奥法妥木单抗(Ofatumumab) - 药物靶点：CD20_在研适应症：复发性多发性硬化，复发-缓解型多发性硬化，多发性硬化症_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

HuMax-CD20、HuMax-CD20, 2F2、Ofatumumab (genetical recombination)

+ [12]

靶点

CD20

作用方式

抑制剂

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [2]

在研适应症

复发性多发性硬化复发-缓解型多发性硬化多发性硬化症+ [5]

非在研适应症

侵袭性 B 细胞非霍奇金淋巴瘤B细胞淋巴瘤复发性B细胞淋巴瘤+ [26]

原研机构

Genmab A/S

在研机构

Novartis Pharmaceuticals Corp.

Novartis AGNovartis Pharma AG

+ [4]

非在研机构

葛兰素史克（中国）投资有限公司

Cephalon, Inc.

Glaxo Group Ltd.

权益机构

Genmab A/SNovartis Pharma AG

Novartis AG

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2009-10-26),

慢性淋巴细胞白血病

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、加速批准 (美国)

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结构/序列

Sequence Code 143593H

来源: *****

Sequence Code 143818L

来源: *****

关联

192

项与奥法妥木单抗相关的临床试验

NCT06869785

/ Recruiting临床3期

An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis

This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

开始日期2025-03-13

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06486779

/ RecruitingN/A

A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)

This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)

开始日期2024-12-10

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06444113

/ Recruiting临床4期

A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.

开始日期2024-11-25

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

100 项与奥法妥木单抗相关的临床结果

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100 项与奥法妥木单抗相关的转化医学

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100 项与奥法妥木单抗相关的专利（医药）

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853

项与奥法妥木单抗相关的文献（医药）

2025-10-01·Multiple Sclerosis and Related Disorders

Real-world change in annualized relapse rate and healthcare resource utilization following initiation of ofatumumab in people with multiple sclerosis

Article

作者: Faucher, Ariane ; Taiji, Riley ; Brown, Brandon ; Ionescu-Ittu, Raluca ; Gadkari, Abhijit ; Vekeman, Francis ; Tai, Ming-Hui

BACKGROUND:

Ofatumumab (OMB) is an FDA-approved CD20-directed monoclonal antibody with demonstrated efficacy in reducing incidence of relapse in multiple sclerosis (MS). Real-world data are needed to ascertain OMB's effectiveness in reducing relapse in a broader MS population and to assess whether clinical benefits of OMB translate into decreased healthcare resource utilization (HCRU). The current study utilized a large US administrative claims database to compare relapse and MS-related HCRU before and after initiation of OMB therapy in a real-world sample of people with MS.

METHODS:

A retrospective pre-post cohort study was conducted using Optum® Clinformatics® Data Mart database (August 2019-December 2023). Adults with an MS diagnosis initiated on OMB (index date) between August 2020 (FDA approval date) and July 2023 were included. Patients were required to be continuously enrolled in a healthcare plan ≥12 months before and ≥6 months after index date and persistent on OMB, defined as no gaps in treatment ≥60 days or treatment switch, for ≥6 months following index date. Relapse was defined using a validated claims-based algorithm. MS-related HCRU included hospitalizations, days of hospitalization, emergency department (ED) visits, and outpatient (OP) visits. The study period was divided into a 12-month pre- (before OMB initiation) and ≥6-month post-index period (from OMB initiation until end of follow-up or persistent OMB use). Rates of relapse and MS-related HCRU per person-year (PPY) were assessed using negative binomial regression and compared between pre- and post-index periods using unadjusted incidence rate ratios (IRRs).

RESULTS:

In 779 included patients, mean (standard deviation) age at index was 48 (11) years, 74 % were female, and 69 % were White, with a mean follow-up of 1.36 years. In the pre-index period, 42 % and 23 % of patients received low-/moderate- and high-efficacy disease-modifying therapies, respectively. Annualized relapse rate (ARR) (95 % confidence interval [CI]; N relapse episodes/N person-years) in the pre-index period was 0.41 (0.36-0.47; 317/779) compared with 0.10 (0.08-0.13; 103/1060) in the post-index period. This equated to a statistically significant 75 % reduction in ARR following OMB initiation (IRR 0.25; 95 % CI, 0.20-0.31; p < 0.001). Hospitalizations PPY (95 % CI) decreased significantly from 0.16 (0.13-0.21) to 0.02 (0.01-0.03; IRR 0.10; 95 % CI, 0.06-0.18; p < 0.001). Similarly, days of hospitalization decreased significantly from 0.39 (0.20-0.75) to 0.12 (0.10-0.14; IRR 0.36; p = 0.004). OP visits also decreased significantly from 6.56 (6.21-6.92) to 4.60 (4.36-4.85; IRR 0.70; p < 0.001), whereas ED visits PPY decreased non-significantly from 0.16 (0.12-0.22) to 0.13 (0.10-0.18; IRR 0.79; p = 0.153). Significant reductions in ARR and MS-related hospitalization, days of hospitalization, and OP visits were observed regardless of whether patients were required to be persistent on OMB post-index for 3, 6, or 12 months.

CONCLUSION:

In a real-world sample of people with MS, ARR was reduced by 75 % following initiation of OMB. MS-related hospitalization, days of hospitalization, and OP visits also decreased significantly following OMB initiation. Results align with clinical trial evidence of OMB's efficacy in reducing relapse incidence in MS and suggest these benefits translate to reduced HCRU.

2025-09-01·American journal of ophthalmology case reports

Bilateral acute retinal necrosis after ofatumumab masquerading as intermediate uveitis in a patient with multiple sclerosis

Article

作者: Arepalli, Sruthi ; Hojjatie, Roxana A ; Ganesh, Prabakaran

Purpose:

To report an unique case of bilateral acute retinal necrosis (ARN) associated with ofatumumab use masquerading as intermediate uveitis in a patient with multiple sclerosis.

Observation:

A 47-year-old female with multiple sclerosis was transitioned to ofatumumab (Arzerra/Kesimpta, Novartis, Cambridge, MA, USA) for better systemic control of her disease. Two months later, she developed floaters with a scotoma in her right eye. Initially, she was diagnosed with intermediate uveitis secondary to a presumed multiple sclerosis flare. However, her symptoms worsened and she was referred to Emory University. Fundus examination revealed bilateral ARN. The patient discontinued the medication and was treated with systemic and intravitreal antivirals with improvement; however, she developed a retinal detachment in her right eye that required surgical repair.

Conclusions and importance:

This is a unique case of bilateral ARN after starting ofatumumab medication for multiple sclerosis. This case also highlights the importance of discerning between intermediate uveitis associated with multiple sclerosis and infectious uveitis in the setting of immunocompromise.

2025-08-09·BMC Neurology

Comparative effectiveness of disease-modifying therapies for highly active relapsing-remitting multiple sclerosis despite previous treatment - a systematic review and network meta-analysis.

Review

作者: Paul, Friedemann ; Ostlender, Sabine ; Kaiser, Thomas ; Köhler, Michael ; Preukschat, Daniela ; Sturtz, Sibylle ; Kerekes, Michaela Florina ; Janke, Kirsten

BACKGROUND:

Comparative assessments of all available disease-modifying therapies (DMTs) in patients with highly active relapsing-remitting multiple sclerosis (RRMS) are lacking, even though some of these DMTs are restricted to this MS subpopulation. We therefore aimed to compare DMTs in patients with highly active RRMS using re-analyses of individual patient data (IPD) provided by study sponsors.

METHODS:

We searched for randomised controlled trials (RCTs) that included adult patients with RRMS and directly compared alemtuzumab, cladribine, dimethyl fumarate, fingolimod, natalizumab, ocrelizumab, ofatumumab, ozanimod, ponesimod and teriflunomide, or compared these DMTs with other drugs or placebo. Re-analyses of IPD for subpopulations of patients with high disease activity despite previous DMT were included in network meta-analyses (NMAs). As there is no widely accepted definition of high disease activity in RRMS, criteria were chosen to cover as wide a range of definitions as possible, while being sufficiently similar across studies.

RESULTS:

We identified 14 relevant RCTs, including only 3 head-to-head comparisons of DMTs, and no relevant studies on natalizumab. All studies were pivotal studies for approval. The available re-analyses of IPD did not allow comprehensive NMAs. The main reasons for this were the overall paucity of RCTs, especially head-to-head comparisons, and a high risk of bias. In addition, data on patient-relevant outcomes and long-term follow-up (> 2 years) were lacking.

CONCLUSION:

Based on the largest possible evidence base, including previously unpublished data, our systematic review shows substantial evidence gaps for DMTs in highly active RRMS. This indicates a need for further research beyond regulatory requirements.

TRIAL REGISTRATION:

Clinical trial number: not applicable.

329

项与奥法妥木单抗相关的新闻（医药）

2025-07-22

·医药地理

【凤采鸾章·博文集】类风湿性关节炎药物治疗新进展

类风湿性关节炎药物治疗新进展New advances in drug therapy for rheumatoid arthritis王营营1 ，纪淑红2 ，夏光涛3* (1. 济南市市中区人民医院内科，山东济南 250000；2. 日照市莒县人民医院内科，山东日照 276500； 3. 山东第一医科大学附属省立医院风湿免疫科，山东济南 250021)引用王营营, 纪淑红, 夏光涛. 类风湿性关节炎药物治疗新进展[J]. 世界临床药物, 2025, 46(6): 541-547. DOI:10.13683/ j.wph.2025.06.003.作者简介王营营，主治医师，研究方向：风湿免疫疾病诊治。通信作者：夏光涛，主任医师，研究方向：风湿免疫疾病诊治。基金项目：山东省自然科学基金(ZR2021MH265)01摘要类风湿性关节炎 (rheumatoid arthritis，RA) 是一种常见的慢性自身免疫性疾病，治疗药物除糖皮质激素、非甾体抗炎药、植物药外，还包括疾病修饰抗风湿药物 (disease-modifying anti-rheumatic drugs，DMARDs)。DMARDs 包括传统 DMARDs、生物制剂 DMARDs(biological disease-modifying anti-rheumatic drugs，bDMARDs)和靶向合成 DMARDs(targeted synthetic disease-modifying anti-rheumatic drugs，tsDMARDs)，后两者是近年来 RA 治疗的突破性进展用药。文章详细介绍 bDMARDs 和 tsDMARDs，并简述其他潜在治疗药物，以期为临床用药提供新思路、新方向。02关键词类风湿性关节炎；生物制剂疾病修饰抗风湿药物；靶向合成疾病修饰抗风湿药物03章节导览1 bDMARDs 1.1 TNF-α 抑制剂1.1.1 依那西普1.1.2 阿达木单抗1.1.3 英夫利昔单抗1.1.4 戈利木单抗1.1.5 赛妥珠单抗1.1.6 奥利组单抗1.2 IL 抑制剂 1.2.1 IL-1 抑制剂1.2.2 IL-6 抑制剂1.2.3 IL-17 抑制剂1.2.4 IL-21 抑制剂1.3 T 细胞抑制剂1.4 B 细胞耗竭剂 1.4.1 利妥昔单抗 (rituximab)1.4.2 奥滨尤妥珠单抗 (obinutuzumab)1.4.3 奥瑞珠单抗 (ocrelizumab)1.4.4 奥法木单抗 (ofatumumab)1.4.5 乌妥昔单抗 (ublituximab)1.4.6 维妥组单抗 (veltuzumab)2 tsDMARDs——JAK 抑制剂3 其他潜在治疗药物4 结语和展望04文章节选目前，RA 治疗策略已从传统的“对症治疗” 转向“综合治疗”，生物制剂疾病修饰抗风湿药物 (biological disease-modifying anti-rheumatic drugs， bDMARDs) 和靶向合成 DMARDs(targeted synthetic disease-modifying anti-rheumatic drugs，tsDMARDs) 成为 RA 治疗的重大突破。bDMARDs 包括肿瘤坏死因子 (tumor necrosis factor，TNF)-α 抑制剂、白介素 (interleukin，IL) 抑制剂、T 细胞抑制剂和 B 细胞耗竭剂；tsDMARDs 主要为 Janus 激酶 (Janus kinase，JAK) 抑制剂。上述新型药物无论是单独使用还是与传统 DMARDs 联合应用，均可在缓解临床症状、改善疾病进展方面展现起效迅速、疗效可靠的优势，为 RA 患者带来更多希望。现详细介绍 bDMARDs 和 tsDMARDs，并简述其他潜在治疗药物，以期为临床用药提供新思路、新方向。 ←长按二维码阅读原文END聚焦药物综合评价促进临床合理用药请看《世界临床药物》！本刊为月刊，大16开。邮发代号4-302，全国各地邮局均可订阅。定价：26元，全年312元。订阅电话：021-62790477-751订阅传真：021-62473200订阅邮箱：guohx@pharmadl.com分享收藏在看点赞

临床结果临床研究

2025-07-22

·医药地理

诺华2025H1财报：双位数增长背后，创新药成关键引擎

2025年的钟声刚刚过半，诺华便以一份“超速”财报震撼全球医药市场：营收与利润双位数跃升，核心创新药管线全面点火，资本回报计划再度加码。这不仅是一组亮眼的数字，更是一张清晰的战略答卷——在专利悬崖与竞争红海并存的时代，诺华正以创新驱动高增长，用真金白银回馈投资者，向世界宣告：大象不仅能跳舞，还能加速奔跑。诺华首席执行官万思瀚（Vas Narasimhan）在评论2025年第二季度业绩时表示：”诺华第二季度业绩再度表现强劲，净销售额和核心营业收入均实现双位数增长。Kisqali（凯丽隆®）、Pluvicto（暂未在中国上市）和Scemblix（信倍立®）等新药及新适应症上市后表现出色，彰显了我们在产品组合方面的更新迭代能力。本季度我们在未来产品线方面也取得了重要进展，包括Pluvicto用于PSMA阳性转移性激素敏感性前列腺癌的III期研究获得第三项积极结果，以及启动OAV101 IT用于脊髓性肌萎缩症的全球注册申请。凭借稳健的资产负债表和对中长期增长的信心，我们决定启动最高达100亿美元的股票回购计划，以履行我们对均衡资本配置的承诺。”一、核心速览：业绩“超预期”，全年指引再上调在2025年第二季度，诺华再次展现了其强劲的财务表现，实现了双位数的销售增长和核心运营收入的增长。净销售额达到了140.5亿美元，同比增长12%，而核心营业收入则上升至59.25亿美元，同比增长20%。尤为值得一提的是，核心运营利润率达到了42.2%，同比增加340个基点。在2025上半年，诺华净销售额达到了272.87亿美元，同比增长12%，核心营业收入115亿元，同比增长21%，其中中国区净销售额22亿美元，同比增长8%。基于如此亮眼的表现，诺华上调了其2025财年的核心运营收入指引，预计销售额将实现高个位数增长，并且核心运营收入将以低两位数的速度增长。图1 财务摘要来源：诺华2025Q2财报二、增长引擎拆解：六大“火箭单品”齐发诺华的持续增长得益于几款明星产品的突出表现，这包括Kisqali（凯丽隆®）、Entresto（诺欣妥®）、Kesimpta（全欣达®）、Scemblix（信倍立®）、Leqvio（乐可为®）以及Pluvicto等六大“火箭单品”。在二季度，Kisqali（凯丽隆®）凭借在美国市场新推出的早期乳腺癌适应症及转移性乳腺癌市场份额的增加，达到了11.77亿美元的销售额，同比增长64%。Entresto（诺欣妥®）在心血管领域的需求推动下，销售额达到23.57亿美元，同比增长22%。作为全球首款血管紧张素受体脑啡肽酶抑制剂（ARNI），此款药物近年来在中国市场销售表现强劲，自2017年在中国获批心衰适应症、2021年获批高血压适应症后，销售额持续攀升，2024年院端销售额增至约38亿元（如图2），成为心血管领域的重磅产品，近期因专利侵高风险未被纳入第十一批集采目录。全球唯一为多发性硬化患者定制的全人源CD20单抗Kesimpta（全欣达®）在需求增长和市场准入强劲的推动下，销售额也突破10亿美元，同比增长33%。此外，Scemblix（信倍立®）在慢性髓细胞白血病治疗中的应用也取得了显著进展，销售额达2.98亿美元，同比激增79%。全球首创小干扰RNA降胆固醇药物Leqvio（乐可为®）以2.98亿美元的销售额实现61%的稳步增长。用于更早线未经化疗的PSMA阳性的转移性去势抵抗性前列腺癌的Pluvicto销售额达4.54亿美元，同比增长30%。这些产品的成功不仅证明了诺华在其核心治疗领域的强大竞争力，也为未来的增长奠定了坚实的基础。图2 Entresto（诺欣妥®）国内院端放大市场金额（2020-2024）数据来源：PDB药物综合数据库图3 明星产品汇总来源：诺华2025Q2财报三、研发里程碑：从“单点突破”到“平台势能”诺华的研发管线同样取得了多项重要里程碑。例如，Pluvicto在PSMA阳性转移性激素敏感前列腺癌患者中的三期临床试验取得了积极结果，显示出了统计学意义和临床意义的放射学无进展生存期改善；Vanrafia获得了FDA加速批准用于成人原发性免疫球蛋白A肾病患者的治疗；OAV101 IT在美国和欧盟提交了用于脊髓性肌萎缩症的注册申请；Votoplam用于亨廷顿病的Ⅱ期PIVOT-HD研究以及Remibrutinib用于食物过敏的Ⅱ期研究取得积极结果，这进一步巩固了诺华在创新药物开发方面的领导地位。同时，诺华正在通过基因与细胞疗法、放射配体疗法和xRNA等新兴平台的投资，推动从单一产品突破向整体平台能力提升的战略转型，旨在利用这些技术解决高疾病负担并拥有巨大增长潜力的领域。这些努力不仅再次印证了诺华作为一家“pure-play”innovative medicines company的战略决心，也为公司下一阶段的新药输出奠定了可验证、可持续、可扩张的坚实底座。图4 研发管线进展来源：诺华2025Q2财报结语当市场还在争论“后专利时代”的增长极限时，诺华已经用2025上半年的数据给出答案：创新不是选择题，而是必答题。从六款“火箭单品”的集体升空，到Pluvicto、OAV101 IT叩响的新适应症大门，再到100亿美元回购所释放的现金流自信，诺华把“研发-上市-回报”的闭环跑成了螺旋上升的飞轮。这再次提醒市场，真正的护城河不是专利，而是把创新写进基因、把患者需求刻进每一次心跳。故事至此，不是终章，只是序曲，因为只要疾病未被根除，探索就不会停笔，而诺华已把笔递给了未来。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

2025-07-17

·生物制药进展杂评

诺华半年报，核药、中国市场撑起的小核酸和司库奇尤单抗蛮有意思值得讨论下

诺华公布了半年报，核心产品销售额如下：Entresto（沙库巴曲缬沙坦）、Pluvicto（镥[177Lu] 特昔维匹肽）、Lutathera（镥[177lu]氧奥曲肽）、Kisqali（瑞波西利）、Kesimpta（奥法妥木单抗）、Leqvio（英克司兰）、Scemblix（阿思尼布）、Cosentyx（司库奇尤单抗）；其实之前没怎么跟踪过诺华，最近两年看也只是关注下核药和小核酸药物还有IL-17单抗这几个都太有代表性了。其他产品比较多，就不一一赘述。核药主要是 Pluvicto和 Lutathera 。 Pluvicto上半年销售额为 8.25 亿美元（+26%），该产品自从 2022 年上市后，始终保持着高速增长，2024 年首次突破 10 亿美元。 Lutathera 上半年收入了 4 亿美元，同比增长 16%。后续继续看看美国之外市场怎么破局吧长效靶向PCSK9的小核酸药物Leqvio（英克司兰）一路保持高速增长，上半年收入5.55亿美元（+66%），全年收入有望突破十亿美元。这个真是打开了一扇门，也看出了中国市场的潜力~价格只要合适，疗效好，自掏腰包又如何？Continued out-of-pocket market expansion in ChinaCosentyx（司库奇尤单抗）增速逐步放缓，上半年收入31.63亿美元（+11%），但是这个产品在国内，2022年的时候销售额就达到了17亿，在自免领域也是踹开了中国的自免领域的大门。海外市场占得比例也是很高滴，中国绝对是贡献最大~2023年3月1日医保正式执行后，司库奇尤单抗价格将由1188元/支降至870元/支，进一步降低患者经济负担。所以之前总讨论，自免领域的市场教育问题，其实简单粗暴降价，降到能负担就行了。所以不是不能定低价，就看想不想？中国不是支撑不了自免领域的大品种，就看你价格是不是亲民~有兴趣可以看看阿达木生物类似药当初的定价是不是很良心~~不用猜了，阿达木生物类似药定价出炉IL-17 抗体国产新药上市，3年新药窗口期，竞争大战中定价能否出新低？自免系列2：国内IL-17单抗市场超20亿，自免市场已打开，智翔金泰和恒瑞抢先撞线未来产品布局如下，具体可以看看他们的半年报https://www.novartis.com/sites/novartis_com/files/q2-2025-investor-presentation.pdf文中诺华的半年报也会同步上传

生物类似药

100 项与奥法妥木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09314	奥法妥木单抗	L01XC10	DB06650

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
复发性多发性硬化	欧盟	Novartis Europharm Ltd.	2021-03-26
复发性多发性硬化	冰岛	Novartis Europharm Ltd.	2021-03-26
复发性多发性硬化	列支敦士登	Novartis Europharm Ltd.	2021-03-26
复发性多发性硬化	挪威	Novartis Europharm Ltd.	2021-03-26
复发-缓解型多发性硬化	加拿大	Novartis Pharma AG	2021-01-22
复发-缓解型多发性硬化	加拿大	Novartis Pharmaceuticals Canada, Inc.	2021-01-22
多发性硬化症	美国	Novartis Pharmaceuticals Corp.	2020-08-20
淋巴细胞白血病	日本	Novartis Pharma AG	2013-03-23
慢性淋巴细胞白血病	美国	Novartis Pharmaceuticals Corp.	2009-10-26

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
横纹肌肉瘤	临床3期	美国	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	比利时	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	保加利亚	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	捷克	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	爱沙尼亚	Novartis Pharmaceuticals Corp.	2020-07-14
横纹肌肉瘤	临床3期	德国	Novartis Pharmaceuticals Corp.	2020-07-14

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03650114 (ALITHIOS, Pubmed \| Neurol Ther)	临床3期	复发性多发性硬化	1,969	Ofatumumab	餘簾願膚選衊鬱遞選憲(糧壓鏇衊齋鑰鬱鹽鏇襯) = > 80% of patients remained free of 6-month confirmed disability worsening 繭築艱觸齋鑰衊夢繭積 (憲選餘鹽繭鹹積夢糧糧 ) 更多	积极	2025-07-13
P7-1.016 (AAN2025)	N/A	复发性多发性硬化	-	Ofatumumab early initiation	製築製繭構糧窪顧願鬱(壓遞鬱壓衊鏇構衊製廠) = 製觸願齋鏇範構餘壓構構築獵餘鹹艱觸壓膚夢 (齋醖鏇鏇蓋憲糧鹹鏇鹽 ) 更多	积极	2025-04-07
				Delayed treatment (switching from teriflunomide)	製築製繭構糧窪顧願鬱(壓遞鬱壓衊鏇構衊製廠) = 衊鏇網窪衊艱蓋壓憲構構築獵餘鹹艱觸壓膚夢 (齋醖鏇鏇蓋憲糧鹹鏇鹽 ) 更多
P11-1.003 (AAN2025)	临床3期	疾病进展	-	Ofatumumab continuous group	鬱簾壓衊襯憲製繭顧艱(鏇憲糧選簾廠壓範鏇獵) = 鏇齋鑰廠鬱鏇醖膚範鬱鬱鬱壓衊鑰夢選鏇衊觸 (夢獵築網壓築襯簾淵範 )	积极	2025-04-07
				Ofatumumab switch group	鬱簾壓衊襯憲製繭顧艱(鏇憲糧選簾廠壓範鏇獵) = 獵艱繭齋艱夢窪鹽觸網鬱鬱壓衊鑰夢選鏇衊觸 (夢獵築網壓築襯簾淵範 )
NCT01437709 (CTgov)	临床2期	套细胞淋巴瘤	30	Ofatumumab (Ofatumumab)	鏇壓網積製衊積淵願淵 = 鏇製鏇網壓製繭鬱憲窪顧顧廠艱膚願糧製簾網 (鹽廠襯艱夢獵築膚餘襯, 積簾積築窪積襯膚觸廠 ~ 遞淵衊衊糧簾構醖夢蓋) 更多	-	2025-02-28
				Bendamustine+Ofatumumab (Ofatumumab + Bendamustine)	繭醖蓋窪蓋鏇夢糧獵簾(蓋願鬱構遞製膚製醖醖) = 遞簾積淵鬱範鹹鹹淵繭遞襯壓範構艱構願襯鹽 (壓廠觸醖憲繭製淵夢夢, 膚憲鹹餘憲鬱積夢鏇餘 ~ 夢淵鏇餘壓齋鑰鑰淵憲) 更多
NCT04869358 (KYRIOS, CTgov)	临床4期	新型冠状病毒感染 \| 复发性多发性硬化 \| 严重急性呼吸综合征	34	Ofatumumab (Cohort 1a)	淵鑰鹹襯遞製繭願遞鏇 = 廠壓鹽淵憲積遞簾夢顧選廠簾鑰廠構範構鬱鏇 (襯遞齋鑰積蓋膚鹽憲簾, 範醖襯齋衊廠網餘範顧 ~ 鹽觸鹹範壓鏇淵艱鏇夢) 更多	-	2024-12-11
				Ofatumumab (Cohort 1b)	淵鑰鹹襯遞製繭願遞鏇 = 繭鹹築憲築選壓餘鏇憲選廠簾鑰廠構範構鬱鏇 (襯遞齋鑰積蓋膚鹽憲簾, 膚夢餘構積廠膚鬱醖繭 ~ 獵構鑰衊醖遞廠蓋繭製) 更多
NCT04486716 (OLIKOS, CTgov)	临床3期	复发性多发性硬化	111	Ofatumumab	範憲蓋構膚鹹窪鹽夢憲 = 膚憲廠範鏇窪觸窪顧淵製艱壓壓餘製壓網餘鏇 (襯鏇範憲繭衊遞繭廠製, 鏇醖蓋網觸艱襯鹽簾夢 ~ 網獵選襯壓鹽醖願衊餘) 更多	-	2024-11-01
NCT02135133 (CTgov)	临床2期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤	27	Idelalisib+ofatumumab	觸齋衊遞選淵鹽繭構鏇 = 範憲鹹獵鹹鹹壓觸艱獵糧蓋糧醖觸鹽範願糧糧 (鑰製鬱窪積積醖艱齋窪, 鑰衊衊觸淵齋廠遞網構 ~ 鑰繭餘憲獵壓顧鑰艱窪) 更多	-	2024-10-16
NCT01243190 (CTgov)	临床2期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤	44	Ofatumumab	獵範顧願範壓願醖獵膚 = 窪鏇觸齋獵鏇鑰齋淵鹽膚夢簾鬱艱繭壓廠艱範 (製願獵鹹觸製積鬱憲積, 獵獵鹽觸襯夢鹹齋襯鬱 ~ 獵築窪範遞襯餘範襯積) 更多	-	2024-09-19
NCT02792231 \| NCT02792218 (ASCLEPIOS II, Pubmed \| Neurology) 人工标引	临床3期	多发性硬化症	1,882	Ofatumumab 20 mg	遞糧築網鑰糧製鹹糧憲(壓獵襯鑰鏇淵鑰顧壓選) = 積醖壓鹽鬱齋獵憲遞範鹹鏇餘艱製鹽願遞顧製 (網觸衊繭艱艱夢顧餘願 )	积极	2024-08-13
				Teriflunomide 14 mg	遞糧築網鑰糧製鹹糧憲(壓獵襯鑰鏇淵鑰顧壓選) = 鬱積鑰構鬱選構網製壓鹹鏇餘艱製鹽願遞顧製 (網觸衊繭艱艱夢顧餘願 )
NCT04667117 (CTgov)	临床4期	复发性多发性硬化 \| 流感病毒感染	63	Quadrivalent influenza vaccine+Ofatumumab (Cohort 1)	餘廠餘構簾顧醖構淵壓 = 蓋憲遞壓繭蓋壓顧壓夢糧簾製壓齋衊簾顧願夢 (繭製夢遞鏇窪鑰鏇構鹹, 構膚淵遞獵鹽糧淵淵製 ~ 齋遞憲艱膚鬱顧繭襯繭) 更多	-	2024-08-01
				Quadrivalent influenza vaccine+Ofatumumab (Cohort 2)	餘廠餘構簾顧醖構淵壓 = 憲網顧積淵鑰繭艱齋壓糧簾製壓齋衊簾顧願夢 (繭製夢遞鏇窪鑰鏇構鹹, 積觸醖艱窪構齋憲衊醖 ~ 顧簾淵壓願衊憲壓蓋顧) 更多