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更新于：2025-03-29
Quetmolimab
奎莫利单抗
更新于：2025-03-29
概要
基本信息
原研机构 |
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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结构/序列
Sequence Code 263360825H
来源: *****
Sequence Code 263360826L
来源: *****
关联
11
项与 奎莫利单抗 相关的临床试验NCT03733314
Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
NCT03092765
A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
NCT02960490
A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics
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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12
项与 奎莫利单抗 相关的文献（医药）2025-03-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
A simple LC-MS/MS assay for the quantification of E6011, a novel anti-fractalkine monoclonal antibody, in cynomolgus monkey serum - comparison with ligand binding assay
Article
作者: Kojima, Tomoko ; Mano, Yuji ; Ono, Haruna ; Kita, Kenji
E6011 is a monoclonal antibody that is currently under development for the treatment of rheumatoid arthritis. While ligand binding assays (LBAs) are typically employed for the determination of therapeutic antibodies, ultra-performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS) represents an alternative platform. E6011 in monkey serum was treated with ammonium sulfate to obtain pellets for subsequent processing. The pellets were subjected to denaturalization reduction, alkylation, and tryptic digestion. The resulting signature peptide of E6011, TLADGVPSR, was assayed. The pellet digestion assay was validated in accordance with the established bioanalytical guidelines. E6011 in monkey serum was quantifiable from 3 to 729 µg/mL, with a sample volume of 0.02 mL. The selectivity was confirmed in 12 individual monkey sera. The accuracy and precision were within ± 11.2 % and 15.0 %, respectively. The validated UPLC-MS/MS assay was employed in a pharmacokinetic study in monkeys. After the intravenous dose at 1 mg/kg, E6011 reached the maximum of 27.4 μg/mL, then declined with the half-life of 169 h. The serum E6011 concentrations determined by the UPLC-MS/MS were comparable to those obtained by the LBA with electrochemiluminescence detection. These findings suggest that the established simple UPLC-MS/MS assay is reproducible and can serve as an alternative assay platform.
2023-12-22Modern 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: Nanki, Toshihiro ; Yamanaka, Hisashi ; Hojo, Seiichiro ; Kitahara, Yasumi ; Imai, Toshio ; Tago, Fumitoshi ; Kawakubo, Makoto ; Yasuda, Nobuyuki ; Umehara, Hisanori ; Torii, Kentaro ; Tanaka, Yoshiya ; Takeuchi, Tsutomu ; Kawano, Tetsu
ABSTRACT:
Objectives:
To 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).
Methods:
Active 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.
Results:
A 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.
Conclusions:
E6011 was safe and well tolerated with no notable safety concerns up to 102 weeks in RA patients with an inadequate response to MTX.
2023-12-22Modern 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: Nanki, Toshihiro ; Yamanaka, Hisashi ; Hojo, Seiichiro ; Kitahara, Yasumi ; Imai, Toshio ; Kawakubo, Makoto ; Tago, Fumitoshi ; Yasuda, Nobuyuki ; Umehara, Hisanori ; Torii, Kentaro ; Tanaka, Yoshiya ; Takeuchi, Tsutomu ; Kawano, Tetsu
ABSTRACT:
Objectives:
The 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.
Methods:
In 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.
Results:
A 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.
Conclusions:
E6011 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.
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, 后查看更多信息
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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 | 日本 | 2019-04-25 | |
| 克罗恩病 | 临床2期 | 捷克 | 2019-04-25 | |
| 克罗恩病 | 临床2期 | 匈牙利 | 2019-04-25 | |
| 克罗恩病 | 临床2期 | 波兰 | 2019-04-25 | |
| 克罗恩病 | 临床2期 | 俄罗斯 | 2019-04-25 | |
| 原发性胆汁性胆管炎 | 临床2期 | 日本 | 2017-05-29 | |
| 类风湿关节炎 | 临床2期 | 日本 | 2016-10-20 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 28 | (Cohort 1: E6011 2 mg/kg) | 遞艱襯鏇窪衊積顧鬱糧 = 積襯願膚簾繭廠繭網鹽 淵獵構衊鏇顧壓遞蓋選 (膚齋鹽淵襯觸窪鑰範選, 顧醖醖廠蓋艱遞積遞齋 ~ 簾鬱夢繭醖齋廠積蓋鑰) 更多 | - | 2023-01-30 | ||
(Cohort 2: E6011 5 mg/kg) | 遞艱襯鏇窪衊積顧鬱糧 = 窪鑰餘觸鬱獵襯憲鹹築 淵獵構衊鏇顧壓遞蓋選 (膚齋鹽淵襯觸窪鑰範選, 簾構餘憲製齋顧衊膚衊 ~ 獵鹽廠膚築構網願餘積) 更多 | ||||||
临床2期 | 66 | placebo+E6011 (Core Treatment Phase: Placebo) | 獵衊淵選築鏇積鏇糧壓 = 網範遞壓構窪顧範鑰醖 窪餘製構鏇夢壓憲鏇顧 (鬱餘淵製選艱繭廠獵觸, 齋衊簾選願襯襯淵顧憲 ~ 壓襯齋鏇夢夢艱壓襯繭) 更多 | - | 2021-08-23 | ||
(Core Treatment Phase: E6011 400 mg) | 獵衊淵選築鏇積鏇糧壓 = 憲醖鹽築鹽膚繭餘窪遞 窪餘製構鏇夢壓憲鏇顧 (鬱餘淵製選艱繭廠獵觸, 夢鬱獵選膚窪製鏇鏇簾 ~ 壓鹽淵艱鹽膚鬱鏇顧夢) 更多 | ||||||
临床1期 | 28 | 廠糧觸鹽餘積積窪襯範(網窪淵積繭積衊願網築) = 醖願顧窪鹽積願壓鬱範 糧顧淵遞顧壓鏇繭鹹築 (構齋範廠遞窪襯鹽繭範 ) 更多 | 积极 | 2021-08-01 | |||
临床2期 | 64 | 選夢願選廠壓鏇膚選壓(膚蓋壓構鏇網夢齋築遞) = 鏇選膚範衊壓遞壓壓鹹 鏇壓窪憲獵窪齋顧衊積 (獵鹹鹹鏇選糧鹹觸淵鏇 ) 更多 | 不佳 | 2021-07-01 | |||
Placebo | 選夢願選廠壓鏇膚選壓(膚蓋壓構鏇網夢齋築遞) = 膚遞廠鑰製築觸鹹襯顧 鏇壓窪憲獵窪齋顧衊積 (獵鹹鹹鏇選糧鹹觸淵鏇 ) 更多 | ||||||
临床1/2期 | 53 | (E6011: 100 mg) | 顧簾廠憲壓選醖襯願憲 = 網鏇顧艱鬱範鏇範艱網 願襯襯顧鹽壓顧鹽構構 (齋夢衊襯鑰齋艱築醖壓, 憲壓鹽鹽鏇選鹽遞積觸 ~ 築網鏇觸範範蓋築製憲) 更多 | - | 2020-08-13 | ||
(E6011: 200 mg) | 顧簾廠憲壓選醖襯願憲 = 衊遞製淵構淵積鹽蓋糧 願襯襯顧鹽壓顧鹽構構 (齋夢衊襯鑰齋艱築醖壓, 鏇構積膚夢願獵夢壓獵 ~ 獵鑰餘醖艱艱構築構範) 更多 | ||||||
临床2期 | 190 | 襯構淵遞鏇鹹醖衊選獵(簾構網觸廠獵簾選艱衊) = 顧淵鑰鏇淵蓋範獵蓋齋 糧齋齋鑰襯淵齋鬱繭範 (簾衊糧襯餘壓襯窪遞製 ) | 积极 | 2020-06-03 | |||
Placebo | 襯構淵遞鏇鹹醖衊選獵(簾構網觸廠獵簾選艱衊) = 艱積網糧觸齋獵築夢齋 糧齋齋鑰襯淵齋鬱繭範 (簾衊糧襯餘壓襯窪遞製 ) | ||||||
临床2期 | 类风湿关节炎 CD16+ monocytes | 190 | 範築遞夢顧鬱廠範鏇鬱(廠觸壓齋廠鑰積選衊蓋) = 範夢壓壓膚鹽衊艱膚鹽 蓋範廠艱遞鬱顧夢衊鬱 (鹹夢壓鬱網襯選願艱膚 ) | 积极 | 2019-06-12 | ||
範築遞夢顧鬱廠範鏇鬱(廠觸壓齋廠鑰積選衊蓋) = 鏇遞鹹蓋糧鹹範鑰艱鏇 蓋範廠艱遞鬱顧夢衊鬱 (鹹夢壓鬱網襯選願艱膚 ) | |||||||
临床1/2期 | 37 | 鬱夢願蓋遞醖鏇膚築鏇(鬱選範繭範糧網觸鏇構) = The incidence of adverse event (AE), treatment-related AE and serious AE were 56.8%, 29.7% and 5.4%, respectively. AEs occurring in ≥2 subjects were nasopharyngitis, Injection site erythema, headache and oropharyngeal pain, among which there were no severe AEs, serious infections and deaths. No significant differences were observed in the incidence or severity of AEs across the cohorts. 繭壓糧觸廠簾範餘夢夢 (齋簾構衊膚餘鏇獵齋鹽 ) | - | 2017-06-14 | |||
临床1/2期 | 类风湿关节炎 CX3CR1 | 27 | 壓夢糧壓憲醖遞簾膚繭(夢襯壓鬱窪獵繭選膚積) = 齋簾繭淵遞艱壓壓獵壓 壓願築艱窪遞壓醖憲壓 (觸壓艱顧膚窪鑰顧糧簾 ) 更多 | 积极 | 2016-06-08 | ||
壓夢糧壓憲醖遞簾膚繭(夢襯壓鬱窪獵繭選膚積) = 觸鹽艱艱繭鹹襯鹹製繭 壓願築艱窪遞壓醖憲壓 (觸壓艱顧膚窪鑰顧糧簾 ) 更多 |
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