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+ [10]

非在研适应症

难治性慢性淋巴细胞白血病化脓性汗腺炎特发性肺纤维化+ [4]

原研机构

MorphoSys AG

在研机构

Novartis Pharma AGLonza AG

Novartis Pharmaceuticals Corp.

+ [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

特殊审评快速通道 (美国)、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: Hueber, Wolfgang ; Fox, Robert ; 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

101

项与 Ianalumab 相关的新闻（医药）

2025-08-26

·PMLiVE

Novartis’ ianalumab shows promise in phase 3 Sjögren’s syndrome studies

Novartis has shared positive top-line results from two late-stage trials of its investigational monoclonal antibody ianalumab in Sjögren’s syndrome. The phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials have been evaluating the safety and efficacy of the drug in a total of 779 patients with the systemic autoimmune disease. Approximately 0.6% of the UK’s adult population is affected by Sjögren’s syndrome, a B cell-driven disease that causes inflammation and tissue damage. The condition primarily affects the exocrine glands, with more than 90% of patients experiencing dry eyes and mouth. Symptoms also include aching muscles and joints, fatigue and widespread pain. Both NEPTUNUS met the primary endpoint of improving disease activity, as assessed by a multi-dimensional disease activity measurement, compared to placebo. The candidate was also found to be well tolerated and demonstrated a favourable safety profile, Novartis said, adding that data from the trials will be presented at an upcoming medical congress. Ianalumab has a dual mechanism of action, B-cell depletion and BAFF-R inhibition, and is being investigated across various B cell-driven autoimmune diseases, including immune thrombocytopenia and systemic lupus erythematosus. The drug has the potential to become the first targeted treatment for patients with Sjögren’s syndrome, according to Novartis. Shreeram Aradhye, president of development and chief medical officer at Novartis, said: “Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognised or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need. “Both phase 3 trials demonstrate that ianalumab improves disease activity in patients with Sjogren’s disease.” Aradhye added that the company is “[looking] forward to engaging with health authorities to discuss these findings in the near future”. Inflammatory diseases are a key focus area for Novartis, which recently entered into a partnership worth $1bn with Matchpoint Therapeutics to develop oral inhibitors for inflammatory diseases that have been historically difficult to treat. The company also entered into an agreement with Kyorin Pharmaceutical in March to gain exclusive worldwide rights to a pre-clinical candidate for chronic spontaneous urticaria and other allergic and inflammatory diseases involving mast cells.

临床3期临床结果细胞疗法

2025-08-23

·抗体圈

有望成为全球首个且唯一获批的抗SS自免药物！

近日，诺华宣布了其在干燥综合征成人患者中评估 ianalumab（VAY736）的三期临床试验的积极顶线结果。两项试验均达到了主要终点，即在疾病活动度方面显示出统计学显著改善。这些结果支持了 ianalumab 的潜力，该药物已获美国FDA快速通道资格，诺华计划近期向全球监管机构递交产品的上市申请，其有望成为首个针对干燥综合征患者的靶向治疗药物。图片来源于企业官网 NEPTUNUS-1 和 NEPTUNUS-2 是首次全球三期临床试验，证明了在干燥综合征患者中疾病活动度的统计学显著降低。 Ianalumab 有望成为首个且唯一获得批准用于干燥综合征患者的靶向治疗药物。在干燥综合征患者中，ianalumab 耐受性良好，并显示出良好的安全性特征。诺华计划在即将召开的医学大会上展示其数据，并向全球卫生部门提交申请 Ianalumab的原研企业是MorphoSys，诺华在2024年收购了该企业，获得了ianalumab。在此之前，二者就启动了对该产品的开发合作。Ianalumab通过B细胞耗竭（ADCC）和抑制BAFF-R介导的B细胞功能和存活信号，双向靶向B细胞，是目前进度最快的BAFF-R抗体。图片来源于企业官网干燥综合征干燥综合征（Sjögren's syndrome, SS）是一种系统性、慢性自身免疫性疾病，会导致炎症和组织损伤，影响全身。它主要影响外分泌腺，导致过度干燥，超过 90% 的患者会出现干眼和口干。该疾病是异质性的，患者会出现干燥、疲劳和全身疼痛，30-40% 的患者还会出现腺外器官受累。腺外表现可能非常多样，可能影响皮肤、肌肉骨骼系统、肾脏、肺和其他器官。患有干燥综合征的患者淋巴瘤风险增加。干燥综合征是最常见的风湿性自身免疫性疾病之一，大约影响 0.25% 的人口，估计有 50% 的患者未被诊断。干燥综合征在女性中的发病率是男性的 9 倍。B 细胞功能障碍在该疾病中起着重要作用，它会引起自身免疫反应，导致炎症和组织损伤。目前没有获得批准的系统性治疗方法，只有有限的对症治疗可以提供暂时和部分的对症缓解，这突显了对有效靶向疗法的需求。 Ianalumab（VAY736） Ianalumab（VAY736）是一种新型全人源单克隆抗体，具有双重作用机制，主要用于治疗多种B细胞驱动的自身免疫性疾病，如干燥综合征、免疫性血小板减少症（ITP）、系统性红斑狼疮（SLE）等。靶点：BAFF-R 作用机制：通过两种方式靶向 B 细胞，即通过抗体依赖性细胞毒性（ADCC）耗竭 B 细胞，并阻断 B 细胞功能和 BAFF-R 介导的信号。知识点小栈 Ianalumab的轻重链序列如下：图片来源于智慧芽数据库 BAFF-R的表达与功能: 来源：https://doi.org/10.3389/fimmu.2018.02285表达特征主要表达于成熟B细胞（如滤泡B细胞、边缘区B细胞）、活化B细胞及浆细胞表面，在脾脏和淋巴结中高表达，静止B细胞中表达水平较高，活化T细胞中表达极低。在B细胞分化过程中，BAFF-R在生发中心（GC）B细胞早期表达上调，随着向浆细胞分化逐渐下调。核心功能：（1）维持B细胞存活（2）调控免疫耐受（3）支持B细胞分化。 BAFFR的信号通路和调控来源：https://doi.org/10.3389/fimmu.2018.02285 （1）NF-κB通路当BAFF与BAFFR结合后，会招募TRAF3并激活激酶NIK。随后，NIK磷酸化IKKα，使其活化。活化的IKKα进一步促使RelB-p100复合物中的p100降解为p52。RelB-p52异二聚体随后进入细胞核，调控抗凋亡基因（如BCL-2）的表达。这一通路的主要功能是促进B细胞的存活，抑制细胞凋亡，从而维持B细胞的稳定性和功能。（2）PI3K/AKT/mTOR通路 BAFFR通过TRAF2/6招募PI3K，PI3K催化PIP2转化为PIP3，从而激活AKT。AKT的激活进一步导致下游mTOR的磷酸化，mTOR通过调控代谢重编程，增强线粒体功能，并抑制凋亡蛋白（如BAD、FOXO）的活性。这一通路支持B细胞的增殖和能量代谢，为B细胞的生长和分裂提供必要的能量支持。在类风湿关节炎（RA）模型中，该通路直接驱动B淋巴细胞的异常扩增，导致疾病的发生和发展。（3）MAPK通路 BAFFR通过TRAF介导激活ERK1/2、JNK和p38 MAPK。具体来说： ERK1/2：促进细胞周期进程，如Cyclin D1的表达，推动细胞从G1期进入S期。 JNK/p38：调控炎症反应和细胞迁移，增强细胞对炎症刺激的响应能力。这一通路参与B细胞的分化、炎症因子的释放（如IL-6、IL-1β）以及组织浸润，促进B细胞在炎症环境中的存活和功能发挥。这三条通路并非独立运作，而是相互协同，形成一个复杂的“增殖-抗凋亡-炎症”网络。在自身免疫病（如系统性红斑狼疮SLE、类风湿关节炎RA）和B细胞淋巴瘤中，这些通路的异常活化尤为显著，导致B细胞的过度增殖和炎症反应的加剧，从而推动疾病的发展，而ianalumab的作用则是通过ADCC以及靶向BAFFR来阻断通路，从而耗竭B细胞，达到降低自免疾病的活跃度的目的。] NEPTUNUS-1 和 NEPTUNUS-2三期临床试验 NEPTUNUS-1 和 NEPTUNUS-2 是全球多中心的关键研究，评估 ianalumab 在干燥综合征患者中的疗效和安全性。这些试验旨在为 ianalumab 作为干燥综合征的靶向治疗提供全面数据，针对活动性腺外疾病的患者。 NEPTUNUS-1 是一项随机、双盲、两臂多中心三期临床试验（N=275），旨在评估每月皮下注射 300 毫克 ianalumab 与安慰剂相比在 52 周内的临床疗效、安全性和耐受性。 NEPTUNUS-2 是一项随机、双盲、三臂多中心三期临床试验（N=504），旨在评估每月或每 3 个月皮下注射 300 毫克 ianalumab 与安慰剂相比在最多 52 周内的临床疗效、安全性和耐受性。这两项试验研究的主要终点均为通过欧洲抗风湿病联盟干燥综合征疾病活动指数（ESSDAI）来衡量系统性疾病活动度的改善。诺华宣布主要终点均已达成，这进一步验证了 ianalumab 在治疗干燥综合征中的潜力，特别是在减少疾病活动度方面表现出显著的疗效和良好的安全性。这些结果为 ianalumab 的全球上市申请提供了重要支持，有望为干燥综合征患者带来新的治疗选择。目前参加 NEPTUNUS-1 和 NEPTUNUS-2 的患者有机会继续在这些研究中进行随访或进入长期扩展试验。截至现有资料，该试验的临床登记信息未包含结果数据披露，主要终点（如疾病活动性改善指标）的具体数值（如应答率、p值或效应量）尚未公开。诺华计划在即将召开的医学会议上公布详细的相关数据。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期免疫疗法临床结果并购

2025-08-18

·思齐俱乐部

国内外大批药企做研发管线“断舍离”！

来源：制药网近日，海创药业宣布：拟暂停募投项目"创新药研发项目"HP501子项目后续的研发推进。HP501是海创药业自主研发的小分子化学创新药，为尿酸盐阴离子转运体1(UrateAnionTransporter1，URAT1)抑制剂。截至今年6月30日，该项目已投入募集资金8111.25万元。对于按下“暂停键”的原因，海创药业解释称，国内已有药企针对URAT1靶点的产品获批上市，并有多项围绕该靶点的Ⅲ期临床研究正在进行。故公司预计，未来URAT1靶点的竞争将较为激烈。公司评估后决定不再将资金投入至HP501项目中。实际上，近期以来，药企研发管线叫停的消息屡见不鲜。除了国内药企以外，一些国际大型药企如阿斯利康、GSK、默沙东等也在积极做“减法”。例如阿斯利康7月29日在上半年财报中披露，将终止AZD5851(GPC3CAR-T)、AZD6422(CLDN18.2CAR-T)和NT-125(TCR-T)的I期临床开发，以及zibotentan+dapagliflozin用于肝硬化、Ultomiris(瑞利珠单抗)用于狼疮性肾炎的II期临床开发。此次终止原因是细胞治疗领域存在研发周期长、制造流程繁琐、成本难控、标准化水平低等问题，公司经权衡后决定重新分配资源，集中投入更具可行性与回报潜力的细胞治疗项目。肝硬化适应症终止可能与临床数据未达预期或战略调整有关，公司更聚焦肿瘤和心血管领域的核心管线。 GSK 7月30日发布2025年H1财报，终止项目中包含两项III期临床，具体包括： TIGIT单抗belrestotug用于非小细胞肺癌和ibrexafungerp用于侵入性念珠菌感染的III期临床。今年5月13日，由于GALAXIESLung-201研究未达成主要终点，GSK决定终止belrestotug开发项目并终止与iTeos的合作。此前，葛兰素史克(GSK)向iTeos公司支付6.25亿美元预付款，获得belrestotug的权益。在该药物|期临床试验失败后，这家生物技术公司原本计划逐步停止运营，但最终于本月早些时候接受了ConcentraBiosciences的收购要约。同时，葛兰素史克(GSK)已终止代号为GSK3437949的佐剂重组蛋白疟疾疫苗II期研发项目。这一决定是基于制药部门近期宣布将重点转向第二代多阶段疟疾疫苗的战略调整。此外，抗生素sanfetrinem的口服前药sanfetrinemcilexetil也已从公司1I期研发管线中移除。罗氏7月24日发布2025年上半年业绩报告，同步更新了研发管线进展。报告显示，2025年上半年，罗氏共削减7个临床项目，其中备受关注的TIGIT单抗RG6058(tiragolumab)仅剩的两项III期临床均被终止。自2022年起，该产品III期研究就不顺利：2024年，其在转移性非鳞状非小细胞肺癌II/III期研究中，无法与对照组拉开疗效差距；同年，该产品联合PD-L1抗体治疗局部复发性或转移性非小细胞肺癌的III期临床也未达到总生存期(OS)主要终点。2025年，其联合Tecentriq用于一线治疗不可切除的III期非小细胞肺癌，以及联合Tecentriq和Avastin用于一线治疗肝细胞癌的两项III期临床，均未达到无进展生存期(PFS)主要终点。诺华7月17日公布第二季度财报，宣布停止Ianalumab在化脓性汗腺炎(一种导致皮肤摩擦区域形成疼痛肿块的疾病)适应症上的开发，因Ianalumab未能达到诺华预设的疗效阈值，。默沙东也在近日公布2025第二季业绩，同时提到多个II期和III期临床管线被终止，其中包括MK-1308(CTLA-4单抗)针对非小细胞肺癌的II期研究、MK-1022(HER3-ADC)针对非小细胞肺癌的III期研究，以及MK-7902(仑伐替尼)针对食管癌的III期研究。此外，赛诺菲、强生等也有在近期宣布终止一些在研项目，原因包括药物上市前景黯淡、疗效不足等。业内认为，药企研发管线的叫停潮，揭示了新药研发领域的高风险与不确定性。这既是市场竞争激烈化、研发回报预期改变的结果，也反映出药企对研发资源的重新审视与合理配置。在这场研发管线的“断舍离”中，药企需要更加审慎地选择研发方向，聚焦真正具有临床价值与市场潜力的项目。只有这样，才能在激烈的市场竞争中，提高研发成功率，为患者带来更多有效的创新药物，实现可持续发展。免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。 8月27-29日敬请期待第十届「MMC医学市场年会」点击阅读原文了解更多

财报临床3期疫苗并购临床1期

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	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 Stein AG	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


NCT05349214 (NEPTUNUS-2, Company_Website) 人工标引	临床3期	干燥综合征	504	ianalumab 300 mg s.c. monthly	餘繭淵獵衊糧艱夢壓積(窪糧網醖範淵鏇願艱壓) = met primary endpoint in patients with Sjögren’s disease. 衊膚鑰鑰艱鹹構觸衊遞 (選鏇廠遞範艱願構鬱壓 ) 达到更多	积极	2025-08-11
				ianalumab every 3 months
NCT05350072 (NEPTUNUS-1, Company_Website) 人工标引	临床3期	干燥综合征	275	ianalumab 300 mg	餘簾齋憲餘膚製廠餘衊(衊簾鑰鑰觸願夢鹹鬱選) = met primary endpoint in patients with Sjögren’s disease. 鏇繭積蓋簾夢膚簾構憲 (壓夢膚襯願願繭憲餘淵 ) 达到更多	积极	2025-08-11
				Placebo
NCT05885555 (VAYHIT3, EHA2025)	临床2期	免疫性血小板减少症	41	Ianalumab 9 mg/kg	網網繭鬱衊鑰醖範製鬱(鑰繭廠蓋鬱餘糧願壓憲) = 82% of pts experienced at least one adverse event 鹹獵糧選鑰觸觸憲觸壓 (積鬱衊窪觸鑰願襯觸鬱 ) 更多	积极	2025-05-14
NCT05885555 (PS2237, EHA2025)	临床2期	免疫性血小板减少症	10	Ianalumab	醖憲襯鏇鑰範範顧鹹積(淵選蓋獵醖築廠積遞淵) = 鬱糧製鑰範窪獵糧遞衊壓艱簾壓膚廠鏇鑰製淵 (鏇淵壓繭膚簾衊齋積襯 ) 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	餘築築鑰壓鑰夢鬱齋齋(齋壓願醖糧鬱選積鹽範) = 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. 衊鏇壓夢艱衊艱遞膚積 (鏇壓艱鏇選遞壓選鏇願 ) 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	餘壓膚鏇夢膚齋廠壓選(憲壓齋醖觸廠範憲繭鏇) = 衊糧襯壓鑰範廠齋願製餘顧膚鹽遞繭鏇膚蓋構 (蓋廠淵蓋鹹窪繭繭膚衊 )	积极	2024-06-14
				placebo	餘壓膚鏇夢膚齋廠壓選(憲壓齋醖觸廠範憲繭鏇) = 鏇選繭醖襯糧積醖壓窪餘顧膚鹽遞繭鏇膚蓋構 (蓋廠淵蓋鹹窪繭繭膚衊 )
EULAR2023	N/A	系统性红斑狼疮	67	Ianalumab	繭糧糧鏇齋顧窪壓選範(壓顧淵鬱壓鬱窪範醖鬱) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) 糧鹽艱襯遞築廠築製遞 (淵淵膚繭膚鑰積鹹廠廠 ) 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	醖鹽糧蓋淵觸網夢蓋遞(獵壓憲糧觸鑰選餘繭積) = 範製鏇淵選鹹鏇夢齋鏇顧鬱齋構範蓋夢淵衊衊 (簾蓋壓範壓窪衊網願衊 ) 更多	积极	2023-04-15
				VAY736+ibrutinib (1L)	醖鹽糧蓋淵觸網夢蓋遞(獵壓憲糧觸鑰選餘繭積) = 積範齋廠醖網蓋憲壓鹹顧鬱齋構範蓋夢淵衊衊 (簾蓋壓範壓窪衊網願衊 ) 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	憲窪製簾選築範鬱壓憲(製遞糧鏇膚鹽製觸糧選) = 醖鹽鹽範構網鹹繭鏇壓窪壓鏇艱願壓網壓積廠 (膚餘網願鏇製憲構製範 ) 更多	积极	2021-11-05
NCT01930175 (CTgov)	临床2期	天疱疮	13	VAY736 (VAY736 3 mg/kg)	鏇網夢簾顧廠網鏇膚衊(顧範膚繭網夢築網糧網) = 衊衊網鏇糧製選廠顧選淵繭願憲鹽糧淵範窪餘 (繭遞繭觸範積淵鏇觸選, 1.836) 更多	-	2020-10-19
				VAY736 (VAY736 10 mg/kg)	鏇網夢簾顧廠網鏇膚衊(顧範膚繭網夢築網糧網) = 顧遞積積顧廠繭膚艱製淵繭願憲鹽糧淵範窪餘 (繭遞繭觸範積淵鏇觸選, 8.273) 更多