曲罗芦单抗(Tralokinumab) - 药物靶点：IL-13_在研适应症：皮炎，特应性皮炎，中度特应性皮炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

tralokinumab-ldrm、BAK-502G9、CAT-354

+ [5]

靶点

IL-13

作用机制

IL-13抑制剂(白细胞介素-13抑制剂)

治疗领域

免疫系统疾病遗传病与畸形皮肤和肌肉骨骼疾病

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

欧盟 (2021-06-17),

特应性皮炎

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 13007322H

来源: *****

Sequence Code 13007734L

来源: *****

关联

49

项与曲罗芦单抗相关的临床试验

CTIS2022-502653-34-01 / Recruiting

A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND) - LP0162-2328

开始日期2024-06-10

申办/合作机构

LEO Pharma A/S

NCT06311682 / Recruiting临床3期

A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.
The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.
The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

开始日期2024-06-10

申办/合作机构

Leo Pharma, Inc.

NCT06366932 / Recruiting临床4期IIT

Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.

开始日期2023-09-25

申办/合作机构

Hospital Universitario La Paz

100 项与曲罗芦单抗相关的临床结果

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100 项与曲罗芦单抗相关的转化医学

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100 项与曲罗芦单抗相关的专利（医药）

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254

项与曲罗芦单抗相关的文献（医药）

2024-12-31·The Journal of dermatological treatment

Injection site reactions after dupilumab or tralokinumab for atopic dermatitis

Article

作者: Martora, Fabrizio ; D'Ascenzo, Silvia ; Napolitano, Maddalena ; Patruno, Cataldo

Background: Injection site reaction (ISR) is a local phenomenon defined as a constellation of symptoms, including swelling, erythema, pruritus, and pain around the site of injection.Objective: ISR is reported as a frequent adverse event after subcutaneous injection (SCI) of several biologics.Methods: We performed an observational real-life study to compare dupilumab and tralokinumab as regards ISR, analysing frequency, duration and intensity of symptoms related to SCI. From January 2023 to June 2023, we enrolled adult patients affected by moderate to severe AD and being on dupilumab or tralokinumab treatment. A 12 items questionnaire was administered to all enrolled patients.Results and conclusions: Three hundred and ninety-two patients were included. ISR was a frequent occurrence in both the treatment groups, with tralokinumab causing ISR more frequently than dupilumab. However, the reactions were generally mild and no patient stopped therapy.

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful use of tralokinumab for the treatment of atopic dermatitis on the genitals

Article

作者: Valenti, Mario ; Locatelli, Andrea Gustavo ; Bianchi, Vittoria G. ; Carugno, Andrea ; Malagoli, Piergiorgio ; Di Nicola, Matteo R. ; Foti, Antonio ; Narcisi, Alessandra ; Sena, Paolo ; Costanzo, Antonio ; Paolino, Giovanni ; Mercuri, Santo R.

BACKGROUND:

Genital involvement in atopic dermatitis(AD) can have a significant impact on the patient's quality of life. However, inspection of genital areas is not usually conducted during routine examination and patients may be reluctant to inform the clinician or show this area.

OBJECTIVE:

to evaluate the efficacy of tralokinumab in AD patients with genital involvement.

METHODS:

Adult patients with moderate/severe AD and genital involvement receiving tralokinumab have been analyzed. Primary endpoints were EASI, DLQI, PP-NRS, genital-IGA (g-IGA) and genital itching (GI) at week 16.

RESULTS:

out of 48 patients with moderate/severe AD under treatment with tralokinumab, 12 patients (25%) showed a genital involvement. Seven patients reported itching in the genital area (58%), while none reported a positive history of genital infections. Median scores at T0 were EASI 17.5, PP-NRS 8 and DLQI 14. After 16 weeks of treatment, we observed a median EASI of 3, a median PP-NRS of 1 and a median DLQI of 1. Finally, concerning the genital response, after 16 weeks of treatment, we observed a statistically significant decrease in mean GI and g-IGA scores.

CONCLUSION:

despite the small size of our sample, tralokinumab can be considered as a valid treatment option for AD with genital involvement.

2024-12-01·CONTACT DERMATITIS

Tralokinumab‐induced injection‐site reactions

Article

作者: De Greef, Axel ; Baeck, Marie

Injection-site reactions (ISR) have been observed in patients receiving s.c. injections of tralokinumab, a human monoclonal antibody designed to specifically target interleukin 13.Tralokinumab is approved for use in adults and adolescents with moderate-to-severe atopic dermatitis (AD).Further investigation is necessary to elucidate the pathophysiol. of these reactions to improve patient management and optimize the therapeutic use of tralokinumab in AD treatment.

66

项与曲罗芦单抗相关的新闻（医药）

2024-11-04

·PMLiVE

LEO Pharma shares final long-term results for atopic dermatitis drug Adbry

LEO Pharma has shared final results from a long-term extension study of its atopic dermatitis (AD) drug Adbry (tralokinumab-ldrm) in adult and adolescent patients aged 12 years and older with moderate-to-severe cases of the condition. The phase 3 ECZTEND study evaluated the safety and efficacy of Adbry, marketed for AD outside of the US under the brand name Adtralza, for up to five years in patients who completed their treatment with the drug in one of nine parent trials. The data presented at this year’s Fall Clinical Dermatology Conference showed that Adbry demonstrated sustained efficacy after up to one year in the parents trials plus up to five years in ECZTEND. A reduction of at least 75% in Eczema Area and Severity Index from baseline to week 248 was observed in 92.9% of patients, and 66.7% achieved an Investigator’s Global Assessment score of clear or almost clear in the same period. Improvements in Itch, sleep and quality of life were also observed. No new safety signals were identified, and the overall long-term safety profile was similar to that observed in the initial placebo-controlled treatment period of the parent trials. Affecting over 26 million people in the US alone, AD is an inflammatory skin disease characterised by intense itch and eczematous lesions. Adbry is designed to bind to and inhibit the interleukin-13 cytokine, which plays a role in the immune and inflammatory processes underlying AD. Brian Hilberdink, executive vice president and president, region North America, LEO, said: “With the release of the final results from the ECZTEND open-label extension study, we are pleased to present robust evidence further supporting the long-term safety and efficacy of [Adbry] in the treatment of moderate-to-severe AD.” International coordinating investigator of the ECZTEND trial, Andrew Blauvelt, Blauvelt Consulting, added that the long-term findings are “crucial for clinical practice, providing healthcare professionals with the data needed to prescribe [Adbry] for sustained use confidently”. “Ultimately, these comprehensive results will help improve their ability to manage this debilitating condition and enhance patient care,” he said. The results come just one month after LEO’s Anzupgo (delgocitinib) cream was approved by the European Commission to treat adults with moderate-to-severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate.

临床结果临床3期上市批准

2024-10-27

·医药魔方

III期研究告捷：礼来「来金珠单抗」对度普利尤单抗经治者有效

10月25日，礼来在秋季临床皮肤病学（FCD）会议上公布了来金珠单抗（商品名：Ebglyss）治疗特应性皮炎（AD）的IIIb期ADapt研究结果。研究结果显示，来金珠单抗对接受过度普利尤单抗治疗的AD患者有效。该研究是一项为期24周的单臂、开放标签临床试验，评估了来金珠单抗治疗既往接受过度普利尤单抗治疗（包括对其无反应、部分反应、不耐受或因某种原因无法继续接受治疗）的青少年和成人中重度AD患者的疗效和安全性。研究的主要终点为第16周达到湿疹面积和严重程度指数至少改善75%（EASI 75）的患者比例。结果显示，分别有57%和60%的患者在第16周和第24周时达到EASI-75。数据与在未接受过度普利尤单抗治疗的AD患者中进行的ADvocate 1和ADvocate 2研究的数据类似。 ADvocate 1和ADvocate 2研究的EASI 75数据此外，在对度普利尤单抗反应不足的患者中，有46%的患者在第16周时也达到了EASI-75。在停用度普利尤单抗后接受来金珠单抗治疗的患者中，分别有53%和62%的患者在第16周和第24周时实现了瘙痒缓解。本研究还观察到了来金珠单抗对AD患者的难治疗区域的症状同样有改善效果。超过一半（52%）的患者在第24周时实现了面部皮炎-研究者整体评估（F-IGA）分数达到0（完全清除）或1（几乎清除）。在手部有皮炎的中重度AD患者中，其修订版总病变症状评分（mTLSS，0-21分，衡量手部皮炎的范围和严重程度）在第24周时下降了75%。来金珠的安全性与既往研究一致，未观察到新的安全性信号。大多数不良事件（AE）为轻度或中度。研究中报告的治疗相关不良事件（TRAE）是结膜炎和注射部位反应。不到6%的患者因AE停药。来金珠单抗是一款具有高结合亲和力的白细胞介素-13（IL-13）抑制剂，可选择性阻断IL-13介导的2型炎症通路信号传导，从而抑制AD的发生发展。来金珠单抗在除欧盟以外地区的独家开发和商业化权益属于礼来，而欧盟的开发和商业化权益归Almirall所有。2023年11月，该药物首次在欧盟获批上市，用于治疗青少年和成人中重度AD患者。目前，全球共5款生物制剂获批用于治疗AD，包括度普利尤单抗（赛诺菲/再生元）、来金珠单抗、tralokinumab（Leo Pharma）、nemolizumab（中外制药/Galderma）和司普奇拜单抗（康诺亚）。度普利尤单抗是其中最畅销的产品。据赛诺菲财报，今年前三季度度普利尤单抗的全球销售额已超过百亿美元，其全年收入将轻松超过去年（117亿美元）。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床3期财报上市批准医药出海引进/卖出

2024-10-25

·Pharmaceutical Technology

LEO’s Adbry demonstrates long-term efficacy in atopic dermatitis

Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes that drive symptoms of atopic dermatitis. Credits: Evgeniia Primavera / Shutterstock. Leo Pharma has announced long term safety and efficacy data for its atopic dermatitis treatment, Adbry (tralokinumab-ldrm), demonstrating the drug’s ability to drive clear or almost clear skin for up to six years. Among patients enrolled in the Phase III ECZTEND study (NCT03587805) who have were on long-term (maintenance) treatment with Adbry, 92.9% of patients observed a reduction of at least 75% on the Eczema Area and Severity Index (EASI-75) at week 248. Additionally, 66.7% of patients achieved clear or almost clear skin, as assessed by the Investigator’s Global Assessment (IGA) scale. No new safety signals were identified. The results were presented in a poster at the Fall Clinical Dermatology Conference, which was held in Las Vegas, Nevada from 24-27 October. Adbry was approved by the US Food and Drug Administration (FDA) in 2021 for the treatment of adults with moderate-to-severe atopic dermatitis. The label was expanded in 2023 when Adbry gained an FDA approval for use in adolescents aged 12 and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. An alternative mode of administration after the approved by the FDA its single dose autoinjector in June 2024. In 2023, LEO generated net sales of DKK 11.4bn ($1.7bn), growth which was driven by growth of Adbry, as per the company’s 2023 annual results. GlobalData’s consensus forecasts project that Adbry will generate global sales of $1.3bn in 2030. See Also: Pharma companies must adapt to keep pace with AI developments, say experts AF stroke patients could benefit from earlier anticoagulant administration GlobalData is the parent company of Pharmaceutical Technology . Participants enrolled in the open label ECZTEND were previously assessed in multiple monotherapy and combination therapy studies of Adbry. Among these studies are the Phase III ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) studies of monotherapy Adbry and the Phase III ECZTRA 3 study (NCT03363854) of a Adbry/topical corticosteroid combination therapy. Patients were eligible to enroll in ECZTEND after completion of their respective parent trials regardless of their treatment response or whether they received Adbry or placebo treatment. Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes that drive symptoms of atopic dermatitis.

临床3期临床结果上市批准

100 项与曲罗芦单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	曲罗芦单抗	D11AH	DB12169

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
皮炎	韩国	Leo Pharma, Inc.	2023-08-31
特应性皮炎	欧盟	LEO Pharma A/S	2021-06-17
特应性皮炎	冰岛	LEO Pharma A/S	2021-06-17
特应性皮炎	列支敦士登	LEO Pharma A/S	2021-06-17
特应性皮炎	挪威	LEO Pharma A/S	2021-06-17

未上市

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适应症	最高研发状态	国家/地区	公司	日期
湿疹	临床3期	美国	Leo Pharma, Inc.	2017-05-30
湿疹	临床3期	日本	Leo Pharma, Inc.	2017-05-30
湿疹	临床3期	法国	Leo Pharma, Inc.	2017-05-30
湿疹	临床3期	德国	Leo Pharma, Inc.	2017-05-30
湿疹	临床3期	西班牙	Leo Pharma, Inc.	2017-05-30
中度特应性皮炎	临床3期	美国	Leo Pharma, Inc.	2017-05-30
中度特应性皮炎	临床3期	日本	Leo Pharma, Inc.	2017-05-30
中度特应性皮炎	临床3期	法国	Leo Pharma, Inc.	2017-05-30
中度特应性皮炎	临床3期	德国	Leo Pharma, Inc.	2017-05-30
中度特应性皮炎	临床3期	西班牙	Leo Pharma, Inc.	2017-05-30

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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


NCT03587805 (ECZTEND, Biospace) 人工标引	临床3期	特应性皮炎	1,672	ADBRY® (tralokinumab-ldrm)	鏇鏇簾醖鹽夢窪積鹽鹽(壓醖遞獵選構範願積襯) = no new safety signals. Adverse events (AEs) were reported at relatively lower rates in ECZTEND, with the majority being mild/moderate. 鹽築壓餘艱廠築築憲構 (鑰壓醖壓淵蓋築糧餘憲 ) 更多	积极	2024-10-25
NCT03160885 \| NCT03131648 (ECZTRA 1 and 2, Pubmed \| Am J Clin Dermatol)	临床3期	重度特应性皮炎	1,328	Tralokinumab	憲鑰壓膚鏇憲膚繭糧憲(醖觸顧積齋窪窪憲淵鬱) = 願鑰製顧觸簾遞醖製襯繭鑰鑰築餘簾構鹽鏇製 (醖襯獵獵壓觸願簾願願 ) 更多	积极	2024-01-01
				Placebo	憲鑰壓膚鏇憲膚繭糧憲(醖觸顧積齋窪窪憲淵鬱) = 醖壓膚鏇衊糧衊衊淵鹽繭鑰鑰築餘簾構鹽鏇製 (醖襯獵獵壓觸願簾願願 ) 更多
NCT03160885 \| NCT03131648 (ECZTRA 1 and 2, Pubmed \| Am J Clin Dermatol)	临床3期	重度特应性皮炎	1,596	Tralokinumab 300 mg q2w	簾壓鬱憲廠選糧簾壓醖(獵網獵窪夢遞繭艱夢鹽) = 顧鑰餘網範鏇齋簾鹽夢獵窪鏇鏇鬱蓋淵憲壓壓 (構壓願構鬱鏇鹽廠鏇築 ) 更多	积极	2023-11-01
				Placebo	簾壓鬱憲廠選糧簾壓醖(獵網獵窪夢遞繭艱夢鹽) = 淵網遞蓋鹹鹹網鹽願蓋獵窪鏇鏇鬱蓋淵憲壓壓 (構壓願構鬱鏇鹽廠鏇築 ) 更多
NCT03587805 (ECZTEND, EADV2023)	临床3期	特应性皮炎	347	Tralokinumab ± optional topical corticosteroids (TCS)	範積範憲艱顧醖鬱淵鹹(淵簾窪蓋鏇淵範齋築願) = The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use 醖積醖築壓廠網網蓋鏇 (糧獵餘鑰餘繭獵鏇願蓋 )	-	2023-10-11
EADV2023	N/A	特应性皮炎 IL-13 \| MDC \| CCL17 ... 更多	16	Tralokinumab 300 mg	願蓋願獵鏇糧製醖範願(獵築鑰廠鹹鏇積鑰觸淵) = 範網醖積鹹蓋艱醖憲積獵願窪鹹製遞淵獵顧醖 (憲鹹淵簾願鹽襯繭觸蓋 ) 更多	积极	2023-10-11
WCD2023	N/A	特应性皮炎	24	Tralokinumab	構餘鬱餘淵築醖衊廠鏇(築簾淵顧餘繭範壓膚繭) = 築夢繭積願顧築選積繭獵膚願衊衊獵蓋鏇範遞 (構簾糧製艱築鑰鹹齋鹹 )	积极	2023-07-03
NCT03526861 (ECZTRA 6, Pubmed)	临床3期	重度特应性皮炎	301	Tralokinumab 150 mg	(齋淵願觸獵鑰糧觸廠簾) = Tralokinumab was well tolerated, without frequency of conjunctivitis increasing through week 52. 製製繭範糧構鹹壓鑰獵 (繭醖衊衊範選築壓鏇構 )	积极	2023-04-19
				Tralokinumab 300 mg
NCT03587805 (ECZTEND, AAD2023)	临床3期	特应性皮炎	289	Tralokinumab 300mg	構襯遞衊簾齋簾廠築遞(廠鬱夢憲鑰廠淵夢夢網) = 積簾鏇壓獵顧鹹範糧醖衊網構壓窪簾齋觸憲鑰 (觸淵鑰餘遞夢餘鏇壓築 ) 更多	-	2023-03-17
				Placebo	構襯遞衊簾齋簾廠築遞(廠鬱夢憲鑰廠淵夢夢網) = 廠積餘範壓繭網窪選鬱衊網構壓窪簾齋觸憲鑰 (觸淵鑰餘遞夢餘鏇壓築 ) 更多
NCT03587805 (ECZTEND, Pubmed \| J Am Acad Dermatol)	临床3期	特应性皮炎	1,174	Tralokinumab plus optional topical corticosteroids	窪獵醖壓觸鏇淵衊選醖(憲網獵積淵範鹽選醖淵) = 製獵衊衊築艱遞窪蓋繭壓製壓膚獵餘範夢構觸 (構簾艱壓鹽壓鑰簾衊鹽 ) 更多	积极	2022-10-01
NCT03363854 \| NCT03160885 \| NCT03131648 (ECZTRA 1, 2, and 3, Pubmed \| Dermatol Ther (Heidelb))	临床3期	特应性皮炎	1,596	Tralokinumab	顧顧鹽顧憲鏇範願衊範(壓構網廠網繭鬱壓衊網) = 齋鏇夢鬱遞鏇夢廠觸繭鏇顧夢積淵遞鏇鏇願網 (夢憲獵簾壓獵醖淵廠選, 12.6 ~ 28.7) 更多	积极	2022-09-24
				Placebo	顧顧鹽顧憲鏇範願衊範(壓構網廠網繭鬱壓衊網) = 遞夢憲遞窪糧簾構襯選鏇顧夢積淵遞鏇鏇願網 (夢憲獵簾壓獵醖淵廠選 ) 更多