更新于：2024-06-23

Nipocalimab

尼卡利单抗

更新于：2024-06-23

概要

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

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胎儿成红细胞增多症+ [9]

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

非在研机构

Momenta Pharmaceuticals, Inc.

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)、突破性疗法 (中国)、孤儿药 (日本)

序列信息

Sequence Code 19395495L

来源: *****

Sequence Code 19395504H

来源: *****

关联

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

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2024-06-25

申办/合作机构

Janssen Research & Development LLC

NCT05912517 / Recruiting临床3期

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

开始日期2023-12-20

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

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.

2024-02-01·CNS drugs

The Efficacy and Safety of Different Targeted Drugs for the Treatment of Generalized Myasthenia Gravis: A Systematic Review and Bayesian Network Meta-analysis

Review

作者: Nie, Xiangtao ; Ma, Yongbo ; Zhu, Geke ; Guo, Xiuming ; Hao, Lei ; Qi, Wenjing

BACKGROUND:

The treatment of generalized myasthenia gravis (gMG) has been transformed by the development and approval of new targeted therapies. This analysis aimed to rank and compare the new therapies for gMG using efficacy and safety data from randomized controlled trials (RCTs).

METHODS:

We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov (up to November 2022) for RCTs of targeted drugs for gMG. We used a Bayesian random-effects network meta-analysis (NMA) model and a Markov chain Monte Carlo (MCMC) model for statistical analysis. The primary outcome was the change in quantitative myasthenia gravis score (QMGS) from baseline, while the secondary outcome was the risk ratio (RR) of adverse events (AEs) during treatment. The surface under the cumulative ranking curve (SUCRA) was used to rank these targeted drugs, with higher SUCRA values indicating better efficacy or lower likelihood of AEs.

RESULTS:

In total, 13 studies (872 subjects) were included in this analysis evaluating 10 targeted drugs (batoclimab, belimumab, CFZ533, eculizumab, efgartigimod, nipocalimab, rituximab, ravulizumab, rozanolixizumab, and zilucoplan). With regards to the primary outcome, batoclimab [standardized mean difference (SMD), - 1.61; 95% credible interval (CrI), - 2.78, - 0.43] significantly reduced QMGS in patients with gMG when compared with placebo and was ranked as the most efficacious drug. Ranked second and third were eculizumab (SMD, - 0.67; 95% CrI, 1.43, 0.01) and zilucoplan (SMD, - 0.54; 95% CrI, - 1.56, 0.46), respectively. Nipoclimab (SMD, - 0.02; 95% CrI, - 1.04, 1.00) had the worst efficacy and ranked last among all targeted drugs. In our study, except for batoclimab, there was no statistically significant difference in the reduction of patient QMGS for the remaining targeted agents compared with placebo. With regards to the secondary outcomes, only batoclimab (RR, 0.19; 95% CrI, 0, 0.97) led to a significant reduction in the incidence of AEs when compared with the placebo. Belimumab (RR, 0.85; 95% CrI, 0.57, 1.19), CFZ533 (RR, 0.95; 95% CrI, 0.72, 1.25), eculizumab (RR, 0.99; 95% CrI, 0.85, 1.21), and efgartigimod (RR, 0.93; 95% CrI, 0.76, 1.15) also led to a lower incidence of AEs, although these effects were not significantly different from the placebo.

CONCLUSIONS:

Batoclimab had the best efficacy and safety for the treatment of gMG and was ranked first out of the 10 targeted drugs included in this study. Eculizumab was ranked second, and nipocalimab had the worst efficacy. With the exception of batoclimab, the incidence of AEs for the remaining drugs was not statistically significantly different from placebo. We note, however, that wide CrIs reflect the uncertainty in this analysis owing to the small number of available studies and low numbers of study participants; moreover, batoclimab had the widest CrI of all drugs in this analysis. More well-designed studies with long-term follow-up are needed to further evaluate and compare the efficacy and safety of these drugs in the future.

2024-01-23·Neurology

Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis

Article

作者: Arroyo, Santiago ; Sun, Hong ; Ramchandren, Sindhu ; Meuth, Sven G ; Gamez, Josep ; Zhu, Yaowei ; Quan, Dianna ; Sevilla, Teresa ; Nowak, Richard J ; Jouvin, Marie-Helene ; Jin, Jim ; Guptill, Jeffrey ; Antozzi, Carlo ; Ling, Leona ; Karcher, Keith ; Bril, Vera

BACKGROUND AND OBJECTIVES:

To evaluate in a phase 2 study the safety and efficacy of IV nipocalimab, a fully human, antineonatal Fc receptor monoclonal antibody, in patients with generalized myasthenia gravis (gMG).

METHODS:

Patients with gMG with inadequate response to stable standard-of-care (SOC) therapy were randomized 1:1:1:1:1 to receive either IV placebo every 2 weeks (Q2W) or one of 4 IV nipocalimab treatments: 5 mg/kg once every 4 weeks (Q4W), 30 mg/kg Q4W, 60 mg/kg Q2W each for 8 weeks, or a 60 mg/kg single dose, in addition to their background SOC therapy. Infusions (placebo or nipocalimab) were Q2W in all groups to maintain blinding. The primary safety endpoint was incidence of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events of special interest. The primary efficacy endpoint was change from baseline to day 57 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total scores. Dose response of change at day 57 was analyzed with a linear trend test over the placebo, nipocalimab 5 mg/kg Q4W, nipocalimab 30 mg/kg Q4W, and nipocalimab 60 mg/kg Q2W groups.

RESULTS:

Sixty-eight patients (nipocalimab: n = 54; placebo, n = 14) were randomized; 64 patients (94.1%) were positive for antiacetylcholine receptor autoantibodies, and 4 patients (6%) were positive for antimuscle-specific tyrosine kinase autoantibodies. Fifty-seven patients (83.8%) completed treatment through day 57. The combined nipocalimab group compared with the placebo group demonstrated similar incidences of TEAEs (83.3% vs 78.6%, respectively) and infections (33.3% vs 21.4%, respectively). No deaths or discontinuations due to TEAEs and no TEAEs of special interest (grade ≥3 infection or hypoalbuminemia) were observed with nipocalimab treatment. A statistically significant dose response was observed for change from baseline in MG-ADL at day 57 (p = 0.031, test of linear trend).

DISCUSSION:

Nipocalimab was generally safe, well-tolerated, and showed evidence of dose-dependent reduction in MG-ADL scores at day 57 in this phase 2 study. These results support further evaluation of nipocalimab for the treatment of gMG.

TRIAL REGISTRATION INFORMATION:

Clinical Trials Registration: NCT03772587; first submitted December 10, 2018; EudraCT Number: 2018-002247-28; first submitted November 30, 2018; date of first patient dosed April 10, 2019.

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that for patients with gMG, nipocalimab was well-tolerated, and it did not significantly improve MG-ADL at any individual dose but demonstrated a significant dose response for improved MG-ADL across doses.

134

项与尼卡利单抗相关的新闻（医药）

2024-06-19

·PMLiVE

Johnson & Johnson’s investigational nipocalimab shows promise in Sjögren’s disease

Johnson & Johnson (J&J) has shared positive phase 2 results of its investigational anti-FcRn antibody, nipocalimab, in Sjögren’s disease (SjD), a chronic autoimmune disease. The DAHLIAS dose-ranging study has been evaluating the effects of nipocalimab in 163 adult patients living with primary SjD, including adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies. Affecting an estimated four million people worldwide, SjD is a prevalent autoantibody-driven disease that is characterised by chronic inflammation and lymphocytic infiltration of the exocrine glandular systems, for which there are no therapies currently approved. Terence Rooney, vice president, rheumatology, immunology and disease area leader, J&J Innovative Medicine, commented: “A clear need exists for patients living with SjD to have advanced therapies that target the underlying cause and systemic nature of this disease, as none have been approved to date.” Representing the first positive results in SjD for nipocalimab, the investigational antibody achieved both its primary and secondary endpoints in SjD patients versus placebo. The investigational antibody demonstrated a statistically significant and clinically meaningful improvement in ClinESSDAI score, which measures disease activity across 11 organ systems, in SjD patients versus placebo at 24 weeks compared to baseline and demonstrated improvements in SjD symptoms at week 24, with the safety and tolerability being consistent with other clinical studies. “This data establishes proof of concept for nipocalimab in SjD and supports further clinical development,” said study investigator, professor Jacques-Eric Gottenberg, department of rheumatology, Strasbourg University Hospital, National Centre for Rare Systemic Autoimmune Diseases. As part of its nipocalimab programme, J&J has been running several clinical trials, including phase 3 studies evaluating the antibody in generalised myasthenia (gMG), chronic inflammatory demyelinating polyneuropathy and warm autoimmune haemolytic anaemia. In February, the company shared positive top-line results from the phase 3 VIVACITY study of nipocalimab in adults with gMG, a chronic autoimmune disorder that affects approximately 700,000 people worldwide. Nipocalimab achieved its primary endpoint, demonstrating a statistically significant reduction in MG-ADLa score, an assessment of symptoms that affect the daily lives of patients, from baseline over weeks 22 to 24 compared with placebo.

临床结果临床3期临床2期

2024-06-17

·药明康德

强生潜在重磅疗法达到2期临床主要终点，可治疗多种自身免疫疾病

▎药明康德内容团队编辑强生（Johnson & Johnson）日前宣布，其靶向新生儿Fc受体（FcRn）的在研抗体疗法nipocalimab在一项针对成人干燥综合征（Sjögren’s disease，SjD）患者的2期临床试验DAHLIAS中达到试验主要终点。接受nipocalimab治疗的患者在第24周与基线相比，其ClinESSDAIa评分显示出统计学显著（P=0.002）和具有临床意义的改善。与安慰剂组相比也达到同样疗效。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。这款疗法今年年初被行业媒体Evalute列为10大潜在重磅在研疗法之一。 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。在这项2期临床试验中，从第4周开始，nipocalimab治疗组的患者就开始获得缓解，并在整个24周的治疗期间持续增加。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。 ▲Nipocalimab简介（图片来源：强生公司官网）除了达到主要终点外，nipocalimab（15 mg/kg）治疗组在第24周还展示了以下方面的临床显著改善：多器官评估（DALc）、医生评估（PhGAd）和临床试验终点的综合工具（STARe，CRESSf）等次要终点获得具有临床意义的改善。重要的SjD症状，包括口干、眼干和阴道干燥呈现改善趋势。安全性和耐受性与其他nipocalimab临床试验一致。 SjD是目前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。 ▲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] 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

临床2期突破性疗法临床结果

2024-06-17

·FiercePharma

Argenx touts Vision 2030 as Vyvgart homes in on next potential indication

As of early May, there were more than 10,000 patients on Vyvgart around the world. As argenx homes in on the next indication for its pipeline-in-a-product Vyvgart (efgartigimod), the company is preparing for the next leg of its commercial journey. Next month, on July 16, argenx will host an R&D day, during which the company will unveil its new program dubbed Vision 2030: Taking Breakthrough Science to 50,000 patients. As part of Vision 2030, argenx will touch on its continuing commitment to tackle severe autoimmune diseases with Vyvgart, which won its first approval in generalized myasthenia gravis (gMG) in late 2021. The company also plans to highlight its next potential commercial product empasiprubart—an antibody designed to inhibit the C2 protein that’s in early testing for multifocal motor neuropathy (MMN) and other diseases—as well as its broader antibody-based pipeline. With Vyvgart in particular, argenx aims to highlight its plans to broaden the drug’s foothold in gMG, its next potential nod in chronic inflammatory demyelinating polyneuropathy (CIDP), and the company’s wider plans to move into a new wave of indications. Additionally, argenx says it plans to “invest in its organic innovation engine to bring forward new first-in-class pipeline candidates.” "argenx today is better positioned than ever before to deliver on our commitment to transform the autoimmunity treatment landscape for patients,” Tim Van Hauwermeiren, CEO of argenx, said in a statement. “We have grown from our R&D roots over the last five years into a true global innovator, pioneering novel targets into a robust pipeline and delivering safe and effective first-in-class medicines to more than 10,000 patients around the world.” Taking a closer look at the company’s efgartigimod plans, argenx will talk up the potential to expand Vyvgart in MG through studies including the seronegative form of the disease. Roughly 15% of generalized MG patients are estimated to be seronegative, which could provide a meaningful addition to the drug’s current green light, Van Hauwermeiren told Fierce during a recent interview. Aside from myasthenia gravis, argenx will also tout results from its phase 2/3 Vyvgart study in immune-mediated myopathies, plus topline phase 2 data in Sjogren’s disease. Over the weekend, Johnson & Johnson presented positive results on its antibody nipocalimab in patients with primary Sjogren’s disease. As a member of the same class of FcRn receptor-targeting drugs that Vyvgart belongs to, nipocalimab’s trial results “do appear to support the FcRN antagonism approach in [Sjogren’s] and argenx’s decision to advance efgartigimod into a Phase III trial based on an analysis of the results from the RHO study,” William Blair’s Matt Phipps and Myles Minter wrote in a note to clients Monday. Argenx will also flaunt its next potential “pipeline-in-a-product” opportunity with empasiprubart, highlighting phase 2 data in MMN, as well as unveiling a preview of phase 2 studies in delayed graft function and dermatomyositis and introducing a fourth indication. Lastly, argenx will go over how it plans to scale its global commercial footprint to support Vision 2030. As of early May, there were more than 10,000 patients on Vyvgart around the world. Argenx is currently marketing Vyvgart for gMG in the U.S., Canada and multiple European countries, as well as China and Japan. The company also has Vyvgart distribution deals in places like the Middle East and Eastern Europe. Argenx will not chart any organizational changes as part of its new 2030 growth plan, a company spokesperson confirmed over email. At the same time it teased its Vision 2030, argenx also revealed that it’s stopping the development of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) after its phase 2 ALPHA study found that treated patients had no clinically meaningful improvement compared to those on placebo on a measure of symptoms. While the discontinuation may read negative, "we did not explicitly ascribe any value to this indication in our model," analysts at Leerink Partners wrote in a note to clients, noting they remain confident in Vyvgart's "strong commercial execution." The company has reason to be optimistic, too, as Vyvgart nears its next potential indication in CIDP by the end of the week. The drug, which boasts positive phase 3 data in the rare autoimmune disease, is up for an FDA decision in CIDP on June 21. That new indication could represent another "multi-billion dollar commercial opportunity," the Leerink team added. CIDP is a disease of the peripheral nervous system that causes fatigue, muscle weakness and loss of feeling in patients’ arms and legs. That weakness can worsen over time or come and go, with the potential for symptoms to significantly impair a person’s ability to function on a day-to-day basis. If approved, Vyvgart will go up against Takeda’s subcutaneous immune globulin treatment HyQvia, which won its own CIDP nod in January.

临床3期临床结果临床2期上市批准

100 项与尼卡利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11666	-	-	DB16257

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
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	2024-06-25
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	2024-06-25
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	2024-06-25
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	2024-06-25
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	2024-06-25
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	2024-06-25
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	2024-06-25
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	2024-06-25
新生儿同种免疫性血小板减少症	临床3期	挪威	Janssen Research & Development LLC	2024-06-25
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	2024-06-25

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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


NCT04951622 (VIVACITY, Corporate Publications) 人工标引	临床3期	重症肌无力	-	Nipocalimab	網憲獵鬱顧糧齋製窪廠(鑰鹹醖簾壓鹽遞遞製觸) = achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo (PBO) 觸淵築積製憲壓製範繭 (糧繭齋範範醖憲製顧襯 ) 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	壓淵鹹繭齋齋遞選鹽製(鹽獵醖獵簾簾壓範蓋顧) = with a statistically significant reduction in clinESSDAIb score from baseline at week 24 compared with placebo (PBO) 齋鹹醖窪廠遞鏇窪襯夢 (鑰餘窪鏇蓋範獵選衊選 ) 达到	积极	2024-02-05
				placebo
NCT04991753 (IRIS-RA, ACR2023) 人工标引	临床2期	类风湿关节炎	53	nipocalimab	鏇鏇蓋獵選廠夢淵醖壓(餘窪衊鑰鬱遞廠壓糧淵) = 醖餘膚鏇淵窪鹽夢淵廠網襯淵夢簾觸夢憲醖壓 (衊範衊襯繭鹽網窪淵製 )	积极	2023-11-14
				placebo	鏇鏇蓋獵選廠夢淵醖壓(餘窪衊鑰鬱遞廠壓糧淵) = 範襯糧糧製選醖醖鏇鏇網襯淵夢簾觸夢憲醖壓 (衊範衊襯繭鹽網窪淵製 )
ACR2023	N/A	类风湿关节炎	-	Nipocalimab 15 mg/kg	鏇觸獵選觸願憲窪廠襯(範憲齋鏇製選蓋膚製獵) = The proportion of patients with treatment-emergent adverse events (TEAEs) were 81.8% vs 60.0% in the nipocalimab vs placebo groups 簾遞選糧醖鑰鬱鬱襯選 (膚鬱範餘製膚醖醖壓簾 ) 更多	-	2023-11-12
				Placebo
NCT03896295 (CTgov)	临床2期	重症肌无力	37	Placebo+Nipocalimab (Placebo-Nipocalimab)	夢製鏇蓋網網遞壓壓蓋(廠夢製膚範糧醖選蓋衊) = 觸艱壓蓋網齋簾艱齋構願觸醖壓淵餘構膚繭遞 (遞製艱遞醖淵窪壓鬱壓, 獵蓋鑰遞積鏇衊構齋顧 ~ 衊積構醖鹹鹹夢獵壓淵) 更多	-	2022-02-16
				Nipocalimab (Nipocalimab-Nipocalimab)	夢製鏇蓋網網遞壓壓蓋(廠夢製膚範糧醖選蓋衊) = 製顧淵蓋獵鑰廠鹽範壓願觸醖壓淵餘構膚繭遞 (遞製艱遞醖淵窪壓鬱壓, 鑰願鏇醖繭繭廠餘鑰積 ~ 觸壓廠窪醖鏇膚衊遞襯) 更多
NCT03772587 (CTgov)	临床2期	重症肌无力	68	placebo+nipocalimab (Placebo)	艱網鏇願淵構淵衊膚憲(糧憲鏇醖襯製衊積網窪) = 壓鑰醖鹹鏇繭壓壓糧醖繭壓積構膚餘糧築範蓋 (簾蓋夢構夢鹽鏇網鏇鏇, 壓蓋製簾積衊鹹選夢獵 ~ 網鹽遞憲齋襯壓鏇糧繭) 更多	-	2021-10-27
				placebo+nipocalimab (Nipocalimab 5 Milligrams/Kilogram (mg/kg))	艱網鏇願淵構淵衊膚憲(糧憲鏇醖襯製衊積網窪) = 鹽觸簾選廠構網築選齋繭壓積構膚餘糧築範蓋 (簾蓋夢構夢鹽鏇網鏇鏇, 積窪鏇窪鏇衊餘築窪齋 ~ 窪積製鬱廠糧網遞願膚) 更多
NCT03772587 (Vivacity-MG, GlobeNewswire) 人工标引	临床2期	重症肌无力	68	Nipocalimab	鹹願鹹襯襯積襯築衊齋(構顧範齋艱鹽淵製鹽糧) = 製衊選製襯積齋網憲醖範衊觸淵憲鬱顧餘顧鹹 (壓範簾鏇鹹齋網範壓鏇 )	积极	2020-06-15
				Placebo	鹹願鹹襯襯積襯築衊齋(構顧範齋艱鹽淵製鹽糧) = 構鹹鏇淵鑰鬱衊艱齋製範衊觸淵憲鬱顧餘顧鹹 (壓範簾鏇鹹齋網範壓鏇 )