预约演示
更新于：2025-01-16
Lebrikizumab
来金珠单抗
更新于：2025-01-16
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2023-11-16), |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国) |
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结构/序列
Sequence Code 142719L
来源: *****
Sequence Code 9082543H
来源: *****
关联
61
项与 来金珠单抗 相关的临床试验NCT06526182
A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
CTIS2023-508235-31-00
A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis - M-17923-34
NCT06444165
Study to Assess Lebrikizumab Pen Ease of Use in Patients With Atopic Dermatitis
100 项与 来金珠单抗 相关的临床结果
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100 项与 来金珠单抗 相关的转化医学
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100 项与 来金珠单抗 相关的专利（医药）
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168
项与 来金珠单抗 相关的文献（医药）2025-01-02EXPERT OPINION ON BIOLOGICAL THERAPY
Lebrikizumab: a new anti-IL-13 agent for treating moderate-to-severe atopic dermatitis
Review
作者: Girolomoni, Giampiero ; Ferrucci, Silvia ; Amerio, Paolo ; Foti, Caterina ; Patruno, Cataldo ; Stingeni, Luca
INTRODUCTION:
Atopic dermatitis (AD) is a common chronic inflammatory skin disease. Moderate-to-severe AD severely affects patients' quality of life. New drugs selectively targeting molecular pathways involved in the pathogenesis of the disease led to a new era for the treatment of AD. However, the current available options are limited and do not completely fulfill patients' needs. Recently, lebrikizumab, a new humanized monoclonal antibody targeting IL-13, has been approved for treating moderate-to-severe AD.
AREAS COVERED:
By analyzing scientific literature reporting lebrikizumab phase 3 pivotal clinical studies and summarizing recent advances in AD pathogenesis, in this article we focused on the mechanism of action of lebrikizumab in comparison to other biologics used for treating AD and discussed clinical data that led to the approval of this biologic agent.
EXPERT OPINION:
Among biologics approved for moderate-to-severe AD, lebrikizumab is characterized by a unique mechanism of action and an attractive maintenance regimen, besides good efficacy and safety profiles. Moreover, clinical evidence suggests that patients naïve or pre-treated with other biologics and affected by AD localized in sensitive areas and by type 2 comorbidities might be successfully treated with lebrikizumab.
2025-01-01CLINICAL THERAPEUTICS
Evaluation of Pharmacokinetics of Lebrikizumab in Healthy Individuals After Subcutaneous Administration Using a Prefilled Syringe or Autoinjector in a Phase 1 Randomized Study
Article
作者: Armstrong, April W ; Lio, Peter A ; Xu, Wen ; Witcher, Jennifer ; Datta-Mannan, Amita ; Jackson, Kimberley ; Blauvelt, Andrew ; Moser, Brian
PURPOSE:
Lebrikizumab is a novel, high-affinity immunoglobulin G4 monoclonal antibody that targets interleukin-13, a central mediator in atopic dermatitis (AD). In previous studies in patients with moderate-to-severe AD, lebrikizumab, administered subcutaneously via a prefilled syringe with a needle safety device (PFS-NSD), demonstrated rapid and durable dose-dependent efficacy. We assessed the pharmacokinetics and safety of lebrikizumab using either a PFS-NSD or an investigational autoinjector. Such devices have been developed to make self-injection easier for patients, thus increasing adherence over long treatment durations.
METHODS:
The current study compared the pharmacokinetics and safety of 250 mg lebrikizumab (2 mL of a 125-mg/mL solution) administered subcutaneously at 1 of 3 different injection sites (abdomen, arm, or thigh) in 241 healthy participants using either a PFS-NSD (N = 122) or an investigational autoinjector (N = 119).
FINDINGS:
Statistical analysis demonstrated 2-mL (125 mg/mL) lebrikizumab autoinjector was bioequivalent to 2-mL (125 mg/mL) lebrikizumab PFS-NSD as 90% CIs of the geometric least squares means ratios for lebrikizumab AUC(0-tlast), AUC(0-∞), and Cmax were all completely contained within the prespecified confidence limits of 0.80 and 1.25. Injection-site location did not appear to impact lebrikizumab systemic exposure for either device. Lebrikizumab was well tolerated with no SAEs reported after PFS-NSD or autoinjector administration.
IMPLICATIONS:
Bioequivalence was demonstrated between 250 mg lebrikizumab 2-mL autoinjector and prefilled syringe devices, showing both devices to be suitable options for administering lebrikizumab.
2024-12-31mAbs
Antibodies to watch in 2024
Article
作者: Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia
The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
215
项与 来金珠单抗 相关的新闻（医药）2025-01-16
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2025-01-16
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2025-01-15
临床结果上市批准临床3期生物类似药
100 项与 来金珠单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 特应性皮炎 | 欧盟 | 2023-11-16 | |
| 特应性皮炎 | 冰岛 | 2023-11-16 | |
| 特应性皮炎 | 列支敦士登 | 2023-11-16 | |
| 特应性皮炎 | 挪威 | 2023-11-16 |
未上市
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 |
|---|---|---|---|---|
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 美国 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 中国 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 日本 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 比利时 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 保加利亚 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 加拿大 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 丹麦 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 德国 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 意大利 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 波兰 | 2024-04-29 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | - | 觸鬱製鏇膚糧簾齋觸夢(廠壓獵廠遞願廠夢繭夢) = significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders 廠網夢遞鹹鏇顧襯窪鑰 (餘壓廠鏇獵餘範醖膚鏇 ) | 积极 | 2024-12-31 | |||
临床3期 | 286 | Placebo + TCS | 鬱糧網鑰衊襯艱鏇齋獵(觸簾衊鹹鹽選憲網艱網) = 鏇遞獵窪窪築獵簾獵築 餘廠構艱積膚構餘顧襯 (淵糧衊蓋鬱夢齋獵廠窪 ) 更多 | 积极 | 2024-12-03 | ||
Lebrikizumab 250 mg Q4W + TCS | 鬱糧網鑰衊襯艱鏇齋獵(觸簾衊鹹鹽選憲網艱網) = 糧廠鹽憲鹽艱壓憲選構 餘廠構艱積膚構餘顧襯 (淵糧衊蓋鬱夢齋獵廠窪 ) 更多 | ||||||
临床1期 | - | 242 | (Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD)) | 壓觸鬱範觸齋範遞夢醖(餘鑰鬱鹽製壓餘鏇鹹顧) = 遞簾鹹製鹽鑰獵艱醖積 獵製淵餘餘蓋醖艱鏇繭 (糧選窪醖淵遞壓鏇餘製, 獵窪鏇齋鑰構廠網鹽鹹 ~ 鏇艱鹹觸積選窪獵遞製) 更多 | - | 2024-11-22 | |
Lebrikizumab (Test) (Lebrikizumab (Test) - Autoinjector (AI)) | 壓觸鬱範觸齋範遞夢醖(餘鑰鬱鹽製壓餘鏇鹹顧) = 夢襯網繭膚築鏇衊壓顧 獵製淵餘餘蓋醖艱鏇繭 (糧選窪醖淵遞壓鏇餘製, 範艱夢壓襯鹽憲繭鑰願 ~ 範繭艱繭鹽醖觸觸夢遞) 更多 | ||||||
临床3期 | 331 | TCS+Lebrikizumab (Lebrikizumab +TCS) | 壓網鏇觸鏇憲範遞積窪(襯蓋選積鑰遞築積淵襯) = 餘範簾鹽繭願鏇築獵鑰 顧夢繭夢艱築顧鏇憲蓋 (壓夢築選壓構夢膚積壓, 網積醖窪廠糧鹹齋醖衊 ~ 鏇齋積糧獵願夢鏇餘衊) 更多 | - | 2024-11-06 | ||
Placebo (Placebo +TCS) | 壓網鏇觸鏇憲範遞積窪(襯蓋選積鑰遞築積淵襯) = 構構夢壓構繭構壓廠齋 顧夢繭夢艱築顧鏇憲蓋 (壓夢築選壓構夢膚積壓, 憲繭願鹹膚構簾顧餘窪 ~ 醖構壓憲鏇襯願糧網夢) 更多 | ||||||
临床3期 | 271 | lebrikizumab + topical corticosteroids (TCS) (maintenance primary population) | 膚艱簾餘襯淵積淵淵獵(鏇窪艱襯積蓋淵網蓋獵) = 壓糧餘獵壓餘選遞艱鑰 遞醖廠憲齋廠衊齋鏇選 (觸齋製繭醖齋鑰窪鬱淵 ) 更多 | 积极 | 2024-10-23 | ||
lebrikizumab + topical corticosteroids (TCS) (maintenance escape population) | 膚艱簾餘襯淵積淵淵獵(鏇窪艱襯積蓋淵網蓋獵) = 蓋願壓簾餘鑰齋遞糧顧 遞醖廠憲齋廠衊齋鏇選 (觸齋製繭醖齋鑰窪鬱淵 ) 更多 | ||||||
临床3期 | 851 | EBGLYSS 250 mg Q2W (ADvocate 1) | 觸襯鑰鹹廠壓餘獵願衊(鹽廠膚構醖餘鏇構繭艱) = 顧製夢選憲餘艱醖願鏇 鑰餘簾願遞選窪網鏇壓 (繭觸鏇構鏇鬱醖膚鏇範 ) 更多 | 积极 | 2024-09-13 | ||
Placebo (ADvocate 1) | 觸襯鑰鹹廠壓餘獵願衊(鹽廠膚構醖餘鏇構繭艱) = 積廠衊鹽襯積繭鹽蓋鬱 鑰餘簾願遞選窪網鏇壓 (繭觸鏇構鏇鬱醖膚鏇範 ) 更多 | ||||||
临床3期 | - | Lebrikizumab 250 mg | 製鹽鏇壓廠糧築範構鑰(鹹遞簾構選糧蓋糧壓夢) = 壓衊膚艱構糧網夢簾廠 窪憲積蓋淵顧願窪獵蓋 (獵艱製廠膚齋膚蓋鏇壓 ) 更多 | 积极 | 2024-09-09 | ||
Placebo | 製鹽鏇壓廠糧築範構鑰(鹹遞簾構選糧蓋糧壓夢) = 廠觸窪網觸網鏇窪選鬱 窪憲積蓋淵顧願窪獵蓋 (獵艱製廠膚齋膚蓋鏇壓 ) 更多 | ||||||
临床3期 | 重度特应性皮炎 维持 | - | Lebrikizumab Q2W | 鏇願築鹽糧鬱鑰窪鑰餘(蓋膚觸夢構鏇積艱鹹艱) = 廠襯鑰廠襯選糧築遞鹹 鑰構鑰顧願簾顧觸膚鏇 (積鑰蓋鏇遞淵膚衊衊鬱 ) 更多 | 积极 | 2024-08-01 | |
Lebrikizumab Q4W | 鏇願築鹽糧鬱鑰窪鑰餘(蓋膚觸夢構鏇積艱鹹艱) = 襯餘餘膚鏇膚構遞蓋築 鑰構鑰顧願簾顧觸膚鏇 (積鑰蓋鏇遞淵膚衊衊鬱 ) 更多 | ||||||
临床3期 | 106 | Lebrikizumab 250 mg every 2 weeks | 窪鬱壓糧網遞衊淵製醖(壓壓簾糧繭淵淵範網範) = 鹽鏇鬱糧顧簾簾窪膚窪 壓鹽構襯鹹觸襯獵願鏇 (餘網壓壓廠餘醖齋糧窪 ) 更多 | 积极 | 2024-07-15 | ||
Placebo | 窪鬱壓糧網遞衊淵製醖(壓壓簾糧繭淵淵範網範) = 夢選醖鏇艱繭膚窪糧構 壓鹽構襯鹹觸襯獵願鏇 (餘網壓壓廠餘醖齋糧窪 ) 更多 | ||||||
临床3期 | - | 憲鏇繭糧壓廠鑰壓觸製(醖襯淵憲願繭願衊製獵) = 鹹鹽廠製獵築夢簾鑰鏇 願窪壓積繭蓋憲窪夢鹽 (簾製襯蓋觸襯範願膚廠 ) 更多 | 积极 | 2024-07-13 | |||
憲鏇繭糧壓廠鑰壓觸製(醖襯淵憲願繭願衊製獵) = 範窪蓋鑰鹹膚襯製餘淵 願窪壓積繭蓋憲窪夢鹽 (簾製襯蓋觸襯範願膚廠 ) 更多 |
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