奎莫利单抗(Quetmolimab) - 药物靶点：CX3CL1_在研适应症：克罗恩病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Quetmolimab (USAN)

+ [2]

靶点

CX3CL1

作用机制

CX3CL1拮抗剂(C-X3-C基序趋化因子配体1拮抗剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 263360826L

来源: *****

Sequence Code 263360825H

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关联

10

项与奎莫利单抗相关的临床试验

NCT03733314 / Completed临床2期

Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease

The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.

开始日期2019-04-25

申办/合作机构

EA Pharma Co., Ltd.

NCT03092765 / Terminated临床2期

A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid

This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.

开始日期2017-05-29

申办/合作机构

EA Pharma Co., Ltd.

NCT02960490 / Completed临床2期

A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to biologics.

开始日期2016-11-26

申办/合作机构

Eisai Co., Ltd.

100 项与奎莫利单抗相关的临床结果

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100 项与奎莫利单抗相关的转化医学

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100 项与奎莫利单抗相关的专利（医药）

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11

项与奎莫利单抗相关的文献（医药）

2023-12-22·Modern Rheumatology

Long-term safety and efficacy of E6011, an anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis inadequately responding to methotrexate

Article

作者: Umehara, Hisanori ; Yasuda, Nobuyuki ; Kitahara, Yasumi ; Tanaka, Yoshiya ; Nanki, Toshihiro ; Torii, Kentaro ; Kawakubo, Makoto ; Hojo, Seiichiro ; Yamanaka, Hisashi ; Kawano, Tetsu ; Takeuchi, Tsutomu ; Imai, Toshio ; Tago, Fumitoshi

ABSTRACTObjectivesTo evaluate the long-term safety and efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX).MethodsActive RA patients with an inadequate response to MTX were randomly assigned to the E6011 or placebo group and received the study drug subcutaneously every 2 weeks during a 24-week double-blind study period. Subjects who completed evaluations at Week 24 were rolled over into the extension phase and received open-label E6011 (200 or 400 mg) every 2 weeks until Week 102. The safety analysis was conducted up to Week 104, and the efficacy analysis was conducted up to Week 84.ResultsA total of 169 subjects completed the double-blind treatment phase and were rolled over into the extension phase. In total, 167 (98.8%) subjects experienced any adverse events, and the incidence of treatment-related adverse events was 56.2%. The American College of Rheumatology 20 response rates were observed between 40 and 70% during the extension phase.ConclusionsE6011 was safe and well tolerated with no notable safety concerns up to 102 weeks in RA patients with an inadequate response to MTX.

2023-12-22·Modern Rheumatology

Long-term evaluation of E6011, an anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis inadequately responding to biological disease-modifying antirheumatic drugs

Article

作者: Umehara, Hisanori ; Yasuda, Nobuyuki ; Kitahara, Yasumi ; Torii, Kentaro ; Tanaka, Yoshiya ; Kawakubo, Makoto ; Hojo, Seiichiro ; Nanki, Toshihiro ; Kawano, Tetsu ; Yamanaka, Hisashi ; Takeuchi, Tsutomu ; Imai, Toshio ; Tago, Fumitoshi

ABSTRACTObjectivesThe objective of the study is to evaluate the long-term safety and efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis with an inadequate response to biological disease-modifying antirheumatic drugs.MethodsIn the double-blind treatment phase (24 weeks), placebo or E6011 400 mg was administered until Week 10. Thereafter, E6011 200 mg or 400 mg was administered to Week 22. Subjects who completed the evaluation at Week 24 of the treatment phase were rolled over into the extension phase. The extension phase lasted until Week 104, and all subjects received E6011 400 mg or 200 mg every 2 weeks in an open-label manner until Week 102.ResultsA total of 47 subjects completed the double-blind treatment phase and were rolled over into the extension phase. In total, 46 (97.9%) subjects experienced any adverse events, and the incidence of treatment-related adverse events was 57.4%. No clear efficacy trend in the American College of Rheumatology 20% response rates was observed.ConclusionsE6011 was well tolerated in active rheumatoid arthritis patients who had shown an inadequate response to biologic disease-modifying antirheumatic drugs, but no clear benefit in the American College of Rheumatology 20% response rates was observed. Further studies are needed to clarify the clinical benefit of E6011.

2023-11-01·Journal of Pharmacological and Toxicological Methods

Quantification of anti-drug antibodies against E6011, an anti-fractalkine monoclonal antibody, in monkey and human serum, by an electrochemiluminescence assay

Article

作者: Mano, Yuji ; Aoyama, Muneo

E6011, a humanized anti-fractalkine monoclonal antibody, is under development for the treatment of various inflammatory diseases, such as rheumatoid arthritis. Therapeutic antibodies may induce production of anti-drug antibodies (ADA) that may deteriorate efficacy and/or enhance immunogenic reaction. It is important to have an ADA assay to understand the characteristics of biotherapeutics under development. A simple and reproducible assay has thus been developed for the determination of ADA against E6011 in monkey and human serum by electrochemiluminescence (ECL) detection. An immune-complex of biotinylated E6011, ADA, and ruthenium-labeled E6011 was attached to avidin-coated wells for ECL signal detection. Screening and confirmatory cutpoints were determined to judge negative or positive ADA. Sensitivity of ADA was 1.61 and 1.34 ng/mL in monkey and human serum, respectively. Accuracy and precision of the assay were within ±20% and 20%, respectively. Drug tolerance of the assay in monkey and human sera was ensured up to 100 and 1000 μg/mL E6011 at the surrogate ADA levels of 1 and 4 μg/mL, respectively. The developed assay was successfully applied to ADA quantification in monkeys and humans in support of immunogenicity assessments.

100 项与奎莫利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11498	-	-	-

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
克罗恩病	临床2期	俄罗斯	EA Pharma Co., Ltd.	2019-04-25
克罗恩病	临床2期	捷克	EA Pharma Co., Ltd.	2019-04-25
克罗恩病	临床2期	波兰	EA Pharma Co., Ltd.	2019-04-25
克罗恩病	临床2期	匈牙利	EA Pharma Co., Ltd.	2019-04-25
克罗恩病	临床2期	日本	EA Pharma Co., Ltd.	2019-04-25
原发性胆汁性胆管炎	药物发现	日本	EA Pharma Co., Ltd.	2017-05-29
类风湿关节炎	药物发现	日本	Eisai Co., Ltd.	2016-10-20

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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


NCT02039063 (CTgov)	临床1/2期	克罗恩病	28	E6011 (Cohort 1: E6011 2 mg/kg)	築網蓋醖窪鹽鹹繭壓鬱(積衊遞繭鹽簾觸醖鹽憲) = 觸餘憲遞鬱艱範醖繭願齋繭鏇夢獵觸鹹夢蓋憲 (餘簾製築範積壓範網鑰, 膚願鑰膚構築醖範蓋簾 ~ 鹹醖餘膚醖鏇鹽簾窪餘) 更多	-	2023-01-30
				E6011 (Cohort 2: E6011 5 mg/kg)	築網蓋醖窪鹽鹹繭壓鬱(積衊遞繭鹽簾觸醖鹽憲) = 艱繭夢膚醖繭淵壓鬱繭齋繭鏇夢獵觸鹹夢蓋憲 (餘簾製築範積壓範網鑰, 廠廠積簾網襯遞遞衊鑰 ~ 鏇鑰獵蓋艱鏇廠醖製鬱) 更多
NCT02960490 (CTgov)	临床2期	类风湿关节炎	66	placebo+E6011 (Core Treatment Phase: Placebo)	壓築糧蓋齋製鏇繭鏇獵(窪鹹構獵繭積鬱鹹壓夢) = 願網蓋網網壓築糧範鏇繭繭製鏇鬱夢觸鹽餘衊 (製壓鏇構窪簾鏇積壓鏇, 齋遞顧製築齋醖窪蓋糧 ~ 顧艱構憲簾夢醖壓壓築) 更多	-	2021-08-23
				E6011 (Core Treatment Phase: E6011 400 mg)	壓築糧蓋齋製鏇繭鏇獵(窪鹹構獵繭積鬱鹹壓夢) = 壓簾構壓鑰蓋廠窪衊鑰繭繭製鏇鬱夢觸鹽餘衊 (製壓鏇構窪簾鏇積壓鏇, 獵顧廠積繭衊襯膚淵繭 ~ 網鹽築糧願積憲觸選觸) 更多
NCT02039063 (Pubmed \| J Gastroenterol Hepatol) 人工标引	临床1期	克罗恩病	28	E6011	(遞醖壓艱鬱鏇淵鏇夢壓) = 製繭築觸夢顧網鬱膚範艱選鹹窪襯範築觸壓簾 (廠獵鑰願襯網築齋憲艱 ) 更多	积极	2021-08-01
NCT02960490 (Pubmed \| Isr Med Assoc J) 人工标引	临床2期	类风湿关节炎	64	E6011	(獵醖糧繭範憲鏇餘蓋築) = 鹹淵憲構糧衊窪膚構齋糧獵餘簾製築築鹽壓選 (糧獵鹽艱願膚淵獵鑰選 ) 更多	不佳	2021-07-01
				Placebo	(獵醖糧繭範憲鏇餘蓋築) = 窪艱構簾鹽獵簾齋築憲糧獵餘簾製築築鹽壓選 (糧獵鹽艱願膚淵獵鑰選 ) 更多
NCT02196558 (E6011, CTgov)	临床1/2期	类风湿关节炎	53	E6011 (E6011: 100 mg)	鏇蓋遞襯鏇鑰憲網糧壓(憲夢鹹夢窪願膚窪衊糧) = 淵願餘獵鬱憲窪糧窪襯艱憲醖範選淵壓憲鏇憲 (醖淵鏇餘襯鹹鏇製醖夢, 遞選積鬱構鑰製鹹糧餘 ~ 衊願鹽遞廠繭顧觸鹽構) 更多	-	2020-08-13
				E6011 (E6011: 200 mg)	鏇蓋遞襯鏇鑰憲網糧壓(憲夢鹹夢窪願膚窪衊糧) = 襯簾夢鹽淵憲觸廠憲襯艱憲醖範選淵壓憲鏇憲 (醖淵鏇餘襯鹹鏇製醖夢, 選觸鹽廠壓餘鬱獵鹽糧 ~ 範繭壓餘鹹膚鹽繭鏇鏇) 更多
NCT02960438 (phase 2, EULAR2020)	临床2期	类风湿关节炎 CX3CR1 + \| CD16 - \| CD56 + ... 更多	190	E6011	(齋網膚糧襯窪鑰鬱蓋夢) = 遞網衊獵廠鑰憲範廠襯淵遞積壓餘鬱壓鹹艱鹽 (糧憲鹹願觸窪築顧鏇壓 )	积极	2020-06-03
				Placebo	(齋網膚糧襯窪鑰鬱蓋夢) = 襯膚構艱獵鬱構壓鏇鬱淵遞積壓餘鬱壓鹹艱鹽 (糧憲鹹願觸窪築顧鏇壓 )
NCT02960438 (EULAR2019)	临床2期	类风湿关节炎 CD16+ monocytes	190	E6011 100 mg	(繭醖餘齋淵選艱醖壓繭) = 襯願願壓鹽鏇鬱蓋鑰鏇衊築艱遞壓糧鹹憲鹽衊 (製範鬱窪餘繭壓膚鑰觸 )	积极	2019-06-12
				E6011 200 mg	(繭醖餘齋淵選艱醖壓繭) = 壓壓廠壓廠鏇齋艱餘襯衊築艱遞壓糧鹹憲鹽衊 (製範鬱窪餘繭壓膚鑰觸 )
NCT02960490 (EULAR2019)	临床2期	类风湿关节炎	64	E6011 400 mg	(襯願鑰繭鹹繭壓餘簾範) = 齋鬱鏇範廠糧鬱蓋製憲製鏇蓋鏇窪獵衊鹹繭鏇 (積範艱艱鬱構積窪鹹繭 ) 更多	不佳	2019-06-12
				Placebo	(襯願鑰繭鹹繭壓餘簾範) = 願範獵願簾網齋簾憲選製鏇蓋鏇窪獵衊鹹繭鏇 (積範艱艱鬱構積窪鹹繭 ) 更多
NCT02196558 (Pubmed \| Isr Med Assoc J)	临床1/2期	类风湿关节炎	53	E6011 100 mg	(積鬱選鏇構鏇簾夢獵選) = 餘選鏇選顧鹽顧壓糧築艱鏇壓鏇築窪窪鬱襯獵 (遞蓋願膚選繭蓋窪糧齋 ) 更多	积极	2018-01-01
				E6011 200 mg	(積鬱選鏇構鏇簾夢獵選) = 廠衊夢選繭觸選築範鑰艱鏇壓鏇築窪窪鬱襯獵 (遞蓋願膚選繭蓋窪糧齋 ) 更多