尼莫利珠单抗(Nemolizumab) - 药物靶点：IL-31RA_在研适应症：中度特应性皮炎，重度特应性皮炎，结节性痒疹_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-IL-31-receptor-monoclonal-antibody、IL-31RA monoclonal antibody、Nemolizumab (Genetical Recombination)

+ [13]

靶点

IL-31RA

作用机制

IL-31RA抑制剂(interleukin 31 receptor A inhibitors)

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+ [1]

在研适应症

中度特应性皮炎重度特应性皮炎结节性痒疹+ [3]

非在研适应症-

原研机构

Chugai Pharmaceutical Co., Ltd.

在研机构

Galderma Holding SA

Maruho Co., Ltd.

Chugai Pharmaceutical Co., Ltd.

+ [2]

非在研机构

Galderma Research & Development SNC

最高研发阶段批准上市

首次获批日期

日本 (2022-03-28),

特应性皮炎

最高研发阶段(中国)-

特殊审评突破性疗法 (美国)、优先审评 (美国)

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序列信息

Sequence Code 81291H

来源: *****

Sequence Code 1151753L

来源: *****

关联

40

项与尼莫利珠单抗相关的临床试验

JPRN-jRCT2021230034 / Suspended临床2期IIT

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis

开始日期2023-11-09

申办/合作机构-

JPRN-jRCT2031230174 / Recruiting临床3期IIT

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

开始日期2023-06-25

申办/合作机构-

NCT05056779 / Withdrawn临床3期

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable

The primary objective of this study is to investigate the efficacy of nemolizumab administered in combination with topical background therapy (topical corticosteroids [TCS] with or without topical calcineurin inhibitors [TCI]) in adult participants with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with or are not advised to use oral cyclosporine A (CsA) for medical reasons. The secondary objective is to investigate the safety of nemolizumab in adult participants with moderate-to-severe AD who are not adequately controlled with or are not advised to use oral CsA for medical reasons.
The study will be carried out in up to 70 different locations across Europe.

开始日期2023-01-01

申办/合作机构

Galderma Holding SA

100 项与尼莫利珠单抗相关的临床结果

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100 项与尼莫利珠单抗相关的转化医学

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100 项与尼莫利珠单抗相关的专利（医药）

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127

项与尼莫利珠单抗相关的文献（医药）

2024-11-18·BRITISH JOURNAL OF DERMATOLOGY

Correction to: Efficacy and safety of nemolizumab and topical corticosteroids for prurigo nodularis: results from a randomized double-blind placebo-controlled phase II/III clinical study in patients aged ≥ 13 years

2024-11-01·Journal of the European Academy of Dermatology and Venereology : JEADV

Primary localized cutaneous amyloidosis associated with atopic dermatitis treated successfully with nemolizumab

Letter

作者: Tanaka, Rio ; Natsuaki, Satoshi ; Yoshioka, Ai ; Hashimoto, Shinya ; Kubo, Akiharu ; Fukumoto, Takeshi ; Tanaka, Ryo

A 67-yr-old Japanese man with paediatric-onset AD had a 20-yr history of PLCA and severe itch.Phys. examination revealed pruritic erythema with lichenification throughout his body and multiple firm hyperpigmented verruciform papules on the extremities.Although an IL-31 signature appears to play a role in pathogenesis in PLCA associated with AD, further studies are required.Our patient exhibited rapid relief from itching 1month after the administration of nemolizumab by inhibiting IL-31 signalling, followed by a gradual improvement in the EASI score, indicating a break in the itch-scratch cycle.

2024-11-01·IMMUNOLOGY AND ALLERGY CLINICS OF NORTH AMERICA

Current and Emerging Biologics for Atopic Dermatitis

Review

作者: Boguniewicz, Mark ; Nevid, Michael

Atopic dermatitis (AD) is a common chronic pruritic inflammatory skin disease that affects all ages and is recognized as a global health problem. Pathophysiology is complex with skin barrier abnormalities, immune dysregulation, and microbial dysbiosis all implicated. Markers of immune and inflammatory activation in the circulation provide a rationale for systemic therapy. Type 2 immune polarization is central, though other cytokine pathways including Th22 and Th17/IL-23 have been described, suggesting additional therapeutic targets in a subset of patients. Dupilumab and tralokinumab are monoclonal antibodies currently approved for moderate-to-severe AD with lebrikizumab and nemolizumab in late stages of development.

72

项与尼莫利珠单抗相关的新闻（医药）

2024-12-20

·高德美Galderma

高德美Nemluvio®（奈莫利珠单抗）获美国FDA批准，用于治疗中重度特应性皮炎

美国约有7%的人口患有特应性皮炎，这是一种以持续瘙痒和反复出现皮损为特征的常见慢性炎症性皮肤病。1-4 虽然目前的治疗方法可缓解部分症状和体征，但许多患者对已获批准的治疗方法反应欠佳，无法实现相同程度的瘙痒缓解和皮损清除。2,5-7 Nemluvio®（奈莫利珠单抗）是首个获批特异性靶向IL-31受体α的单克隆抗体，可抑制IL-31的信号传导。IL-31是一种神经免疫细胞因子，可引发瘙痒，并在特应性皮炎的炎症和表皮功能失调中发挥作用。2,9-11 此前，Nemluvio®（奈莫利珠单抗）已于2024年8月获得美国食品药品监督管理局（FDA）批准，用于治疗成人结节性痒疹。12 2024年12月13日，高德美宣布，美国食品药物监督管理局（FDA）已批准Nemluvio®（奈莫利珠单抗）用于治疗12岁及以上的中重度特应性皮炎患者，当局部处方疗法（包括局部外用糖皮质激素（TCS）和/或钙调磷酸酶抑制剂（TCI））无法充分控制病情时，可联合使用Nemluvio®（奈莫利珠单抗）。此前，美国FDA已于2024年8月批准Nemluvio®（奈莫利珠单抗）用于皮下注射治疗成人结节性痒疹。12 特应性皮炎影响着全球2.3亿多人，在美国约有7%的人口受其影响。2-4瘙痒常被视为最困扰患者的症状之一，87%的特应性皮炎患者表示他们渴望摆脱瘙痒，因此患者和医生都高度重视止痒速度。13-16特应性皮炎具有高度异质性，可伴有多种合并症，包括精神疾病和其他自身免疫或免疫介导的疾病。2,13,17-19因此，仍然需要更多新颖、有效的治疗方案，因为尽管目前可用的特应性皮炎治疗方法可改善某些症状和体征，但许多患者对已获批准的疗法反应欠佳，不能在相同程度上缓解瘙痒和清除皮损2,5-7。 Nemluvio®（奈莫利珠单抗）是首个获批能够特异性靶向IL-31受体alpha的单克隆抗体，可抑制IL-31的信号通路。8IL-31是一种神经免疫细胞因子，可引起瘙痒，并参与特应性皮炎的炎症过程和表皮功能失调。2,9-11 “ Nemluvio®（奈莫利珠单抗）是我们基于科学创新研发管线中的一个典范，它是特应性皮炎患者的一个重要且有效的全新治疗选择，满足特应性皮炎患者的未尽之需。此次获得FDA批准是高德美发展历程中的又一个重要里程碑，它将加速我们美国组织的成长和皮肤治疗业务的持续发展，同时也彰显了我们致力于，在快速增长的皮肤科市场中为患者提供一流创新解决方案的坚定承诺。 FLEMMING ØRNSKOV 医学博士，公共卫生硕士高德美首席执行官此次获批是基于ARCADIA三期临床试验的积极成果。该试验针对1728名12岁及以上中度至重度特应性皮炎患者，评估了Nemluvio®（奈莫利珠单抗）与基础外用糖皮质激素（TCS）联合使用（无论是否联用钙调磷酸酶抑制剂（TCI）），相较于安慰剂组与外用糖皮质激素（TCS）联合使用（无论是否联用钙调磷酸酶抑制剂（TCI））的疗效和安全性。20 试验结果表明，每四周一次接受皮下注射Nemluvio®（奈莫利珠单抗），并与TCS联用（无论是否联用TCI），患者在两个共同主要终点的皮损清除率方面均有统计学意义的显著改善。两个共同主要终点分别为，与安慰剂联合TCS（无论是否联用TCI）相比，治疗16周后皮损清除（0）或基本清除（1），以及湿疹面积和严重程度指数（EASI）降低75%。20 此外，试验还达到了所有关键的次要终点，证实与安慰剂联合TCS（无论是否联用TCI）相比，Nemluvio®（奈莫利珠单抗）与TCS联用（无论是否联用TCI），可最早在第1周即对瘙痒产生显著疗效，并在统计学上显著改善了睡眠障碍。20 总体而言，Nemluvio®（奈莫利珠单抗）的耐受性良好，安全性在Nemluvio®（奈莫利珠单抗）组和安慰剂组之间基本一致。20 “ 尽管目前已有多种治疗方案，但特应性皮炎在全球范围内仍有巨大影响。患者不仅要承受剧烈瘙痒和反复皮损的折磨，还可能面临睡眠问题、疼痛、焦虑和抑郁等相关症状。我期待在诊疗实践中，能为这些寻求缓解瘙痒和皮损折磨的特应性皮炎患者提供这一新选择。 JONATHAN SILVERBERG ARCADIA临床试验首席顾问和研究人皮肤病学教授美国乔治华盛顿大学医学与健康科学学院 2024年8月，美国食品药品监督管理局（FDA）还批准了Nemluvio®（奈莫利珠单抗）作为预填充笔，用于皮下注射治疗成人结节性痒疹。12 2024年12月12日，欧洲药品管理局（EMA）下辖人用医药产品委员会（CHMP）通过了一项积极意见，建议在欧盟（EU）批准奈莫利珠单抗用于治疗特应性皮炎和结节性痒疹。21该意见随后将由欧洲委员会审核，该委员会有权批准所有27个欧盟成员国以及冰岛、列支敦士登和挪威的药品上市。此外，高德美关于Nemluvio®（奈莫利珠单抗）治疗特应性皮炎和结节性痒疹的上市许可申请，目前正接受多个监管机构的审评，包括Access Consortium框架下的澳大利亚、新加坡和瑞士等国，以及加拿大、巴西和韩国的监管机构。222025年还将继续向其他监管机构提交申请。据高德美预计，奈莫利珠单抗的销售峰值将有望超过20亿美元（预计超过2023—2027年中期指导期）。到2027年底，奈莫利珠单抗的净销售额将接近“重磅级”水平。 *说明：截至目前，Nemluvio®（奈莫利珠单抗）尚未在中国市场获批上市向上滑动阅览关于 Nemluvio®（奈莫利珠单抗） Nemluvio®（奈莫利珠单抗）最初由中外制药有限公司开发。2016年，高德美获得了奈莫利珠单抗在全球（日本和中国台湾除外）的独家开发和销售权。在日本，奈莫利珠单抗以Mitchga®的名称销售，获准用于治疗结节性痒疹以及儿童、青少年和成人患者与特应性皮炎相关的瘙痒症23,24。关于ARCADIA临床试验项目20,25,26 ARCADIA项目包括两项设计相同的关键性三期临床试验（ARCADIA 1和ARCADIA 2），共计招募1700余名患者。这些全球性、随机、多中心、双盲、安慰剂对照的三期临床试验，评估了每四周皮下注射一次奈莫利珠单抗的疗效和安全性，并与安慰剂进行了比较（两项研究均与基础外用TCS治疗联合，无论是否联用外用TCI）。试验在患有中度至重度特应性皮炎的青少年和成人患者（12岁及以上）中进行，初始治疗阶段为16周。治疗有反应的患者（定义为研究者的总体评估评分达到“清除”（0）或“基本清除”（1），或湿疹面积和严重程度指数评分改善75%或更多）将被重新随机分配到试验的维持治疗阶段，维持治疗最长持续48周。关于特应性皮炎特应性皮炎是一种常见的慢性炎症性皮肤病，以持续瘙痒和反复出现皮损为特征。1-3全球范围内有超过2.3亿人患有这种疾病，它是最常见的炎症性皮肤病之一，患病人数几乎是银屑病的四倍。2,27虽然目前可用的特应性皮炎治疗方法能在一定程度上改善体征和症状，但并非所有患者都能获得相同程度的瘙痒缓解和皮损清除，许多患者对已获批的疗法反应欠佳。2,5-7 关于高德美高德美（瑞士证券交易所：股票代码为"GALD"）致力于成为专注皮肤学领域的全球领导者，业务遍及约90个国家和地区。我们提供创新、以科学为基础的优质旗舰品牌和服务组合，横跨注射美学、日常护肤和皮肤治疗这三个快速增长的皮肤学细分市场。自1981年成立以来，我们一直热忱专注于人体最大的器官——皮肤，与专业医务工作者合作，以卓越成果满足求美者、消费者和患者的个性化需求。肌肤塑造了我们的人生故事，由此，我们致力于不断推进“每一个进步为每一寸肌肤”。更多信息请访问： www.galderma.com 向上滑动查看参考文献 1、 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8): 2867. doi: https://doi-org.libproxy1.nus.edu.sg/10.3390/ijms21082867 2、 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140- 6736(20)31286- 1 3、 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 4、 Silverberg JI, et al. Sleep Disturbances in Adults with Eczema Are Associated with Impaired Overall Health: A US Population-Based Study. J Invest Derm. 2015; 135, 56–66; doi:10.1038/jid.2014.325 5、 Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi:10.3390/biomedicines10112927 6、 Katoh N, Ohya Y, Ikeda M, et al. Clinical practice guidelines for the management of atopic dermatitis 2018. J Dermatol. 2019;46(12): 1053-1101. doi:10.1111/1346-8138.15090 7、 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi:10.1002/cti2.1390 8、 Silverberg J, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/j.jaci.2019.08.013 9、 Bağci IS and Ruzicka T. IL-31: A new key player in dermatology and beyond. J Allergy Clin Immunol. 2018;141(3): P858-866. doi: 10.1016/j.jaci.2017.10.045 10、 Dillon SR, et al. Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice [published correction appears in Nat Immunol. 2005;6(1):114.] Nat Immunol. 2004;5(7):752-760. doi: 10.1038/ni1084 11、 Datsi A, et al. Interleukin-31: The “itchy” cytokine in inflammation and therapy. Allergy. 2021;76:2982-2997. doi: 10.1111/all.14791 12、 NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024 13、 Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7: 102:adv00830. doi: 10.2340/actadv.v102.3932 14、 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 15、 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 16、 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi:10.1016/j.anai.2018.07.006 17、 Halvorsen J, et al. Suicidal Ideation, Mental Health Problems, and Social Function in Adolescents with Eczema: A Population-Based Study. J Invest Derm. 2014;134: 1847-1854. doi:https://doi-org.libproxy1.nus.edu.sg/10.1038/jid.2014.70 18、 Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23(8 suppl):S115-S123. PMID:28978208 19、 Hahn EL, Bacharier LB. The atopic march: the pattern of allergic disease development in childhood. Immunol Allergy Clin North Am. 2005;25(2):231-246. doi:10.1016/j.iac.2005.02.004 20、 Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024. doi: 10.1016/S0140-6736(24)01203-0 21、 Galderma. CHMP recommends approval of Galderma’s nemolizumab for moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union. Available online. Accessed December 2024 22、 Galderma. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. Available online. Accessed December 2024 23、 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed December 2024 24、 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed December 2024 25、 ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed December 2024 26、 ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed December 2024 27、 Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257

临床3期上市批准临床结果加速审批

2024-12-18

·drugs

FDA Approves Nemluvio for Moderate-to-Severe Atopic Dermatitis

WEDNESDAY, Dec. 18, 2024 -- The U.S. Food and Drug Administration has approved Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older. The approval is for use in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Nemluvio is the first approved monoclonal antibody that targets interleukin-31 receptor alpha, which drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis. The approval is based on the results of the phase 3 ARCADIA clinical trial program that included 1,728 patients aged 12 years and older with moderate-to-severe atopic dermatitis. After 16 weeks, patients treated with Nemluvio, administered subcutaneously every four weeks, in combination with TCS (with or without TCI) had statistically significant improvements on skin clearance (either clearance or almost-clearance using the Investigator's Global Assessment score). Patients also achieved a 75 percent reduction in the Eczema Area and Severity Index versus placebo in combination with TCS (with or without TCI), after 16 weeks of treatment. All key secondary end points were met, including significant responses on itch as early as week 1 and statistically significant improvements in sleep disturbance. Overall, Nemluvio was well tolerated, with similar safety profiles observed in both the Nemluvio and placebo groups. "Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms, including sleep issues, pain, anxiety, and depression," lead investigator of the ARCADIA trial, Jonathan Silverberg, M.D., Ph.D., from George Washington University in Washington, D.C., said in a statement. "I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions." Approval of nemolizumab was granted to Galderma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床3期上市批准

2024-12-17

·PMLiVE

CHMP recommends Galderma’s nemolizumab for atopic dermatitis and prurigo nodularis

The European Medicines Agency’s human medicines committee has recommended Galderma’s nemolizumab to treat atopic dermatitis and prurigo nodularis in patients with moderate-to-severe cases of the skin diseases. The Committee for Medicinal Products for Human Use (CHMP) has recommended that nemolizumab be used subcutaneously to treat atopic dermatitis patients aged 12 years and older, and in adults with prurigo nodularis. Those eligible for the drug must also be candidates for systemic therapy, according to the recommendations. Affecting up to 40 million people in the EU, atopic dermatitis is characterised by intense itch and eczematous lesions. The prevalence of prurigo nodularis, which causes chronic itch and skin nodules, is not well-documented, but it is estimated to affect up to 111 people per 100,000 in the EU depending on the country. Initially developed by Chugai Pharmaceutical, nemolizumab is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction in both conditions. The CHMP’s recommendation in atopic dermatitis was based on results from the phase 3 ARCADIA 1 and 2 trials, in which nemolizumab in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The committee’s decision in prurigo nodularis was supported by data from the late-stage OLYMPIA 1 and 2 trials, which met both their primary and key secondary endpoints, indicating that treatment with nemolizumab resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. The European Commission (EC) will now consider the CHMP’s recommendation as it makes a decision on nemolizumab in these indications. Galderma’s chief executive officer, Flemming Ørnskov, said: “The robust evidence base we have built for nemolizumab in both atopic dermatitis and prurigo nodularis shows the extent of its potential in improving outcomes for these diseases where the burden and unmet needs remain high. “We now await the EC’s approval decision and hope to be able to bring nemolizumab to patients in the EU in due course.”

临床结果临床3期上市批准

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外链

KEGG	Wiki	ATC	Drug Bank
D11080	尼莫利珠单抗	-	DB15252

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适应症	国家/地区	公司	日期
中度特应性皮炎	美国	Galderma Laboratories LP	2024-12-13
重度特应性皮炎	美国	Galderma Laboratories LP	2024-12-13
结节性痒疹	日本	Maruho Co., Ltd.	2024-03-26
特应性皮炎	日本	Maruho Co., Ltd.	2022-03-28

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适应症	最高研发状态	国家/地区	公司	日期
瘙痒	临床3期	美国	Galderma Holding SA	2021-12-29
瘙痒	临床3期	匈牙利	Galderma Holding SA	2021-12-29
瘙痒	临床3期	波兰	Galderma Holding SA	2021-12-29
瘙痒	临床3期	西班牙	Galderma Holding SA	2021-12-29
系统性硬皮病	临床2期	日本	Maruho Co., Ltd.	2022-04-20

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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


NCT04562116 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	17	CYP 450 Substrates+Nemolizumab	簾衊膚顧繭夢製觸齋製(齋壓繭選衊憲繭鬱獵簾) = 餘範鬱淵衊糧獵齋齋觸構築餘鏇淵繭艱網衊憲 (選淵遞醖遞選積積餘構, 願鏇願獵鹽憲襯網顧顧 ~ 窪遞窪築願壓糧鏇顧製) 更多	-	2024-12-05
NCT04501666 (OLYMPIA 1, Pubmed \| JAMA Dermatol)	临床3期	结节性痒疹	286	Nemolizumab 30 mg	願糧窪醖顧範繭醖鏇積(範鏇廠壓糧鏇糧選鹹鹹) = 艱艱積膚齋構壓網選夢淵淵鏇鹹蓋廠繭糧網鑰 (製襯齋鏇餘築範夢鹽壓, 6.7% ~ 22.6%) 更多	积极	2024-11-27
				Placebo	願糧窪醖顧範繭醖鏇積(範鏇廠壓糧鏇糧選鹹鹹) = 廠衊鏇壓憲鏇觸鏇餘繭淵淵鏇鹹蓋廠繭糧網鑰 (製襯齋鏇餘築範夢鹽壓 ) 更多
NCT05052983 (CTgov)	临床3期	结节性痒疹	34	Nemolizumab (Nemolizumab)	範構醖繭構鏇糧壓鑰鏇(鹹蓋鬱齋鹽夢積襯築鹽) = 選鏇顧網鹽獵憲窪蓋夢艱壓醖窪願淵廠蓋遞範 (觸淵遞繭鑰範艱築積廠, 齋築鑰蓋積網鹹選蓋繭 ~ 獵夢齋繭構鏇網衊艱選) 更多	-	2024-10-08
				Placebo (Placebo)	範構醖繭構鏇糧壓鑰鏇(鹹蓋鬱齋鹽夢積襯築鹽) = 簾齋築襯願觸齋觸壓鏇艱壓醖窪願淵廠蓋遞範 (觸淵遞繭鑰範艱築積廠, 鏇鬱鹹夢願製觸淵簾範 ~ 廠齋製餘願觸齋觸壓築) 更多
NCT03989349 (ARCADIA 2, CTgov)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	787	Nemolizumab (Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)	網壓蓋壓簾鹽願襯顧餘(選觸鬱鑰艱顧願繭醖壓) = 膚網觸襯鬱鑰壓糧鑰憲範糧製製築蓋艱鏇網鑰 (夢蓋衊齋願築膚齋鏇鹹, 願築鏇夢鹹窪廠醖鑰齋 ~ 齋壓壓鬱鏇艱顧憲糧襯) 更多	-	2024-08-14
				Placebo (Initial Treatment Period (Baseline - Week 16 Predose): Placebo)	網壓蓋壓簾鹽願襯顧餘(選觸鬱鑰艱顧願繭醖壓) = 蓋鹽廠鹽鹹艱壓構鑰艱範糧製製築蓋艱鏇網鑰 (夢蓋衊齋願築膚齋鏇鹹, 壓繭餘糧鏇鹽選構繭艱 ~ 製遞築鑰鑰顧範鹽製繭) 更多
NCT03985943 (ARCADIA 1, CTgov)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	941	Placebo (Initial Treatment Period (Baseline - Week 16 Predose): Placebo)	醖餘鹹糧夢顧齋醖選網(淵餘製淵鑰願簾願積範) = 襯廠簾構繭夢憲襯淵憲築網艱鬱糧獵糧鏇壓遞 (鹹觸餘膚醖願衊繭構積, 廠壓夢艱構獵淵襯鬱衊 ~ 餘製窪艱蓋範選窪願憲) 更多	-	2024-08-14
				Nemolizumab (Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)	醖餘鹹糧夢顧齋醖選網(淵餘製淵鑰願簾願積範) = 廠積鏇築襯醖膚簾觸積築網艱鬱糧獵糧鏇壓遞 (鹹觸餘膚醖願衊繭構積, 顧繭積鬱齋鬱窪衊膚窪 ~ 窪廠艱範製憲獵觸範廠) 更多
NCT04501679 \| NCT04501666 (OLYMPIA 2, FDA_CDER) 人工标引	临床3期	结节性痒疹	560	NEMLUVIO (OLYMPIA 1)	網鏇餘鏇醖繭繭繭積壓(窪構範醖選蓋壓醖醖壓) = 獵觸壓壓齋夢廠顧積鏇夢顧齋鬱憲憲簾觸壓繭 (醖憲鹽範繭顧襯膚艱壓 ) 更多	积极	2024-08-12
				Placebo (OLYMPIA 1)	網鏇餘鏇醖繭繭繭積壓(窪構範醖選蓋壓醖醖壓) = 蓋遞鏇壓餘夢築憲鹹範夢顧齋鬱憲憲簾觸壓繭 (醖憲鹽範繭顧襯膚艱壓 ) 更多
NCT03985943 \| NCT03989349 (ARCADIA 2, Lancet 1 \| Lancet 2 \| Pubmed) 人工标引	临床3期	特应性皮炎	1,728	Nemolizumab 30 mg	簾壓鏇蓋夢觸製願憲簾(網衊顧鬱構蓋簾襯糧願) = 衊憲願餘繭蓋構獵憲餘獵餘壓壓鹽製壓齋廠蓋 (夢醖窪觸繭廠繭夢窪鑰 ) 更多	积极	2024-07-24
				Placebo	簾壓鏇蓋夢觸製願憲簾(網衊顧鬱構蓋簾襯糧願) = 願鑰鑰鹹鏇膚網鬱壓醖獵餘壓壓鹽製壓齋廠蓋 (夢醖窪觸繭廠繭夢窪鑰 ) 更多
NCT04501666 (OLYMPIA 1, CTgov)	临床3期	结节性痒疹	286	Nemolizumab 30 mg (Nemolizumab)	鑰顧糧製簾醖廠鏇衊築(壓蓋選鹽餘繭窪齋積齋) = 積遞憲鹹壓夢觸艱壓壓淵壓糧獵鏇夢願觸顧範 (鹽鏇顧餘鑰醖積選蓋醖, 餘鏇蓋齋壓鬱窪鬱鑰齋 ~ 衊窪築觸構鏇鏇觸淵獵) 更多	-	2024-07-10
				Placebo (Placebo)	鑰顧糧製簾醖廠鏇衊築(壓蓋選鹽餘繭窪齋積齋) = 夢壓範淵積顧壓獵衊淵淵壓糧獵鏇夢願觸顧範 (鹽鏇顧餘鑰醖積選蓋醖, 網衊繭醖鬱襯鑰願壓鹽 ~ 簾憲選壓積餘獵鏇襯襯) 更多
NCT04501679 (OLYMPIA 2 \| Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis, CTgov)	临床3期	结节性痒疹	274	Nemolizumab (Nemolizumab)	獵繭鑰顧顧鑰獵夢鑰鏇(艱餘憲積襯觸廠獵獵積) = 淵衊餘鹹壓築膚鹽襯餘醖壓齋醖選壓糧遞獵願 (遞窪積齋網顧憲壓構顧, 鬱淵獵窪蓋鑰築製願獵 ~ 鹽夢鑰蓋憲遞獵積繭簾) 更多	-	2024-07-10
				Placebo (Placebo)	獵繭鑰顧顧鑰獵夢鑰鏇(艱餘憲積襯觸廠獵獵積) = 壓願願鏇糧壓繭衊觸範醖壓齋醖選壓糧遞獵願 (遞窪積齋網顧憲壓構顧, 醖鹹顧餘積艱醖窪顧鹽 ~ 遞獵鏇製繭壓遞齋餘蓋) 更多
OLYMPIA 1 (Biospace) 人工标引	临床3期	结节性痒疹 \| 特应性皮炎	-	Nemolizumab	範膚繭餘鬱淵範簾襯顧(鹹選淵廠築積衊壓夢鹽) = 窪範廠齋鑰鏇餘製壓繭窪鏇觸憲遞網製鹽襯壓 (憲鏇鏇築糧築願鹽夢簾 ) 更多	积极	2023-10-11
				placebo	範膚繭餘鬱淵範簾襯顧(鹹選淵廠築積衊壓夢鹽) = 醖獵繭範膚簾簾積選衊窪鏇觸憲遞網製鹽襯壓 (憲鏇鏇築糧築願鹽夢簾 ) 更多