This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

开始日期2026-01-01

申办/合作机构

The University of California, San Francisco

NCT07444801

/ RecruitingN/AIIT

Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact

Hypothesis: Treatment with tralokinumab in patients with moderate-to-severe AD involving the genital region is expected to lead to significant improvements in PROs and clinical disease severity. These improvements will be assessed using genital-specific scoring systems, validated PRO instruments, and non-invasive imaging techniques, including optical coherence tomography (OCT), confocal microscopy, or line-field optical coherence tomography (LC-OCT). Objectives: To investigate improvements in genital scores and PROs in patients with moderate-to-severe AD involving the genital region during treatment with tralokinumab in routine clinical care. Clinical assessment of genital AD severity will be conducted using genital-specific scoring systems (e.g., Genital-Numerical Rating Scale (g-NRS), Genital-Investigator Global Assessment (g-IGA)), validated PRO instruments (e.g., Patient Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT)), and non-invasive imaging techniques (e.g., confocal microscopy, OCT, LC-OCT)

开始日期2025-10-20

申办/合作机构

Leo Pharma, Inc.

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.

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100 项与曲罗芦单抗相关的专利（医药）

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356

项与曲罗芦单抗相关的文献（医药）

2026-03-02·Dermatitis

Decision-Making Factors for Systemic Therapies in Atopic Dermatitis: A Clinical Review.

Review

作者: Mehta, Apoorva ; Guttman-Yassky, Emma ; O'Hagan, Ross ; Lamb, Angela J ; Levine, Jasmine

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that significantly impairs quality of life. In recent years, treatment has advanced from broad immunosuppressants to targeted biologics and small-molecule therapies that modulate type 2 inflammation and itch signaling. Dupilumab, tralokinumab, lebrikizumab, and nemolizumab are now FDA-approved biologics with demonstrated efficacy and favorable long-term safety, while oral Janus kinase inhibitors (JAKis) such as abrocitinib, upadacitinib, and baricitinib often provide rapid disease control but carry black-box warnings. Comparative trials highlight faster itch relief with JAKis but durable disease control and safety advantages with biologics. The expanding treatment landscape necessitates individualized therapy selection. Key clinical considerations include patient age, pregnancy status, infection, malignancy, or thromboembolic risk, comorbid conditions, and history of adverse effects. Equally important are patient-centered preferences such as dosing frequency, route of administration, storage logistics, and willingness to self-inject. Access and affordability also influence care, with many manufacturers offering copay support and patient assistance programs. Future directions emphasize head-to-head comparative studies, biomarker development for precision treatment, and equitable access to advanced therapies. This narrative review synthesizes current evidence on biologics and JAKis in AD, outlining efficacy, safety, and practical decision-making factors to guide dermatologists in aligning therapies with both clinical context and patient priorities.

2026-03-01·JOURNAL OF DERMATOLOGY

Long‐Term, Site‐Specific Effectiveness of Tralokinumab in Atopic Dermatitis: A 72‐Week Real‐World Study

Article

作者: Saeki, Hidehisa ; Hagino, Teppei ; Fujimoto, Eita ; Kanda, Naoko ; Shiba, Mizuki ; Motegi, Sei‐ichiro ; Uchiyama, Akihiko

ABSTRACT:
Tralokinumab, an anti‐IL‐13 antibody, is effective for atopic dermatitis (AD); however, its long‐term (> 1 year) effectiveness specific to each anatomical site is unknown in real‐world settings. To evaluate 72‐week effectiveness of tralokinumab on different anatomical sites in AD, we studied 208 patients with moderate‐to‐severe AD treated with tralokinumab for 72 weeks. Eczema area and severity index (EASI) scores were analyzed on four anatomical sites (head/neck, trunk, upper limbs, and lower limbs). Tralokinumab consistently reduced EASI on all anatomical sites. The achievement rates of EASI 75 and 100 on each site gradually increased from Week 4 to Week 72, and those on lower limbs appeared higher compared to the other sites. The percent reductions of EASI throughout 72 weeks appeared slightly lower on head and neck compared to the other sites. Week 72 achievement rate of EASI 75 on head/neck, trunk, upper limbs, or lower limbs was 80.4%, 80%, 80.3%, or 86.7%, while that of EASI 100 was 37.3%, 25.0%, 27.4%, and 40.0%, respectively. Tralokinumab reduced EASI scores through 72 weeks across different anatomical sites in AD patients. The achievement rates of EASI 75 and 100 appeared slightly higher on lower limbs compared to the other sites.

2026-03-01·JOURNAL OF DERMATOLOGY

Clinical Outcomes of Tralokinumab and Lebrikizumab in Japanese Atopic Dermatitis Patients With Persistent Head and Neck Dermatitis After Long‐Term Treatment With Dupilumab: A Single‐Center Retrospective Study

Letter

作者: Chijiwa, Chika ; Okada, Yoshiki ; Tada, Yayoi ; Suzuki, Shoya ; Hiura, Azusa ; Kamata, Masahiro ; Tomura, Yayoi ; Hayashi, Kotaro ; Watanabe, Ayu ; Tanaka, Takamitsu

207

项与曲罗芦单抗相关的新闻（医药）

2026-04-02
·自免e声

AAD2026年会报道：特应性皮炎进入“长期管理与全维度结局”新时代

作者 |自免e声银杏特别说明 | 本文仅供医疗卫生等专业人士阅读在American Academy of Dermatology（AAD）2026年会上，特应性皮炎（atopic dermatitis, AD）再次成为最受关注的慢性炎症性皮肤病之一。本届会议从患者叙事、疾病定义重塑、长期疗效、综合干预到系统性负担等多个维度，展现了AD研究与管理范式的持续演进。 01 社交媒体中的患者声音一项基于社交媒体的研究提供了一个颇为“现实世界”的视角（Poster 77026）。Lapenda等分析了TikTok、Facebook和Instagram三个平台共150条患者原创内容，其中TikTok的互动最为活跃，累计评论数达到2275条。从人群特征来看，发帖者以女性为主（90%），白人占57.3%，成人占86%。在治疗方面，讨论最多的是度普利尤单抗(dupilumab)（80%），其次是乌帕替尼（upadacitinib）（14%）和曲罗芦单抗（tralokinumab）（6%）。从疗效反馈来看，52.7%的患者报告“显著改善”，28.7%为“中度改善”，8%为“轻微改善”，6.7%认为“无变化”，仅0.7%提到症状加重。不良反应方面，主要集中在眼部症状（22.3%）和注射部位疼痛（21%），严重不良事件较少见。整体情绪倾向上，81%的内容为正面，9%为负面，10%为中性或不明确。这些数据反映出生物制剂和JAK抑制剂在患者中的总体接受度较高，也提示社交媒体已经成为患者获取信息的重要渠道，其影响力不容忽视。同时这也提示临床医生需主动参与数字平台，提升科普信息质量，以对抗潜在的健康错误信息传播。 02 疾病活动度与缓解定义达成全球共识疾病评估的一个关键进展是关于疾病活动度与缓解的定义逐渐明确（Poster 73585）。Merola等通过国际湿疹委员会开展的三轮Delphi研究，在≥70%共识标准下，提出了一系列量化指标。例如，低疾病活动度（LDA）被定义为vIGA-AD=2或EASI ≤7，同时PP-NRS ≤4（96%达成一致）；极低疾病活动度（vLDA）为vIGA-AD=0/1或EASI ≤3，且PP-NRS 0/1（97%）；而“用药中完全控制”要求vIGA-AD=0或EASI=0持续≥6个月（95%）；“停药后缓解”则需在停用治疗后维持同样标准≥12个月（96%）。这些具体阈值的提出，使得较为模糊的“控制良好”或“缓解”有了清晰的界定，也为临床试验设计和日常管理提供了参照。 03 长期疗效证据持续强化与评估标准的细化相对应，关于长期疗效的证据也在不断积累（Poster 75662）。在乌帕替尼的研究中，对在第16周达到患者报告结局应答的患者进行随访，结果显示在第140周时，仍有62.3%（15 mg组）和66.0%（30 mg组）的患者维持“几乎无瘙痒”状态；约70%的患者报告生活质量不受疾病影响（70.7%和69.4%）；而在睡眠方面，83.5%和77.9%的患者仍然没有明显睡眠干扰，同时超过80%的患者（82.2%和83.8%）对治疗保持高度满意。这些数据提示，一旦早期达到良好应答，后续维持的可能性相对较高。类似的趋势也体现在度普利尤单抗的真实世界研究中（Poster 74515）。在RELIEVE-AD研究的6年随访数据中，共有298名患者完成72个月调查，其中70.5%仍在持续用药。疾病控制率（ADCT<7）从基线的5.9%提升至82.6%；79%的患者在72个月时报告瘙痒“显著改善”；过去4周无复发的比例从3.0%提高至48.3%；而睡眠问题则从基线的77.5%下降至9.4%。 04 AD的隐匿负担：疲劳与睡眠障碍越来越多研究也在提醒，AD的负担远不止皮肤表现本身（Poster 77201）。关于疲劳和睡眠的综述显示，超过60%的儿童以及相当比例的成人患者存在睡眠障碍，并且这一问题与疾病严重程度密切相关。瘙痒被认为是最主要的驱动因素，与疲劳发生风险增加约2倍有关。进一步来看，这种长期的睡眠和疲劳负担还可能与认知功能下降、儿童注意力问题，以及高血压、糖代谢异常等心代谢风险相关。这些数据让提示AD需要从系统性疾病的角度来理解和管理。 05 非传统干预的整合治疗除了标准药物治疗，一些非传统干预也逐渐被纳入研究视野（Poster 74769）。现有证据显示，针灸在缓解瘙痒方面有一定积极信号，部分植物制剂可能有助于皮肤屏障修复，而正念、认知行为治疗等身心干预则在改善睡眠和心理负担方面显示潜力。但这类研究普遍存在样本量较小、结局指标不一致等问题，因此目前更适合作为常规治疗的补充，而非替代。关于特应性皮炎的研究虽然切入点不同，但指向却比较一致：一方面是治疗目标在不断提高，从“缓解症状”走向“长期稳定甚至缓解”；另一方面是评估维度在不断扩展，从医生主导的皮损评分转向更加重视患者自身感受。同时，信息获取方式和治疗模式也在发生变化，从单一的医疗场景逐渐延伸到数字平台之中。信息来源 https://eposters.aad.org/ 免责声明：本微信文章中的信息仅供向医疗卫生专业人士传递专业信息，不可直接作为决策依据，发布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。往期推荐 RECOMMEND JAK抑制剂怎么用更准？2025中国专家共识解读！乏力、血尿？警惕“沉默的ANCH相关性血管炎” 从诺贝尔医学奖看临床应用：皮肤局部免疫耐受的可塑性新机制如有学术会议服务/学术报道商务合作/原创投稿等需求请联系我们商务合作：姚女士 13752623793 原创投稿：yaohongli@methealth.cn 点分享点收藏点在看点点赞

2026-03-30
·Business Wire

LEO Pharma Presents New 12-Month Real-World Data for Tralokinumab at AAD 2026

The majority of atopic dermatitis (AD) patients with hand and/or foot (H&F) involvement experienced clearance over 12 months of treatment with ADBRY ® (tralokinumab-ldrm)/ADTRALZA® (tralokinumab). 1 12-month data demonstrated that treatment with tralokinumab reduced AD severity and provided improved quality of life among patients with skin of color. 2 Nearly all patients treated with tralokinumab achieved at least one moderate treatment target, including both clinician and patient reported outcomes. 3 MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the presentation of new post-hoc analyses of 12‑month real‑world data from the TRACE study of tralokinumab, at the 2026 American Academy of Dermatology (AAD) Annual Meeting. TRACE is a prospective, non-interventional, international study evaluating adult patients receiving tralokinumab, with analyses assessing minimal disease activity and outcomes in patient subgroups, including those with H&F involvement, or skin of color.1-3 “LEO Pharma is committed to moving the science forward on our understanding of the pathogenesis of atopic dermatitis and how tralokinumab works in difficult to treat populations. These 12-month real-world results build on data from the tralokinumab clinical trial program and help address evidence gaps in specific patient populations and high burden areas, like the hands and feet,” said Shannon Schneider, Vice President of North America Medical Affairs for LEO Pharma. Tralokinumab Treatment in AD Patients with H&F Involvement In a post-hoc analysis of the TRACE patients with H&F involvement (n=495 of 824) at baseline treated with tralokinumab, the proportion of patients reporting any H&F involvement decreased markedly to 46.3% (n=430) at Month 3 and 31.6% (n=272) at Month 12. Early and clinically significant improvements in disease severity, patient reported outcomes, and quality of life were also observed, as measured by Investigator’s Global Assessment (IGA), Peak Pruritus/Sleep Numerical Rating Scale (PP/Sleep-NRS) scores, and Dermatology Life Quality Index (DLQI) scores, respectively.1 Real-World Effectiveness of Tralokinumab Treatment in AD Patients with Skin of Color In a post-hoc analysis among patients with skin of color (Fitzpatrick skin types IV–VI; n=131 of 824), 80.4% (n=56) achieved at least one clinically meaningful disease control endpoint at 12 months, defined as an IGA score of 0/1 (clear or almost clear), an Eczema Area and Severity Index (EASI) score of ≤7 (no to mild disease), or a SCORing Atopic Dermatitis (SCORAD) score of <10 (minimal to mild). Improvements in quality of life were also observed.2 “Atopic dermatitis affects people with all skin tones and frequently impacts high-burden areas such as the hands and feet,” said April Armstrong, MD, MPH, Professor and Chief of Dermatology, UCLA, and primary author of the study. “These results reinforce clinical experience, demonstrating that tralokinumab helps deliver meaningful benefits across diverse patient groups and challenging areas of the body.” Disease Control Data with Tralokinumab Treatment in Adults with AD Complementing these subgroup analyses, a third TRACE post-hoc analysis measured improvements in disease control across the study population (n=824). After 12 months of tralokinumab, 91% of patients achieved at least one moderate treatment target, which included clinical and patient reported outcomes (ClinRO and PRO). Three out of four achieved both a moderate ClinRO and PRO target, and nearly half achieved both an optimal ClinRO and PRO (minimal disease activity) target.3 In the pivotal clinical trials, the most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.4 The TRACE study presentations are part of LEO Pharma’s extensive data program at AAD, which includes 17 accepted abstracts across the company’s medical dermatology portfolio and pipeline. About TRACE TRACE is a prospective, non-interventional, international, single-cohort study of adult patients with AD who were prescribed tralokinumab according to the national approved label at the treating physician’s discretion. Concomitant medications were allowed. 835 patients were enrolled between November 2021 and July 2023, of whom 824 were included in the full analysis set, and followed for up to one year.5 About Atopic Dermatitis Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.6 AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.7 Type 2 cytokines, including IL-13, play an important role in the key aspects of AD pathophysiology.6,7 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.8 About ADBRY® (tralokinumab-ldrm)/ADTRALZA® (tralokinumab) ADBRY® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename ADTRALZA® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.4,9 Tralokinumab specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).10 Tralokinumab is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, South Korea, the U.S., and Saudi Arabia. Tralokinumab is approved for use in adults with moderate- to-severe AD in Switzerland and Japan. INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY® (TRALOKINUMAB) What is ADBRY? ADBRY ® (tralokinumab) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids. It is not known if ADBRY is safe and effective in children under 12 years of age. Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients. What should I discuss with my healthcare provider before starting ADBRY? Tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY. are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/ . are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ADBRY? Use ADBRY exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much ADBRY to inject and when to inject it. ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector. ADBRY is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult. If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time. If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to. What are the possible side effects of ADBRY? ADBRY can cause serious side effects including: Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems itching skin rash swelling of the face, mouth, and tongue fainting, dizziness, feeling lightheaded (low blood pressure) hives breathing problems itching skin rash swelling of the face, mouth, and tongue fainting, dizziness, feeling lightheaded (low blood pressure) hives Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision. The most common side effects of ADBRY include: upper respiratory tract infections Eye and eyelid inflammation, including redness, swelling, and itching Injection site reactions High count of a certain white blood cell (eosinophilia) These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin. For more information, visit www.leo-pharma.com. References Armstrong AW, Rodriguez A, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab in 495 adult patients with atopic dermatitis and hand and foot involvement: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77138. Oral Poster Presentation. Armstrong AW, Rubin C, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and moderate-to-severe atopic dermatitis: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77199. Oral Poster Presentation. Pink A, Pezzolo E, Jarell A, et al. Minimal disease activity with 12 months of tralokinumab treatment in adults with atopic dermatitis: real-world data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 74527. Online ePoster. ADBRY ® (tralokinumab). Prescribing Information. FDA. December 2025. Ameen A, Becherel P, Rubin C, et al. Patient-reported outcomes evaluations of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Real-world data from the prospective, non-interventional, international, single-cohort TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025. Paris, France. 17-20 September 2025. E-poster Presentation. P3225. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747-785. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62. Popovic B, Breed J, Rees DG, et al. Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219. MAT-93283 March 2026

临床结果上市批准

2026-03-30
·得码学苑

解码AAD 2026丨剖析特应性皮炎的“转化革命”：从发病机制到精准靶向治疗

在2026 AAD年会上，题为“炎症性皮肤病：转化医学革命”的专题研讨会汇聚了该领域的顶尖学者，系统回顾了从银屑病起始、并已席卷特应性皮炎、斑秃等常见炎症性皮肤病的深刻变革。其中一项重要报告聚焦于特应性皮炎（AD），探讨其病理机制和治疗演进，特别介绍了度普利尤单抗等新型生物制剂在AD治疗中的疗效与安全性数据，为临床实践提供了重要依据。得码学苑特作系统整理，以飨读者。 AD是全球最常见的炎症性皮肤病，影响大量儿童和成人，并与心血管疾病风险增加相关。AD的核心病理机制涉及Th2和Th22细胞因子网络，导致免疫异常和皮肤屏障受损。传统广谱免疫抑制剂如环孢素A等因安全性问题限制了长期应用。自2017年起，AD治疗进入精准靶向时代，度普利尤单抗等生物制剂和JAK抑制剂等新药相继推出，显著丰富了治疗选择，未来药物研发正逐步向特异性阻断关键细胞因子通路发展。新型生物制剂的涌现，标志着AD治疗已进入精准靶向时代，其疗效与安全性数据为临床实践提供了重要依据。 1 IL-4/IL-13通路双重抑制：度普利尤单抗确立治疗基石度普利尤单抗通过阻断IL-4Rα，同时抑制IL-4和IL-13的信号传导，从而从源头上削弱Th2驱动的病理级联反应，包括皮肤屏障破坏、瘙痒以及Th2与Th17/Th22等其他通路的协同炎症效应。疗效：SOLO 1 & 2两项Ⅲ期研究16周数据显示，与安慰剂相比，度普利尤单抗300 mg每2周或每周一次给药，EASI-75应答率分别为47.7%和50.2% （vs 13.3%），EASI-90应答率也达到了32.8%和31.8%（vs.7.4%），且起效迅速。作用机制：EXPLORE研究通过皮肤活检的基因表达谱分析，发现度普利尤单抗治疗16周后，能特异性且显著下调与2型炎症相关的基因表达（如CCL17、CCL18、CCL26、CCL13等），而对1型炎症相关基因（如IFNγ、CXCL9）无显著影响。同时，皮肤屏障相关终末分化标志物（如FLG、LOR）的表达上调，印证了其兼具抗炎与修复皮肤屏障的双重作用。长期安全性与儿科应用：长期随访研究（如OLE和CHRONOS试验）数据显示，度普利尤单抗总体安全性可控。另有一项研究展示了一名7岁重症AD患儿经度普利尤单抗联合外用激素治疗16周后皮损显著改善的案例，支持其在儿科患者中的疗效。 2 靶点深耕：IL-13单靶点抑制剂的探索与定位在探讨AD的靶向治疗路径时，三种针对IL-13的单克隆抗体——曲罗芦单抗、来瑞奇珠单抗以及新型在研药物APG777，为此提供了重要的研究视角。 ✅ 来瑞奇珠单抗：ADvocate 1 & 2研究证实，其单药治疗16周在IGA 0/1和EASI-75等主要终点上显著优于安慰剂（分别有59.3%和50.8%的患者达到EASI-75），疗效持续至52周。安全性方面，其结膜炎发生率低于度普利尤单抗的早期临床试验数据。在分子层面，它能显著降低血清中的Th2生物标志物（如CCL17、CCL26、periostin、CCL22、lgE）。 ✅ 曲罗芦单抗：ECZTEND开放标签扩展研究的中期分析显示，持续使用Tralokinumab治疗56周，EASI-75应答率可达到82.8%，且疗效随时间持续深化。长达2年的皮肤转录组学研究显示，曲罗芦单抗能使AD皮损的基因表达谱逐渐向非皮损（正常）皮肤模式转变，从分子层面证实了其逆转AD病理的能力。 ✅ APG777：Ⅱ期试验结果显示，其治疗16周时，EASI-75应答率高达66.9%（vs 安慰剂24.6%），且在第4周即显示出统计学显著的疗效，展现了快速起效与强效控炎的潜力，为AD的IL-13靶向治疗武器库增添了新的可能。 3 IL-31抑制剂：直击瘙痒核心的新策略瘙痒是AD最核心且致残的症状，IL-31是介导瘙痒的关键细胞因子，直接作用于皮肤神经纤维引发瘙痒，进而通过“瘙痒－抓挠”循环加重皮损、破坏屏障，形成恶性循环。奈莫利珠单抗作为抗IL-31受体A的单抗，在控制瘙痒方面表现出突出疗效。 ARCADIA 1 & 2Ⅲ期试验数据显示，奈莫利珠单抗联合外用药物治疗，能快速（第4周）且显著地改善中重度AD患者的瘙痒症状，对于基线瘙痒更严重的患者获益尤其明显。同时，它在皮损严重程度改善（IGA、EASI）方面也显示出显著疗效。其安全性良好，无肝毒性信号，结膜炎风险低，但需关注外周水肿这一相对特异的不良反应（发生率较低）。转录组学研究同样证实，奈莫利珠单抗治疗能显著逆转AD皮损的异常基因表达谱，且基线瘙痒更严重的患者分子层面的修复效应更显著，实现了症状控制与病理改善的双重目标。 4 靶向表皮异常：IL-22/IL-17通路抑制剂的突破性进展尽管Th2通路是AD炎症的核心，但疾病慢性化、苔藓样变等结构性改变，与Th22/Th17通路驱动的表皮增生和屏障修复抑制密切相关。IL-22/IL-22R/IL-17通路在AD病理中起到核心驱动作用。该通路在环境触发下被激活，IL-22与IL-17协同作用，通过抑制丝聚蛋白等屏障蛋白合成、促进表皮增生、并阻碍屏障功能修复，最终导致苔藓样变的形成，构成“屏障破坏-增生-苔藓样变”的恶性循环。针对此通路，IL-22抑制剂Temtokibart的Ⅱb期剂量探索研究数据令人瞩目。研究显示，治疗16周时，300mg、600mg和450mg剂量组的EASI改善（-64.27%至-57.05%）均显著优于安慰剂（-41.74%）。安全性方面，严重不良事件罕见，且结膜炎发生率低，展现出良好的耐受性。这为靶向IL-22通路治疗以表皮增生和苔藓样变为特征的中重度AD提供了强有力的中期临床证据。此外，抗IL-13/IL-17A/IL-17F的多特异性抗体Galvokimig的Ⅱa期研究取得了突破性成果。治疗12周，其EASI 75应答率高达64.9%，显著高于安慰剂的12.3%；瘙痒改善率也达到73.1%。此外，抑制IL-17可能减轻由IL-13驱动的免疫表型转换相关不良事件（如面部、眼部皮炎及附着点炎），为兼具强效与安全性优势的联合靶向治疗开辟了新路径。 5 靶向免疫源头：OX40/OX40L通路拮抗剂的深度探索与挑战 OX40R/OX40L通路在驱动Th2、Th17等效应T细胞活化与存活中的核心作用。对此，目前有两种干预策略：靶向T细胞上OX40的Rocatinlimab和靶向抗原提呈细胞上OX40L的Amlitelimab。 Rocatinlimab的临床开发历程提供了丰富的数据。其Ⅱ期研究显示，300mg每2周给药组在16周时EASI-75应答率达53.8%，显著优于安慰剂（10.5%）。长期治疗至36周，疗效持续增强，且停药后应答表现出显著的持久性，高频剂量组在停药24周内仍有超过80%的患者维持EASI-75应答。这提示靶向OX40通路可能诱导了长期的免疫调节，而非单纯的症状抑制。其Ⅲ期试验进一步证实了疗效，300mg每4周组在24周时EASI-75应答率（42.3%）是安慰剂（12.8%）的3倍以上。安全性方面，最常见的不良事件包括发热、AD加重、鼻咽炎和头痛。其中注射相关反应多为轻中度，主要发生于首次给药后，并在48小时内缓解。靶向OX40L的Amlitelimab则提供了另一视角的数据。其Ⅱb期研究（STREAM-AD）数据显示，在第16周和第24周，各剂量Amlitelimab组患者EASI评分较基线的下降幅度均显著大于安慰剂组。同时，治疗也显著降低了血液中嗜酸性粒细胞计数以及Eosinophils、TARC、IL-13、IL-22等生物标志物水平。在Ⅲ期研究（COAST-1）试验中，无论是每4周还是每12周给药，24周时vIGA-AD 0/1和EASI-75应答率均显著优于安慰剂，且疗效随时间持续提升。其安全性特征与Rocatinlimab类似，未显示新的风险信号。 6 重塑免疫平衡：调节性T细胞（Treg）靶向治疗的新范式 Rezpegaldesleukin（REZPEG）是一种选择性调节性T细胞（Treg）诱导的IL-2偶联物，其作用机制在于通过特异性作用于IL-2受体，促进具有免疫抑制功能的Treg细胞增殖并恢复其功能，从而抑制效应T细胞的过度活化，重建免疫调节平衡。其Ⅱb期REZOLVE-AD研究结果显示，所有剂量组16周EASI较基线变化达主要终点（P<0.001），高剂量组（24μg/kg每2周）EASI 75（42%）、EASI 90（25%）应答率显著高于安慰剂（17%、9%），瘙痒NRS及vIGA - AD评分早期即有改善。安全性方面，REZPEG总体耐受性可管理。最常见的不良事件是注射部位反应（ISR），大多数为轻中度；嗜酸性粒细胞增多、发热、淋巴结病呈剂量依赖性，严重不良事件发生率较低。2025年2月，REZPEG已获得FDA针对中重度AD的快速通道资格。总结与展望展望未来，AD的治疗革命仍在继续。对AD复杂免疫网络理解的不断深化，是推动这一领域持续创新的根本动力。面对琳琅满目的新选择，未来的临床决策将更加依赖于对患者个体内表型的精准识别，以及对不同药物作用机制与风险特征的深刻把握。AD的治疗，正站在一个从控制症状迈向疾病修正，并最终实现个体化精准医疗的新起点。参考文献： [1]S036 Inflammatory Skin Diseases: The Translational Revolution；Atopic Dermatitis: An Evolving Success Story and Beyond. 免责声明本微信文章中的信息仅供向医疗卫生专业人士提供科学信息，不可直接作为决策内容，得码学苑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。以上内容如涉版权请联系删除。

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
中度特应性皮炎	沙特阿拉伯	LEO Pharma A/S	-
中度特应性皮炎	阿拉伯联合酋长国	LEO Pharma A/S	-
重度特应性皮炎	沙特阿拉伯	LEO Pharma A/S	-
重度特应性皮炎	阿拉伯联合酋长国	LEO Pharma A/S	-

未上市

10 条进展最快的记录,
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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
卡恩斯-塞尔综合征	临床3期	美国	AstraZeneca PLC	2015-02-19
卡恩斯-塞尔综合征	临床3期	比利时	AstraZeneca PLC	2015-02-19
卡恩斯-塞尔综合征	临床3期	法国	AstraZeneca PLC	2015-02-19
卡恩斯-塞尔综合征	临床3期	德国	AstraZeneca PLC	2015-02-19
卡恩斯-塞尔综合征	临床3期	荷兰	AstraZeneca PLC	2015-02-19

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临床结果

适应症

分期

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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, J Eur Acad Dermatol Venereol \| Pubmed) 人工标引	临床3期	特应性皮炎	347	Tralokinumab + optional topical corticosteroids/calcineurin inhibitors	餘膚範簾鹹鬱構範積願(醖夢窪夢壓膚構醖壓鏇) = 積夢夢築壓鹽鹹簾範鏇簾廠繭壓選築鏇醖觸壓 (齋餘遞蓋窪選鑰夢蓋構 ) 更多	积极	2025-11-11
NCT03363854 \| NCT03160885 \| NCT03131648 \| NCT03587805 (ECZTRA 1, Pubmed \| Am J Clin Dermatol)	临床3期	特应性皮炎	2,268	Tralokinumab	醖壓顧構廠構願簾淵憲(製觸選餘衊鹹鑰鏇積窪) = The safety profile of tralokinumab was comparable to placebo, and serious adverse events and adverse events leading to treatment discontinuation were rare, across racial subgroups. 選願鏇觸廠簾願顧蓋鑰 (艱糧糧膚築積憲積壓鹽 ) 更多	积极	2025-10-21
	临床3期	特应性皮炎	2,268	Placebo		积极	2025-10-21
NCT05194540 (INJECZTRA, Pubmed \| Dermatol Ther (Heidelb))	临床3期	特应性皮炎	136	Tralokinumab 300 mg	網製構觸齋鑰簾齋構製(鹹網選選繭觸廠鹹構鏇) = 遞齋積鬱構鏇遞壓廠醖壓遞廠醖餘廠積顧觸糧 (遞簾餘醖廠醖膚製衊膚 ) 更多	积极	2025-09-01
NCT03526861 (ECZTRA 6, Pubmed \| Dermatol Ther (Heidelb))	临床3期	特应性皮炎	247	Tralokinumab 150 mg	壓鹹觸繭簾簾鹹選醖憲(窪壓鑰願淵鑰網繭鏇膚) = 遞構艱糧膚範廠衊鹽網繭選餘蓋蓋壓製鏇衊蓋 (選衊鹹夢繭醖積糧願鑰 ) 更多	积极	2025-07-28
NCT03526861 (ECZTRA 6, Pubmed \| Dermatol Ther (Heidelb))	临床3期	特应性皮炎	247	Tralokinumab 300 mg	壓鹹觸繭簾簾鹹選醖憲(窪壓鑰願淵鑰網繭鏇膚) = 獵構鏇網選膚築積築鬱繭選餘蓋蓋壓製鏇衊蓋 (選衊鹹夢繭醖積糧願鑰 ) 更多	积极	2025-07-28
NCT03160885 \| NCT03131648 \| NCT03587805 (ECZTRA 1 \| ECZTRA 2 \| ECZTEND, Pubmed \| Am J Clin Dermatol)	临床3期	特应性皮炎	1,192	Tralokinumab	構壓鑰憲憲艱憲鹽積鬱(製築網廠膚夢鹹夢窪顧) = 遞窪鑰鹹簾築鹽鹹壓窪選衊觸衊膚鹹鏇蓋膚鹹 (顧糧糧襯鏇壓繭鬱築鑰 ) 更多	积极	2025-03-14
AAD2025	N/A	特应性皮炎	48	Tralokinumab	鑰願糧鏇獵簾廠壓構鹽(鹹餘齋醖積製鬱製遞網) = 壓鑰窪築製積鹽構選遞醖鹽鏇糧糧艱糧衊鑰構 (鹹範廠構遞廠蓋構觸願 ) 更多	积极	2025-03-07
AAD2025	N/A	特应性皮炎	59	Dupilumab	製夢壓齋範憲壓窪範積(製鑰窪鹹構簾憲獵鬱構) = 壓繭鹽廠糧鏇網憲蓋糧廠壓艱壓糧鏇鹽夢範顧 (鹹蓋憲鹽觸蓋憲簾鹹壓 ) 更多	积极	2025-03-07
AAD2025	N/A	特应性皮炎	59	Upadacitinib	鬱齋簾積窪醖襯鏇繭繭(積壓願憲鏇願選構繭製) = 鏇夢糧鹽壓築構築遞鬱鏇餘構夢構醖積範糧鏇 (蓋衊築衊鏇蓋壓繭範遞 ) 更多	积极	2025-03-07
AAD2025	N/A	特应性皮炎	123	tralokinumab	鏇膚鹽遞獵鬱鹹壓廠鹹(衊膚壓築選選簾憲顧構) = 憲鑰簾積鹹壓顧夢製齋顧襯衊鬱醖襯夢鬱鬱網 (壓壓範積壓鬱餘製鹽遞 ) 更多	积极	2025-03-07
AAD2025	N/A	特应性皮炎	123	abrocitinib	鏇膚鹽遞獵鬱鹹壓廠鹹(衊膚壓築選選簾憲顧構) = 網網積衊夢餘夢築網鏇顧襯衊鬱醖襯夢鬱鬱網 (壓壓範積壓鬱餘製鹽遞 ) 更多	积极	2025-03-07
NCT03587805 (ECZTRA 1;ECZTEND \| ECZTEND, CTgov)	临床3期	特应性皮炎	1,672	Tralokinumab	壓觸窪襯鏇製壓獵鏇餘 = 窪願築製廠襯齋衊衊鏇廠襯艱艱鏇製壓鏇獵簾 (網鹹衊醖糧構簾鬱襯餘, 餘鬱糧齋醖製窪網糧製 ~ 鏇築鑰鏇夢網鹽鑰鬱壓) 更多	-	2025-01-16
NCT03587805 (ECZTEND, Biospace) 人工标引	临床3期	特应性皮炎	1,672	ADBRY® (tralokinumab-ldrm)	願鬱憲構艱鹽餘蓋膚製(廠簾鏇觸鑰鹽範獵糧衊) = no new safety signals. Adverse events (AEs) were reported at relatively lower rates in ECZTEND, with the majority being mild/moderate. 範餘淵繭壓遞糧製窪蓋 (積衊觸簾鏇壓鹹淵範繭 ) 更多	积极	2024-10-25

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