尼莫利珠单抗(Nemolizumab) - 药物靶点：IL-31RA_在研适应症：结节性痒疹，特应性皮炎，系统性硬皮病_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)

+ [11]

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

结节性痒疹特应性皮炎系统性硬皮病+ [1]

非在研适应症-

原研机构

Chugai Pharmaceutical Co., Ltd.

在研机构

Maruho Co., Ltd.

Galderma Holding SA

Chugai Pharmaceutical Co., Ltd.

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)-

特殊审评优先审评 (美国)、突破性疗法 (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

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

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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95

项与尼莫利珠单抗相关的文献（医药）

2024-01-01·Pediatric dermatology

Effectiveness of systemic treatments on pruritus associated with atopic dermatitis: A systematic review in pediatric patients

Review

作者: de Jong, Elke M G J ; Kouwenhoven, Tessa A ; van Muijen, Marloes E ; Kamsteeg, Marijke ; Seyger, Marieke M B ; van de Kerkhof, Peter C M

Abstract:

Background/Objectives:

Itch is one of the hallmarks of atopic dermatitis (AD), which has a significant impact on the quality of life of pediatric patients with AD and their caregivers. We aimed to conduct a systematic review and meta‐analysis to evaluate the antipruritic effects of systemic AD treatments in pediatric patients with AD.

Methods:

PubMed, EMBASE, Cochrane, and Web of Science databases were searched, including studies providing original data on the effects of systemic treatment on pruritus in pediatric patients (<18 years) with AD. Placebo‐controlled trials reporting a Peak Pruritus Numerical Rating Scale 4 (PP‐NRS4) response were included in a meta‐analysis.

Results:

A total of 30 studies were included, with most evidence available for dupilumab. Overall, marked improvements of pruritus (50% or greater reduction in pruritus outcome measurements) were found for treatment with cyclosporin A (2–16 years), dupilumab (6 months–17 years), abrocitinib, and upadacitinib (both 12 and 17 years). Nemolizumab (12–17 years) may be promising in reducing pruritus in pediatric patients; however, data are limited. Only five randomized controlled trials could be included in our meta‐analysis, in which dupilumab, abrocitinib, and upadacitinib showed a significantly higher probability of achieving a PP‐NRS4 response compared with placebo. Our study was limited by a lack of homogeneity of included studies.

Conclusions:

Cyclosporin A, dupilumab, abrocitinib, and upadacitinib are all effective in decreasing pruritus and, therefore, in improving the quality of life in children with AD. As more systemic treatments for AD become available, it will be imperative to incorporate patient‐oriented treatment goals such as reduction of pruritus into therapeutic decision‐making.

2024-01-01·American journal of clinical dermatology

Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments

Review

作者: Zeidler, Claudia ; Müller, Svenja ; Ständer, Sonja

Chronic prurigo (CPG) is a neuroinflammatory, fibrotic dermatosis that is defined by the presence of chronic pruritus (itch lasting longer than 6 weeks), scratch-associated pruriginous skin lesions and history of repeated scratching. Patients with CPG experience a significant psychological burden and a notable impairment in their quality of life. Chronic prurigo of nodular type (CNPG; synonym: prurigo nodularis) represents the most common subtype of CPG. As CNPG is representative for all CPG subtypes, we refer in this review to both CNPG and CPG. We provide an overview of the clinical characteristics and assessment of CPG, the burden of disease and the underlying pathophysiology including associated therapeutic targets. The information provided results from a PubMed search for the latest publications and a database search for current clinical trials (ClinicalTrials.gov, EU Clinical Trials Register [European Medicines Agency]; using the following terms or combinations of terms: 'chronic prurigo', 'prurigo', 'prurigo nodularis', 'pathophysiology', 'therapy', 'biologics', 'treatment'). Dupilumab is the first authorized systemic therapy by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for CNPG to date. Topical and systemic agents that are currently under investigation in clinical randomized, placebo-controlled phase II and III trials such as biologics (e.g., nemolizumab, vixarelimab/KPL-716, barzolvolimab/CDX-0159), small molecules (ruxolitinib cream, povorcitinib/INCB054707, abrocitinib) and the opioid modulator nalbuphine are highlighted. In the last past 15 years, several milestones have been reached regarding the disease understanding of CPG such as first transcriptomic analysis, first terminology, first guideline, and first therapy approval in 2022, which contributed to improved medical care of affected patients. The broad range of identified targets, current case observations and initiated trials offers the possibility of more drug approvals in the near future.

2024-01-01·The Journal of allergy and clinical immunology

Single-cell profiling of prurigo nodularis demonstrates immune-stromal crosstalk driving profibrotic responses and reversal with nemolizumab

Article

作者: Tsoi, Lam C ; Ma, Feiyang ; Maverakis, Emanual ; Harms, Paul ; Plazyo, Olesya ; Patrick, Matthew T ; Xing, Xianying ; Lazzari, Anne ; Chaskar, Prasad ; Julia, Valerie ; Nakamura, Mio ; Piketty, Christophe ; Krishnaswamy, Jayendra Kumar ; Billi, Allison C ; Gudjonsson, Johann E ; Hile, Grace ; Modlin, Robert L ; Kahlenberg, J Michelle ; Gharaee-Kermani, Mehrnaz ; Van Delm, Wouter

BACKGROUND:

Prurigo nodularis (PN) is a chronic neuroimmune skin disease characterized by bilaterally distributed pruritic hyperkeratotic nodules on extremities and trunk. Neuroimmune dysregulation and chronic scratching are believed to both induce and maintain the characteristic lesions.

OBJECTIVES:

This study sought to provide a comprehensive view of the molecular pathogenesis of PN at the single-cell level to identify and outline key pathologic processes and the cell types involved. Features that distinguish PN skin from the skin of patients with atopic dermatitis were of particular interest. We further aimed to determine the impact of the IL31RA antagonist, nemolizumab, and its specificity at the single-cell level.

METHODS:

Single-cell RNA-sequencing of skin from 15 healthy donors and nonlesional and lesional skin from 6 patients each with PN and atopic dermatitis, combined with spatial-sequencing using the 10x Visium platform. Integration with bulk RNA-sequencing data from patients treated with nemolizumab.

RESULTS:

This study demonstrates that PN is an inflammatory skin disease characterized by both keratinocyte proliferation and activation of profibrotic responses. This study also demonstrates that the COL11A1⁺ fibroblast subset is a major contributor to fibrosis and is predominantly found in the papillary dermis of PN skin. Activation of fibrotic responses is the main distinguishing feature between PN and atopic dermatitis skin. This study further shows the broad effect of nemolizumab on PN cell types, with a prominent effect driving COL11A1⁺ fibroblast and keratinocyte responses toward normal.

CONCLUSIONS:

This study provides a high-resolution characterization of the cell types and cellular processes activated in PN skin, establishing PN as a chronic fibrotic inflammatory skin disease. It further demonstrates the broad effect of nemolizumab on pathological processes in PN skin.

32

项与尼莫利珠单抗相关的新闻（医药）

2024-05-10

·医药笔记

成立不到1年，Attovia完成1.05亿美元B轮融资

▎Armstrong2024年5月9日，Attovia Therapeutics宣布超额完成1.05亿美元B轮融资，本轮融资由Goldman Sachs Alternatives领投，Cormorant Asset Management, Nextech Ventures, Redmile Group, EcoR1 Capital, Marshall Wace, Logos Capital跟投.。老股东Frazier Life Sciences, venBio, Illumina Ventures继续追加。Attovia成立于2023年6月，由蛋白组学公司Alamar Biosciences与Frazier Life Sciences孵化，技术来自Alamar Biosciences的双表位纳米抗体技术Attobody，资金方面由Frazier Life Sciences领投，Venbio、Illumina跟投。Attobody为一种双表位纳米抗体技术。Attovia的核心产品为长效IL-31抗体、IL-31/IL-13双抗，用于治疗特应性皮炎和其他瘙痒疾病。2022年3月28日，日本皮肤病药物研发公司Maruho旗下IL-31R抗体在日本获得批准，用于治疗特应性皮炎相关的瘙痒，商品名为Mitchga。Alamar的创始人为罗玉玲和陈世平，两人是中科大校友，也是多年的连续创业伙伴，两人先后共同创办了Panomics、ACD，其中Panomics于2008年被Affimetrix以7300万美元收购，ACD于2016年被Bio-techne以3.3亿美元收购。罗玉玲为Attovia的董事，A轮领投方Frazier的投资人Jamie Topper为董事长。Attovia的管理团队同样以华人为主，傅涛（此前为再鼎医药CEO）担任CEO。总结瘙痒性疾病并不致命，但严重影响生活质量，且在临床上存在严重的未满足需求。IL-31/IL-31R/OSMR通路导致神经纤维的延长和分支，产生瘙痒效应，同时炎症性反应也会加剧。除验证通路外，聚焦瘙痒受体的Escient，前不久刚刚被Incyte以7.5亿美元收购。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

并购抗体药物偶联物

2024-04-10

·药融圈

2017年以来瑞士最大IPO，皮肤科学巨头高德美

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。从雀巢集团分离出来的高德美（Galderma）（瑞士高德美集团股份公司（“高德美”）致力于成为皮肤学领域的全球领导者，在大约90个国家和地区开展业务。公司横跨注射美学、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，高德美一直热忱专注于人体最大的器官——皮肤。目前高德美的旗舰品牌组合包括注射美学品牌（Injectable Aesthetics）瑞蓝、吉适、Azzalure、Alluzience和Sculptra，皮肤治疗品牌（Therapeutic Dermatology）Soolantra、Epiduo、达芙文、Aklief、Epsolay、Twyneo、Oracea、Metvix、班赛和罗每乐，以及日常护肤品牌丝塔芙和Alastin（以上品牌包含尚未在中国大陆（不含中国港澳台地区）正式获批上市的产品）。2024年3月22日，高德美集团股份公司（“高德美”）正式登陆瑞士证券交易所（SIX Swiss Exchange），是该交易所2024年的首次公开募股（IPO）。这是2017年以来瑞士最大规模IPO。高德美（股票代码为"GALD"）开盘价为每股61.00瑞士法郎，当时市值高达145亿瑞士法郎（约合人民币1164亿元）。高德美已发行股本包括 237,897,635 股登记股，其中 37,233,708 股新发行登记股和 276,909 股现有登记股在首次公开募股中发行。按每股登记股 53.00 瑞士法郎的发行价计算，配售量约为 20 亿瑞士法郎（不包括超额配售权）。此外，作为超额配售权的一部分，股东们还发售了最多 5,626,592 股现有登记股票，这些股票可在瑞士证券交易所首个交易日后的 30 个日历日内行使超额配售权。高德美首席执行官Flemming Ørnskov博士指出：“对于公司在瑞士证券交易所的成功上市感到自豪。”他强调了高德美致力于通过其创新的注射美学、日常护肤和皮肤治疗产品，进一步巩固其市场领导地位的决心，并对所有员工多年来的辛勤工作和贡献表达了感激之情。瑞士证券交易所首席执行官Jos Dijsselhof表示，“对高德美的加入表示欢迎，高德美的加入将加强交易所作为欧洲领先的消费者和医疗保健公司首选平台的地位。”他对高德美作为一家上市公司的未来表达了乐观的预期，并期待双方在资本市场的未来合作。在研新产品01RelabotulinumtoxinA（QM1114）药融云数据www.pharnexcloud.com显示：由高德美开发的新型液态A型肉毒毒素（RelabotulinumtoxinA），是一种创新的、高活性的、不含复合物的、即用型液态A型肉毒毒素，使用专有菌株，并采用独特的先进工艺制造。它被设计为即用液体形态，避免了传统的粉末复溶要求，消除了与复溶相关的可变性、误差和风险，从而有望提高治疗效果的一致性。作为公司丰富的注射美学产品组合的一部分，高德美正在全球范围内对新型液态A型肉毒毒素（RelabotulinumtoxinA）开展研究，进一步扩展其肉毒毒素领域的产品组合。新型液态A型肉毒毒素（RelabotulinumtoxinA）是一款在研产品，尚未在任何国家和地区获得任何适应症的批准。02奈莫利珠单抗（nemolizumab）此前高德美公布了用奈莫利珠单抗（nemolizumab）治疗特应性皮炎和结节性痒疹的四项III期试验的积极数据，均达到了各项试验的所有主要和次要终点。2024年2月14日，高德美宣布美国和欧盟已受理奈莫利珠单抗用于治疗结节性痒疹和特应性皮炎的新药上市申请（BLA/MAA）。2022年3月28日，Maruho宣布Mitchga（nemolizumab），全球首款IL-31Rα抗体,特应性皮炎相关的瘙痒适应症在日本获得MHLW批准上市。本品最早由罗氏控股旗下日本中外制药（Chugai Pharmaceutical）开发，研发代号CIM331（罗氏“东方之子”：日本中外制药，打造抗体工程之王者）。药融云数据www.pharnexcloud.com显示：Maruho拥有权益nemolizumab日本权益。高德美（Galderma）拥有除日本和中国台湾省之外的权益。Nemolizumab由中外制药的抗体工程技术ACT-Ig开发，ACT-Ig可延长抗体在血液中的半衰期。抗体相关专利：WO-2014208645。▲多方合作，促进新药研发03trifarotene2023年，关于曲法罗汀（trifarotene，Aklief）（一种选择性靶向视黄酸受体（RAR）γ的局部类维生素A）的最新数据持续加强了高德美在痤疮治疗方面的领先地位，来自IV期START研究的新数据显示，萎缩性痤疮瘢痕风险在统计和临床上显著降低，患者满意度和依从性较高。IV期LEAP研究的数据也显示炎症后色素沉着有所减轻。2023财年业绩高德美2023财年实现净销售额40.82亿美元，按固定汇率计算，同比增长8.5%，接近2023财年净销售额增长6-9%业绩指引的上限，净销售额首次突破40亿美元大关。按固定汇率计算，注射美学、日常护肤和皮肤治疗三大业务的净销售额同比增长分别为6.5%、12.1%和8.7%。2023年核心EBITDA（息税摊销前利润）为9.42亿美元，核心 EBITDA 利润率为23.1%，按固定汇率计算，同比增长21.4%。2023年6月26日，高德美宣布向现有股东、新投资者及管理层组成的集团私募约10亿美元。所得资金用于加强公司的资产负债表，并进一步加快公司的有机增长。高德美历史高德美公司的历史可追溯到1961年，M. Owen在美国德克萨斯州达拉斯成立了欧文皮肤病实验室。1972年，欧文实验室被Alcon（爱尔康）收购。1977年，Alcon被雀巢收购。1979年，Hans Schaefer教授在欧莱雅前CEO François Dalle的协助下在法国索菲亚·安蒂波里斯建立了国际皮肤病研究中心（CIRD）。François Dalle希望将美容研究延伸到药物领域。1981年，雀巢和欧莱雅共同合资成立了Galderma高德美实验室，CIRD成为了高德美研发中心（Galderma R&D）。2014年，雀巢从欧莱雅回购了高德美所有剩余的股份，成立雀巢皮肤健康（Nestlé Skin Health），被作为雀巢的全资子公司运营。药融圈旗下，药融云数据www.pharnexcloud.com显示：2019年，雀巢以102亿瑞士法郎（约合103亿美元）的价格将雀巢皮肤健康业务出售，并将这一板块重新命名为高德美。收购方是由殷拓VIII基金、阿布扎比投资局（ADIA）旗下全资子公司Luxinva、PSP Investments以及其他知名机构投资者牵头的财团。参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；www.galderma.com;雀巢103亿美元出售高德美（Galderma）等皮肤健康业务|药融圈；Galderma reports net sales by two geographies: U.S. and International markets;Galderma data on file: initial results of the phase IIIb 43QM2106 trial; initial results of the phase IIIb 43QM2107 trial;https://www.maruho.co.jp/english/about/activities/pipeline/；https://www.maruho.co.jp/english/information/20220328.html；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 5月 • 第八届大湾区生物医药创新者峰会关键词：小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

IPO上市批准

2024-03-21

·Firstwordpharma

Galderma prices massive $2B Swiss IPO as Boundless readies for $100M US offering

While US markets have just started warming up to biotech IPOs this year, the Swiss stock exchange (SIX) on Thursday saw what will most likely be one of the largest public debuts of the year from a drug developer.Dermatology company Galderma priced its IPO at the high end of its proposed range between CHF49 and CHF53 per share, earning a market capitalisation of CHF12.6 billion ($14 billion) and gross proceeds of CHF2 billion.The offering comprises 37 million newly issued shares and close to 277,000 existing shares. If the over-allotment option of 5.6 million shares is purchased, the company will raise a total of CHF2.3 billion.Galderma, which will start trading Friday on SIX, recently presented data at the American Academy of Dermatology (AAD) meeting showing that the every-eight-week dosing schedule of its IL-31 antibody nemolizumab could offer a leg up on Sanofi’s Dupixent (dupilumab) to treat atopic dermatitis. For more, see What you need to know from AAD 2024.Meanwhile, cancer drug developer Boundless Bio set terms for its upcoming IPO on NASDAQ. The San Diego-based biotech proposed to sell 6.25 million shares at $15-$17 apiece. At the midpoint, Boundless would raise $100 million and be valued at about $355 million.With two synthetic lethality programmes in Phase I/II trials, Boundless may have a better IPO performance than that of preclinical genetic medicines company Metagenomi, whose shares are down about 25% from its debut price.

IPO

100 项与尼莫利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11080	-	-	DB15252

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
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

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
系统性硬皮病	临床2期	日本	Maruho Co., Ltd.	2022-04-20
瘙痒	临床2期	美国	Galderma Holding SA	2017-06-14
瘙痒	临床2期	澳大利亚	Galderma Holding SA	2017-06-14
瘙痒	临床2期	加拿大	Galderma Holding SA	2017-06-14
瘙痒	临床2期	法国	Galderma Holding SA	2017-06-14
瘙痒	临床2期	德国	Galderma Holding SA	2017-06-14
瘙痒	临床2期	波兰	Galderma Holding SA	2017-06-14

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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


OLYMPIA 1 (Biospace) 人工标引	临床3期	特应性皮炎 \| 结节性痒疹	-	Nemolizumab	築獵鑰艱餘積選網繭醖(獵構網憲積膚齋獵簾鏇) = 淵繭餘糧繭淵構餘鏇遞遞簾衊鑰鏇繭窪獵膚鹹 (淵壓鬱窪餘壓餘願蓋襯 ) 更多	积极	2023-10-11
				placebo	築獵鑰艱餘積選網繭醖(獵構網憲積膚齋獵簾鏇) = 夢壓醖艱壓築蓋鹹憲構遞簾衊鑰鏇繭窪獵膚鹹 (淵壓鬱窪餘壓餘願蓋襯 ) 更多
NCT03985943 \| NCT03989349 (ARCADIA 1 and ARCADIA 2, EADV2023)	临床3期	特应性皮炎 interleukin-31 receptor alpha	-	Nemolizumab 30 mg	鹹艱築鏇夢夢製齋襯壓(網鬱夢膚鬱蓋窪鑰網觸) = 齋製觸壓糧鏇齋獵憲鹹構蓋窪廠夢夢壓繭鏇觸 (鬱鏇淵遞願願鏇簾鑰鹽 ) 更多	积极	2023-10-11
				Placebo	鹹艱築鏇夢夢製齋襯壓(網鬱夢膚鬱蓋窪鑰網觸) = 蓋築蓋構顧蓋範餘窪範構蓋窪廠夢夢壓繭鏇觸 (鬱鏇淵遞願願鏇簾鑰鹽 ) 更多
NCT04501666 (OLYMPIA 1, EADV2023)	临床3期	结节性痒疹	-	Nemolizumab	選憲遞選鏇範襯觸繭簾(淵蓋鏇獵願觸鹹遞構窪) = 憲構獵鬱淵網築範憲膚築積餘鬱顧壓選醖憲遞 (窪積醖醖憲網鹽鬱齋選 )	积极	2023-10-11
				Placebo	選憲遞選鏇範襯觸繭簾(淵蓋鏇獵願觸鹹遞構窪) = 襯築願顧製鹹構範繭壓築積餘鬱顧壓選醖憲遞 (窪積醖醖憲網鹽鬱齋選 )
NCT03921411 (CTgov)	临床2期	特应性皮炎	20	Nemolizumab	積構鹽積衊餘鹹繭製襯(膚廠遞顧獵淵簾選蓋蓋) = 製夢鹹艱鑰淵願簾範艱積獵獵蓋餘鏇構選簾糧 (艱齋鏇積願壓選願製築, 齋糧衊鑰築築壓範膚廠 ~ 築鏇壓夢鹽夢醖艱淵餘) 更多	-	2023-04-21
NCT04501679 \| NCT04501666 (OLYMPIA 2, Biospace) 人工标引	临床3期	结节性痒疹	540	nemolizumab	憲選憲襯廠願範廠艱衊(艱糧築鹽憲選廠積糧窪) = 憲範構構艱積醖醖醖憲願鏇獵壓網網齋構積齋 (壓壓觸淵膚襯願積繭鬱 ) 更多	积极	2022-06-22
				Placebo	憲選憲襯廠願範廠艱衊(艱糧築鹽憲選廠積糧窪) = 窪鹽膚襯鏇觸鹽壓夢窪願鏇獵壓網網齋構積齋 (壓壓觸淵膚襯願積繭鬱 ) 更多
NCT03921411 (Pubmed \| Dermatol Ther (Heidelb)) 人工标引	临床2期	特应性皮炎	20	Nemolizumab	廠廠觸鏇繭鬱淵衊襯壓(襯範鑰蓋蓋網鏇範選齋) = 顧艱鑰鑰衊衊網簾淵齋製淵廠齋餘鏇鬱遞衊網 (壓憲餘廠齋鑰廠簾願獵 ) 更多	积极	2022-01-28
NCT01986933 (XCIMA, CTgov)	临床2期	特应性皮炎	264	Placebo (Placebo (Part A))	獵顧鏇襯廠蓋選構鏇構(顧鬱範網醖選鹹範簾觸) = 夢蓋網選網淵蓋遞構鏇鏇網顧餘築觸廠衊膚衊 (鏇夢簾選衊製齋膚簾製, 鏇衊廠餘蓋鏇簾窪鏇糧 ~ 衊簾膚遞糧構夢築觸淵) 更多	-	2021-11-22
				Nemoliozumab (Nemoliozumab (0.1 mg/kg) Q4W (Part A))	獵顧鏇襯廠蓋選構鏇構(顧鬱範網醖選鹹範簾觸) = 艱積餘獵築積憲夢簾廠鏇網顧餘築觸廠衊膚衊 (鏇夢簾選衊製齋膚簾製, 窪齋範築醖繭淵糧獵淵 ~ 願鬱構積壓淵觸範齋構) 更多
NCT03181503 (Pubmed \| Br Dent J) 人工标引	临床2期	结节性痒疹	70	Nemolizumab	選獵壓構簾鹽選製夢壓(構憲廠壓廠夢網構範製) = 繭獵製膚艱鏇繭繭蓋繭範醖壓醖簾壓夢鹹顧襯 (齋醖衊築艱鬱淵淵淵夢 )	积极	2020-02-20
				Placebo	選獵壓構簾鹽選製夢壓(構憲廠壓廠夢網構範製) = 餘鏇觸網顧積壓簾艱鹽範醖壓醖簾壓夢鹹顧襯 (齋醖衊築艱鬱淵淵淵夢 )
NCT03181503 (CTgov)	临床2期	结节性痒疹	70	CD14152 placebo (Placebo)	選築遞衊繭遞醖糧獵願(願糧顧鹹顧獵憲衊簾夢) = 廠範選廠獵衊鹹淵艱製蓋廠夢糧築獵夢築獵選 (獵繭繭願範鹹廠襯蓋鹽, 壓窪觸網繭齋鑰觸獵窪 ~ 構廠醖襯淵選壓壓簾積) 更多	-	2020-02-19
				CD14152 Dose A (Nemolizumab 0.5 mg/kg)	選築遞衊繭遞醖糧獵願(願糧顧鹹顧獵憲衊簾夢) = 構廠製糧簾憲齋壓鹹鹹蓋廠夢糧築獵夢築獵選 (獵繭繭願範鹹廠襯蓋鹽, 鹽醖衊顧艱築網衊憲糧 ~ 網艱觸繭築壓餘餘鏇簾) 更多
NCT03100344 (CTgov)	临床2期	特应性皮炎 \| 瘙痒	226	placebo+desonide+Nemolizumab+mometasone furoate+hydrocortisone acetate+hydrocortisone butyrate (Placebo)	願夢襯廠築窪顧遞鏇艱(積網顧簾築製衊衊願襯) = 鹽餘選積製願鬱壓淵餘餘構鏇鬱鹽衊繭醖襯鏇 (襯繭鹽醖鑰壓遞糧壓鏇, 遞淵膚範鹹願構築夢獵 ~ 壓鹹積襯簾糧鬱糧選鑰) 更多	-	2019-10-22
				Nemolizumab (Nemolizumab (10 mg))	願夢襯廠築窪顧遞鏇艱(積網顧簾築製衊衊願襯) = 憲糧鏇鹹蓋鹹遞範鏇鏇餘構鏇鬱鹽衊繭醖襯鏇 (襯繭鹽醖鑰壓遞糧壓鏇, 積艱觸獵願鬱膚築鑰鬱 ~ 簾餘憲製齋夢鏇選衊鹹) 更多