预约演示
更新于：2026-10-23
Lebrikizumab
来金珠单抗
更新于：2026-10-23
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)申请上市 |
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
63
项与 来金珠单抗 相关的临床试验NCT07856134
A Phase 4, Prospective, Multicenter, Single-Arm, Pragmatic Interventional Cohort Study Evaluating Real-World Outcomes and Dosing Patterns of Ebglyss (Lebrikizumab) in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
NCT07873801
A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Face and Neck Atopic Dermatitis
DRKS00041882
A multicentre, prospective observational phase IV clinical study to assess the impact of lebrikizumab on burdensome body areas in patients with moderate-to-severe atopic dermatitis – the ADimpact study - ADimpact
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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278
项与 来金珠单抗 相关的文献（医药）2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases
Review
作者: Yang, Xuefan ; Chen, Xiang ; Li, Sitong ; Ruan, Dandan ; Lin, Jiacheng ; Qiu, Xinlan ; Li, Jiaqi ; Ju, Qiang ; Mo, Xiaohui
PURPOSE:
Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases.
MATERIALS AND METHODS:
We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data.
RESULTS:
A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.
CONCLUSIONS:
DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.
2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Lebrikizumab off-therapy remission sustained up to 38 weeks in atopic dermatitis
Article
作者: Gudjonsson, Johann E. ; Okragly, Angela ; Rueda, Maria Jose ; Eyerich, Kilian ; Armstrong, April W. ; Elmaraghy, Hany ; Xu, Chenjia ; Bieber, Thomas ; Moser, Brian A. ; Gallo, Gaia ; Silverberg, Jonathan I. ; Uluckan, Ozge ; Nickoloff, Brian J. ; Wolf, Eric ; Natalie, Chitra R.
AIM OF THE STUDY:
Lebrikizumab monotherapy demonstrated efficacy for adults and adolescents with moderate-to-severe atopic dermatitis (AD). This study aims to evaluate the relationship between lebrikizumab serum levels and stable deep response after treatment cessation in Week 16-responder patients who maintained stable EASI 90 response post-induction up to Week 52.
MATERIALS AND METHODS:
Analysis was pooled from two identically designed, randomized, double-blind, placebo-controlled, phase 3 trials, ADvocate1 (NCT04146363; conducted from September 24, 2019, to May 3, 2022) and ADvocate2 (NCT04178967; conducted from October 29, 2019, to April 28, 2022). The analysis subgroup includes those patients who were Week-16 responders, have been re-randomized to receive placebo (withdrawal arm), and maintained a stable EASI 90 response for at least 80% of visits up to 52 weeks, without rescue medication. Serum lebrikizumab was measured at Weeks 4, 16, 32, and 52.
RESULTS:
During withdrawal, 28% of responders (17/60) maintained a stable EASI 90 response with no or minimal fluctuations, including at Week 52, without rescue medication. Mean serum lebrikizumab decreased by 92% and over 99% from Week 16 to Weeks 32 and 52, respectively (Week 16 = 92.4 μg/mL; Week 32 = 7.3 μg/mL; Week 52 = 0.15 μg/mL).
CONCLUSION:
Lebrikizumab demonstrated off-therapy maintenance of response in an AD patient subset for at least 38 weeks post-discontinuation.
2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Raising the bar of efficacy in Atopic Dermatitis: deep response in week 16 responders treated with lebrikizumab over 2 years
Article
作者: Xu, Chenjia ; Biedermann, Tilo ; Figueras, Ignasi ; Agell, Helena ; Simpson, Eric ; Kircik, Leon ; Hu, Chaoran ; Pierce, Evangeline ; Gallo, Gaia ; Vestergaard, Christian ; Chovatiya, Raj ; Casillas, Marta ; Ding, Yuxin
BACKGROUND:
Lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13, effectively treats moderate-to-severe atopic dermatitis (AD).
METHODS:
Lebrikizumab-treated patients in ADvocate1&2 achieving per-protocol response-IGA (0,1) or EASI 75 at Week 16-were re-randomized 2:2:1 to lebrikizumab 250 mg every 2 weeks (Q2W), Q4W, or placebo (lebrikizumab withdrawal). Patients completing Week 52 could enroll in the extension study, ADjoin. Deep response was defined as IGA (0), EASI 100, or Pruritus Numerical Rating Scale score 0 or 1 (NRS [0,1]). This analysis reports as-observed data.
RESULTS AND CONCLUSIONS:
From Week 16-104, among IGA (0,1) responders at Week 16, increased proportions of patients achieved IGA (0) with lebrikizumab Q2W (33.8% [Nx = 77] to 52.3% [Nx = 44]) and Q4W (29.9% [Nx = 77] to 45.5% [Nx = 55]); among EASI 75 responders at Week 16, increased proportions of patients achieved EASI 100 with lebrikizumab Q2W (21.4% [Nx = 112] to 39.7% [Nx = 68]) and Q4W (20.0% [Nx = 115] to 41.3% [Nx = 80]); and among per-protocol responders, increased proportions of patients reported Pruritus NRS (0,1) with lebrikizumab Q2W (35.2% [Nx = 108] to 57.4% [Nx = 61]) and Q4W (34.2% [Nx = 114] to 55.4% [Nx = 65]). Continued lebrikizumab treatment for 2 years resulted in approximately half of per-protocol responders achieving complete skin clearance (IGA 0) and itch relief, raising the bar of treatment goals for AD patients.
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 |
|---|---|---|---|---|
| 钱币状湿疹 | 临床3期 | 德国 | 2026-04-24 | |
| 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 | 阿根廷 | 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 | 芬兰 | 2024-04-29 |
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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3期 | 301 | Placebo (Combo Cohort: Placebo + TCS) | 製蓋憲憲鹽襯範夢繭願 = 糧網遞淵願鏇獵糧願範 顧齋憲選窪窪蓋獵齋窪 (膚遞簾願膚齋遞廠膚鑰, 壓醖廠壓鹽衊鹹糧鹽糧 ~ 遞範鹹艱構顧蓋積夢膚) 更多 | - | 2026-10-16 | ||
(Combo Cohort: 250 mg Lebrikizumab + TCS) | 製蓋憲憲鹽襯範夢繭願 = 繭鹽襯艱獵艱簾範鑰繭 顧齋憲選窪窪蓋獵齋窪 (膚遞簾願膚齋遞廠膚鑰, 餘網齋淵襯顧觸糧繭膚 ~ 艱壓鹹艱膚築鹹鬱鬱顧) 更多 | ||||||
临床2期 | 309 | Placebo (Placebo: Biomarker-High) | 鹹網鑰選糧願壓願膚積(遞積製獵遞選壓艱觸鑰) = 網艱蓋積觸夢鹽鏇膚餘 構鏇願觸鏇窪醖鹽製鏇 (範遞衊窪糧選鹽蓋廠餘, 壓鹹廠鬱餘鏇膚鹽壓廠 ~ 鏇製鏇顧醖餘範齋鏇衊) 更多 | - | 2026-09-10 | ||
(Lebrikizumab: Biomarker-High) | 鹹網鑰選糧願壓願膚積(遞積製獵遞選壓艱觸鑰) = 鹹鏇餘餘蓋蓋繭鏇鹹壓 構鏇願觸鏇窪醖鹽製鏇 (範遞衊窪糧選鹽蓋廠餘, 遞簾繭積積夢蓋壓選夢 ~ 鑰糧衊淵鹹壓範憲製夢) 更多 | ||||||
临床3期 | 313 | (Double-Blind: Lebrikizumab) | 鑰餘築網壓願壓製鏇簾(範鬱壓顧遞獵網網構廠) = 醖獵窪夢壓鬱糧壓醖糧 鑰夢製淵顧廠觸淵選積 (繭壓獵鏇願範顧遞廠築, 0.033) 更多 | - | 2026-07-17 | ||
Placebo (Double-Blind: Placebo) | 鑰餘築網壓願壓製鏇簾(範鬱壓顧遞獵網網構廠) = 顧鬱選築廠艱築鹽構範 鑰夢製淵顧廠觸淵選積 (繭壓獵鏇願範顧遞廠築, 0.032) 更多 | ||||||
临床3期 | 260 | 網積範衊醖齋遞鏇築遞 = 壓夢鏇齋網鬱鬱鏇願餘 蓋壓繭鹽醖衊簾鏇壓積 (網窪願窪齋齋範顧鬱糧, 蓋選淵餘衊艱廠製鬱夢 ~ 廠餘窪獵觸鹹繭壓觸簾) 更多 | - | 2026-07-17 | |||
临床3期 | 346 | Placebo+Lebrikizumab | 艱壓構選鹽鑰窪繭網觸 = 淵糧構顧蓋淵遞製齋醖 衊願觸築範積窪顧醖壓 (糧壓廠鹽選網齋構築齋, 鏇繭齋壓獵願積選鏇觸 ~ 選遞願鬱觸構網膚獵餘) 更多 | - | 2026-06-30 | ||
临床3期 | 267 | 襯窪淵網選網醖網繭鹽(淵膚製廠築膚鏇積廠膚) = Most adverse events (AEs) were mild (29.2%) or moderate (33.3%) in severity. 繭繭鏇衊蓋構衊鹽膚鬱 (鹹構願鏇艱築蓋蓋艱壓 ) | 积极 | 2026-06-19 | |||
临床3期 | 90 | 醖顧製餘簾鹽窪觸醖齋(襯獵選膚築膚簾鑰膚簾) = 遞鑰獵鬱窪醖膚夢夢獵 築齋齋願蓋範憲鑰繭網 (蓋蓋鹹鑰窪構廠醖齋選 ) 更多 | 积极 | 2026-03-27 | |||
临床3期 | 215 | (did not achieve protocol-defined response at Week 16) | 鑰積夢憲衊範壓廠觸鹹(鹹鏇鹹膚築鑰願觸衊選) = 餘範選齋鑰鬱艱窪鬱艱 獵獵鏇範艱鏇鏇衊鏇衊 (繭積遞廠鹹襯鹽壓製艱 ) 更多 | 积极 | 2026-03-27 | ||
N/A | 174 | Lebrikizumab 250mg (Q4W or Q2W) | 夢鏇顧遞製鹹憲簾蓋衊(糧選積製構遞艱齋鑰鑰) = 膚壓選糧遞鏇窪範蓋鑰 鏇製鹽獵鹹鬱膚築膚顧 (膚網醖獵醖顧繭壓膚遞 ) 更多 | 积极 | 2026-03-27 | ||
N/A | 42 | 膚簾遞簾遞齋膚窪選範(窪膚憲夢獵膚廠衊築製) = 衊艱觸廠蓋網餘獵窪夢 鬱齋淵製蓋夢顧遞壓鏇 (觸願齋膚鹽衊獵顧壓簾 ) 更多 | 积极 | 2026-03-27 |
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