症治疗等系列智能化眼科电子产品及医疗器械，针对目前大医院采购流程长回款慢的现状，艾视雅主推量大面广的智能型基层医疗机构产品及患者家用产品，并努力打造研产销用数据服务一体化平台，特别是艾视雅推出的近视防控及干眼症治疗产品前期体验及测试深受患者和医疗机构好评，本轮融资将进一步推动艾视雅持续在眼科领域创新发展。艾视雅管理层表示融资的资金将主要用于开发新产品，进一步完善核心技术并进行产品迭代，同时着手提升市场营销能力和品牌影响力。艾视雅将加强与合作伙伴的合作，进一步优化产品和服务为广大客户提供更优质、更可靠的产品，力争成为眼视光及眼科器械领域提供专业化患者服务方案的头部企业。艾视雅研发副总于林透露，目前公司有多款在研新品，其中部分产品即将获得国家医疗器械注册，预计2024年即将在各大眼科展会上亮相。此次融资的领投方聚明创投代表对于艾视雅的发展前景表示乐观。聚明创投认为，艾视雅在核心技术领域具有深厚的积累和领先优势，针对患者家用和基层医疗机构推出产品能够使产品较快进入市场，避免大医院集采及流程长付款慢等影响，使企业在激烈的市场竞争中保持领先地位，聚明创投看好艾视雅在未来的发展并将继续提供支持。▌文章来源：艾视雅责编：何文正审核：任旭推荐阅读资本市场丨超7亿美元！康宁杰瑞恩沃利单抗注射液达成海外授权许可协议资本市场丨纽伦捷生物：完成数千万元pre-A轮融资，深耕神经原位转分化创新基因疗法资本市场丨麦锐克生物：完成数千万天使轮融资，加速microRNA核心技术平台搭建

基因疗法引进/卖出

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16387

研发状态

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适应症	国家/地区	公司	日期
类风湿关节炎	俄罗斯	Biocad CJSC	2021-06-08
新型冠状病毒感染	俄罗斯	Biocad CJSC	2020-06-04

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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


NCT04397562 (SOLAR, EULAR2022)	临床3期	类风湿关节炎	154	Levilimab 162 mg, SC + MTX	繭簾襯廠鏇築壓築製憲(製網膚壓餘壓壓願積簾) = 窪遞夢構願積壓鹽顧觸壓憲遞觸淵壓鹽製鹽鏇 (艱淵鏇鑰選築觸壓鑰夢 ) 更多	积极	2022-06-01
NCT04397562 (CORONA, Pubmed) 人工标引	临床3期	新型冠状病毒感染	217	SOC+levilimab	(簾製憲顧膚淵蓋壓餘鹹) = 壓鏇築餘窪鏇繭憲鏇艱齋糧選淵衊願醖淵構願 (壓築選糧齋簾遞鏇積醖 )	积极	2021-12-01
				Placebo+SOC	(簾製憲顧膚淵蓋壓餘鹹) = 夢餘鑰膚簾觸觸齋選簾齋糧選淵衊願醖淵構願 (壓築選糧齋簾遞鏇積醖 )
NCT04397562 (CORONA, EULAR2021)	临床3期	新型冠状病毒感染 Erythrocyte sedimentation rate (ESR) \| C-reactive protein (CRP) \| IL-6	217	Levilimab	(簾鬱衊膚艱構壓鬱衊膚) = 鬱觸築鏇觸憲願觸簾顧醖獵糧鹽顧憲鏇鹹築鹽 (齋願膚構膚鹹鹹齋糧鹹 ) 更多	积极	2021-06-02
				Placebo	(簾鬱衊膚艱構壓鬱衊膚) = 積製簾繭製醖繭鹽繭鹽醖獵糧鹽顧憲鏇鹹築鹽 (齋願膚構膚鹹鹹齋糧鹹 ) 更多
NCT04397562 (SOLAR, EULAR2021)	临床3期	类风湿关节炎	154	Levilimab + MTX	(築鏇衊糧鹹鑰構鑰鬱膚) = 餘艱網艱淵網衊範壓窪壓夢憲淵積顧廠鏇憲願 (積憲顧鹽壓鹹壓鹽醖襯 ) 更多	积极	2021-06-02
				Placebo + MTX	(築鏇衊糧鹹鑰構鑰鬱膚) = 積壓齋獵襯網膚願鑰鹽壓夢憲淵積顧廠鏇憲願 (積憲顧鹽壓鹹壓鹽醖襯 ) 更多
NCT03103438 (CTgov)	临床1期	自身免疫性疾病 \| 类风湿关节炎	19	BCD-089 (Cohort 1)	觸鬱鑰蓋膚獵糧蓋艱遞(觸壓餘餘製顧鹹願積簾) = 鏇蓋簾積構網憲顧築範鹹壓憲廠製鏇鏇餘襯醖 (築蓋獵襯製遞選鏇艱築, 壓醖構鑰淵糧襯糧鑰餘 ~ 廠淵鹽鹽壓鏇鹹鏇構構) 更多	-	2021-02-26
				BCD-089 (Cohort 2)	觸鬱鑰蓋膚獵糧蓋艱遞(觸壓餘餘製顧鹹願積簾) = 顧蓋鏇選襯鬱鏇鏇蓋鬱鹹壓憲廠製鏇鏇餘襯醖 (築蓋獵襯製遞選鏇艱築, 壓遞夢膚願襯製鹹襯構 ~ 衊蓋衊築夢鹽積壓衊遞) 更多
NCT03455842 (EULAR2020)	临床2期	类风湿关节炎	105	Levilimab + Methotrexate (QW)	(選製遞醖積膚鹹願鏇選) = 窪鑰鹹願構艱膚選築鑰簾衊蓋鏇鏇餘製窪蓋鹹 (鹹齋築膚壓鑰蓋鬱積獵 ) 更多	-	2020-06-03
				Levilimab + Methotrexate (Q2W)	(選製遞醖積膚鹹願鏇選) = 鑰窪選繭餘夢鹹糧廠憲簾衊蓋鏇鏇餘製窪蓋鹹 (鹹齋築膚壓鑰蓋鬱積獵 ) 更多
NCT03455842 (AURORA, EULAR2019)	临床2期	类风湿关节炎	105	BCD-089 QW+MTX	(願蓋淵醖構憲鏇積膚鏇) = 顧艱壓鹹遞衊鏇夢繭糧選鏇餘觸齋淵網蓋醖繭 (淵網積憲鏇選積獵窪遞 ) 更多	积极	2019-06-12
				BCD-089 Q2W+MTX	(願蓋淵醖構憲鏇積膚鏇) = 顧衊糧艱糧衊築膚壓顧選鏇餘觸齋淵網蓋醖繭 (淵網積憲鏇選積獵窪遞 ) 更多