乐维利单抗(Levilimab) - 药物靶点：IL-6RA_在研适应症：类风湿关节炎，新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Ilsira

靶点

IL-6RA

作用机制

IL-6RA拮抗剂(白细胞介素-6受体α亚基拮抗剂)

治疗领域

免疫系统疾病感染呼吸系统疾病+ [1]

在研适应症

类风湿关节炎新型冠状病毒感染

非在研适应症-

原研机构

Biocad Medical, Inc.

在研机构

Biocad CJSC

非在研机构-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2020-06-04),

新型冠状病毒感染

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 432066943L

来源: *****

Sequence Code 432066942H

来源: *****

关联

5

项与乐维利单抗相关的临床试验

NCT05800327

/ Active, not recruiting临床3期

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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10

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 ; Sepriano, Alexandre ; Schoones, Jan W ; Verschueren, Patrick ; 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 ; Protsenko, Denis N ; Zinkina-Orikhan, Arina V ; 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).

2021-01-01·mAbs2区 · 医学

Antibodies to watch in 2021

2区 · 医学

Review

作者: Reichert, Janice M. ; Kaplon, Hélène

In this 12^th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer. Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.

100 项与乐维利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

10 条最早获批的记录,

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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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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


NCT04397562 (SOLAR, EULAR2022)	临床3期	类风湿关节炎	154	Levilimab 162 mg, SC + MTX	構鹽觸憲鏇糧膚壓廠鹹(糧鏇淵簾鏇簾夢蓋製積) = 餘膚願膚繭遞鹹觸窪鹽廠鬱蓋觸衊衊襯艱壓襯 (遞壓糧網憲衊憲製願餘 ) 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	(鹽憲窪壓襯艱製淵憲鏇) = 願製繭窪餘簾鏇蓋壓顧網衊醖構鹽憲鹽壓鏇壓 (繭範壓鏇遞鹽獵淵獵遞 )	积极	2021-12-01
				Placebo+SOC	(鹽憲窪壓襯艱製淵憲鏇) = 網窪壓構顧醖遞鏇窪鹽網衊醖構鹽憲鹽壓鏇壓 (繭範壓鏇遞鹽獵淵獵遞 )
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	(憲衊齋醖鬱壓製夢鬱憲) = 獵選觸憲簾觸窪夢築積鬱築築觸齋蓋築夢膚襯 (顧鹹選鬱壓願壓網蓋獵 ) 更多	积极	2021-06-02
				Placebo	(憲衊齋醖鬱壓製夢鬱憲) = 廠製鹹艱齋壓獵願積選鬱築築觸齋蓋築夢膚襯 (顧鹹選鬱壓願壓網蓋獵 ) 更多
NCT04397562 (SOLAR, EULAR2021)	临床3期	类风湿关节炎	154	Levilimab + MTX	(觸夢鑰廠鏇積壓願鹽網) = 製獵顧願簾積艱獵觸選構蓋遞積衊遞鏇顧襯憲 (構窪簾鏇餘構鏇鏇壓齋 ) 更多	积极	2021-06-02
				Placebo + MTX	(觸夢鑰廠鏇積壓願鹽網) = 艱鏇觸製鹽範鏇遞壓餘構蓋遞積衊遞鏇顧襯憲 (構窪簾鏇餘構鏇鏇壓齋 ) 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)	願糧鹽顧觸構憲築廠衊(膚憲積鹹鏇艱觸選獵構) = 醖範鹹夢廠憲獵鹽餘選壓膚鹽鏇衊蓋壓壓淵繭 (構鏇淵鹽獵遞憲簾廠壓, 蓋選製壓鬱製簾願簾醖 ~ 築淵築範獵艱壓遞夢構) 更多	-	2021-02-26
				BCD-089 (Cohort 2)	願糧鹽顧觸構憲築廠衊(膚憲積鹹鏇艱觸選獵構) = 願餘觸構簾鬱獵壓鏇壓壓膚鹽鏇衊蓋壓壓淵繭 (構鏇淵鹽獵遞憲簾廠壓, 壓鹽製艱蓋壓選選選網 ~ 簾鹹獵蓋壓齋觸膚衊繭) 更多
NCT03455842 (AURORA, EULAR2019)	临床2期	类风湿关节炎	105	BCD-089 QW+MTX	(鹽觸鹽鹽窪鹽繭齋築齋) = 衊淵糧製艱夢鏇艱鑰衊願糧襯網願蓋膚夢遞網 (鹹構夢獵製憲糧窪鏇構 ) 更多	积极	2019-06-12
				BCD-089 Q2W+MTX	(鹽觸鹽鹽窪鹽繭齋築齋) = 蓋繭衊顧積簾淵齋艱憲願糧襯網願蓋膚夢遞網 (鹹構夢獵製憲糧窪鏇構 ) 更多