An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects

The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.

开始日期2024-08-06

申办/合作机构

Amgen, Inc.

NCT06527404

/ Recruiting临床3期

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

开始日期2024-07-18

申办/合作机构

Amgen, Inc.

NCT06376045

/ Recruiting临床2期

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

开始日期2024-05-24

申办/合作机构

Amgen, Inc.

100 项与 Rocatinlimab 相关的临床结果

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100 项与 Rocatinlimab 相关的转化医学

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100 项与 Rocatinlimab 相关的专利（医药）

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项与 Rocatinlimab 相关的文献（医药）

2025-02-01·The Journal of clinical and aesthetic dermatology

Investigating Efficacy of Atopic Dermatitis Systemic Therapeutics After Discontinuation Part I: Biologics.

Review

作者: Al-Tariq, Kabir ; Kaiser, Michael ; Del Rosso, James ; Issa, Naiem T ; Abdin, Rama ; Kwatra, Shawn ; Jaalouk, Dana

Objective:

The authors sought to review published literature on the efficacy of biologics as monotherapy for atopic dermatitis (AD) following discontinuation.

Methods:

A comprehensive search of PubMed/MEDLINE was conducted examining drug withdrawal in AD clinical trials where participants were treated with biologics. Trials were included if they exclusively involved participants with AD that reported the maintenance or achievement of Eczema Area and Severity Index (EASI)-75 and Investigator Global Assessment (IGA) scores of 0 or 1 after withdrawal of biologic therapy. Clinical trials involving multidrug regimens, including those investigating concomitant topical therapeutics, were excluded from our analysis.

Results:

Five clinical trial programs met our inclusion criteria, each investigating a different biologic: dupilumab, tralokinumab, lebrikizumab, amlitelimab, and rocatinlimab.

Limitations:

Limitations to this review include a small number of trials that met the inclusion criteria, variations in study design that hinder direct comparisons, and the absence of long-term follow up data.

Conclusion:

The variability in eligibility criteria, treatment durations, and withdrawal periods across trials presents a major challenge in assessing biologics for AD, complicating the comparison of their sustained responses in the absence of head-to-head studies. This heterogeneity, combined with factors such as disease duration and prior use of systemic medications before trial enrollment, hampers the identification of key pathways in AD pathogenesis and impedes efforts to better understand and characterize the disease.

2025-01-22·Immunotherapy

ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis

Article

作者: Hercogová, Janá Tresnak ; Bissonnette, Robert ; Charuworn, Prista ; Mano, Hirotaka ; Luna, Paula C. ; Wang, Andrea ; Simpson, Eric ; Guttman-Yassky, Emma ; Worm, Margitta ; Arai, Takahiro ; Spelman, Lynda ; Kricorian, Gregory ; Kabashima, Kenji ; Eichenfield, Lawrence F. ; Esfandiari, Ehsanollah

Atopic dermatitis (AD) is a chronic inflammatory disease affecting ~ 10% of adults and ~ 20% of children globally. Many patients with moderate-to-severe AD receiving systemic therapies, including biologics and Janus kinase (JAK) inhibitors, fail to reach or maintain treatment goals due to lack of durable response or safety/tolerability issues. Rocatinlimab is a T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. ROCKET, a large, global phase 3 program of eight clinical trials (NCT05398445; NCT05651711; NCT05724199; NCT05899816; NCT05704738; NCT05633355; NCT05882877; NCT06224192), will evaluate the efficacy, durability of response, and long-term safety of rocatinlimab as monotherapy and combination therapy in adult and adolescent patients with moderate-to-severe AD with or without prior exposure to biologics or systemic JAK inhibitors.

2024-12-01·Dermatology and Therapy

Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study

Article

作者: Guttman-Yassky, Emma ; Igawa, Ken ; Nixon, Annabel ; Rylands, Angela J ; Simpson, Eric ; Kabashima, Kenji ; Williams, Angela ; Dent, Jennifer E ; Dent, Jennifer E. ; Gooderham, Melinda ; Esfandiari, Ehsanollah ; Rylands, Angela J.

INTRODUCTION:

In adults with moderate-to-severe atopic dermatitis (AD), rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo. This post hoc analysis of a phase 2b study was undertaken to understand the disease burden and to assess the impact of rocatinlimab on patient-reported outcomes (PROs).

METHODS:

This analysis used baseline data from a multicenter, randomized, double-blind study of adults with moderate-to-severe AD, who completed a Worst Pruritus numerical rating scale (NRS), Sleep Disturbance NRS, and the Dermatology Life Quality Index (DLQI). A mixed model for repeated measures was used to estimate changes in PRO scores from baseline; scores were also compared with clinically meaningful change benchmarks.

RESULTS:

The analysis included 267 subjects, mean (SD) age 37.9 (14.7) years, 40.8% female; 55.1% grade 3 and 44.9% grade 4 Investigator Global Assessment for AD. Mean (SD) scores were: Worst Pruritus NRS 7.5 (1.9), Sleep Disturbance NRS 5.5 (2.9), DLQI total score 12.6 (7.1). Worst Pruritus and Sleep NRS scores had low positive correlations with SCORing AD (SCORAD) score (r = 0.44, r = 0.45 respectively) and negligible correlations with Eczema Area and Severity Index (EASI) score and area affected (r < 0.30). DLQI score varied by sex, study country, race, age, longer disease duration, disease severity (EASI and SCORAD), presence of asthma, and Worst Pruritus NRS, Sleep disturbance NRS, and DLQI scores. Rocatinlimab showed benefit on all three PROs, with significant improvements from baseline at the end of the double-blind period (week 18) and active treatment extension (week 36). Benefits were maintained over 20 weeks' post-treatment follow-up. The benefit of rocatinlimab treatment on PROs is rapid and maintained for at least 20 weeks following treatment completion.

CONCLUSION:

This analysis demonstrates the importance of characterizing the burden of moderate-to-severe AD from the patient's perspective, alongside clinical disease measures, to develop a fuller picture of treatment benefit.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT03703102.

120

项与 Rocatinlimab 相关的新闻（医药）

2025-07-29

·PRNewswire

Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress

PRINCETON, N.J. and TOKYO, July 29, 2025 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025. AD, a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T-cell-dependent inflammatory pathways. Expansion of OX40R+ pathogenic T cells leads to T-cell imbalance, a root cause of inflammatory diseases including AD. Title: Efficacy & Safety of OX-40 Receptor Targeting with Rocatinlimab in Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET-IGNITE Trial Presenter: Emma Guttman-Yassky, MD, PhD Date: Friday, September 19th Time: 4:40 – 4:50 pm CEST Session: FC 08 Atopic Dermatitis Location: Paris Convention Centre, Pavillon 7.3, Room W05-W06 About the ROCKET Phase 3 Program ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens. About Moderate to Severe Atopic Dermatitis Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life. More than half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection. Atopic dermatitis (all severities) affects 15-20% of children and up to 10% of adults. T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms. About Rocatinlimab Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for the treatment of moderate to severe atopic dermatitis. Rocatinlimab has the potential to be the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. Rocatinlimab is also being studied for prurigo nodularis, moderate to severe uncontrolled asthma and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology. Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: . Amgen and Kyowa Kirin Collaboration On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. CONTACT: Kyowa Kirin Hiroki Nakamura: Japan Corporate Communications Department [email protected] Subrenie Thomas-Smith: North America Sr. Director, R&D Patient Engagement & Communications [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期引进/卖出

2025-07-29

·生物制品圈

OX40/OX40L靶点：折戟于肿瘤，崛起于自免

五年前，当辉瑞、罗氏相继宣布终止OX40激动剂研发时，整个OX40靶点研发笼罩在悲观情绪中。谁也没想到，这个肿瘤领域的“弃子”，如今在在特应性皮炎等自免疾病中焕发新生。2021年赛诺菲以14.5亿美元收购Kymab从而将Amlitelimab收入囊中；安进则通过4亿美元首付和8.5亿美元里程碑付款，引进了Rocatinlimab——MNC真金白银的押注背后，OX40靶点正上演一场华丽的科学逆袭。要点速览：● 备受期待的OX40靶点在肿瘤领域接连受挫，自免领域取得良好进展；● 当前证据表明抑制OX40/OX40L信号轴治疗AD患者具有有效性和安全性；● 安进和赛诺菲的OX40抑制剂均已启动3期临床，首款OX40药物有望2026年前获批。 01 免疫系统的“油门”，OX40的独特定位在免疫治疗界，OX40（CD134）有个响亮的绰号——“免疫油门”。与PD-1这类“松开刹车”的检查点抑制剂不同，OX40属于共刺激分子，能主动激活T细胞，增强免疫应答。图1 OX40-OX40L 相互作用建立了一个重要的共刺激途径从分子结构看，OX40是肿瘤坏死因子受体（TNFR）超家族成员，主要在活化的CD4+和CD8+T细胞上表达。当它与抗原呈递细胞上的配体OX40L结合时，会形成三聚体结构，激活下游2条关键通路：图2 OX40-OX40L连接激活NF-κB1和PI3K-PKB/Akt通路①NF-κB1通路：促进T细胞增殖和存活②PI3K/Akt通路：抑制细胞凋亡这种独特的双向调节能力让OX40与众不同：既能增强效应T细胞的抗肿瘤活性，又能抑制调节性T细胞（Treg）的免疫抑制作用。一位免疫学家形象地比喻：“它像免疫交响乐的指挥棒，既能调动弦乐部（效应T细胞）激情演奏，又能让铜管部（Treg）适时安静。” 02 肿瘤战场折戟，为何“油门”失效？2019年，OX40抗肿瘤领域遭遇寒流。辉瑞宣布终止OX40激动PF-04518600研发，其1期临床客观缓解率仅为5.8%，多数患者毫无响应。紧随其后，罗氏、BMS、GSK、阿斯利康等巨头纷纷放弃在研OX40激动剂。分析失败根源，问题出在两方面：①疗效不足：单药缓解率普遍低于10%，联合PD-1抑制剂效果也差强人意。②安全性挑战：过度激活免疫系统可能引发细胞因子风暴，药企为保安全不得不降低抗体活性，反而削弱疗效。因此，不要低估T细胞激活的精密调控机制，猛踩油门不一定跑得更快，还可能烧坏引擎。 03 自免领域破局，特应性皮炎成突破口戏剧性转折发生在自身免疫领域。研究者发现：阻断OX40/OX40L通路可改善自身抗原特异性T细胞反应，降低免疫过度激活。特应性皮炎（AD）成为首要突破口。特应性皮炎（AD）是最常见的炎症性皮肤病，影响全球近20%的儿科人口、15%的青少年和10%的成年人。AD是由皮肤屏障破坏和T1淋巴细胞依赖性炎症途径功能障碍驱动的，且已在AD患者病变皮肤的T淋巴细胞上特异性观察到OX40表达。图三种药物OX40抑制剂的治疗模型已在中度至重度AD患者中进行了临床试验（图1），使用了1种OX40L抗体（amlitelimab（KY1005）-Sanofi）和2种OX40抗体（rocatinlimab（AMG451/KHK4083）-Amgen、telazorlimab（GBR830）-IchnosSciencesSA），均观察到积极的结果，说明靶向OX40/OX40L共刺激途径的提供了一种有前途的治疗方法。3.1 Amlitelimab进度最快，具有良好的疗效和耐受性Amlitelimab（KY1005）是一种非消耗性人IgG4单克隆抗体（mAb），可与OX40L结合，有效阻断OX40刺激，随后阻碍T细胞介导的炎症反应。其对AD的影响已在1期、2a期和2b期试验中进行了研究。①1期临床研究证明Amlitelimab通过了安全性、耐受性和免疫原性考验。②2a期临床研究发现，在第16周时，低剂量组（LD，200 mg负荷剂量，100 mg维持剂量）和高剂量组（HD，500 mg负荷剂量，250 mg维持剂量）的湿疹面积和严重程度指数（EASI）评分相对于基线的平均百分比变化分别为80%和70%，而安慰剂组为49%。此外，接受LD或HD Amlitelimab的患者分别有44%和37%的患者评分达到的IGA 0/1（即皮损基本清除或几乎清除），而安慰剂组只有8%的患者评分达到了IGA 0/1。接受Amlitelimab治疗的患者血清促炎细胞因子IL-13和IL-22水平也降低。③2b期临床研究，在最初的24周治疗期间，与安慰剂相比，四种剂量组的EASI百分比变化均显示出统计学上的显著改善，-32.1%，-27.3%，-22.2%，-30.2%。Amlitelimab在所有剂量组中均具有良好的耐受性，但未报道TEAE的具体细节。本研究的第二部分正在进行中，将进一步评估Amlitelimab至第52周的效果。此外，目前正在开发2期长期扩展研究（NCT05492578，NCT05769777）和3期研究（NCT06130566），以更好地理解该药物在中度至重度AD中的作用。表1 Amlitelimab治疗中度至重度特应性皮炎患者的临床试验总结Q2W，每 2 周一次;Q4W，每 4 周一次。3.2 Rocatinlimab表现亮眼，效果不劣于明星药物度普利尤单抗Rocatinlimab是一种非岩藻糖基化的抗OX40单克隆IgG1抗体，可抑制并减少OX40+T细胞的数量。其在AD中的疗效已在1期和2b期试验中进行了评估。①1期临床研究显示，从基线到第22周，EASI评分降低了74%，35%的患者在第22周评分达到IGA 0/1。②2b期临床研究中，与安慰剂相比，所有Rocatinlimab剂量组从基线到第16周的EASI评分降低幅度显著（48-61% VS 15%）。到第36周，300 mg Q2W组显示EASI降低88%，IGA 0/1和EASI75分别增加到52%和64%。值得注意的是，在第36周停止治疗后，当时达到EASI75的患者中只有4-27%在第56周时出现复发。生物标志物调节和耐受性支持其作为AD持久和安全治疗方法的潜力。Rocatinlimab目前正在进行综合3期ROCKET计划。表2 Rocatinlimab治疗中度至重度特应性皮炎患者的临床试验总结Q2W，每 2 周一次;Q4W，每 4 周一次。3.3 Telazorlimab可能因为副作用而面临中止Telazorlimab（GBR830/ISB830）是一种针对OX40的人源化IgG1中和单克隆抗体，可阻断其与OX40L的相互作用，在AD患者的2a期和2b期试验中进行了评估。①2a期试验（n=62）中，头痛是两组中最常见的不良事件。与安慰剂相比，Telazorlimab组术后感染和肌痛发生率更高（9% VS 0%和7% VS 0%）。次要终点包括EASI 评分（EASI50）至少改善50%的患者比例，与安慰剂相比，接受Telazorlimab的患者达到EASI50 的比例更高（76.9% VS 37.5%）。②2b期试验（n=462）显示，在第16周时，与安慰剂相比，接受Telazorlimab 300 mg Q2W（第1部分）和600 mg Q2W（第2部分）患者的EASI显著改善（第1部分：-54.4% VS -34.2%；第2部分：-59.0% VS -41.8%）。TEAE在各组间分布相似（66% VS 61.7%），鼻咽炎、上呼吸道感染和头痛是最常见的不良事件。尽管目前尚无正在进行的或计划中的Telazorlimab治疗AD的试验，但其开发可能会继续用于类风湿性关节炎或其他自身免疫性疾病。表3 Telazorlimab治疗中度至重度特应性皮炎患者的临床试验总结Q2W，每 2 周一次;Q4W，每 4 周一次OX40抗体（rocatinlimab、telazorlimab）或OX40L（amlitelimab）在中度至重度AD中的早期临床试验结果令人鼓舞，凸显了靶向OX40通路作为治疗AD的新治疗方法的潜力。小结虽然以上发现表明OX40/OX40L抑制剂有可能改变AD的病程，国内药企也闻风而动，如信达生物的抗OX40L单克隆抗体处于临床1期阶段，华东制药的OX40L&TNF-α双抗处于临床1/2期，但仍需要进一步研究。患者群体较多且随访期较长的3期试验对于全面评估其长期疗效、安全性、耐受性以及确定最佳给药方案和给药途径至关重要。其次，由于OX40激动剂目前正在早期癌症临床试验中进行测试，因此在未来的研究中应排除潜在的免疫肿瘤学影响，解决长期安全性问题。此外，不少论文已提出对其他自免疾病（如牛皮癣、斑秃、天疱疮、哮喘、溃疡性结肠炎、克罗恩病和移植物抗宿主病）的潜在治疗作用，工业界正在摩拳擦掌兑现OX40/OX40L靶点价值。主要参考文献 1.Valenzuela F, Meza V. OX40/OX40L as a Therapeutic Target in Atopic Dermatitis: A Scoping Review. Biologics. 2025 May 2;19:281-288. doi: 10.2147/BTT.S511125. PMID: 40331215; PMCID: PMC12054532.2.Sadrolashrafi K, Guo L, Kikuchi R, Hao A, Yamamoto RK, Tolson HC, Bilimoria SN, Yee DK, Armstrong AW. An OX-Tra'Ordinary Tale: The Role of OX40 and OX40L in Atopic Dermatitis. Cells. 2024 Mar 28;13(7):587. doi: 10.3390/cells13070587. PMID: 38607026; PMCID: PMC11011471.3.Licata, Gaetano et al. “Emerging Therapies in the Treatment of Prurigo Nodularis: Biological Therapy and Systematic Review of Literature.” Dermatology and therapy, 10.1007/s13555-025-01437-8. 15 May. 2025, doi:10.1007/s13555-025-01437-84.Stephan Weidinger, Thomas Bieber et al. Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial, British Journal of Dermatology, Volume 189, Issue 5, November 2023, Pages 531–539, https://doi.org/10.1093/bjd/ljad2405.Guttman-Yassky, Emma et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. The Lancet, Volume 401, Issue 10372, 204 - 214识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

临床1期临床3期临床结果免疫疗法临床终止

2025-07-22

·药研网

多面手OX40：炎症、自免、肿瘤治疗新希望

前言2025年7月2日，创响生物宣布，抗OX40单抗IMG-007在中重度特应性皮炎（AD）国际多中心IIb期研究（ADAPTIVE，NCT07037901）中完成首例患者给药。该2b期ADAPTIVE临床试验的顶线结果将于2026年Q4公布。随着IMG-007进入关键临床阶段，OX40这一免疫靶点再次受到关注。作为调控T细胞活化与炎症反应的关键分子，OX40正成为自身免疫与炎症性疾病治疗的重要新方向。OX40/OX40L概述OX40/OX40L相互作用在炎性疾病、自身免疫性疾病、肿瘤以及移植免疫的发生、发展中起非常重要的作用。近年来，此研究越来越受到国内外学者的关注。OX40又叫做CD134、ACT35、TNFRSF4，于1987年首次在激活的老鼠CD4+ T细胞上被发现，属于TNFR超家族的一员。OX40基因和其它几个TNFR家族的分子（TNFR2, 4-1BB, HVEM, CD30, GITR, DR3)成簇的排列在人的1号染色体上。OX40是一个由249个氨基酸组成的Ⅰ型跨膜糖蛋白，其中49个氨基酸在细胞质内，186个氨基酸在胞外区域。OX40包含了具有三个全半胱氨酸结构域（CRD）和一个部分C端CRD。图1.OX40结构展示，包含3个完整的CRD，一个残缺的CRDOX40主要在活化的CD4+ T细胞和CD8+ T细胞上表达，与其配体OX40L(也称为TNFSF4或gp34)结合后，能够有效增强T细胞的增殖和存活，对抗原及肿瘤的免疫反应产生重要影响。图2 OX40/OX40Linteraction with downstream signaling results in T cell activation, proliferation, and increased survival.OX40通过TCR、CD28/CD80、CD40/CD40L等信号在T细胞上诱导表达，并在T细胞激活后的48-72小时达到峰值。TCR信号传导可以启动多种细胞上OX40的表达，CD28和其他细胞因子可以进一步促进其在活化的T细胞上的表达。也有报道称，IL-2、IL-4和TNF可以增强或延长OX40的表达。IL-2、TNF-α和IFN-γ在非酒精性脂肪性肝炎动物模型的肝组织中高表达，但只有外源性IL-2刺激才能上调CD4+ T细胞上OX40的表达。OX40L主要在抗原递呈细胞（APCs）上表达，APC在接触抗原后的1-3天内可以检测到OX40L的表达。通过Toll样受体传递的CD40信号和炎症信号可诱导抗原提呈细胞（APCs）上OX40L的表达。IL-18、IFN-g、胸腺基质淋巴细胞生成素（TSLP）、前列腺素E2等因子也能促进OX40L的表达。除在活化B细胞、树突状细胞（DC）和巨噬细胞等专业APCs外，OX40L也在NK、肥大细胞及平滑肌细胞和血管内皮细胞上表达。OX40/OX40L信号通路OX40-OX40L信号通路的生物学作用是增强T细胞受体（TCR）对T细胞的激活信号。图3. OX40/OX40L 相互作用模型缩写：Th2（辅助性T细胞2）、NK（自然杀伤细胞）、TCR（T细胞受体）、MHC（主要组织相容性复合体）、APC（抗原提呈细胞）OX40L是三聚体，每个OX40L与三个OX40分子结合。OX40/OX40L信号可通过PI3K-PKB/AKT、活化T细胞核因子（NFAT）和NF-κB等途径启动下游系列信号途径。OX40/OX40L信号对这些途径的持续激活导致部分抗凋亡B淋巴细胞瘤-2 基因（B-cell lymphoma-2，Bcl-2）家族成员（如 Bcl-xL、Bcl-2 和 Bfl-1）及调节细胞分裂分子上调，从而介导细胞因子及T细胞活化和增殖。OX40/OX40L 存在逆向信号转导，其逆向信号可通过调节胞内游离钙离子水平参与内皮细胞中基质金属蛋白酶 9（matrix metalloprotein 9，MMP-9）表达调控。此外，OX40/OX40L 的逆向信号则能促进 DCs成熟及B细胞活化，并促进生发中心（Ger-minal centers，GCs）形成和 DCs 分化成熟，使B细胞产生高效价抗体及抗体类别转换。图5.OX40下游信号通路吉满生物提供OX40/OX40L靶点相关细胞系、蛋白和抗体产品，满足抗体筛选、一致性评价等多场景应用，助力药企高效推进临床申报进程。（咨询吉满客服联系同微信：18916119826）吉满生物拥有HEK293、Jurkat E6.1 和 CHO-K1 等细胞商业使用授权，并提供全面的溯源文件，使我们的合作伙伴能够从临床前开发到 IND/BLA 阶段进行合规研究——帮助减轻法律风险并加速商业化进程。OX40与疾病治疗肿瘤治疗中的OX40作用OX40信号可增强T细胞存活和免疫活性，提升肿瘤特异性T细胞应答与记忆形成。研究显示，OX40单药疗效有限，联合其他免疫疗法可显著增强抗肿瘤效果，是当前重要的研究方向。自身免疫与炎症调控OX40/OX40L通路在多种自身免疫疾病中活跃，阻断该通路可减轻免疫过度激活，已在SLE、RA、IBD、1型糖尿病等疾病模型中展现治疗潜力。同时，该通路也与特应性皮炎等炎症性疾病密切相关，具备靶点价值。OX40相关药物进展目前正在针对OX40或OX40L自免领域的临床试验中，进度较快的分别是安进/协和麒麟的Rocatinlimab(首个成功完成III期研究)，以及赛诺菲的amlitelimab（临床III期）以及Ichnos Sciences靶向OX40的Telazorlimab（临床II期）。还有一些目前处于I期临床的靶向OX40/OX40L的药物，如IMG-007（和黄医药/创响生物），IBI356 (信达生物)，APG990 (Apogee Therapeutics)等。RocatinlimabRocatinlimab是一种创新的全人源化抗OX40单克隆抗体，安进通过与协和麒麟（Kyowa Kirin）达成一项高达12.5亿美元的合作，以共同开发和商业化该产品。2025年3月8日，安进和协和麒麟共同宣布抗OX40单抗Rocatinlimab，治疗特应性皮炎的两项III期研究（ROCKET-IGNITE和ROCKET-SHUTTLE）达到主要终点。该药物是第一款顺利完成III期研究的抗OX40单抗，并且已经连续在3项III期研究中取得积极数据，有望成为全球首个上市获批的OX40单抗。AmlitelimabAmlitelimab是一款靶向OX40L的全人源非清除性单克隆抗体，能够阻断OX40L，相比直接作用于OX40具备优势。该药目前在特应性皮炎和哮喘适应症上处于临床IIb期阶段。4月15日，赛诺菲宣布Amlitelimab治疗哮喘的II期TIDE-Asthma研究未达到48周年化恶化率主要终点，但在异质性炎症性哮喘亚组中表现出令人信服的疗效。不过虽然没有达到统计学显著差异，治疗60周仍然表现出数字上的降低，赛诺菲仍在计划推进Amlitelimab的哮喘三期临床。IMG-007国内企业中，创响生物自主研发的IMG-007在特应性皮炎患者中的临床IIa期研究中取得积极顶线结果：经IMG-007 治疗第16周，EASI评分较基线平均下降了77%，并且54%的患者达到了EASI-75的改善标准。该疗效表现与其他靶向OX40/OX40L的研究性单克隆抗体在较长治疗周期中的疗效相当。2025年7月创响生物宣布，抗OX40单抗IMG-007在中重度特应性皮炎（AD）国际多中心IIb期研究（ADAPTIVE，NCT07037901）中完成首例患者给药,该试验的顶线结果将于2026年第四季度公布。总结OX40靶点的快速崛起，标志着自身免疫治疗正从传统的“下游通路抑制”迈向“上游免疫调控”。在特应性皮炎领域，中外药企正围绕OX40形成对IL-4Rα路径（代表药物为度普利尤单抗）的有力挑战格局。若OX40类药物能在长期安全性与患者依从性方面持续验证其优势，有望重塑治疗范式，推动自免治疗迈入“去IL-4Rα化”新阶段。吉满生物吉满生物深耕 OX40/OX40L 靶点，赋能创新药研发全流程，提供全面、高质、可靠的研究工具产品线，包括：靶点相关细胞系：适用于药物功能筛选、活性评价、药效学研究及信号通路验证。高活性重组蛋白：满足结合分析、筛选及免疫研究需求。高特异性抗体：提供经严格验证的抗体产品，支持流式细胞术、ELISA 等多种检测应用，确保实验结果准确可靠。（咨询吉满客服联系同微信：18916119826）今年我们还成功获得了HEK293、Jurkat E6.1、CHO-K1 等细胞商业使用授权，提供全面的溯源文件，赋能合作伙伴从临床前开发到IND/BLA 阶段进行合规研究，帮助客户规避法律风险并加速商业化进程。产品列表数据展示GM-C18986 H_OX40 CHO-K1 Cell Line使用GM-23373AB：Anti-H_OX40 hIgG2 Antibody(Ivuxolimab)流式验证GM-C35016 H_OX40L CHO-K1 Cell Line使用GM-82533AB：Anti-OX40L hIgG4 Antibody(Amlitelimab)流式验证GM-C30855 H_OX40 Reporter Cell Line使用Human OX40L Protein蛋白激活验证GM-C36735 H_OX40 Reporter DDX35™ Cell Line使用Human OX40L Protein蛋白激活验证GM-87515RP Human OX40 Protein; His Tag ELISA验证联系我们吉满生物(Genomeditech)成立于2011年，是专业从事生物科技服务和前沿技术研发的高新技术企业。吉满生物专注为生物药开发赋能，自主创立了国内知名的细胞系品牌-DDXCELL，目前已布局近400个热门靶向药靶点，超1000株现货单克隆细胞系，涵盖GPCR、细胞因子、免疫检查点、TAA等多领域，做到进口细胞的国产替代。此外，吉满生物还可在药物研发进程中提供一系列抗体、蛋白产品，旨在为客户提供高效的研发工具和解决方案!扫码咨询扫码找现货参考文献：1.https://scispace.com/pdf/ox40-ox40-ligand-and-its-role-in-precision-immune-oncology-339j8l9m3a.pdf2.https://www.amgen.com/newsroom/press-releases/2025/03/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-with-moderate-to-severe-atopic-dermatitis3.https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-30613684.https://inmagenebio.com/press-release/inmagene-reports-positive-topline-results-of-img-007-a-nondepleting-anti-ox40-monoclonal-antibody-with-an-extended-half-life-for-the-treatment-of-atopic-dermatitis/

临床1期临床2期临床终止

100 项与 Rocatinlimab 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
结节性痒疹	临床3期	美国	Amgen, Inc.	2024-07-08
中度特应性皮炎	临床3期	美国	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	中国	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	日本	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	阿根廷	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	巴西	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	加拿大	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	克罗地亚	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	捷克	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	德国	Amgen, Inc.	2022-05-31

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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


NCT05724199 (ROCKET-SHUTTLE, Company_Website) 人工标引	临床3期	重度特应性皮炎	746	Rocatinlimab higher dose + TCS/TCI	積憲願願壓鏇醖遞淵構(齋膚構憲鹽構築願鏇膚) = 積選範願齋簾襯憲鑰鏇網夢鑰艱夢齋憲蓋選遞 (醖鑰簾遞壓簾遞選憲鏇 ) 达到更多	积极	2025-03-08
				Rocatinlimab lower dose + TCS/TCI	積憲願願壓鏇醖遞淵構(齋膚構憲鹽構築願鏇膚) = 鑰糧襯願醖醖襯遞獵廠網夢鑰艱夢齋憲蓋選遞 (醖鑰簾遞壓簾遞選憲鏇 ) 达到更多
NCT05398445 (ROCKET-IGNITE, Company_Website) 人工标引	临床3期	特应性皮炎	769	Rocatinlimab higher dose	醖獵壓餘鹽醖獵觸製願(鬱製鬱醖憲製糧夢鹽衊) = 廠鏇製蓋糧膚蓋廠鑰積齋蓋艱鹽淵壓夢蓋膚遞 (襯餘窪醖鹽鹹簾選餘製 ) 达到更多	积极	2025-03-08
				Rocatinlimab lower dose	醖獵壓餘鹽醖獵觸製願(鬱製鬱醖憲製糧夢鹽衊) = 築壓顧襯鹽襯齋範蓋觸齋蓋艱鹽淵壓夢蓋膚遞 (襯餘窪醖鹽鹹簾選餘製 ) 达到更多
NCT05651711 (ROCKET HORIZON, Corporate Publications) 人工标引	临床3期	特应性皮炎	726	Rocatinlimab	膚鏇壓醖鹽築鏇艱遞鹹(願簾蓋餘蓋積壓鹽壓憲) = 膚醖壓繭觸鹹鹽網壓築窪觸窪膚製製夢製壓範 (獵簾糧憲襯淵願鏇觸鹽 ) 达到更多	积极	2024-09-25
				Placebo	膚鏇壓醖鹽築鏇艱遞鹹(願簾蓋餘蓋積壓鹽壓憲) = 艱憲淵鹽製膚鏇襯蓋衊窪觸窪膚製製夢製壓範 (獵簾糧憲襯淵願鏇觸鹽 ) 达到更多
NCT05651711 (ROCKET HORIZON, Company_Website) 人工标引	临床3期	重度特应性皮炎	726	Rocatinlimab	遞鹹鹹襯艱襯淵淵餘願(遞積鬱艱製積網鹽鹹窪) = 繭顧餘鑰繭衊夢衊築願願鑰齋鹹餘憲襯壓衊憲 (製鬱糧鑰鏇襯願獵齋鹹 ) 达到更多	积极	2024-09-25
				Placebo	遞鹹鹹襯艱襯淵淵餘願(遞積鬱艱製積網鹽鹹窪) = 構鹽醖餘廠簾範糧艱築願鑰齋鹹餘憲襯壓衊憲 (製鬱糧鑰鏇襯願獵齋鹹 ) 达到更多
NCT03703102 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	274	KHK4083 (KHK4083 150 mg SC Q4W)	蓋蓋糧廠淵鹹醖鏇鑰餘(繭憲鬱繭膚襯襯膚襯顧) = 壓廠觸餘觸簾衊鹽淵構築願齋蓋艱積壓廠範膚 (繭窪餘糧鹽鑰構簾淵憲, 構醖淵選製製簾衊選鬱 ~ 觸鹹齋遞糧繭齋獵鬱選) 更多	-	2022-06-09
				KHK4083 (KHK4083 600 mg SC Q4W)	蓋蓋糧廠淵鹹醖鏇鑰餘(繭憲鬱繭膚襯襯膚襯顧) = 選構簾積獵廠願遞簾範築願齋蓋艱積壓廠範膚 (繭窪餘糧鹽鑰構簾淵憲, 觸網鑰淵廠窪廠鏇範顧 ~ 鬱膚鑰齋醖遞餘鬱壓醖) 更多
NCT02647866 (CTgov)	临床2期	腹痛 \| 溃疡性结肠炎	66	KHK4083 (KHK4083 Cohort 1)	餘選鹹構構廠選繭壓餘 = 築淵艱顧鏇糧構蓋衊簾繭鏇膚窪獵膚鏇膚製淵 (齋糧積醖選繭憲製積襯, 醖齋淵積築範壓餘鑰獵 ~ 獵網積壓淵鬱艱製範鏇) 更多	-	2020-03-05
				KHK4083 (KHK4083 Cohort 2)	餘選鹹構構廠選繭壓餘 = 願選齋壓簾淵衊鏇夢壓繭鏇膚窪獵膚鏇膚製淵 (齋糧積醖選繭憲製積襯, 壓襯壓鏇製糧簾選繭選 ~ 蓋鹽願鹹積壓衊襯觸壓) 更多