尼卡利单抗(Nipocalimab) - 药物靶点：FcRn_在研适应症：重症肌无力，胎儿/新生儿同种免疫性血小板减少症，新生儿同种免疫性血小板减少症_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

anti-FcRn monoclonal antibody(Momenta Pharmaceuticals)、Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer、Nipocalimab (USAN)

+ [4]

靶点

FcRn

作用机制

FcRn拮抗剂(IgG受体FcRn大亚基p51拮抗剂)、免疫调节剂

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [7]

在研适应症

重症肌无力胎儿/新生儿同种免疫性血小板减少症新生儿同种免疫性血小板减少症+ [10]

非在研适应症-

原研机构

Momenta Pharmaceuticals, Inc.

在研机构

Janssen Research & Development LLC

强生（中国）投资有限公司Janssen-Cilag International NV

非在研机构

Momenta Pharmaceuticals, Inc.

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、罕见儿科疾病 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、突破性疗法 (中国)

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序列信息

Sequence Code 19395495L

来源: *****

Sequence Code 19395504H

来源: *****

关联

30

项与尼卡利单抗相关的临床试验

NCT04883619 / Not yet recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

开始日期2026-01-15

申办/合作机构

Janssen Research & Development LLC

NCT06533098 / Not yet recruiting临床3期

Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

开始日期2025-02-05

申办/合作机构

Janssen Research & Development LLC

NCT06449651 / Recruiting临床3期

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT).

开始日期2024-10-01

申办/合作机构

Janssen Research & Development LLC

100 项与尼卡利单抗相关的临床结果

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100 项与尼卡利单抗相关的转化医学

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100 项与尼卡利单抗相关的专利（医药）

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36

项与尼卡利单抗相关的文献（医药）

2024-12-31·mAbs

Interactions of the anti-FcRn monoclonal antibody, rozanolixizumab, with Fcγ receptors and functional impact on immune cells in vitro

Article

作者: Craggs, Graham ; Bithell, Rosemary F. ; Rapecki, Stephen ; Humphreys, David P. ; Cutler, Rona M. ; Barnes, Nicholas M. ; West, Shauna M. ; Smith, Bryan J. ; Qureshi, Omar S. ; Sutton, Emma J. ; Shock, Anthony ; McCluskey, Gillian ; Maroof, Asher

Rozanolixizumab is a humanized anti-neonatal Fc receptor (FcRn) monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4) sub-class, currently in clinical development for the treatment of IgG autoantibody-driven diseases. This format is frequently used for therapeutic mAbs due to its intrinsic lower affinity for Fc gamma receptors (FcγR) and lack of C1q engagement. However, with growing evidence suggesting that no Fc-containing agent is truly "silent" in this respect, we explored the engagement of FcγRs and potential functional consequences with rozanolixizumab. In the study presented here, rozanolixizumab was shown to bind to FcγRs in both protein-protein and cell-based assays, and the kinetic data were broadly as expected based on published data for an IgG4 mAb. Rozanolixizumab was also able to mediate antibody bipolar bridging (ABB), a phenomenon that led to a reduction of labeled FcγRI from the surface of human macrophages in an FcRn-dependent manner. However, the presence of exogenous human IgG, even at low concentrations, was able to prevent both binding and ABB events. Furthermore, data from in vitro experiments using relevant human cell types that express both FcRn and FcγRI indicated no evidence for functional sequelae in relation to cellular activation events (e.g., intracellular signaling, cytokine production) upon either FcRn or FcγR binding of rozanolixizumab. These data raise important questions about whether therapeutic antagonistic mAbs like rozanolixizumab would necessarily engage FcγRs at doses typically administered to patients in the clinic, and hence challenge the relevance and interpretation of in vitro assays performed in the absence of competing IgG.

2024-08-08·NEW ENGLAND JOURNAL OF MEDICINE

Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn

Article

作者: Ling, Leona E ; Emery, Stephen P ; Markham, Kara ; Pandya, Pranav ; Ocón-Hernández, Olga ; Windrim, Rory ; Audibert, François ; Schwartz, Lisa B ; Bussel, James B ; Norton, Mary E ; Moise, Kenneth J ; Tjoa, May Lee ; Oepkes, Dick ; Streisand, James B ; Devlieger, Roland ; Mirza, Arpana ; Smith, Valerie ; Sachs, Ulrich J ; Leu, Jocelyn H ; Bein, Gregor ; Miller, Russell S ; Kilby, Mark D ; Verweij, E J T Joanne ; Saeed-Khawaja, Shumyla ; Lopriore, Enrico ; Smoleniec, John ; Silver, Robert M ; Tiblad, Eleonor ; Pereira, Leonardo ; Komatsu, Yosuke

BACKGROUND:

In early-onset severe hemolytic disease of the fetus and newborn (HDFN), transplacental transfer of maternal antierythrocyte IgG alloantibodies causes fetal anemia that leads to the use of high-risk intrauterine transfusions in order to avoid fetal hydrops and fetal death. Nipocalimab, an anti-neonatal Fc receptor blocker, inhibits transplacental IgG transfer and lowers maternal IgG levels.

METHODS:

In an international, open-label, single-group, phase 2 study, we assessed treatment with intravenous nipocalimab (30 or 45 mg per kilogram of body weight per week) administered from 14 to 35 weeks' gestation in participants with pregnancies at high risk for recurrent early-onset severe HDFN. The primary end point was live birth at 32 weeks' gestation or later without intrauterine transfusions as assessed against a historical benchmark (0%; clinically meaningful difference, 10%).

RESULTS:

Live birth at 32 weeks' gestation or later without intrauterine transfusions occurred in 7 of 13 pregnancies (54%; 95% confidence interval, 25 to 81) in the study. No cases of fetal hydrops occurred, and 6 participants (46%) did not receive any antenatal or neonatal transfusions. Six fetuses received an intrauterine transfusion: five fetuses at 24 weeks' gestation or later and one fetus before fetal loss at 22 weeks and 5 days' gestation. Live birth occurred in 12 pregnancies. The median gestational age at delivery was 36 weeks and 4 days. Of the 12 live-born infants, 1 received one exchange transfusion and one simple transfusion and 5 received only simple transfusions. Treatment-related decreases in the alloantibody titer and IgG level were observed in maternal samples and cord blood. No unusual maternal or pediatric infections were observed. Serious adverse events were consistent with HDFN, pregnancy, or prematurity.

CONCLUSIONS:

Nipocalimab treatment delayed or prevented fetal anemia or intrauterine transfusions, as compared with the historical benchmark, in pregnancies at high risk for early-onset severe HDFN. (Funded by Janssen Research and Development; UNITY ClinicalTrials.gov number, NCT03842189.).

2024-08-01·CLINICAL DRUG INVESTIGATION

Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Neonatal Fc Receptor Blocker, in Healthy Japanese Volunteers

Article

作者: Harigae, Hideo ; Duffner, Jay ; Matsushima, Nobuko ; Shibata, Sayori ; Schwartz, Lisa B ; Vermeulen, An ; Ling, Leona E ; Leu, Jocelyn H

BACKGROUND AND OBJECTIVES:

Nipocalimab is a high-affinity, fully human, effectorless immunoglobulin G1 monoclonal antibody targeting the neonatal Fc receptor and is currently under evaluation for the treatment of rare and prevalent immunoglobulin G autoantibody-mediated and alloantibody-mediated diseases. This phase I, randomized, double-blind, placebo-controlled, single-dose escalation study in healthy Japanese volunteers (N = 24) assessed the safety, pharmacokinetics, and effect on the serum immunoglobulin G level of single doses of nipocalimab.

METHODS:

Volunteers were grouped into three cohorts and received intravenous nipocalimab at 10, 30, or 60 mg/kg or placebo. To complement the study, genetic variation in the Fcγ receptor and transporter subunit of the neonatal Fc receptor was analyzed in Japanese and diverse populations.

RESULTS:

Nipocalimab was generally safe and well tolerated at all dose levels, with three (12.5% [3/24]) volunteers experiencing treatment-emergent adverse events across all nipocalimab doses. Mean serum immunoglobulin G levels decreased in a dose-dependent manner from baseline with nipocalimab treatment compared with placebo. Maximum serum nipocalimab concentrations demonstrated proportional increases with dose, while the area under the concentration-time curve was dose dependent and demonstrated non-linear increases with dose. Mean observed half-life was longer as the dose increased. Analysis of genetic variation in Fcγ receptor and transporter identified no unique Japanese variants or variants that alter amino acid sequences in or near the neonatal Fc receptor immunoglobulin G binding site targeted by nipocalimab.

CONCLUSIONS:

The comparable pharmacokinetic/pharmacodynamic profiles and highly conserved neonatal Fc receptor structure among diverse populations further support the clinical development of nipocalimab for the treatment of various immunoglobulin G autoantibody-mediated and alloantibody-mediated diseases across global sites and populations, including the Japanese population.

180

项与尼卡利单抗相关的新闻（医药）

2024-11-13

·药明康德

首款！疾病活动程度改善超70%，强生潜在重磅单抗获突破性疗法认定

▎药明康德内容团队编辑强生（Johnson & Johnson）日前宣布，美国FDA已授予其靶向新生儿Fc受体（FcRn）的在研抗体疗法nipocalimab突破性疗法认定（BTD），用于治疗中度至重度干燥综合征（Sjögren’s disease，SjD）成人患者。根据新闻稿，nipocalimab是在SjD领域获得BTD的首个疗法。值得一提的是，这款疗法今年年初被行业媒体Evaluate列为10大潜在重磅在研疗法之一。 SjD是最常见的自身抗体驱动的疾病之一，目前尚无获批疗法针对该疾病的根本原因。它是一种慢性自身免疫疾病，估计影响全球约四百万人，女性的发病率是男性的九倍。SjD的特点是自身抗体生成、慢性炎症和外分泌腺系统的淋巴细胞浸润。大多数患者受到粘膜干燥（眼睛、口腔、阴道）、关节疼痛和疲劳的困扰。SjD患者患多种相关疾病的风险很高，与一般人群相比，患B细胞淋巴瘤的风险提高达20倍。该BTD的授予主要基于2期DAHLIAS研究的数据。该研究评估了nipocalimab在中度至重度SjD成人患者中的疗效和安全性。该试验共有163名SjD患者入组（5 mg/kg nipocalimab组，n=53；15 mg/kg nipocalimab组，n=54；安慰剂组，n=56），各组患者的基线特征相似。试验的主要终点ClinESSDAI是一个专门针对SjD的综合量表，评估11个器官系统领域的疾病活动，包括皮肤、肺、肾、关节、肌肉、周围神经系统（PNS）、中枢神经系统（CNS）、血液、腺体、淋巴结肿大和淋巴瘤等组分，分数越高，症状越严重。分析显示，15 mg/kg组达到主要终点，与安慰剂组相比，15 mg/kg组患者在ClinESSDAI评分上的最小二乘均差为–2.65（90% CI：–4.03，–1.28；p=0.002）；5 mg/kg组为–0.34（90% CI：–1.71，1.03；p=0.681）。从第4周开始，15 mg/kg组患者就开始获得缓解，并在整个24周的治疗期间持续增加。在第24周，与安慰剂相较，15 mg/kg nipocalimab组受试者在主要终点上，显示出平均系统性疾病活动程度相对于安慰剂超过70%的改善。 ▲DAHLIAS研究疗效结果摘要（图片来源：参考资料[2]）在大多数次要/探索性终点上，15 mg/kg nipocalimab组患者也显示出相对于安慰剂的改善，包括第24周疾病严重度的医生总体评估（PhGA）、根据干燥综合征治疗应答评估工具（STAR）的缓解、干燥综合征相关终点组合（CRESS）和疾病活动水平（DAL）应答等。患者报告的结果在15 mg/kg nipocalimab组中相对于安慰剂也有数值上的改善，且患者重要的SjD症状，包括口干、眼干和阴道干燥也呈现改善趋势。该试验药物的安全性和耐受性结果与之前的临床试验一致。 ▲DAHLIAS研究安全性结果摘要（图片来源：参考资料[2]）新闻稿指出，这些数据代表了nipocalimab治疗SjD的首个积极临床试验结果，支持在研FcRn阻断剂作为SjD的潜在靶向疗法。DAHLIAS试验的积极结果支持进行中的3期研究持续进行。 Nipocalimab是一款潜在“best-in-class”，靶向FcRn的抗体疗法。它通过与FcRn结合，让被单核细胞和内皮细胞摄入的自身抗体不会重新释放到血液中，而是在细胞内被降解。已有研究显示，它可以将血液循环中包括致病自身抗体在内的IgG水平降低超过75%。这款抗体疗法有望治疗多种自身抗体介导的免疫疾病。此前，它已经获得FDA授予的突破性疗法认定，用于治疗有高风险出现严重新生儿溶血病（HDFN）的孕妇。Nipocalimab在治疗成人全身性重症肌无力（gMG）成人患者的关键性3期临床试验VIVACITY中也已获得积极顶线结果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease. Retrieved November 12, 2024 from https://www.prnewswire.com/news-releases/nipocalimab-is-the-first-and-only-investigational-therapy-granted-us-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-living-with-moderate-to-severe-sjogrens-disease-302301655.html [2] LBA0010 EFFICACY AND SAFETY OF NIPOCALIMAB, AN ANTI-FcRn MONOCLONAL ANTIBODY, IN PRIMARY SJOGREN’S DISEASE: RESULTS FROM A PHASE 2, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY (DAHLIAS). Retrieved November 12, 2024 from https://ard-bmj-com.libproxy1.nus.edu.sg/content/83/Suppl_1/240.2 [3] Late-breaking results show nipocalimab significantly improves Sjögren’s disease activity in a Phase 2 study. Retrieved June 17, 2024, from https://www.jnj.com/media-center/press-releases/late-breaking-results-show-nipocalimab-significantly-improves-sjogrens-disease-activity-in-a-phase-2-study 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

突破性疗法临床结果临床2期

2024-11-13

·PMLiVE

J&J’s nipocalimab granted FDA breakthrough designation for Sjögren's disease

Johnson & Johnson (J&J) has announced that its anti-FcRn antibody nipocalimab has become the first investigational therapy to be granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) as a treatment for adults with moderate-to-severe Sjögren’s disease (SjD). A breakthrough therapy designation is given by the FDA to accelerate the development and regulatory review of potential new medicines for serious conditions that address a significant unmet medical need. Estimated to impact approximately four million people globally, SjD is a chronic autoimmune disease that causes symptoms such as mucosal dryness, joint pain and fatigue. Extraglandular manifestations are also common in SjD patients and may impact multiple organ systems, including the joints, lungs, kidneys and nervous system. Nipocalimab is designed to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially without impact on other immune functions. The regulator’s decision on the drug was supported by positive results from the mid-stage DAHLIAS study evaluating its effects in more than 160 adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. Results presented earlier this year at the European Alliance of Associations for Rheumatology Congress demonstrated a statistically significant and clinically meaningful improvement in ClinESSDAI score, which measures disease activity across 11 organ systems, in nipocalimab-treated SjD patients versus placebo at 24 weeks compared to baseline. A phase 3 trial of the candidate in SjD is currently underway, the company outlined. Terence Rooney, vice president, rheumatology, immunology disease area leader, J&J Innovative Medicine, said: “[This] announcement marks an important step forward in the continued research and development of nipocalimab, the first investigational FcRn blocker to demonstrate positive results in a phase 2 study in adult patients with moderate-to-severe SjD. “With no treatments currently approved that may directly address the underlying cause(s) of the disease, innovation is critically needed to improve patient outcomes in SjD.” The announcement comes just one month after J&J shared positive results from a phase 2/3 trial of nipocalimab in patients with the rare autoimmune disease generalised myasthenia gravis.

临床3期突破性疗法临床结果临床2期优先审批

2024-11-12

·美迪西Medicilon

诚益生物小分子GLP-1新药在华获批临床 | 1分钟药闻速览

医线药闻 11月12日，CDE官网公示，诚益生物（Eccogene）申报的1类新药AZD5004薄膜包衣片就两项适应症获批临床，拟用于在至少有一种肥胖相关合并症的超重或者肥胖成年人中长期体重管理，以及2型糖尿病患者治疗。这是阿斯利康（AstraZeneca）以潜在超20亿美元的总额从诚益生物引进的每日一次口服小分子GLP-1受体激动剂。 11月12日，CDE 官网公示，强生尼卡利单抗注射液拟被纳入优先审评，适用于治疗自身抗体阳性的全身型重症肌无力（gMG）成人患者和青少年患者（大于 12 岁）。尼卡利单抗（Nipocalimab）是强生通过约 65 亿美元收购 Momenta Pharmaceuticals 获得的一款在研 FcRn 抗体。 11月11日，鲁抗医药公告，公司近日收到国家药品监督管理局核准签发的注射用CIGB-814的《药物临床试验批准通知书》。该药品为1类创新药，临床拟用于成人活动性类风湿性关节炎。 11月11日，NMPA官网显示，普洛药业旗下的子公司浙江普洛康裕制药有限公司申报的丁二磺酸腺苷蛋氨酸肠溶片获批上市，视同过评。公开资料显示，该药品适用于肝硬化前和肝硬化所致肝内胆汁淤积和妊娠期肝内胆汁淤积。投融药事近日，Alteogen公司宣布，已与第一三共（Daiichi Sankyo ）达成独家许可协议。第一三共将获得在全球范围内使用ALT-B4 （Alteogen专有的新型透明质酸酶，利用Hybrozyme™技术开发）的权利，以开发和商业化皮下注射版本的Enhertu（trastuzumab deruxtecan，德曲妥珠单抗）。这是一种靶向HER2的抗体偶联药物（ADC），由第一三共和阿斯利康（AstraZeneca）联合开发和商业化。根据协议条款，Alteogen将获得2000万美元预付款，并有资格在第一三共达到指定的开发、监管和销售里程碑时获得高达2.8亿美元的里程碑付款。科技药研 11月5日，北京大学陈鹏教授课题组在 Nature Chemistry 期刊发表了题为：Spatiotemporal protein interactome profiling through condensation-enhanced photocrosslinking 的研究论文。该研究报道了一种时空特异的蛋白质光交联技术——DenseMAP，通过将空间特异的蛋白质标记与凝聚增强的光交联相结合，对活细胞中特定生物分子凝集体的蛋白质相互作用进行了高效捕捉和鉴定。 [1]Li, K., Xie, X., Gao, R. et al. Spatiotemporal protein interactome profiling through condensation-enhanced photocrosslinking. Nat. Chem. (2024). https://doi-org.libproxy1.nus.edu.sg/10.1038/s41557-024-01663-1 直播预告

引进/卖出抗体药物偶联物并购上市批准优先审批

100 项与尼卡利单抗相关的药物交易

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外链

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
重症肌无力	申请上市	美国	强生（中国）投资有限公司	2024-08-29
胎儿/新生儿同种免疫性血小板减少症	临床3期	比利时	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	巴西	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	法国	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	意大利	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	挪威	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	斯洛伐克	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	西班牙	Janssen Research & Development LLC	2024-10-01
胎儿/新生儿同种免疫性血小板减少症	临床3期	瑞典	Janssen Research & Development LLC	2024-10-01
新生儿同种免疫性血小板减少症	临床3期	比利时	Janssen Research & Development LLC	2024-10-01

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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


NCT05265273 (Vibrance-MG, Corporate Publications) 人工标引	临床2/3期	重症肌无力	7	Nipocalimab plus standard of care (SOC)	顧築廠選範壓廠觸廠鹹(範膚憲網築範遞鬱襯鏇) = 簾壓繭網積鹽衊網壓窪構衊廠顧網齋簾窪餘廠 (糧淵構繭壓衊鏇築鏇鏇 ) 达到更多	积极	2024-10-15
NCT03842189 (UNITY, Pubmed \| N Engl J Med)	临床2期	胎儿成红细胞增多症 maternal antierythrocyte IgG alloantibodies	13	Nipocalimab 30 mg/kg	製範獵遞鏇蓋壓繭壓衊(選鏇鏇範構顧壓遞獵淵) = consistent with HDFN, pregnancy, or prematurity 淵觸選鬱顧壓鹽獵鏇窪 (網網鹽窪網鏇製鬱構製 )	积极	2024-08-08
NCT04951622 (Vivacity-MG3, GlobeNewswire) 人工标引	临床3期	重症肌无力 anti-AChR+ \| anti-MuSK+ \| anti-LRP4+	153	nipocalimab plus SOC	膚鑰鏇構簾夢窪鬱鑰衊(築襯構選鑰艱壓膚築醖) = 糧襯選膚醖製壓窪築鬱範艱獵鏇膚繭艱夢廠憲 (鹹窪蓋顧窪鑰繭糧窪願 ) 达到更多	积极	2024-06-28
				Placebo plus SOC	膚鑰鏇構簾夢窪鬱鑰衊(築襯構選鑰艱壓膚築醖) = 積鬱艱鏇鏇鬱糧膚觸餘範艱獵鏇膚繭艱夢廠憲 (鹹窪蓋顧窪鑰繭糧窪願 ) 达到更多
NCT04968912 (DAHLIAS, EULAR2024) 人工标引	临床2期	干燥综合征	163	NIPOCALIMAB 5 mg/kg	艱觸鹹淵築顧糧積夢簾(糧鏇醖顧網積鑰簾窪夢) = 淵鹹遞顧繭齋範願構簾齋糧觸襯餘醖糧蓋憲齋 (鬱構憲繭憲蓋淵鑰艱繭, -5.10 ~ -3.07) 更多	积极	2024-06-12
				NIPOCALIMAB 15 mg/kg	艱觸鹹淵築顧糧積夢簾(糧鏇醖顧網積鑰簾窪夢) = 構膚膚襯蓋簾獵憲構願齋糧觸襯餘醖糧蓋憲齋 (鬱構憲繭憲蓋淵鑰艱繭, -7.43 ~ -5.36) 更多
NCT04951622 (VIVACITY, Corporate Publications) 人工标引	临床3期	重症肌无力	-	Nipocalimab	網艱醖簾糧選構選蓋憲(醖製醖繭繭積鹽窪願夢) = achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo (PBO) 構遞繭鹹構淵糧簾齋襯 (遞獵製蓋願齋網憲鹽製 ) 达到	积极	2024-02-05
				placebo
NCT04968912 (DAHLIAS , Corporate Publications) 人工标引	临床2期	干燥综合征	-	Nipocalimab	餘繭襯衊淵鬱壓顧觸選(繭網窪觸觸製鏇簾廠顧) = with a statistically significant reduction in clinESSDAIb score from baseline at week 24 compared with placebo (PBO) 淵淵餘選構觸積積憲齋 (蓋餘衊願顧構網願願壓 ) 达到	积极	2024-02-05
				placebo
NCT03772587 (2018-002247-28, Pubmed \| Neurology)	临床2期	重症肌无力 antiacetylcholine receptor autoantibodies \| antimuscle-specific tyrosine kinase autoantibodies	-	Nipocalimab 5 mg/kg Q4W	鏇衊鹹選膚艱構積網鑰(獵築築遞鏇觸鏇繭顧夢) = A statistically significant dose response was observed for change from baseline in MG-ADL at day 57 壓簾夢範憲憲醖網夢齋 (糧範繭範遞顧蓋鏇壓構 )	积极	2024-01-23
				Nipocalimab 30 mg/kg Q4W
ACR2023	N/A	类风湿关节炎	-	Nipocalimab 15 mg/kg	鏇積糧網選範襯網遞網(襯選鬱夢願鑰齋衊餘遞) = The proportion of patients with treatment-emergent adverse events (TEAEs) were 81.8% vs 60.0% in the nipocalimab vs placebo groups 鑰憲構簾製膚衊鑰襯積 (製鬱築艱簾顧網淵憲鬱 ) 更多	-	2023-11-12
				Placebo
NCT03896295 (CTgov)	临床2期	重症肌无力	37	Placebo+Nipocalimab (Placebo-Nipocalimab)	淵鹽簾鹽簾鬱艱構積簾(鹹壓獵選網範繭艱鏇顧) = 廠齋網鹽壓憲選顧網艱鹽鑰壓夢獵膚窪願齋醖 (餘餘範醖夢窪繭願構製, 廠顧遞築壓遞製鏇憲構 ~ 顧築醖艱壓糧遞鹽鹹廠) 更多	-	2022-02-16
				Nipocalimab (Nipocalimab-Nipocalimab)	淵鹽簾鹽簾鬱艱構積簾(鹹壓獵選網範繭艱鏇顧) = 顧獵鹽蓋鑰鹹願鬱築壓鹽鑰壓夢獵膚窪願齋醖 (餘餘範醖夢窪繭願構製, 遞餘窪鏇襯築鹽鬱餘願 ~ 願蓋憲蓋鹽構淵簾選繭) 更多
NCT03772587 (Vivacity-MG \| 2018-002247-28, CTgov)	临床2期	重症肌无力	68	placebo+nipocalimab (Placebo)	觸窪壓餘艱鑰鏇壓齋鬱(鏇襯衊鹹襯顧蓋遞鬱簾) = 選壓艱網醖構鏇顧簾積窪鏇齋襯選憲築願艱鏇 (選鹽鹹網鑰願獵顧窪鏇, 簾鹹夢廠遞積觸鬱廠選 ~ 夢觸獵網獵壓鏇簾積艱) 更多	-	2021-10-27
				placebo+nipocalimab (Nipocalimab 5 Milligrams/Kilogram (mg/kg))	觸窪壓餘艱鑰鏇壓齋鬱(鏇襯衊鹹襯顧蓋遞鬱簾) = 淵淵網選鹽積願繭鹽顧窪鏇齋襯選憲築願艱鏇 (選鹽鹹網鑰願獵顧窪鏇, 構鏇選網膚獵窪選衊蓋 ~ 遞願齋壓網糧艱壓鑰醖) 更多