Ianalumab(Ianalumab) - 药物靶点：BAFF-R_在研适应症：系统性红斑狼疮，免疫性血小板减少症，温热型自身免疫性溶血性贫血_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

NOV-5、VAY-736、VAY736

靶点

BAFF-R

作用方式

抑制剂

作用机制

BAFF-R抑制剂(B细胞活化因子受体抑制剂)

治疗领域

免疫系统疾病眼部疾病血液及淋巴系统疾病+ [7]

在研适应症

系统性红斑狼疮免疫性血小板减少症温热型自身免疫性溶血性贫血+ [11]

非在研适应症

难治性慢性淋巴细胞白血病特发性肺纤维化边缘区B细胞淋巴瘤+ [3]

原研机构

MorphoSys AG

在研机构

Novartis Pharmaceuticals Corp.诺华（中国）生物医学研究有限公司Novartis Pharma AG

+ [6]

非在研机构-

权益机构

Novartis AG

MorphoSys AG

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评孤儿药 (美国)

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结构/序列

Sequence Code 155090L

来源: *****

Sequence Code 155096H

来源: *****

关联

33

项与 Ianalumab 相关的临床试验

NCT07039422

/ Not yet recruiting临床2期

Exploratory Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab (VAY RE-HIT)

This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).

开始日期2025-08-01

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06711887

/ Recruiting临床3期

An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)

The purpose of this 2-year extension study is the evaluation of the efficacy and safety
1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response [CRR] or partial renal response [PRR]) on double-blind treatment at the end of the SIRIUS-LN core study, and
2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

开始日期2025-05-19

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06411639

/ Withdrawn临床1期

A Multicenter, Open-label, Single-arm, Multiple-dose Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Ianalumab in Chinese Adult Participants With Autoimmune Diseases

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

开始日期2024-11-25

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

100 项与 Ianalumab 相关的临床结果

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100 项与 Ianalumab 相关的转化医学

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100 项与 Ianalumab 相关的专利（医药）

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20

项与 Ianalumab 相关的文献（医药）

2025-05-01·Arthritis & Rheumatology

Safety and Efficacy of Ianalumab in Patients With Sjögren's Disease: 52‐Week Results From a Randomized, Placebo‐Controlled, Phase 2b Dose‐Ranging Study

Article

作者: Fox, Robert ; Hueber, Wolfgang ; Schulze‐Koops, Hendrik ; Junge, Guido ; Papas, Athena ; Luo, Wen‐Lin ; Bowman, Simon J. ; Grader‐Beck, Thomas ; Fisher, Benjamin A. ; Woznicki, Janice ; Moots, Robert J. ; De Vita, Salvatore ; Sopala, Monika ; Mariette, Xavier ; Barcelos, Filipe ; Avrameas, Alexandre ; Dörner, Thomas

Objective:

The objective of this study was to report 52‐week safety and efficacy of ianalumab from phase 2b dose‐finding study in patients with Sjögren's disease (SjD).

Methods:

Patients randomly received (1:1:1:1) ianalumab (5, 50, or 300 mg) or placebo subcutaneously every 4 weeks until week 24 (treatment period [TP]1). At week 24, patients on 300 mg were rerandomized to continue 300 mg or receive placebo until week 52 (TP2), patients on placebo were switched to ianalumab 150 mg, and patients on 5 and 50 mg directly entered posttreatment safety follow‐up. Patients who discontinued treatment early or completed treatment entered safety follow‐up (≥20 weeks).

Results:

During TP1, 190 patients were randomized (placebo = 49, 5 mg = 47, 50 mg = 47, 300 mg = 47). Of these 190 patients, 90 (47.4 %; 43 continued 300 mg and 47 received placebo) entered TP2, and 81 of 90 (90.0%) completed the study treatment. By week 52, efficacy was sustained in patients who continued 300 mg in TP2 (EULAR Sjögren's Syndrome Disease Activity Index, EULAR Sjögren's Syndrome Patient Reported Index, patient global assessment, and physician global assessment change from week 24: −1.45, −0.46, −4.69, and −6.86, respectively). Stimulated salivary flow rates and autoantibody levels numerically improved in the 300 mg group. Treatment‐emergent adverse events were not dose‐dependent, except for injection‐site reactions. Cases of decreased neutrophil counts (Common Terminology Criteria for Adverse Events v4.03 grade 3 according to laboratory listings) were observed in three patients during the posttreatment follow‐up, occurring at 3.5, 5.5, and 3 months, after the last ianalumab administration. None were associated with infection except one incidental finding of asymptomatic cytomegalovirus infection (IgM‐positive).

Conclusion:

In patients with SjD, ianalumab 300 mg demonstrated sustained efficacy through week 52 and a favorable safety profile up to two years of follow‐up.

2024-09-01·Expert Review of Hematology

Novel treatments for immune thrombocytopenia: targeting platelet autoantibodies

Review

作者: Arnold, Donald M. ; Harnett, Brian ; Al‐Samkari, Hanny ; Dalmia, Shreyash ; Al-Samkari, Hanny ; Arnold, Donald

INTRODUCTION:

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelets and an increased risk of bleeding. Platelet autoantibodies target major platelet glycoproteins and cause Fc-mediated platelet destruction in the spleen and reticuloendothelial systems. As mechanisms of disease, platelet autoantibodies are important therapeutic targets. Neonatal Fc receptor (FcRn) antagonists are a new class of therapeutics that reduce the half-life of immunoglobulin G including pathogenic platelet autoantibodies. Spleen tyrosine kinase (Syk) inhibitors interfere with Fc-mediated platelet clearance. Bruton's tyrosine kinase (BTK) inhibitors and B-cell activating factor (BAFF) inhibitors reduce antibody production. The efficacy of these targeted therapies provides new support for the role of platelet autoantibodies in pathogenesis of ITP even these antibodies can be difficult to detect.

AREAS COVERED:

This review includes an in-depth exploration of the pathophysiologic mechanisms of ITP, focusing on autoantibodies. Treatments outlined in this review include a) FcRn antagonists, b) complement inhibitors, c) B-cell directed therapies such as BTK inhibitors, and anti-BAFF agents, d) Syk inhibitors, e) plasma-cell directed therapies, and f) novel cellular therapeutic products.

EXPERT OPINION:

Platelet autoantibodies are often elusive in ITP, yet novel treatments targeting this pathway reinforce their role in the pathogenesis of this autoimmune platelet disorder.

2024-06-01·DEUTSCHE MEDIZINISCHE WOCHENSCHRIFT

Review

作者: Witte, Torsten ; Ernst, Diana ; Zehrfeld, Nadine

67

项与 Ianalumab 相关的新闻（医药）

2025-07-30

·CPHI制药在线

从10.6亿美元交易，看诺华自免野心

关注并星标CPHI制药在线近日，诺华宣布与Matchpoint Therapeutics达成合作协议，双方将共同开发用于治疗炎症性疾病靶向转录因子的小分子共价抑制剂新药。根据协议，诺华支付6000万美元预付款，最高达10亿美元的里程碑金额包括选择权执行费。Matchpoint Therapeutics成立于2021年，具有独特的ACE（Advanced Covalent Exploration）技术平台。该平台整合了机器学习、化学蛋白质组学和化合物库，可以筛选难成药靶点的共价小分子抑制剂。本次合作是诺华在免疫炎症疾病领域又一次重金布局。Matchpoint Therapeutics：将共价药物用于免疫治疗Matchpoint Therapeutics主要应用化学蛋白质组学技术、开发创新共价小分子药物。所谓共价药物，是指通过与靶蛋白的氨基酸残基结合，形成共价键，抑制其生物学功能。共价键的高亲和力使得共价药物能更长时间与靶蛋白结合，所以共价药物比一般的小分子药物表现出更强的抑制作用。Matchpoint公司的目标是针对已经被临床验证的靶点，开发利用共价化学的治疗手段。该公司的先进ACE平台结合了多种独有工具，具有革新共价药物发现和开发的潜力。ACE平台能针对丰度很低的靶点，在自然细胞环境中进行筛选。而且，Matchpoint正在构建一个专有的共价化合物文库，其中既包括能最大限度地识别致病蛋白隐蔽口袋的探针片段，还有能够以更少的时间和资源推进临床的候选化合物。Matchpoint Therapeutics自上市以来，已完成多轮融资，其中赛诺菲风投、祥峰投资、Alexandria Venture Investments、Atlas VenturePharmaInvestTM皆是其投资者。关于本次与诺华的合作，双方均未透露具体靶点，只表示是“一种与多种炎症疾病相关的转录因子”。免疫与炎症是仅次于肿瘤的第二大疾病领域，免疫炎症疾病的核心机制是免疫系统失衡误伤自身组织而导致慢性炎症。该领域市场空间及潜力巨大。诺华在自免领域布局已久，而且手握重磅药物，此时重金寻求合作，彰显其在自免领域纵深布局的野心以及面对专利悬崖的焦虑。核心产品承压诺华急寻下一个重磅炸弹诺华在自免领域的拳头产品主要有Cosentyx（司库奇尤单抗）和Xolair（奥马珠单抗）。Cosentyx是一种IL-17A单抗，2015年获FDA批准上市，成为全球首个靶向IL-17A的全人源单抗。目前，该药已累计治疗患者超180万，适应症覆盖银屑病、强直性脊柱炎等10余种自免疾病。2024年，Cosentyx全球销售额达61亿美元，是诺华当之无愧的“现金奶牛”，但是其关键专利将在2025、2026年陆续到期。Xolair由诺华和罗氏联合开发，是一款人免疫球蛋白 E（IgE）人源化单克隆抗体，该药通过减少游离IgE、下调高亲和力IgE受体，并限制肥大细胞脱颗粒化，从而最小化过敏炎症级联过程里的中介物释放。目前，Xolair已获批用于治疗中度至重度持续性过敏性哮喘、慢性自发性荨麻疹（CSU）和慢性鼻窦炎伴鼻息肉（CRSwNP）、食物过敏等适应症。自上市以来，该药的销售额也是一路上涨，是自免领域的重磅炸弹级别药物。不过，Xolair的化合物专利已经到期，其配方专利也将于2025年11月到期。面对专利悬崖和生物类似药的夹击，诺华也在做接力产品储备。在自免领域在研管线中，诺华的瑞米布替尼（Remibrutinib）是一款新型、口服共价不可逆BTK抑制剂，通过快速结合无活性的BTK构象，来阻止引起瘙痒、荨麻疹等的组胺释放。在III期研究REMIX-1 和 REMIX-2 中，与安慰剂相比，瑞米布替尼在治疗第2周时就能快速起效，而且在第12周所展现的显著的症状改善持续至第24周。在第 24 周时，接受安慰剂治疗的患者转为使用瑞美布替尼，在转换后的第一周就观察到了瑞米布替尼的疗效，并且一直持续到研究结束（治疗 28 周）。在第 52 周时，近一半的患者完全摆脱了瘙痒和风团（UAS7=0）。2025年2月，瑞米布替尼率先在中国申报上市，用于H1抗组胺药治疗后仍有症状的成人慢性自发性荨麻疹（CSU），成为BTK产品在非肿瘤治疗领域的首次正式亮相。诺华另一款进展较快的自免产品是Ianalumab，这是一款双机制的B细胞耗竭抗体，靶向BAFF-R蛋白，目前正在开展干燥综合征的治疗试验，诺华计划明年提交Ianalumab的上市申请。另外，诺华还在开展Ianalumab治疗二线免疫性血小板减少症的后期研究。诺华在自免赛道上另外10余个在研产品，一共涵盖23个适应症。加上此次与Matchpoint Therapeutics的合作，未来这位自免领域的老将，仍将具有领头羊地位。主要参考资料：1.https://www.globenewswire.com/news-release/2024/02/25/2834763/0/en/New-England-Journal-of-Medicine-publishes-Phase-III-data-showing-Xolair-significantly-reduced-allergic-reactions-across-multiple-foods-in-people-with-food-allergies.html.2、https://www.vbdata.cn/1518977222.END智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

2025-07-27

·空之客

【医苑观畴】2025年二季度海外药企进展更新：诺华NVS

1整体表现NVS依然保持着几乎匀速的业绩增长，这在MNC中实属难得、特别是考虑到完全没有GLP1或ADC等热点的贡献；然而，市值始终无法跳出$200b左右的中枢，凸显了市场对这种剑走偏锋战略的反感，亦或是对未来在错失上述热点情况下的担忧，无论如何4x PS和15x PE对于这样成长性的大药企而言都代表着鲜明的负面情绪。二季度收入同比增长11%，核心EPS同比增长24%（利润率提升了340bps），展现出强劲的增长二阶导，这使得公司果断再次调高了全年指引，收入增速维持high single-digit、核心利润增速调高到low-teens。2已上市产品NVS过去的产品组合业绩其实看着挺舒服，成长稳定不说，也算是多核驱动、而不是依赖一两个爆款。然而问题在于近些年缺少新的重磅，RLT、siRNA、CGT之流在业绩上贡献都排不进前列，至今扛大旗的依然是几个老产品，然而毕竟LoE这一刀总会落下来，之前越坚挺的支柱轰然倒塌时就破坏力越大，现在就轮到Entresto了。肿瘤板块就很像整个公司状态的缩影：最可靠的增量还是上市8年多同比增速还超过60%的CDK4/6抑制剂Ribociclib，特别是在eBC获批后的增量还在线性持续，美国市场eBC的新处方量份额超过60%、mBC的总处方量份额也维持在50%左右，目前单季$1.2b、LTM累计$3.8b，距离公司给的峰值预期$8b还空间巨大，这不比那些花里胡哨更香么；而核药Pluvicto在VISION setting（post-taxane）触顶后，终于等到了PSMAfore setting（pre-taxane）获批，公司安利了很久的“两倍于VISION的患者群体”总算到了验证的关头，首个季度趋势看起来还不错，环比销售额增长25%达到$454m、新患增长40%。自免板块处在青黄不接的当口：IL17A单抗Secukinumab连续几个季度在单季$1.6b附近徘徊，即使有HS适应症和IV剂型的加持，仍然抵挡不住Part D铁拳，虽然公司依然在安利HS适应症的$1b峰值和整个药的$8b峰值；CD20单抗Ofatumumab仍在持续冲高，其在B细胞清除机制里依然享有独有的给药便利性优势地位（“one minute, once a month, at home or on the go, no pre-medications”听起来确实很有吸引力），单季突破$1b大关，LTM累计$3.8b，在这个基数上公司认为仍有巨大空间，美欧市场还有50-70%的适用患者并没有用上这种便利有效的药物；Iptacopan在IgAN和C3G适应症齐头并进的推动下，单季好不容易达到$120m，短期内或难当大任。心血管板块的形势就比较微妙：Entresto看起来已经到了悬崖边的最后一舞，单季$2.4b、LTM累计达到$8.7b，在7月15日化合物专利和儿科排他权到期之前，NVS还试图以无定型专利继续狙击MSN的仿制药上市，而7月11日特拉华联邦地区法院做出最终判决认为MSN仿制药并不侵犯这一制剂专利，即便NVS还在继续尝试各种续命操作，但LoE大概率已经迫在眉睫了；肩负填坑重任的Inclisiran虽然在线性爬坡，但二阶导一直比较平缓，单季好不容易接近$300m、LTM累计也才接近$1b，达到这一成就花了足足4.5年，实在与前辈Entresto以及市场对峰值的预期相去甚远，甚至已经连续几个季度电话会没有分析师问及Inclisiran了。https://fingfx.thomsonreuters.com/gfx/legaldocs/akvexaoqepr/NOVARTIS%20ENTRESTO%20PATENT%20LAWSUIT%20andrews.pdf其他产品更是没多少看点了，Lucentis彻底日薄西山，Zolgensma还在挣扎，偏头痛药物Erenumab也基本涨不动了。3在研管线NVS是真的爱肾病，在收购来Chinook终于在上季度Atrasentan开花结果之后，本季度又再次解囊，$800m upfront + $900m milestone收购Regulus获得miR-17抑制剂Farabursen，这个管线年初刚公布治疗ADPKD的1b期临床结果，即将在Q3进入三期临床。公司赖以为柱石的Pluvicto，继mCSPC pre-taxane setting上季度获批后，本季度又读出了治疗mHSPC的三期临床PSMAddition试验中期结果，Pluvicto相比SOC具有显著的rPFS获益，且OS呈积极趋势，预计下半年提交sNDA。沉积在管线里多年的CAR-T又随着自免大潮浮出水面，靶向CD19的YTB-323在治疗SLE的1/2期临床中表现尚佳，在13例患者中输注2-3周后达到扩增峰值并观察到B细胞清除，多数在60-90天后实现B细胞重建，3例随访至少9个月的患者SLEDAI-2K评分平均下降14.7分。后续公司给YTB-323开了4个二期临床，2027年开始读出数据并启动BLA，公司也画了个“multi-billion opportunity”的大饼。去年底以$2.9b从PTCT引进的亨廷顿症药物PTC-518，读出了二期临床PIVOT-HD的12个月顶线数据，然而看起来略有点翻车：低剂量5mg组对2/3阶段HD患者的血液HTT蛋白水平分别降低了23%，高剂量5mg组的HTT降幅分别是39%和36%，这都低于去年中NVS引进前披露高剂量组的43%降幅，且在针对3阶段患者的NfL等终点剂量依赖性很差。无怪乎读出之后，PTCT股价暴跌了30%多。https://ir.ptcbio.com/static-files/c0babb34-ab5f-442b-8a92-8733a00efebf除此以外，值得关注的进展还包括：上季度读出三期结果的Zolgensma IT剂型提交上市申请，Remibrutinib在食物过敏二期临床达到主要终点；此外，Ianalumab在化脓性汗腺炎二期未达到主要终点、因而该适应症被终止开发，Secukinumab在GCA三期临床未达到主要终点。看着眼前这些未来五年的核心管线，不由得理解了市场对NVS的负面情绪，毕竟让这几位来填眼前LoE留下的大坑，实在有点勉为其难了。结合去年底公司给出的五年指引及核心业绩支撑品种，看看填坑的难度吧：Entresto身后，整个CVRM板块的支撑点，就落在已经获批的Leqvio、以及这几年东拼西凑的Pelacarsen+Abelacimab+Atrasentan，是不是汗流浃背；Cosentyx身后，整个自免板块的支撑点，就落在Remibrutinib+Iptacopan+Ianalumab，虽然CSU、IgAN、C3G、SLE、ITP这些适应症不是没价值，只是跟IL17的适应症覆盖面似乎都不在一个量级上啊喂；最后就指望Pluvicto天神下凡，挽狂澜于既倒吗……众所周知，NVS作为一家原本底蕴相当深厚、很多既往产品也相当成功的大药企，过去这5-10年在战略方向上选取了非常独特的路径，包括在CGT、核药、肾病等非共识方向投下重注，结果则是连续错失PD1+ADC+GLP1等全行业最大风口。春播秋收，现在到了检验Vas上任以来播下的种子收获成色的时候，Entresto等核心重磅品种专利悬崖到来，全部重担落在了Leqvio、Pluvicto、Fabhalta身上。然而看看这几位略显瘦弱的身躯，大明的两京一十三省交到你的肩上扛得住么？诺华NVS往期季报分析：【医苑观畴】主流技术方向谁说了算：2022年上半年全球大药企核心产品管线进展总览【医苑观畴】主流技术方向谁说了算：2022年下半年全球大药企核心产品管线进展总览【医苑观畴】2023年上半年全球大药企核心进展总览【医苑观畴】2024年一季度海外药企进展更新：诺华NVS【医苑观畴】2024年二季度海外药企进展更新：诺华NVS【医苑观畴】2024年三季度海外药企进展更新：诺华NVS【医苑观畴】2025年一季度海外药企进展更新：诺华NVS

专利到期抗体药物偶联物

2025-07-17

·FierceBiotech

Novartis\' B-cell-depleting antibody fails to show promise in phase 2 dermatology study

\"All other studies for ianalumab in B-cell driven diseases continue as planned,” Novartis said.\n Novartis has ended work on ianalumab in a painful skin condition after the monoclonal antibody failed to meet “predefined efficacy thresholds” in a phase 2 study.The Swiss pharma had been evaluating ianalumab, a dual-mechanism, B-cell-depleting antibody that targets the protein BAFF-R, in a midstage study of hidradenitis suppurativa—a skin disease that causes painful lumps to form in areas where the skin rubs together. The company already markets Cosentyx for the skin condition.In its second-quarter earnings results, Novartis revealed that it will now stop development of ianalumab in this indication after the phase 2 trial “did not meet our target criteria despite demonstrating efficacy versus placebo.”“No new safety signals were observed and all other studies for ianalumab in B-cell driven diseases continue as planned,” the drugmaker added.Novartis is still, however, lining up the drug for an approval application next year in Sjögren’s disease, an immune disorder that causes dry eyes and a dry mouth. At the start of the year, the company abandoned attempts to develop its anti-CD40 antibody iscalimab for the same disorder.At the time, Novartis’ chief medical officer and head of development Shreeram Aradhye, M.D., pointed out to Fierce Biotech that ianalumab had already “shown meaningful differences in patients with this very difficult to treat disease” in a phase 2 trial. A pair of phase 3 trials for ianalumab in Sjögren’s disease are due to read out in the second half of this year, along with a late-stage study in second-line immune thrombocytopenia.Despite not pursuing ianalumab in hidradenitis suppurativa, Novartis still has another pipeline option for the skin condition in the form of remibrutinib. The BTK inhibitor was shown to reduce disease activity in a phase 2b trial last year and is currently being studied in pair of phase 3 trials due to read out in 2028.

$Novartis\' B-cell-depleting antibody fails to show promise in phase 2 dermatology study$

临床2期临床3期免疫疗法

100 项与 Ianalumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Ianalumab	-	-

研发状态

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
系统性红斑狼疮	临床3期	日本	诺华（中国）生物医学研究有限公司	2023-03-02
系统性红斑狼疮	临床3期	日本	Novartis Pharma AG	2023-03-02
系统性红斑狼疮	临床3期	日本	Novartis Pharma Stein AG	2023-03-02
系统性红斑狼疮	临床3期	日本	Novartis Pharmaceuticals Corp.	2023-03-02
系统性红斑狼疮	临床3期	巴西	诺华（中国）生物医学研究有限公司	2023-03-02
系统性红斑狼疮	临床3期	巴西	Novartis Pharma Stein AG	2023-03-02
系统性红斑狼疮	临床3期	保加利亚	Novartis Pharmaceuticals Corp.	2023-03-02
系统性红斑狼疮	临床3期	加拿大	Novartis Pharma Stein AG	2023-03-02
系统性红斑狼疮	临床3期	加拿大	诺华（中国）生物医学研究有限公司	2023-03-02
系统性红斑狼疮	临床3期	加拿大	Novartis Pharma AG	2023-03-02

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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


NCT05885555 (PS2237, EHA2025)	临床2期	免疫性血小板减少症	10	Ianalumab	蓋餘憲廠醖齋糧製積顧(製鬱鬱淵觸糧願壓糧選) = 範遞顧餘鏇糧範鏇選築衊醖獵網網觸醖獵積願 (網憲艱願齋夢築範顧網 ) 更多	积极	2025-05-14
NCT05885555 (VAYHIT3, EHA2025)	临床2期	免疫性血小板减少症	41	Ianalumab 9 mg/kg	範願獵醖衊膚齋壓鏇選(遞鏇鏇簾齋選網夢餘鬱) = 82% of pts experienced at least one adverse event 齋壓鏇鑰窪膚憲鑰廠製 (廠鬱網顧鏇觸壓壓醖積 ) 更多	积极	2025-05-14
NCT05885555 (ASH2024)	临床2期	免疫性血小板减少症	-	Ianalumab 9 mg/kg	夢廠淵製窪窪憲鹽鹹簾(鏇築壓繭繭獵範築壓餘) = all 10 patients (100%) and 3 patients (30%) experienced any-grade adverse events (AEs) and Grade ≥3 AEs, respectively. Six patients had infections and 2 patients had infusion-related reactions; all of these events were Grade 1 or 2. No patients discontinued treatment due to AEs. After Week 25 there was one death due to pulmonary edema, which was assessed as unrelated to ianalumab. No safety signal was detected up to data cutoff. 鹹鏇壓襯憲獵艱齋選壓 (艱醖膚顧膚窪餘構糧網 ) 更多	-	2024-12-09
NCT03656562 (CVAY736X2208, EULAR 12024 \| EULAR 22024) 人工标引	临床2期	系统性红斑狼疮	67	ianalumab 300 mg subcutaneous	糧鹹構鹽鏇鹹衊衊鹽襯(構憲鹽餘積築製淵齋構) = 糧積網鏇築範觸獵網艱鹹範鏇願壓餘繭鏇齋膚 (積鑰簾鹽鏇鑰顧憲廠觸 )	积极	2024-06-14
				placebo	糧鹹構鹽鏇鹹衊衊鹽襯(構憲鹽餘積築製淵齋構) = 憲襯鏇膚願遞構壓觸顧鹹範鏇願壓餘繭鏇齋膚 (積鑰簾鹽鏇鑰顧憲廠觸 )
EULAR2023	N/A	系统性红斑狼疮	67	Ianalumab	餘顧鑰餘齋構壓憲廠鏇(壓遞製夢鬱遞繭選廠積) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) 艱膚壓繭艱鹽簾夢窪顧 (夢鹽餘淵網憲遞齋獵網 ) 更多	-	2023-05-31
				Placebo
NCT03400176 (AACR2023) 人工标引	临床1期	慢性淋巴细胞白血病	39	VAY736+ibrutinib	夢糧簾鹹鹽淵簾糧鑰鹽(膚窪網鹹鑰廠淵築選鑰) = 窪蓋廠窪顧範範艱蓋廠襯鬱廠範膚憲鏇觸餘鏇 (範壓鹹製蓋膚範簾壓觸 ) 更多	积极	2023-04-15
				VAY736+ibrutinib (1L)	夢糧簾鹹鹽淵簾糧鑰鹽(膚窪網鹹鑰廠淵築選鑰) = 鑰鑰築製窪衊網願積蓋襯鬱廠範膚憲鏇觸餘鏇 (範壓鹹製蓋膚範簾壓觸 ) 更多
NCT03400176 (ASH 12021 \| ASH 22021) 人工标引	临床1期	慢性淋巴细胞白血病一线 \| 二线	32	Ibrutinib+Ianalumab	壓範窪衊鏇簾簾餘窪鬱(膚選艱憲餘網築積網餘) = 醖鏇繭夢遞夢網製範獵顧製遞選憲憲顧遞遞觸 (壓壓鹽鏇淵顧艱鑰構衊 ) 更多	积极	2021-11-05
NCT01930175 (CTgov)	临床2期	天疱疮	13	VAY736 (VAY736 3 mg/kg)	簾繭醖淵構醖願築淵壓(簾憲糧艱鹹繭觸蓋鏇構) = 醖餘廠壓鬱艱鏇廠鬱鹽築鹽窪衊簾簾選襯簾繭 (選襯構繭鏇廠膚襯選繭, 1.836) 更多	-	2020-10-19
				VAY736 (VAY736 10 mg/kg)	簾繭醖淵構醖願築淵壓(簾憲糧艱鹹繭觸蓋鏇構) = 窪鑰簾顧鏇糧窪鏇壓醖築鹽窪衊簾簾選襯簾繭 (選襯構繭鏇廠膚襯選繭, 8.273) 更多
EULAR2020	临床2期	原发性干燥综合征 anti-Ro/SSA+	190	VAY736 300mg	淵觸繭鹹製築積醖餘製(壓鑰鑰鹹壓廠糧壓蓋選) = 積製選鬱艱鹹憲憲獵糧淵繭鏇壓鬱構選餘蓋鬱 (膚醖構壓顧壓網選簾顧 )	积极	2020-06-03
				Placebo	淵觸繭鹹製築積醖餘製(壓鑰鑰鹹壓廠糧壓蓋選) = 廠膚獵鏇鑰壓鹽構膚願淵繭鏇壓鬱構選餘蓋鬱 (膚醖構壓顧壓網選簾顧 )
NCT02038049 (CTgov)	临床2期	复发-缓解型多发性硬化	8	VAY736 (VAY736)	壓衊鏇蓋鏇窪簾顧網鏇 = 遞願夢築糧顧簾觸繭製餘鬱衊廠網範願顧鹽衊 (醖範糧廠襯選鏇壓淵鏇, 鑰觸淵鑰壓遞襯積網積 ~ 醖鬱築鹹鹽觸醖餘廠顧) 更多	-	2019-10-30
				Placebo (Placebo to VAY736)	壓衊鏇蓋鏇窪簾顧網鏇 = 艱繭網壓襯簾鏇簾積窪餘鬱衊廠網範願顧鹽衊 (醖範糧廠襯選鏇壓淵鏇, 淵廠夢顧觸鬱鏇齋獵鏇 ~ 憲壓夢願觸簾鬱願壓範) 更多