伊奈利珠单抗(Inebilizumab-cdon) - 药物靶点：CD19_在研适应症：水通道蛋白4抗体阳性视神经脊髓炎谱系疾病，视神经脊髓炎，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

Inebilizumab、Inebilizumab (Genetical Recombination)、英比利珠单抗

+ [9]

靶点

CD19

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤免疫系统疾病感染+ [5]

在研适应症

水通道蛋白4抗体阳性视神经脊髓炎谱系疾病视神经脊髓炎系统性硬皮病+ [4]

非在研适应症

侵袭性 B 细胞非霍奇金淋巴瘤B细胞恶性肿瘤骨髓肿瘤+ [7]

原研机构

Duke University

在研机构

Horizon Therapeutics Ireland DAC

Amgen, Inc.MedImmune Pharma BV

+ [2]

非在研机构

MedImmune LLC

AstraZeneca PLC

最高研发阶段批准上市

首次获批日期

美国 (2020-06-11),

视神经脊髓炎

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (韩国)、孤儿药 (美国)

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序列信息

Sequence Code 319372678L

来源: *****

Sequence Code 1191632826H

来源: *****

关联

34

项与伊奈利珠单抗相关的临床试验

NCT05909761 / RecruitingN/A

An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

开始日期2025-02-14

申办/合作机构

Amgen, Inc.

NCT06570798 / Not yet recruiting临床2期

A Phase 2a, Open Label, Multi Center, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab (Subprotocol A) and subcutaneous (SC) blinatumomab (Subprotocol B) in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis.

开始日期2024-12-31

申办/合作机构

Amgen, Inc.

NCT05891379 / RecruitingN/AIIT

Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study

This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

开始日期2024-07-09

申办/合作机构

首都医科大学宣武医院

100 项与伊奈利珠单抗相关的临床结果

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100 项与伊奈利珠单抗相关的转化医学

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100 项与伊奈利珠单抗相关的专利（医药）

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108

项与伊奈利珠单抗相关的文献（医药）

2024-12-01·Journal of central nervous system disease

Advances in the long-term treatment of neuromyelitis optica spectrum disorder

Review

作者: Anderson, Monique ; Levy, Michael

Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune neuroinflammatory disorder with a prevalence of 1-5/100,000 globally, characterized by attacks of the central nervous system including but not limited to optic neuritis, transverse myelitis and brainstem lesions, including area postrema lesions. These autoimmune attacks can lead to irreversible damage if left untreated, therefore strategies have been developed to prevent relapses. Initial off-label treatments have achieved variable levels of success in relapse prevention, but improved relapse prevention and quality of life remain a goal in the field. A better understanding of the underlying pathophysiology of NMOSD over the last 10 years has led to newer, more specific approaches in treatment, culminating in the first FDA approved treatments in the disease. In this review, we will discuss the seminal trials of PREVENT or Eculizumab in the treatment of aquaporin-4 (AQP4)-IgG positive NMOSD, N-Momentum or Inebilizumab in the study of NMOSD (both AQP4-IgG positive and negative) and SAkura Sky and SAkuraStar which studied satralizumab in AQP4-IgG seropositive and seronegative NMOSD patients. We will also discuss the extension trials of each of these medications and what lead to their approval in AQP4-IgG seropositive NMOSD patients. We will then examine treatments in the pipeline for adult and pediatric NMOSD patients and conclude with discussions on treatment considerations in pregnant patients and how to approach treatment of NMOSD patients during COVID.

2024-11-01·Heliyon

Neuromyelitis optica spectrum disorder with ultra-longitudinally extensive transverse myelitis: A case report and literature review

Article

作者: Pan, Xin ; Xie, Lili ; Liu, Chang ; Li, Furong ; Sui, Xiaowen ; Ma, Shubei ; Zhao, Hongling

Background:

Neuromyelitis optica spectrum disorders (NMOSD) is characterized by inflammatory demyelinating events in the central nervous system (CNS), primarily affecting the spinal cord and optic nerve, with a significant influence of astrocytes. Longitudinal extensive transverse myelitis (LETM) is a distinct and relatively rare spinal cord syndrome, commonly associated with NMOSD.

Case presentation:

This report describes a unique case of myelitis in a patient diagnosed with NMOSD. The patient exhibited an uncommon manifestation of ultra- LETM (u-LETM), coexisting with connective tissue disorders including Sjögren's syndrome and autoimmune hepatitis-primary cholestatic cirrhosis. In the acute phase, high-dose methylprednisolone pulse therapy was administered in combination with intravenous human immunoglobulin, while prednisone was gradually tapered and discontinued upon stabilization of the patient's condition. Simultaneously, sequential disease-modifying therapy was initiated, starting with long-term oral administration of mycophenolate mofetil, followed by cyclophosphamide, telitacicept, and Inebilizumab. During follow-up visits conducted every three months, the patient showed gradual improvement, eventually achieving the ability to stand and walk independently.

Conclusions:

Early and comprehensive evaluation of autoimmune diseases is crucial in patients with NMOSD presenting with u-LETM as the initial symptom. Prompt treatment initiation, followed by disease-modifying therapy, is essential for improving patient prognosis.

2024-11-01·Med

Recurrent late-onset neutropenia following treatment with different B cell-depleting strategies in multiple sclerosis

Article

作者: Fleischer, Vinzenz ; Protopapa, Maria ; Pape, Katrin ; Zipp, Frauke ; Schraad, Muriel ; Bittner, Stefan ; Steenken, Livia ; Steffen, Falk

BACKGROUND:

As B cell-depleting therapies in multiple sclerosis (MS) have gained significant importance in the last several years, their long-term safety profile is of considerable clinical interest. Late-onset neutropenia (LON) is a rare, but potentially severe, adverse event that was first described in patients with rheumatic disorders under therapy with rituximab. Ofatumumab was approved in 2021 for the treatment of relapsing-remitting multiple sclerosis (RRMS). Neutropenia occurred in 0.2% of patients in clinical phase 3 trials, and to date, no cases of LON have been reported under ofatumumab treatment.

METHODS:

Here, we report a case of repetitive symptomatic LON under ocrelizumab as well as ofatumumab treatment. Additionally, we review the literature on rare occurrences of LON in patients with MS, neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) undergoing B cell-depleting therapies, including rituximab, ocrelizumab, ofatumumab, inebilizumab, and ublituximab.

FINDINGS:

In our case, the patient presented with repetitive symptomatic LON under ocrelizumab as well as ofatumumab treatment leading to febrile infections, subsequent use of antibiotics, and application of granulocyte-colony-stimulating factor. After repetitive episodes of LON under both B cell-depleting strategies, cladribine was subsequently initiated. A nine-month follow-up showed a normal neutrophil count and no evidence of disease activity.

CONCLUSIONS:

This case highlights the significance of symptomatic late-onset blood count changes under both ocrelizumab and ofatumumab and emphasizes the importance of continuous monitoring of the differential blood count under B cell-depleting treatment.

FUNDING:

This study was supported by the Deutsche Forschungsgemeinschaft (DFG; SFB CRC-TR-128 to F.Z., V.F., and S.B..; SFB 1080 and SFB CRC-1292 to F.Z..; and SFB/TRR 355 to S.B.) and the Hermann and Lilly Schilling Foundation (to S.B.).

200

项与伊奈利珠单抗相关的新闻（医药）

2024-11-28

·翰森制药

喜报 | 翰森制药4款创新药成功续约2024年国家医保目录

2024年11月28日，国家医保局与人力资源社会保障部发布《国家基本医疗保险、工伤保险和生育保险药品目录(2024年)》(以下简称“2024国家医保目录”)，翰森制药4款创新药续约纳入，1款合作的创新药新增适应症纳入，该目录将于2025年1月1日正式执行。阿美乐®（甲磺酸阿美替尼片）翰森制药自主研发的中国首个原研三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）创新药，其已获批的两项适应症均已纳入2024国家医保目录： 1. EGFR外显子19 缺失或外显子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗； 2. 既往经EGFR-TKI治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性NSCLC成人患者的治疗。豪森昕福®（甲磺酸氟马替尼片）翰森制药自主研发的中国首个原研新型二代Bcr-AbI TKI，用于治疗费城染色体阳性的慢性髓性白血病（Ph+ CML）慢性期成人患者。昕越®（伊奈利珠单抗注射液）靶向CD19 B细胞消耗性抗体，用于抗水通道蛋白4（AQP4）抗体阳性的视神经脊髓炎谱系疾病（NMOSD）成人患者。孚来美®（聚乙二醇洛塞那肽注射液）翰森制药自主研发的中国首个长效GLP-1受体激动剂，也是全球第一款PEG化长效降糖药物，用于改善成人2型糖尿病患者的血糖控制。希维奥®（塞利尼索片）翰森制药合作的全球首个全新机制口服选择性核输出蛋白（XPO1）抑制剂，其已获批的两项适应症均已纳入2024国家医保目录，医保支付范围为： 1. 用于既往接受过治疗且对至少一种蛋白酶体抑制剂，一种免疫调节剂以及一种抗CD38单抗难治的复发或难治性多发性骨髓瘤成人患者； 2. 用于既往接受过至少2线系统性治疗的复发或难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）成人患者。此外，创新药圣罗莱®（培莫沙肽注射液）、恒沐®（艾米替诺福韦片）已纳入2023国家医保目录，目前尚在协议期内，协议有效期至2025年12月31日；迈灵达®（吗啉硝唑氯化钠注射液）已纳入国家医保常规目录乙类。公司已上市创新药所有适应症均位列医保目录内，有助于进一步提高各创新药在患者中的可及性和可负担性。翰森制药始终聚焦未被满足的临床需求，探索生物科技前沿技术领域，推动医药产业高质量发展，努力将创新成果惠及更多患者。关于翰森翰森制药是中国领先的创新驱动型制药企业，下属豪森药业、常州恒邦药业、翰森生物医药等子公司，重点关注抗肿瘤、抗感染、中枢神经系统、代谢及自身免疫等重大疾病治疗领域，致力于通过持续创新提高人类生命质量。截至2024上半年，公司已上市7款创新药，创新产品营收占比达77.4%。公司连续多年位居全球制药企业百强、中国医药研发产品线最佳工业企业前3强，是国家重点高新技术企业、国家技术创新示范企业。公司于2019年6月在香港联交所挂牌上市（股票代码：03692.HK）。更多信息请访问：https://cn.hspharm.com/。声明：1、翰森制药不推荐任何未获批药品使用或未获批适应症用药。 2、本新闻稿中的医疗信息仅供信息和新闻报道使用，不用于广告目的，不要将其用于医疗保健或诊断建议。前瞻性说明本新闻稿旨在提供关于翰森制药集团有限公司及其附属公司（包括其子公司，统称为“翰森制药”）的信息。它不构成对翰森制药或任何投资建议的信息披露。本新闻稿包含的信息可能包括与翰森制药业务和产品前景、计划、信念、预期和策略相关的前瞻性声明。这些声明是基于推测性假设的预测，并不保证未来的表现。它们受到诸如科学、商业、政治、经济、财务、法律因素以及竞争环境和社会条件等风险和不确定性的影响，这些因素很多都是翰森制药无法控制且难以预测的，因此实际结果可能与此处所述有显著差异，且过去的证券价格趋势不应作为未来行情的指导。因此，投资者在使用这些信息进行投资决策时应谨慎行事。“致力于”“预期”“相信”“预测”“意图”“预计”“可能”“将”“应该”“计划”“继续”“目标”“考虑”“估计”“指导”“潜在”“追求”以及于任何未来计划、行动或事件的讨论中使用的类似词语和术语，均表示前瞻性声明。翰森制药不承诺或保证前瞻性信息的准确性、及时性或完整性，并且不承担更新或修订这些前瞻性声明的义务。无论是翰森制药还是其任何董事、员工或代理人，均不对任何证明不准确或无法实现的前瞻性声明负责，也不对因依赖本新闻稿中提供的信息而产生的任何损失或损害负责，包括但不限于直接、偶然、间接或惩罚性的损害。本新闻稿中的所有信息均为发布之日的最新信息。翰森制药不承担因新发展、未来事件或其他情况而更新或修订这些信息的责任，除非法律要求。此外，翰森制药保留在任何时候未经通知对本新闻稿的全部或部分内容进行更改、更正或中断的权利。对于特别与上市公司有关的信息，公司鼓励投资者参考翰森制药（03692.HK）的公告和财务报告。 END

申请上市上市批准

2024-11-26

·drugs

American College of Rheumatology, Nov. 14-19

The annual meeting of the American College of Rheumatology was held this year from Nov. 14 to 19 in Washington, D.C., and attendees included rheumatology specialists, physicians, scientists, and other health professionals. The conference featured presentations focusing on the latest advances in the diagnosis and treatment of arthritis as well as other rheumatic and musculoskeletal diseases. During one presentation, Chuan-Ju Liu, Ph.D., of the Yale University School of Medicine in New Haven, Connecticut, discussed how the sodium channel Nav1.7 represents a novel and actionable target to preserve joint structure and slow osteoarthritis progression, addressing not only pain but also structural deterioration. Liu highlighted recent discoveries linking sodium channel Nav1.7 to the regulation of joint structure in osteoarthritis. He outlined how sodium channels in chondrocytes play a critical role in maintaining cartilage integrity and how targeting these channels could mitigate cartilage degeneration. "Preclinical studies demonstrated that modulating Nav1.7 can prevent joint deterioration, suggesting a promising therapeutic approach," Liu said. "Although still in the early stages, this research points toward the potential for developing sodium channel inhibitors or modulators as disease-modifying treatments for osteoarthritis. Over time, this approach may complement or reduce reliance on existing treatments like nonsteroidal anti-inflammatory drugs, which primarily address symptoms and often have side effects." Press Release In another presentation, Daniel Clauw, M.D., of the University of Michigan in Ann Arbor, discussed cannabis therapy for chronic pain among patients with rheumatic diseases. Currently, there are very few randomized clinical trials evaluating the effectiveness and safety of cannabis products. In addition, the results of these studies can vary based on dose, mode of administration, and an individual's metabolism. It is also difficult to determine how much cannabidiol (CBD) and tetrahydrocannabinol (THC) are contained within cannabis products. However, Clauw stressed that cannabis can still be a relatively safe and effective option for the treatment of chronic pain. "Cannabis products likely have a role in treating pain but more research needs to be done regarding what cannabis products work for what types of pain," Clauw said. "We know that CBD is quite safe and legal in all of the United States and people should try that before venturing to THC, which may be helpful in some but has far more potential side effects." Press Release Lihi Eder, M.D., of the Women's College Hospital and University of Toronto, discussed how understanding sex-related differences in psoriatic arthritis is critical to developing approaches that consider the sex of the patient in disease management. Male and female patients with psoriatic arthritis may present differently, with female patients having more pain and disability and a lower response to biologic therapies compared with their male counterparts. Eder said that the mechanisms behind these findings remain unclear, but the differences could be related to biological mechanisms such as pain processing, immune function, and the pharmacokinetics of drugs. They could also be due to sociocultural factors, including coping mechanisms, support systems, and access to care. "Considering sex/gender in patient care could improve outcomes. For example, use of more sensitive imaging such as ultrasound to investigate the source of pain may be more important in females and could provide insights about the cause of pain and inform therapy," Eder said. "More research is needed to identify mechanisms for the observed differences." Press Release ACR: Inebilizumab Reduces Risk for Flares in IgG4-Related Disease TUESDAY, Nov. 19, 2024 -- For patients with immunoglobulin G4-related disease, inebilizumab reduces the risk for flares and increases the likelihood of flare-free complete remission, according to a study published online Nov. 14 in the New England Journal of Medicine to coincide with the annual meeting of the American College of Rheumatology, held from Nov. 14 to 19 in Washington, D.C. Read Full Text ACR: Colchicine No Benefit for Painful Knee Osteoarthritis TUESDAY, Nov. 19, 2024 -- Colchicine fails to improve knee pain, function, or size of synovial effusions with painful knee osteoarthritis, according to a study presented at the annual meeting of the American College of Rheumatology, held from Nov. 14 to 19 in Washington, D.C. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

2024-11-20

·药学进展

行业动态|伊奈利珠单抗（昕越®）获得美国 FDA突破性疗法认定，用于治疗 IgG4相关性疾病，并在ACR 2024上展示新数据

“ 点击蓝字关注我们伊奈利珠单抗（昕越®）获得美国 FDA突破性疗法认定，用于治疗 IgG4相关性疾病，并在ACR 2024上展示新数据 PPS 翰森制药集团有限公司（以下简称“翰森制药”，03692.HK）宣布，伊奈利珠单抗获得美国 FDA 授予的突破性疗法认定（BTD），这是基于全球 III 期 MITIGATE 研究对免疫球蛋白 G4 相关疾病 (IgG4-RD) 治疗取得的积极结果。MITIGATE 研究中伊奈利珠单抗的最新研究数据于 2024 年11月14-19 日在美国华盛顿特区召开的美国风湿病学会年会（ACR）上展示。 MITIGATE研究及其在IgG4相关性疾病 (IgG4-RD) 中的关键发现 MITIGATE (NCT04540497) 在包括中国在内的22个国家的80个临床试验研究中心进行。这是首次在IgG4相关疾病中进行的随机、双盲、安慰剂对照研究，确立了伊奈利珠单抗通过CD19+ B细胞耗竭治疗IgG4-RD的安全性和有效性。关键研究数据包括： •与安慰剂相比，IgG4-RD复发风险在52周的安慰剂对照期内显著降低了87%，具有临床意义及统计学意义（风险比0.13，p<0.001）；接受伊奈利珠单抗治疗的68名受试者中有7人出现复发，而接受安慰剂治疗的67名受试者中有40人出现复发。 •在安慰剂对照期间，接受治疗并经裁定委员会确定的年化复发率降低；接受伊奈利珠单抗治疗的受试者为0.10，而接受安慰剂的受试者为0.71（p<0.001）。 •57.4%（68名受试者中有39人）的接受伊奈利珠单抗治疗的受试者在第 52 周时达到无复发、无需治疗的完全缓解，而安慰剂组为 22.4%（67名受试者中有15人）(p<0.001)。 •接受伊奈利珠单抗治疗的58.8%（68名中有40人）的受试者在第 52 周时达到了无复发、无需皮质类固醇的完全缓解，而安慰剂组这一比例为 22.4%（67名中有15人）(p<0.001)。 •确认伊奈利珠单抗的独特作用机制，能够快速并持续地耗竭外周B细胞的数量，从而降低疾病生物标志物的水平。疾病复发是高疾病活动性的指标。值得注意的是，接受伊奈利珠单抗治疗的89.7%（68名中有61人）的患者在安慰剂对照期间不需要使用糖皮质激素来控制疾病，而安慰剂组的比例为37.3%（67名受试者中有25人）。第8周后，伊奈利珠单抗治疗组患者的总糖皮质激素用量比安慰剂组减少了十倍。安慰剂对照期的安全性结果与伊奈利珠单抗已知的安全性特征一致。最常见的治疗相关不良事件包括COVID-19、淋巴细胞减少、尿路感染和头痛。数据同时发表在《新英格兰医学杂志》上。8月，美国食品药品监督管理局根据MITIGATE研究的数据授予伊奈利珠单抗用于IgG4相关性疾病的突破性疗法认定，目前监管申报活动正在进行中。 *所有 P 值遵循《新英格兰医学杂志》报告指南；小于 0.001 的值均表示为 0.001。 MITIGATE研究是在翰森制药和其他合作伙伴的支持下进行。翰森制药是中国的独家被许可方、注册代理和商业化总代理。文章来源：豪森药业美编排版：覃冰冰文章审核：覃冰冰罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由中国药科大学和中国药学会共同主办、国家教育部主管，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

突破性疗法临床结果临床3期

100 项与伊奈利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	伊奈利珠单抗	L01XC	DB12530

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
水通道蛋白4抗体阳性视神经脊髓炎谱系疾病	加拿大	Horizon Therapeutics Ireland DAC	2023-12-15
视神经脊髓炎	美国	Horizon Therapeutics Ireland DAC	2020-06-11

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3期	日本	Mitsubishi Tanabe Pharma Corp.	2022-07-20
免疫球蛋白G4相关疾病	临床3期	美国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	中国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	日本	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	阿根廷	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	澳大利亚	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	加拿大	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	法国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	德国	Amgen, Inc.	2020-10-26
免疫球蛋白G4相关疾病	临床3期	中国香港	Amgen, Inc.	2020-10-26

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临床结果

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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


NCT04540497 (MITIGATE, ACR2024 \| Literature) 人工标引	临床3期	免疫球蛋白G4相关疾病	135	Placebo	網艱餘衊觸蓋築鏇鹽願(廠顧鏇觸膚艱顧醖鹽衊) = 獵鹹糧窪鹽鹹廠簾顧構艱蓋觸淵簾鏇襯願簾襯 (製願範構製築鹹鏇齋願 ) 更多	积极	2024-11-16
				inebilizumab	網艱餘衊觸蓋築鏇鹽願(廠顧鏇觸膚艱顧醖鹽衊) = 獵壓鹽醖獵積餘簾鑰製艱蓋觸淵簾鏇襯願簾襯 (製願範構製築鹹鏇齋願 ) 更多
NCT04524273 (MINT, Company_Website) 人工标引	临床3期	重症肌无力	238	UPLIZNA	遞積醖鑰選鏇膚築顧醖(壓糧壓壓衊鏇膚廠鬱鬱) = 襯衊繭獵構簾齋鏇衊壓餘獵觸壓醖淵製艱獵遞 (糧顧蓋遞淵鏇觸鬱願願 ) 达到更多	积极	2024-10-15
				Placebo	遞積醖鑰選鏇膚築顧醖(壓糧壓壓衊鏇膚廠鬱鬱) = 窪願鑰鑰廠餘壓簾夢襯餘獵觸壓醖淵製艱獵遞 (糧顧蓋遞淵鏇觸鬱願願 ) 达到更多
NCT02200770 (N-ÂMomentum, EAN2024)	临床2/3期	视神经脊髓炎	213	Inebilizumab 300mg	糧築顧淵觸糧鬱繭網廠(築蓋選糧衊醖餘範製顧) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants â‰¥65âyears 齋築範淵製選積範廠範 (獵製鏇鏇襯築鑰糧選繭 )	积极	2024-06-28
				Placebo
NCT04540497 (MITIGATE, NEWS) 人工标引	临床3期	免疫球蛋白G4相关疾病	-	Uplizna	顧鬱蓋襯鹽製窪衊遞繭(繭簾廠顧襯獵鏇鏇淵齋) = 膚製膚選簾願襯廠獵願衊壓簾壓觸醖願齋範簾 (鏇獵糧製觸憲蓋憲鏇鏇 ) 达到	积极	2024-06-06
				Placebo	-
ACTRIMS2024	N/A	干燥综合征 \| 全血细胞减少 \| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病	-	Inebilizumab 300 mg	窪製網膚繭範簾夢遞製(蓋襯積構鹽憲鹽糧壓製) = 餘齋構築鹽獵鹽鹽觸糧鹹範築鹹衊夢構壓願鏇 (醖壓膚蓋夢觸顧鹹積襯 ) 更多	-	2024-03-01
NCT02200770 (N-MOmentum, ACTRIMS2024)	临床2/3期	视神经脊髓炎 AQP4+	213	Inebilizumab 300 mg	構鑰窪艱製遞願齋廠觸(襯顧糧構鹹選餘製衊淵) = 16.0% (4/25) reported ≥1 investigational product-related treatment-emergent adverse event (IP-TEAE) versus 20.0% (3/15) on PBO, and among non-Hispanic/Latino participants, the IP-TEAE was 26.4% (36/136) in the INEB group and 27.0% (10/37) in the PBO group. No IP-related serious events or deaths occurred in the Hispanic/Latino participants in INEB or PBO groups of the RCP 鹹壓鹹壓觸觸簾鹹鏇願 (膚醖膚簾廠鹹簾餘範襯 )	积极	2024-03-01
				Placebo
ACTRIMS2024	N/A	视神经脊髓炎	-	Inebilizumab 300 mg	顧鹹願艱壓選獵鹹廠鏇(繭糧觸壓範淵艱衊製鹹) = 積願蓋遞獵壓顧顧憲壓衊網繭鹹窪積餘壓構築 (範鬱蓋製鬱壓範顧艱鬱 )	-	2024-02-29
				Placebo	顧鹹願艱壓選獵鹹廠鏇(繭糧觸壓範淵艱衊製鹹) = 構獵遞網製鹽衊網壓繭衊網繭鹹窪積餘壓構築 (範鬱蓋製鬱壓範顧艱鬱 )
EUCTR2014-000253-36-GR (N-MOmentum, Biospace) 人工标引	临床2/3期	视神经脊髓炎	-	inebilizumab (AQP4-IgG+ group)	獵簾構積顧蓋衊醖繭鏇(鏇鹹獵鑰遞窪齋願獵鑰) = 餘糧鹽築艱製網糧淵願齋鹽蓋糧範壓顧餘艱襯 (顧廠壓遞夢夢簾鏇獵願 )	积极	2024-01-16
NCT02200770 (N-MOmentum, ECTRIMS2023)	临床2/3期	视神经脊髓炎 aquaporin-4 antibody (AQP4+)	208	Inebilizumab	憲艱糧膚淵夢膚簾膚築(憲觸製廠鬱鏇膚憲遞憲) = 鹽範襯蓋觸衊構鹹衊製選觸網壓衊鹽遞醖範鬱 (積選夢淵願構顧築願網, 71 ~ 83)	积极	2023-09-30
				Azathioprine and other immunosuppressive therapies (AZA/IST)	憲艱糧膚淵夢膚簾膚築(憲觸製廠鬱鏇膚憲遞憲) = 淵選糧齋鏇鹽網衊簾鏇選觸網壓衊鹽遞醖範鬱 (積選夢淵願構顧築願網, 27 ~ 46)
N-MOmentum (ACTRIMS2023)	N/A	新型冠状病毒感染 \| 视神经脊髓炎 aquaporin-4 seropositive	182	Inebilizumab	窪襯鬱醖簾構憲壓壓鏇(憲鹹築夢觸壓簾壓鹹鑰) = In all, there were 17 reports of confirmed COVID-19 infections among inebilizumab treated NMOSD patients (women, n=15, unknown, n=2) from March 2020-July 2022. Median (range) age was 57 (32-68) years (n=15). Among 182 patients in N-MOmentum, 2 COVID-19 infections were reported between March-November 2020, prior to vaccine availability. The incidence rate was 0.024 (E/PY). In the safety database, 15 events were reported as of July 31, 2022. Median inebilizumab exposure was 123 days (range 10-2379 days, n=11) from first infusion to COVID-19 diagnosis.Of the total of 17 events, 10 events were reported as serious. COVID-19 vaccination status was not known. Five patients had pneumonia. Of 10 patients with known outcomes 6 were reported as ârecovered/resolvedâ, 2 as not recovered/resolved at the time of reporting, and 2 died: 1 patient, 62 years, in Peru, died May 2020 before vaccine availability, possible COVID pneumonia, possible renal failure, received antibiotics, hydroxychloroquine and ivermectin; and 1 patient, 32 years, in US, died Feb 2021, possibly partially vaccinated, history of obesity, deep vein thromboembolism (DVT), sickle cell trait, treated for possible COVID pneumonia complicated by pulmonary embolism (PE). Inebilizumab treatment was reported as not changed in 3 patients, discontinued in 1 patient, and action was unknown for the rest. 壓構選築觸繭築艱繭壓 (蓋鬱憲選範窪選築醖夢 )	积极	2023-05-30