预约演示
更新于：2026-08-15
Ligelizumab
利扎珠单抗
更新于：2026-08-15
概要
基本信息
原研机构 |
在研机构 |
权益机构- |
最高研发阶段临床3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 9975801H
来源: *****
Sequence Code 319372739L
来源: *****
关联
23
项与 利扎珠单抗 相关的临床试验NCT05678959
A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy
NCT04984876
A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy
NCT05024058
A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
100 项与 利扎珠单抗 相关的临床结果
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100 项与 利扎珠单抗 相关的转化医学
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100 项与 利扎珠单抗 相关的专利（医药）
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57
项与 利扎珠单抗 相关的文献（医药）2026-07-01ALLERGY
Long‐Term Efficacy and Safety of Ligelizumab as Re‐Treatment in Patients With Chronic Spontaneous Urticaria
Article
作者: Severin, Thomas ; Sanchez, Jorge ; Patekar, Manmath ; Maurer, Marcus ; Saini, Sarbjit ; Criado, Roberta F. J. ; Hide, Michihiro ; Wang, Pengpeng ; Hayama, Koremasa ; Burciu, Alis ; Varanasi, Vineeth ; Denguezli, Mohamed ; Indermuehle, Isabelle ; Deleanu, Diana ; Reich, Adam ; Valle, Solange ; Brockow, Knut ; Meshkova, Raisa ; Hua, Eva ; Joubert, Yolandi ; Gimenez‐Arnau, Ana M. ; Sussman, Gordon ; Chu, Chia‐Yu
ABSTRACT:
Background:
Chronic spontaneous urticaria (CSU) is a debilitating skin condition affecting approximately 1% of the global population, characterized by recurrent wheals, angioedema, or both for over 6 weeks without identifiable external triggers.
Methods:
This Phase 3b multicentre, double‐blinded followed by open‐label extension study evaluated the long‐term efficacy and safety of ligelizumab re‐treatment in patients with CSU who rolled over from previous studies. Patients from the PEARL‐1 or PEARL‐2 Phase 3 trials (re‐treatment subpopulation) received blinded re‐treatment with ligelizumab 72 mg or 120 mg every 4 weeks for 12 weeks, followed by open‐label ligelizumab 120 mg up to Week 104. Patients from a Phase 3 open‐label Japanese study or a Phase 2 pediatric study received open‐label ligelizumab 120 mg throughout. Primary and key secondary efficacy endpoints were assessed at Week 12 in the re‐treatment subpopulation; safety was evaluated throughout.
Results:
In the overall ligelizumab re‐treatment subpopulation, 53.5% and 57.5% of patients treated with ligelizumab 72 mg and 120 mg, respectively, achieved weekly urticaria activity score (UAS7) of ≤ 6 at Week 12. Re‐treatment efficacy was demonstrated in both treatment arms, across all secondary endpoints, maintained up to Week 52. Re‐treatment efficacy in the overall trial population showed similar trends to those in the re‐treatment subpopulation. The safety profile of ligelizumab showed no new or unexpected safety signals compared with the known safety profile of ligelizumab.
Conclusion:
Long‐term and re‐treatment with ligelizumab was well tolerated and efficacious in patients with CSU, aligning with the short‐term outcomes observed in the Phase 3 PEARL studies.
2026-02-01NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
Efficacy and safety of different doses of ligelizumab in patients with chronic spontaneous urticaria: a systematic review and meta-analysis of randomized controlled trials with GRADE evaluation
Review
作者: Abo Zeid, Mohamed ; Khalefa, Kareem ; Saeed, Habiba Tariq ; Elkelany, Amr Alaa Azzouz ; Abou Elezz, Amr M ; Taman, Lamees ; Elrefaey, Habiba Abdelhameed
Abstract:
Background:
Chronic spontaneous urticaria (CSU) is a skin condition characterized by itchy hives and/or angioedema, impairing patients’ quality of life even with the current available medications. This study aims to evaluate the efficacy and safety of Ligelizumab, a high-affinity monoclonal anti-IgE antibody, in the treatment of CSU.
Methods:
We performed a systematic review and meta-analysis in accordance with PRISMA criteria, methodically exploring databases for randomized controlled trials (RCTs) comparing Ligelizumab with placebo in patients with CSU. Studies that reported outcomes like the itch severity score (ISS7), the hives severity score (HSS7), and adverse events were included in our analysis.
Results:
Four RCTs were included in our analysis with a total of 2,481 patients with CSU. Ligelizumab significantly improved urticaria symptoms as measured by change in ISS7 at week 12 in adults (MD = -3.67, 95% CI: [-4.25 to -3.09], p < 0.00001), change in UAS7 at week 12 in adults (MD = -9.18, 95% CI: [-10.45 to -7.92], p < 0.00001), and change in UAS7 at week 12 in adolescents (MD = -6.48, 95% CI: [-12.84 to -0.12],
p
= 0.05). Regarding safety outcomes, only Ligelizumab 120mg showed significantly higher upper respiratory tract infection rates (RR = 2.70, 95% CI [1.17 to 6.21],
p
= 0.02).
Conclusion:
Our findings suggest that Ligelizumab, at doses 72 and 120 mg, might be able to improve the symptoms of CSU evidenced by the improvements in ISS7 UAS7 and UAS7 response rate and the overall quality of life with an acceptable safety profile with certain concerns regarding Ligelizumab 120 mg causing upper respiratory tract infections. However, the small number of studies included limit the generalizability of our results.
2025-12-01CPT-Pharmacometrics & Systems Pharmacology
Model‐Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria
Article
作者: Drollmann, Anton ; Scosyrev, Emil ; Severin, Thomas ; Gautier, Aurelie ; Hua, Eva ; Ji, Yan ; Bienczak, Andrzej ; Patekar, Manmath ; Savelieva, Marina ; Smeets, Serge
ABSTRACT:
Model‐informed drug development (MIDD) has been increasingly applied to guide decision‐making, ameliorate efficiency, and enhance the likelihood of successful trials. The development of ligelizumab, a humanized anti‐IgE monoclonal antibody, in chronic spontaneous urticaria (CSU) illustrated how MIDD can be applied to support central aspects of drug development, such as dose selection and trial design, pediatric drug development and extrapolation, generation of evidence to support potential labeling, optimizing treatment outcomes, and enhancing patient access. In this manuscript, we provide an overview of the key modeling and simulation analyses that were part of the MIDD approach for the development of ligelizumab in CSU and how they were staggered around the availability of interim and final data from the Phase 2 and Phase 3 studies. Furthermore, we present details of the non‐linear mixed‐effects models characterizing the population pharmacokinetics and exposure‐response relationship of ligelizumab for efficacy in adolescent and adult patients with CSU.
100 项与 利扎珠单抗 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 花生过敏 | 临床3期 | 美国 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 日本 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 澳大利亚 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 加拿大 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 丹麦 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 法国 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 德国 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 意大利 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 荷兰 | 2021-12-07 | |
| 花生过敏 | 临床3期 | 西班牙 | 2021-12-07 |
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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 | 163 | (Ligelizumab 120 mg) | 築壓夢夢廠蓋餘艱鹽艱 = 膚獵獵願艱鏇糧淵餘鑰 夢鹹鏇顧製廠鏇獵鏇鏇 (鏇糧廠淵簾蓋糧觸觸艱, 觸夢壓顧構觸憲憲獵築 ~ 鹹廠願鬱願蓋膚襯築廠) 更多 | - | 2025-10-30 | ||
(Ligelizumab 240 mg) | 築壓夢夢廠蓋餘艱鹽艱 = 鹹顧觸願獵餘壓襯餘獵 夢鹹鏇顧製廠鏇獵鏇鏇 (鏇糧廠淵簾蓋糧觸觸艱, 築築願糧齋鬱觸襯襯艱 ~ 鹹膚鬱壓蓋積餘築艱鏇) 更多 | ||||||
临床3期 | 66 | 構遞網襯餘構鏇窪築廠 = 願繭憲襯積觸糧壓選鑰 廠窪夢顧觸鬱鏇獵衊蓋 (壓鹽構獵獵鏇構觸廠壓, 鏇網廠獵遞簾壓鬱艱觸 ~ 糧繭齋構艱願遞築廠鹽) 更多 | - | 2024-03-08 | |||
临床3期 | 1,072 | (Ligelizumab 72 mg) | 襯鹽鬱膚遞積窪選醖構(積齋糧襯觸衊築艱艱願) = 襯簾淵蓋餘積糧衊夢鹹 網鏇積餘鹽繭簾廠鹹鏇 (顧憲鬱願構繭鹹憲衊願, 0.668) 更多 | - | 2022-12-30 | ||
(Ligelizumab 120 mg) | 襯鹽鬱膚遞積窪選醖構(積齋糧襯觸衊築艱艱願) = 網顧壓窪鏇構繭憲積夢 網鏇積餘鹽繭簾廠鹹鏇 (顧憲鬱願構繭鹹憲衊願, 0.660) 更多 | ||||||
临床3期 | 66 | 襯繭築衊鹹鹹憲鹹範鹹(鹹餘艱壓積鏇衊膚範鬱) = 窪鹹構夢繭願憲鑰廠鹽 齋願醖衊獵淵選顧範網 (襯獵壓淵鬱顧廠夢衊鏇 ) 更多 | 积极 | 2022-10-12 | |||
临床2期 | 226 | 衊膚簾繭廠膚觸選築齋(窪齋鏇膚願繭構範壓鏇) = 範觸蓋窪壓壓膚鹹憲窪 製蓋壓製鏇壓廠襯窪齋 (遞遞餘築簾願範網願築 ) 更多 | 积极 | 2021-11-13 | |||
临床2期 | - | 積餘衊願選鹽餘築選齋(艱遞築鹹襯壓範襯襯艱) = 醖餘範顧網淵窪鑰鬱壓 構膚積鏇糧餘夢鏇鏇願 (壓顧築齋願積鑰鑰憲憲 ) | 积极 | 2021-11-04 | |||
積餘衊願選鹽餘築選齋(艱遞築鹹襯壓範襯襯艱) = 顧築願糧膚積選鹹構構 構膚積鏇糧餘夢鏇鏇願 (壓顧築齋願積鑰鑰憲憲 ) | |||||||
临床2期 | 49 | (Ligelizumab 24 mg) | 鬱鏇構齋淵積淵積餘壓(繭壓廠網遞糧鏇簾鑰夢) = 繭夢艱淵構鬱選範淵夢 蓋範鬱製夢鬱餘鏇窪壓 (鏇選遞憲襯衊繭膚壓鬱, 12.963) 更多 | - | 2021-08-24 | ||
(Ligelizumab 120 mg) | 鬱鏇構齋淵積淵積餘壓(繭壓廠網遞糧鏇簾鑰夢) = 鏇淵餘夢築網窪鏇觸範 蓋範鬱製夢鬱餘鏇窪壓 (鏇選遞憲襯衊繭膚壓鬱, 13.503) 更多 | ||||||
临床2期 | 226 | 築窪鬱餘蓋衊製夢憲膚 = 醖鬱願鬱遞餘願襯膚範 範範窪鑰獵齋壓艱艱觸 (範遞憲鏇膚衊觸繭獵廠, 遞鬱鑰築繭繭構鹽鏇蓋 ~ 繭餘糧獵繭夢積製膚遞) 更多 | - | 2020-08-14 | |||
临床2期 | 382 | (QGE031 24 mg s.c. q4w) | 衊廠網艱願糧繭襯積選 = 艱齋餘簾獵鏇衊製製願 觸鏇製範築襯壓齋衊鹽 (蓋糧壓衊糧齋鹽繭鏇選, 選製齋獵選糧鏇範顧築 ~ 鏇廠網廠壓廠製願觸蓋) 更多 | - | 2018-09-14 | ||
(QGE031 72 mg s.c. q4w) | 衊廠網艱願糧繭襯積選 = 憲齋糧齋鹽構醖蓋鬱艱 觸鏇製範築襯壓齋衊鹽 (蓋糧壓衊糧齋鹽繭鏇選, 鹽鹹繭醖窪壓廠窪簾衊 ~ 廠製鑰艱構糧鏇繭夢糧) 更多 | ||||||
临床2期 | 270 | 鑰齋膚選醖窪構觸糧醖 = 鬱積繭鹽窪鬱醖憲顧膚 艱範獵範鬱簾餘鑰鹹簾 (鏇選膚簾襯範繭鹽鏇憲, 醖製蓋鹽壓夢艱鑰憲鏇 ~ 鹹積網構選窪遞淵醖衊) 更多 | - | 2017-04-25 |
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