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更新于：2025-10-11
Telazorlimab
更新于：2025-10-11
概要
基本信息
非在研机构 |
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 181288H
来源: *****
Sequence Code 181308L
来源: *****
关联
5
项与 Telazorlimab 相关的临床试验NCT03568162
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
NL-OMON44196
A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects - GBR 830 SAD and MAD study
NL-OMON42954
An open-label, single-dose, parallel-arm study to evaluate the pharmacokinetics and absolute bioavailability of GBR 830 following single dose administration by the subcutaneous (SC) route - GBR 830 pharmacokinetics, absolute bioavailability and safety study
100 项与 Telazorlimab 相关的临床结果
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100 项与 Telazorlimab 相关的转化医学
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100 项与 Telazorlimab 相关的专利（医药）
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8
项与 Telazorlimab 相关的文献（医药）2024-02-01The journal of allergy and clinical immunology. Global
Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis
Article
作者: Anstett, Victor ; Mozaffarian, Neelufar ; Sher, Lawrence D ; Pulka, Grazyna ; Rewerska, Barbara ; Martinet, Camille ; Jabert, Wafaa ; Blein, Stanislas ; Turrini, Riccardo ; Alpizar, Sady ; Macoin, Julie ; Ca, Vinu ; Doucey, Marie-Agnès ; Pauser, Sylvia ; Machkova, Martina ; Gn, Sunitha ; Konto, Cyril ; Salhi, Yacine ; Gudi, Girish
Background:
Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell-mediated diseases.
Objective:
This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis.
Methods:
In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks' blinded treatment, followed by 38 weeks' open-label treatment and 12 weeks' drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events.
Results:
The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (-54.4% vs -34.2% for part 1 and -59.0% vs -41.8% for part 2, P = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2.
Conclusion:
Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis.
2022-02-17The Journal of dermatological treatment4区 · 医学
Review and analysis of biologic therapies currently in phase II and phase III clinical trials for atopic dermatitis
4区 · 医学
Review
作者: Uppal, Shelley K. ; Wu, Jashin J. ; Han, George ; Chat, Vipawee S. ; Kearns, Donovan G.
Biologic medications are recent advances that have clinical significance in the treatment of moderate-to-severe AD. A systemic literature review was performed to examine the efficacy and safety of biologic therapies currently in phase II and phase III of clinical trials for moderate-to-severe AD. Our team searched the databases, PubMed, Google Scholar, and ClinicalTrials.gov, on September 2019 for studies pertaining to the use of biologic drugs in AD. Key words included each drug (lebrikizumab, tralokinumab, fezakinumab, etokimab, nemolizumab, tezepelumab, and GBR 830) or 'biologic drugs' or 'immunotherapies' combined with 'atopic dermatitis.' References within retrieved articles were also reviewed to identify potentially missed studies. A total of 19 articles were included in this review. Lebrikizumab, tralokinumab, fezakinumab, nemolizumab, and GBR 830 lead to statistically significant improvements in disease severity and multiple endpoint outcome scores. Tezepelumab and etokimab, however, did not demonstrate statistically significant changes in primary outcome endpoints. Further assessment of tezepelumab and etokimab are needed to assess their safety and efficacy in patients with moderate-to-severe AD. Tralokinumab, lebrikizumab, fezakinumab, nemolizumab, and GBR 830 are effective treatment options for adults with moderate-to-severe AD, but further large-scale studies are needed to confirm their efficacy as monotherapy in children with moderate-to-severe AD.
2022-02-01Allergy1区 · 医学
A mathematical model to identify optimal combinations of drug targets for dupilumab poor responders in atopic dermatitis
1区 · 医学
Article
作者: Irvine, Alan D. ; Tanaka, Reiko J. ; Miyano, Takuya
Abstract:
Background:
Several biologics for atopic dermatitis (AD) have demonstrated good efficacy in clinical trials, but with a substantial proportion of patients being identified as poor responders. This study aims to understand the pathophysiological backgrounds of patient variability in drug response, especially for dupilumab, and to identify promising drug targets in dupilumab poor responders.
Methods:
We conducted model‐based meta‐analysis of recent clinical trials of AD biologics and developed a mathematical model that reproduces reported clinical efficacies for nine biological drugs (dupilumab, lebrikizumab, tralokinumab, secukinumab, fezakinumab, nemolizumab, tezepelumab, GBR 830, and recombinant interferon‐gamma) by describing system‐level AD pathogenesis. Using this model, we simulated the clinical efficacy of hypothetical therapies on virtual patients.
Results:
Our model reproduced reported time courses of %improved EASI and EASI‐75 of the nine drugs. The global sensitivity analysis and model simulation indicated the baseline level of IL‐13 could stratify dupilumab good responders. Model simulation on the efficacies of hypothetical therapies revealed that simultaneous inhibition of IL‐13 and IL‐22 was effective, whereas application of the nine biologic drugs was ineffective, for dupilumab poor responders (EASI‐75 at 24 weeks: 21.6% vs. max. 1.9%).
Conclusion:
Our model identified IL‐13 as a potential predictive biomarker to stratify dupilumab good responders, and simultaneous inhibition of IL‐13 and IL‐22 as a promising drug therapy for dupilumab poor responders. This model will serve as a computational platform for model‐informed drug development for precision medicine, as it allows evaluation of the effects of new potential drug targets and the mechanisms behind patient variability in drug response.
12
项与 Telazorlimab 相关的新闻（医药）2025-09-22
·抗体圈
临床结果细胞疗法临床终止临床研究
2025-07-29
临床1期临床3期临床结果免疫疗法临床终止
2024-12-24
临床2期临床结果临床1期
100 项与 Telazorlimab 相关的药物交易
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外链
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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 |
|---|---|---|---|---|
| 中度特应性皮炎 | 临床2期 | 美国 | 2016-03-01 | |
| 中度特应性皮炎 | 临床2期 | 美国 | 2016-03-01 | |
| 中度特应性皮炎 | 临床2期 | 加拿大 | 2016-03-01 | |
| 中度特应性皮炎 | 临床2期 | 加拿大 | 2016-03-01 | |
| 重度特应性皮炎 | 临床2期 | 美国 | 2016-03-01 | |
| 重度特应性皮炎 | 临床2期 | 美国 | 2016-03-01 | |
| 重度特应性皮炎 | 临床2期 | 加拿大 | 2016-03-01 | |
| 重度特应性皮炎 | 临床2期 | 加拿大 | 2016-03-01 | |
| 特应性皮炎 | 临床2期 | 美国 | - | |
| 自身免疫性疾病 | 临床1期 | 荷兰 | 2014-08-20 |
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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2期 | 462 | ISB (ISB 830 300 mg q2w) | 鏇蓋鑰蓋醖夢鹽夢鬱壓(膚遞夢積願遞夢壓簾願) = 淵築選遞遞窪遞齋鑰鑰 構鹹窪積製齋壓蓋醖鑰 (選窪膚選積鏇遞觸顧積, 36.2014) 更多 | - | 2022-06-28 | ||
ISB (ISB 830 300 mg q4w) | 鏇蓋鑰蓋醖夢鹽夢鬱壓(膚遞夢積願遞夢壓簾願) = 遞鑰鑰鏇艱遞簾築憲鹹 構鹹窪積製齋壓蓋醖鑰 (選窪膚選積鏇遞觸顧積, 32.5395) 更多 | ||||||
临床2期 | 64 | (GBR 830) | 膚蓋窪窪醖鹽糧壓觸觸 = 窪蓋構積艱淵顧齋築鹽 選製鹹繭顧淵網齋遞製 (繭顧製艱糧蓋襯觸衊願, 壓膚鹽艱範築觸築製願 ~ 鏇積築構鑰遞壓網艱顧) 更多 | - | 2020-05-18 | ||
Placebo (Placebo) | 膚蓋窪窪醖鹽糧壓觸觸 = 鏇衊願積繭顧製衊鹹鏇 選製鹹繭顧淵網齋遞製 (繭顧製艱糧蓋襯觸衊願, 鏇廠鏇糧壓選艱網選繭 ~ 壓願齋醖鑰選鬱繭壓襯) 更多 | ||||||
临床2期 | 62 | 顧壓觸糧製鬱醖艱壓鹹(鏇襯衊鹹構選觸襯齋齋) = 淵襯鑰繭淵窪選餘鏇衊 憲膚構獵艱艱餘艱觸鹽 (壓積選窪獵廠衊醖淵衊 ) 更多 | 积极 | 2019-08-01 | |||
Placebo | 顧壓觸糧製鬱醖艱壓鹹(鏇襯衊鹹構選觸襯齋齋) = 夢餘膚餘構鹽襯繭醖鏇 憲膚構獵艱艱餘艱觸鹽 (壓積選窪獵廠衊醖淵衊 ) 更多 |
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