An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.

开始日期2025-08-25

申办/合作机构

Sanofi

CTR20242734

/ Recruiting临床2期

CONQUEST 治疗硬化症平台临床研究：一项评价试验药物在系统性硬化症相关间质性肺疾病受试者中的安全性和有效性的多中心、双盲、随机、安慰剂对照、IIb 期平台临床研究

本研究的主要目的是根据第 52 周治疗期结束时 FVC（mL；在 SSc-ILD 研究受试者中测量）较基线的变化来评价 IP 相比安慰剂的有效性。本研究的次要目的是评价如下内容：？根据第 52 周如下指标较基线的变化来评价 IP 相比安慰剂的有效性： o 通过高分辨率计算机断层扫描（HRCT）定量 ILD（QILD）-全肺（WL）[QILD-WL]测量的肺部受累；以及 o 通过慢性疾病治疗功能评估（FACIT）-呼吸困难评分测量的呼吸困难（严重程度和功能限制）。？第 52 周时在弥漫性皮肤型 SSc 研究受试者中通过修订版弥漫性 SSc 综合反应指数（CRISS）评分测量的总体治疗反应；以及？ IP 的安全性和耐受性。

开始日期2025-06-27

申办/合作机构

北京MEDPACE医药科技有限公司

[+2]

NCT06686628

/ Active, not recruiting临床1期

An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis

This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).
The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.

开始日期2024-11-20

申办/合作机构

Sanofi

100 项与 Amlitelimab 相关的临床结果

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100 项与 Amlitelimab 相关的转化医学

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100 项与 Amlitelimab 相关的专利（医药）

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项与 Amlitelimab 相关的文献（医药）

2025-06-01·Journal of Scleroderma and Related Disorders

Design of CONQUEST, a novel, randomized, placebo-controlled, Phase 2b platform clinical trial to investigate new treatments for patients with early active systemic sclerosis with interstitial lung disease

Article

作者: Assassi, Shervin ; Steffgen, Juergen ; Benton, Wade W ; Maher, Toby M ; Gordon, Gregory ; Maslova, Karina ; Khanna, Dinesh ; Evnin, Luke B

Objective::

Safe, effective therapies are urgently needed for patients with systemic sclerosis. However, clinical trial recruitment is challenging given the limited number of people with systemic sclerosis and further restrictions imposed by eligibility criteria. Innovative approaches are needed to accelerate development of new therapies. This article describes the rationale and trial design for CONQUEST (NCT06195072), a novel platform clinical trial sponsored by the Scleroderma Research Foundation, a not-for-profit organization.

Methods::

CONQUEST is a multicentre, double-blind, randomized, placebo-controlled, Phase 2b platform trial evaluating the efficacy, safety and pharmacodynamics of multiple investigational products to treat early active systemic sclerosis with interstitial lung disease versus placebo. The primary objective is to evaluate change from baseline to Week 52 in forced vital capacity (mL). Secondary objectives include evaluating changes from baseline to Week 52 in high-resolution computed-tomography-assessed lung involvement and dyspnoea, and overall treatment response (measured using the revised composite response index in diffuse systemic sclerosis score in participants with diffuse cutaneous systemic sclerosis).

Results::

Patients will be enrolled across more than 150 centres in over 25 countries. Recruitment started on 15 April 2024.

Conclusion::

As the first platform clinical trial in the rheumatology field, CONQUEST aims to meaningfully accelerate the development of new therapies for early active systemic sclerosis. Depending on regimen-specific results, trial data could be used to plan and design a Phase 3 trial or may be used alone or together with another registrational trial to establish substantial evidence of effectiveness and safety. The first molecules to be studied, amlitelimab and nerandomilast, both have a strong scientific rationale to modify underlying disease processes in systemic sclerosis.

ClinicalTrials.gov::

Platform Clinical Study for Conquering Scleroderma (CONQUEST); NCT06195072; https://www.clinicaltrials.gov/study/NCT06195072

2025-04-01·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis

Article

作者: Blauvelt, Andrew ; Weidinger, Stephan ; Wei, Xiaodan ; Rynkiewicz, Natalie ; Papp, Kim A ; O'Malley, John T ; Hurbin, Fabrice ; Yen, Karl ; Adelman, Samuel ; Weber, Christine ; Worm, Margitta ; Lynde, Charles ; Wong, Wanling ; Lee, Chih-Hung ; Reich, Adam ; Foley, Peter ; Bernigaud, Charlotte ; Papp, Kim A. ; Kataoka, Yoko ; Davey, Sonya ; O’Malley, John T. ; Solente, Anne-Catherine

BACKGROUND:

Amlitelimab, a fully human nondepleting mAb targeting OX40 ligand on antigen-presenting cells, could prevent T-cell-driven inflammation seen in atopic dermatitis (AD).

OBJECTIVE:

This trial evaluated the efficacy and safety of amlitelimab in adults with AD.

METHODS:

In this 2-part, phase 2b, randomized, double-blinded placebo-controlled trial (ClinicalTrials.gov identifier NCT05131477), patients received subcutaneous amlitelimab every 4 weeks at doses of 250 mg plus a 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg or placebo for 24 weeks in Part 1 (1:1:1:1:1 randomization). In Part 2, clinical responders were reallocated 3:1 to stop taking amlitelimab or continue the previous dose regimen for 28 weeks. The primary end point was percentage of change in Eczema Area and Severity Index (EASI) from baseline to week 16.

RESULTS:

In all, 390 and 190 patients enrolled in Part 1 and Part 2, respectively. A significant percentage of change decrease in EASI was observed with amlitelimab doses versus with placebo (P < .001). Clinical responses at week 24 (Investigator Global Assessment 0/1 and/or a 75% reduction in EASI) were maintained at week 52 in patients continuing or stopping amlitelimab. Of the patients maintaining clinical response at week 52 after no longer receiving treatment, more than 80% had serum amlitelimab concentrations less than the 4-μg/mL threshold for several weeks before week 52. Reductions in AD-related biomarkers during Part 1 were maintained through Part 2. Amlitelimab was well tolerated over 52 weeks.

CONCLUSIONS:

Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52. Sustained responses were observed in the majority of patients for 28 weeks after they had stopped taking amlitelimab.

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.

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项与 Amlitelimab 相关的新闻（医药）

2025-08-29

·EndPoints

FDA approves BTK inhibitor that’s key to Sanofi’s immunology strategy

The FDA approved Sanofi’s BTK inhibitor that the French drugmaker acquired in its $3.7 billion buyout of Principia Biopharma. The company said Friday that the regulators cleared rilzabrutinib in a rare disease called immune thrombocytopenia, or ITP. The drug is branded as Wayrilz. The wholesale acquisition cost for Wayrilz will be $17,500 a month, which is before discounts, rebates or patient assistance programs, a Sanofi spokesperson said. Wayrilz is part of a larger effort at Sanofi to become the leading immunology pharma company. Sanofi has unveiled or acquired a handful of programs targeting immunological conditions in recent years, and the company expects Wayrilz to produce between €2 billion and €5 billion in annual peak sales. So far, Sanofi’s strategy hasn’t always led to success. The company was forced to shelve studies of another drug from Principia called tolebrutinib in 2023 after trials were put on hold . The drug continued to be dogged by safety concerns despite positive efficacy results in a multiple sclerosis trial that read out last year. Tolebrutinib had been Principia’s lead drug at the time Sanofi acquired the company in 2020. Another program called itepekimab underwhelmed in a COPD study earlier this year. And even the path for Wayrilz has been bumpy. The drug failed an atopic dermatitis study in 2023. Sanofi’s immunology pipeline also includes amlitelimab, an OX40L drug from Kymab that’s currently in Phase 3 studies for atopic dermatitis; lunsekimig, an anti-IL-13/TSLP program with a Phase 2 readout in asthma expected next year; and frexalimab, a CD40L-targeting therapy that’s expecting Phase 2 lupus data in the second half of 2026. “Our current and evolving portfolio within immunology and immunoscience more broadly really explores the multifaceted nature of key neurologic nodes within the immune system,” Sanofi CSO Mike Quigley told Endpoints News in an interview ahead of the decision. As for Wayrilz, ITP is a rare autoimmune disorder that leads to low platelet counts and an increased risk of bleeding and bruising. Quigley estimates there are about 100,000 ITP patients in the US. In addition to ITP, Sanofi is continuing to study Wayrilz in asthma, chronic hives, IgG4-related disease and other rare diseases, though these studies are early and no readouts are expected until 2027. Editor’s note: This story was updated to add the drug’s wholesale acquisition cost.

免疫疗法并购临床3期上市批准临床2期

2025-08-02

·医学新视点

治疗肥胖、肺癌、高血脂、抑郁症等…2025下半年值得关注的十大临床试验

行业媒体BioPharma Dive近日发布专题报道，从众多在研项目中精选出10项有望在今年下半年公布结果的潜力临床试验。这些试验聚焦于肥胖症、肺癌和特应性皮炎（AD）等多个关键治疗领域，其中部分结果已陆续披露。这些研究有望为整个生物医药行业带来突破性进展，进一步推动医学创新，惠及更多患者。图片来源：123RF药物名称：Orforglipron（LY3502970）适应症：患有肥胖相关共病的肥胖或超重患者开发公司：礼来（Eli Lilly and Company）临床试验：Attain-1（NCT05869903）Orforglipron是礼来开发的一种每日一次口服、非肽类GLP-1受体小分子激动剂。该药物是一种非肽分子，这使得它更容易被制造和包装成药片。这一特性还可能有助于提高其在患者中的可负担性和可及性。ATTAIN-1是一项3期、随机、双盲临床研究，旨在评估每日一次口服orforglipron在伴有体重相关合并症的成人肥胖或超重患者中的疗效与安全性。该研究将orforglipron与安慰剂进行对比，观察其在减重方面的效果及耐受性。该试验的初步结果预计在今年第三季度公布。药物名称：Amlitelimab适应症：特应性皮炎开发公司：赛诺菲（Sanofi）临床试验：Coast-1（NCT06130566）、SHORE（NCT06224348）赛诺菲研发的amlitelimab是一款靶向OX40配体（OX40L）的单克隆抗体，相较于直接作用于OX40受体的药物，其在抑制T细胞依赖性炎症的同时，避免了对免疫细胞的清除，或可降低免疫抑制相关副作用。在一项2b期临床试验中，amlitelimab在第16周和第24周均显著改善中重度特应性皮炎患者的症状，显示出每12周给药一次的潜力，有望减轻患者的治疗负担。目前，该药正在开展多项3期临床研究，包括Coast-1和SHORE试验，进一步评估其在12岁及以上中重度AD患者中的疗效与安全性。Coast-1为三组平行设计的单药治疗研究，纳入对外用处方药应答不足或不适合继续使用外用疗法的患者；而SHORE则在外用糖皮质激素（TCS）和/或钙调神经磷酸酶抑制剂（TCI）治疗背景下，评估amlitelimab在治疗应答不足患者中的系统性治疗效果。这两项研究将为amlitelimab作为AD新型治疗方案的临床价值提供关键证据。两项试验的初步结果预计在今年第三季度公布。药物名称：Sonelokimab适应症：化脓性汗腺炎（hidradenitis suppurativa）开发公司：Moonlake Immunotherapeutics临床试验：Vela-1（NCT06411899）、Vela-2（NCT06411379）Sonelokimab是一种分子量约为40 kDa的人源化纳米抗体，由三个抗体重链可变区蛋白域共价连接组成。其中两个蛋白域可高亲和力选择性结合IL-17A和IL-17F，有效阻断IL-17A/A、IL-17A/F及IL-17F/F二聚体介导的炎症信号通路；第三个蛋白域则结合人类白蛋白，有助于药物在炎症水肿部位的富集，从而增强局部疗效。为了进一步验证其在治疗中重度化脓性汗腺炎中的临床潜力，sonelokimab目前正在开展两项3期临床研究Vela-1和Vela-2。两项研究均为多中心、随机、双盲、安慰剂对照设计，纳入中重度化脓性汗腺炎成人患者，按2：1比例随机接受每周一次的皮下注射sonelokimab或安慰剂，治疗持续至第16周，旨在系统评估其疗效与安全性，为该类难治性皮肤病提供新的治疗选择。药物名称：Ivonescimab适应症：非小细胞肺癌（NSCLC）开发公司：Summit Therapeutics、康方生物（Akesobio）临床试验：HARMONi（NCT06396065）Ivonescimab是一种靶向PD-1和VEGF的双特异性抗体，能够同时阻断PD-1与其配体PD-L1/PD-L2的结合，以及VEGF与其受体的结合，从而协同抑制肿瘤免疫逃逸和血管生成。鉴于VEGF和PD-1在肿瘤微环境中的共表达，ivonescimab通过单药双靶点机制，有望较联合疗法更有效地增强抗肿瘤活性，并显著降低与VEGF相关的不良反应，展现出更优的安全性。该药目前正在开展HARMONi临床研究，这是一项随机、双盲、多中心的3期临床试验，旨在评估ivonescimab联合培美曲塞和卡铂治疗EGFR突变型局部晚期或转移性非鳞状非小细胞肺癌患者的疗效与安全性。这些患者此前已接受EGFR酪氨酸激酶抑制剂（TKI）治疗并且疾病出现进展。研究计划入组约420名受试者，按1：1比例分组，接受ivonescimab或安慰剂联合化疗，随后进入维持治疗阶段，最多持续至2年。该研究结果预计在今年年底公布。药物名称：Fenebrutinib适应症：复发型多发性硬化（RMS）开发公司：罗氏（Roche）临床试验：FENhance（NCT04586010）、FENhance 2（NCT04586023）Fenebrutinib是一种在研的口服、可逆性、非共价布鲁顿酪氨酸激酶（BTK）抑制剂，能够阻断BTK在B细胞发育及活化中的关键作用，同时调控巨噬细胞和小胶质细胞等髓系免疫细胞的活化。该药具有高选择性，对BTK的抑制选择性高出其他激酶130倍，这一特性有望降低脱靶效应，提升长期使用的安全性。在2期FENopta研究的开放标签扩展阶段中，罗氏公布的48周数据显示，接受fenebrutinib治疗的RMS患者中，多达96%在一年内未出现疾病复发或进展，显示出良好的疗效与耐受性。目前，该药正通过两项关键性3期临床研究FENhance和FENhance 2进一步验证其在RMS中的临床价值。两项研究均为多中心、随机、双盲试验，旨在评估fenebrutinib相比标准治疗药物，在延缓疾病进展和降低复发率方面的疗效与安全性。药物名称：WVE-006适应症：α-1抗胰蛋白酶缺乏症（AATD）开发公司：Wave Life Sciences 临床试验：RestorAATion-2（NCT06405633）WVE-006是一款潜在“first-in-class”的RNA编辑寡核苷酸疗法，基于Wave Life Sciences独有的AIMer平台，能够将腺嘌呤编辑为肌苷（A-to-I），并通过PN化学修饰与GalNAc偶联实现靶向肝脏的皮下注射给药。WVE-006旨在修复AATD患者SERPINA1基因中导致Z突变的单碱基错误，从而恢复功能性野生型AAT蛋白的表达，并减少有害的Z-AAT蛋白聚集，有望用于治疗与AATD相关的肺病和/或肝病。该药目前正通过RestorAATion-2研究进行评估，该研究为一项1b/2a期、开放标签、单剂量递增（SAD）和多剂量递增（MAD）设计的临床试验，纳入Pi*ZZ型AATD患者，旨在系统评估WVE-006的安全性、耐受性、药效学和药代动力学特征。去年10月，Wave Life Sciences宣布该研究取得积极结果，WVE-006在患者体内成功实现了机制验证。根据当时新闻稿，这标志着RNA编辑疗法首次在人类中实现临床机制验证的关键里程碑。公司预计将在今年分享该疗法多次给药数据。药物名称：Evolocumab适应症：高脂血症开发公司：安进（Amgen）临床试验：VESALIUS-CV（NCT03872401）研究表明，低密度脂蛋白胆固醇（LDL-C）水平升高是心血管疾病（CVD）发展的关键可调节风险因素之一。Evolocumab作为一款PCSK9抑制剂，通过阻断PCSK9与LDL受体（LDLR）的结合，增强LDLR在肝细胞表面的表达，从而加速LDL-C的清除，有效降低心肌梗死与中风等重大心血管事件的风险。为进一步验证其在高危人群中的心血管保护效应，evolocumab正在开展VESALIUS-CV研究，这是一项双盲、随机、安慰剂对照的多中心临床3期试验，旨在评估该药在无既往心肌梗死或中风史、但具有较高心血管事件风险的成人患者中，降低重大心血管事件发生率的效果。该试验结果预计在今年第三季度公布。药物名称：VLA15适应症：莱姆病（Lyme disease）开发公司：辉瑞（Pfizer）、Valneva临床试验：VALOR（NCT05477524）VLA15是一款在研的多价蛋白亚单位疫苗，靶向伯氏疏螺旋体的外表面蛋白A（OspA），该蛋白是莱姆病致病菌在蜱虫体内的关键抗原。通过拮抗OspA，VLA15有望阻断病原体从蜱虫向人类传播。此前公布的2期研究显示，VLA15具有良好的免疫原性和安全性，尤其是在第二剂加强免疫后的免疫反应维持稳定。该疫苗目前正在开展一项名为VALOR的3期临床研究。这是一项大型、安慰剂对照试验，旨在系统评估该疫苗的有效性、安全性、耐受性及免疫原性。研究计划招募约9400名来自莱姆病高发地区、年龄在5岁及以上的健康受试者，按约1：1的比例随机分配接受VLA15疫苗或安慰剂。部分受试者还将接种来自不同批次的疫苗，以评估批次间的一致性。接种方案包括三剂基础免疫（分别在第0、2和第5至9个月接种）以及一剂加强针（在基础免疫后约12个月接种），旨在覆盖连续两季甚至三季的莱姆病流行期，从而更全面地评估疫苗在真实世界中的保护效果。该研究的初步结果有望于今年年底公布。药物名称：BHV-7000适应症：抑郁症（MDD）开发公司：Biohaven临床试验：NCT06419608BHV-7000是由Biohaven公司开发的一款新型、选择性激活Kv7.2/Kv7.3钾通道的小分子疗法，该离子通道在神经信号传导和调控神经元过度兴奋状态中发挥关键作用，适用于癫痫和情绪障碍等疾病的治疗。此前公布的1期多剂量递增研究数据显示，该药的每日一次缓释剂型在各剂量水平下均展现出良好的耐受性。目前，BHV-7000正在开展治疗抑郁症的2期临床试验。这是一项多中心、随机、双盲、安慰剂对照研究，旨在评估BHV-7000作为单药治疗在MDD患者中的疗效与安全性。该研究有望为该药物在情绪障碍领域的潜在应用提供关键的临床数据支持。药物名称：mRNA-1010适应症：季节性流感开发公司：Moderna临床试验：P304（NCT06602024）mRNA-1010是Moderna开发的一款基于mRNA技术的季节性流感疫苗，旨在针对流感A型和B型多种毒株提供更广泛和高效的免疫保护。该疫苗目前正处于3期关键性临床研究阶段，重点评估其在50岁及以上成人中的安全性、免疫原性以及相较于已获批标准剂量灭活流感疫苗的相对疫苗效力（rVE）。该项名为P304的研究为一项随机、观察者设盲、阳性对照、病例驱动的3期试验，共招募逾4万名受试者，接受单剂mRNA-1010或对照疫苗，并进行了为期中位6个月的随访。结果显示，mRNA-1010达到了预设的最严格优效性标准，在总体人群中实现了26.6%的rVE（95% CI：16.7%-35.4%），在A/H1N1、A/H3N2及B/Victoria等所有毒株中均展现出稳健保护效力。此外，该疫苗在65岁及以上人群中rVE为27.4%，并在不同年龄、基础疾病和疫苗接种背景的亚组中保持一致优势。mRNA-1010的安全性与耐受性良好，大多数不良事件为轻度，整体与既往研究结果相符。参考资料（可上下滑动查看）[1] 10 clinical trials to watch the rest of 2025. Retrieved July 20, 2025 from https://www.biopharmadive.com/news/biotech-pharma-clinical-trials-watch-2025/736120/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202025-06-30%20BioPharma%20Dive%20%5Bissue:74500%5D&utm_term=BioPharma%20Dive[2] A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT05869903?term=NCT05869903&rank=1[3] A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 1). Retrieved from https://clinicaltrials.gov/study/NCT06130566?term=coast-1&rank=3[4] A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (SHORE). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06224348?term=amlitelimab&page=2&rank=11[5] A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06411899?term=VELA-1&rank=1[6] Phase III Study of AK112 for NSCLC Patients. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06396065?term=Harmoni&aggFilters=phase:3&rank=1[7] A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT04586010?term=NCT04586010&rank=1[8] Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance 2). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT04586023[9] A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants with Pi*ZZ AATD. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06405633?term=NCT06405633%20&rank=1[10] Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV). Retrieved July 20, 2025 from https://www.clinicaltrials.gov/study/NCT03872401[11] An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). Retrieved July 20, 2025 from https://www.clinicaltrials.gov/study/NCT05477524[12] Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06419608[13] Biohaven Presents New Data with BHV-7000 Once-Daily Extended-Release Formulation Demonstrating Excellent Safety Profile and Nonclinical Data Updates at American Epilepsy Society 2024 Annual Meeting. Retrieved July 20, 2025 from https://ir.biohaven.com/news-releases/news-release-details/biohaven-presents-new-data-bhv-7000-once-daily-extended-release[14] A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06602024免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

临床3期临床2期临床成功临床结果

2025-08-02

·Biotech前瞻

自免药王度普利尤单抗还能称王多久？OX40单抗来势汹汹

2025 【OX40单抗】【OX40单抗】2025年3月8日，安进与协和麒麟共同宣布，其OX40单抗Rocatinlimab在治疗特应性皮炎的两项III期试验（ROCKET-IGNITE和ROCKET-SHUTTLE）中均达到主要终点。该药物成为全球首个完成III期临床的OX40单抗，并在三项研究中均展现积极数据，有望率先获批上市。2025年4月15日，赛诺菲公布其OX40L单抗Amlitelimab治疗哮喘的II期研究（TIDE-Asthma）未达主要终点（年化恶化率未降低），但披露关键亚组数据后调整策略。而就在同一赛道，中国药企创响生物凭借自主开发的IMG-007（OX40单抗）在II期试验中刷新疗效纪录，并通过反向收购美股企业Ikena Oncology实现资本跃升。这场“中外双雄”对垒度普利尤单抗的战役，正在重塑全球自免药市场格局。2025 阅读指南 1、赛诺菲丨度普利尤单抗2、OX40单抗丨国内外快讯3、OX40靶点及单抗整理VIEW看点【赛诺菲丨度普利尤单抗】近期，各大药企陆续公布2025年一季度财报，本文走进赛诺菲旗下重磅产品度普利尤单抗（Dupixent），2025年上半年（H1），大卖73.12亿欧元（约80.15亿美元，+20.7%）。度普利尤单抗2024年销售额141.79亿美元，垄断特应性皮炎（AD）市场超60%份额，凭借IL-4Rα靶点“一药治多病”（获批7项适应症：特应性皮炎、哮喘、慢性鼻窦炎伴鼻息肉（CRSwNP）、节性痒疹、慢性自发性荨麻疹、酸性食管炎（EoE）和慢性阻塞性肺疾病（COPD））成为当之无愧的自免药王。“药王”的隐忧：耐药性与依从性痛点：30%患者对度普利尤单抗失效，且需每2周注射一次，长期用药负担沉重。竞争者围剿：IL-13抑制剂（如Lebrikizumab）、JAK抑制剂（如Upadacitinib）及OX40抑制剂迅速崛起，试图分食市场。本文聚焦OX40单抗的最新国内外进展。OX40单抗丨国内外快讯赛诺菲丨amlitelimab2025年4月15日，赛诺菲公布其抗OX40配体单抗amlitelimab治疗中重度哮喘的二期研究（TIDE-Asthma，NCT05421598）未达主要终点：最高剂量组在第48周的年化严重哮喘急性发作率（AAER）未达到预设目标。但中剂量组显示“具有统计学意义的显著减少”，高剂量组在60周时恶化率呈数值趋势性下降。赛诺菲研发负责人Houman Ashrafian表示：“Amlitelimab在异质性患者中的表现提示其可能成为该未满足需求领域的突破性疗法。我们期待三期数据验证其差异化潜力。”OX40赛道升温：安进Rocatinlimab（II期）、信达IBI356（I期）加速布局，国内创响生物IMG-007（长效设计）紧随其后。安进/协和麒麟丨Rocatinlimab2025年3月8日，安进与协和麒麟共同宣布，其OX40单抗Rocatinlimab在治疗特应性皮炎的两项III期试验（ROCKET-IGNITE和ROCKET-SHUTTLE）中均达到主要终点。Rocatinlimab为一款OX40抗体，最初由协和发酵麒麟研发，2021年，安进引进日本外全球市场的权益，支付对价为4亿美元预付款，8.5亿美元里程碑金额，以及一定比例的销售分成。和黄/创响生物OX40单抗II期结果2024年1月9日，创响生物公布了IMG-007在治疗中度至重度特应性皮炎（AD）患者中的二期临床试验（2a期）积极结果，同时还披露了IMG-007皮下注射（SC）制剂的一项I期临床试验结果。在4周的IMG-007治疗后，16周时的湿疹面积和严重度指数（EASI）平均减少77%，并且54%的患者达到了EASI-75。治疗的耐久性也表现在对炎症标志物的持久抑制上，持续时间可达24周。IMG-007的皮下注射制剂展示了约35天的延长半衰期，表明其具备了潜在的长期给药优势。此外，IMG-007在临床研究中整体耐受性良好，没有报告发热或寒战等不良事件，进一步增强了其临床应用的可行性。创响生物的创始人兼首席执行官王健表示：“IMG-007是唯一一种能够在不耗竭T细胞的情况下，特异性阻断OX40/OX40L信号通路的临床阶段单抗。结合其延长的半衰期和持续的疗效，我们计划探索更长的给药间隔，比如每24周一次，用于AD等疾病的维持治疗。”IMG-007是创响生物的重要核心管线之一，目前正处于二期临床开发阶段。创响生物还计划在2025年第一季度启动IMG-007 SC制剂的二期b期剂量探索试验，进一步评估其在中度至重度特应性皮炎患者中的疗效。依托该产品的极大利好，2024年12月23日，创响生物宣布与Ikena Oncology达成合并协议，合并和融资完成后，创响生物将成为第一大股东，Ikena的原有股东则拥有约34.8%的股份。公司将以“ImageneBio”为新名，预计将于2025年中完成合并，并在纳斯达克以“IMA”为股票代码进行交易。值得一提的是，IMG-007来自于和黄医药，2024年2月，和黄医药发布公告称，创响生物根据2021年1月与其达成的战略合作条款，已行使由和黄医药发现的2款候选药物IMG-007（OX40单克隆抗体）和IMG-004（BTK抑制剂）授权许可相关的选择权，每款候选药物，和黄医药将获最高9250万美元开发里程碑付款和最高1.35亿美元的潜在商业销售里程碑付款，以及商业化后分成，交易总金额高达4.55亿美元。OX40靶点及单抗整理本章节就全球OX40靶点竞争态势进行梳理。来源：Nature Reviews Clinical OncologyOX40与OX40L的结合可增强效应T细胞、NK、NK-T细胞活性，解除Treg的免疫抑制作用，既可增强特异性免疫反应，也可增强固有免疫反应，从而增强抗肿瘤免疫。OX40单抗临床研究汇总目前，OX40激动剂已经被用于肿瘤的免疫治疗。全球有多种Anti-OX40抗体药物正在用于针对肿瘤及免疫系统疾病的临床试验，最快的已经进入临床2期。不乏有辉瑞，施贵宝，基因泰克，葛兰素史克等国际巨头，恒瑞，信达，百济神州等国内药企也有布局。2023年12 月 25 日，据 CDE 临床试验登记与信息公示平台，信达生物 OX40L 单抗 IBI356 启动临床，用于特应性皮炎（登记号：CTR20234129）。来自：CDE 官网2023年10 月 8 日，据 CDE 官网显示，安进 OX40 单抗 Rocatinlimab（AMG 451）国内启动新 III 期临床 ROCKET-ASCEND 试验（登记号：CTR20233073），这是一项旨在评估 Rocatinlimab 用于中度至重度特应性皮炎（AD）成人和青少年受试者的长期安全性、耐受性和有效性的多中心、双盲维持研究。目前，全球范围内尚未有OX40抗体获批上市,在肿瘤治疗领域的研究进展更为缓慢。相比阻断型抗体，激动型抗体的早期开发更为困难，临床安全性评估更为复杂，因此激动型抗体的成功相比要艰难得多！✦ • ✦【会员福利】Biotech前瞻公众号已然制备了肿瘤基础类、研究进展类、研究设计小课堂及行业研究类幻灯。此外，ASCO和ESMO为代表的国际大会会后简版幻灯材料也会在会后一周左右时间发给会员。都为可编辑无水印资料。不定期还有会员福利惊喜赠送或享限时优惠价格哦！早购买，早获益，意愿者请联系如下。【新版会员福利】按瘤种选择基础/进展幻灯，尽享研究设计/行研幻灯

临床2期财报突破性疗法临床3期上市批准

100 项与 Amlitelimab 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
中度特应性皮炎	临床3期	美国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	中国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	阿根廷	Sanofi	2023-11-08
中度特应性皮炎	临床3期	澳大利亚	Sanofi	2023-11-08
中度特应性皮炎	临床3期	巴西	Sanofi	2023-11-08
中度特应性皮炎	临床3期	加拿大	Sanofi	2023-11-08
中度特应性皮炎	临床3期	智利	Sanofi	2023-11-08
中度特应性皮炎	临床3期	法国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	德国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	希腊	Sanofi	2023-11-08

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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


NCT05421598 (TIDE-Asthma, Company_Website) 人工标引	临床2期	哮喘辅助	437	Amlitelimab	顧獵顧膚範窪艱簾膚鬱(醖餘積夢衊鑰製窪鏇餘) = the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level. 糧衊構範遞網襯觸觸艱 (壓簾鑰積鏇餘衊糧蓋憲 ) 未达到	不佳	2025-04-15
				Placebo
NCT05131477 (STREAM-AD, Pubmed) 人工标引	临床2期	特应性皮炎	580	Amlitelimab (Part 1)	製網範餘艱選範築網獵(顧夢鹽顧衊鏇構顧獵築): P-Value = < 0.001	积极	2024-11-08
				Amlitelimab (Part 2)
NCT05131477 (STREAM-AD, GlobeNewswire) 人工标引	临床2期	特应性皮炎	390	amlitelimab (patients with continued treatment)	構鹽觸糧築鹽窪糧廠膚(選顧顧鬱憲糧糧襯壓壓) = 蓋積遞顧衊鏇廠積鑰鑰夢鹹製願繭製鹽獵餘遞 (觸製糧網壓獵簾願範觸 ) 更多	积极	2024-03-11
				amlitelimab (patients withdrawn from treatment)	構鹽觸糧築鹽窪糧廠膚(選顧顧鬱憲糧糧襯壓壓) = 觸網鬱積壓範遞憲選構夢鹹製願繭製鹽獵餘遞 (觸製糧網壓獵簾願範觸 ) 更多
NCT05131477 (STREAM-AD, NEWS) 人工标引	临床2期	特应性皮炎	390	amlitelimab	壓繭廠顧衊顧鹽築鏇餘(積簾顧廠網網夢範夢蓋) = 憲衊廠顧膚憲壓壓蓋艱獵獵範繭廠鏇蓋築艱夢 (夢顧鹽製構網範衊鏇糧 ) 更多	积极	2023-10-15
				placebo	壓繭廠顧衊顧鹽築鏇餘(積簾顧廠網網夢範夢蓋) = 廠襯鏇醖簾選鏇憲積鹽獵獵範繭廠鏇蓋築艱夢 (夢顧鹽製構網範衊鏇糧 ) 更多
NCT03754309 (AAD2023)	临床2期	特应性皮炎	89	Amlitelimab low-dose	膚獵選壓蓋鹹顧鬱繭淵(簾廠齋顧鏇糧範構廠艱) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study 獵繭夢壓製憲構醖壓繭 (夢餘鏇衊選廠鏇蓋壓鬱 ) 更多	-	2023-03-17
				Amlitelimab high-dose
NCT03754309 (Phase 2a, EADV2022)	临床2期	特应性皮炎 IL-22	89	Amlitelimab low dose (200 mg loading/100 mg maintenance every 4 weeks [Q4W])	遞選餘襯網齋觸製簾繭(觸鹽廠簾衊選夢膚窪襯) = 鬱鹹製糧壓醖蓋窪膚膚鏇顧窪鏇艱壓鑰鹹積淵 (齋鹽衊壓鹹繭築鏇繭繭 )	积极	2022-09-07
				Amlitelimab high dose (500 mg/250 mg Q4W)	遞選餘襯網齋觸製簾繭(觸鹽廠簾衊選夢膚窪襯) = 憲蓋膚齋範夢鹽積鹹窪鏇顧窪鏇艱壓鑰鹹積淵 (齋鹽衊壓鹹繭築鏇繭繭 )
NCT03161288 (Pubmed \| Clin Pharmacol Ther)	临床1期	-	64	KY1005	繭壓顧遞顧選襯製鬱醖(襯觸醖齋襯網鏇積鑰醖) = No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. 築獵顧願築糧壓醖構衊 (夢遞網選築夢衊廠觸糧 ) 更多	-	2022-01-29
				Placebo