罗泽利昔单抗(Rozanolixizumab) - 药物靶点：FcRn_在研适应症：血小板减少症，重症肌无力，髓鞘少突胶质细胞糖蛋白抗体相关疾病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Rozanolixizumab-noli、洛利昔珠单抗、罗扎诺利珠单抗

+ [10]

靶点

FcRn

作用方式

拮抗剂、调节剂

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+ [4]

在研适应症

血小板减少症重症肌无力髓鞘少突胶质细胞糖蛋白抗体相关疾病+ [3]

非在研适应症

慢性血小板减少症慢性炎症性脱髓鞘性多发性神经病原发性血小板减少症+ [1]

原研机构

UCB SA

在研机构

UCB Biopharma SRL

UCB SAUCB Pharma Ltd.

+ [5]

非在研机构

UCB Pharma SA

Nova Laboratories Ltd.UCB Celltech

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2023-06-26),

重症肌无力

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、优先审评 (日本)、优先审评 (美国)

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结构/序列

Sequence Code 9474006L

来源: *****

Sequence Code 9474023H

来源: *****

关联

21

项与罗泽利昔单抗相关的临床试验

NCT06720714

/ Completed临床1期

An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab

开始日期2024-12-03

申办/合作机构

UCB Biopharma SRL

NCT06540144

/ Enrolling by invitation临床3期

An Open-label Extension Study to Evaluate Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

开始日期2024-10-08

申办/合作机构

UCB Biopharma SRL

NCT06149559

/ Recruiting临床2/3期

An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to <18 years with generalized Myasthenia Gravis (gMG).

开始日期2024-06-14

申办/合作机构

UCB Biopharma SRL

100 项与罗泽利昔单抗相关的临床结果

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100 项与罗泽利昔单抗相关的转化医学

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100 项与罗泽利昔单抗相关的专利（医药）

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59

项与罗泽利昔单抗相关的文献（医药）

2025-09-01·CYTOKINE

FcRn inhibitors in immune thrombocytopenia: A comprehensive review of therapeutic advances and clinical outcomes

Review

作者: Abdollahi Namanloo, Mahdi ; Heidari, Nazila ; Nilforoushzadeh, Mohammad Ali ; Heidari, Amirhossein ; Ghotbi, Negar ; Hosseini, Seyedayin

Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet counts, leading to bleeding risks. Despite existing treatments, many patients with chronic or refractory ITP remain inadequately managed. Fc-receptors, including neonatal Fc receptor (FcRn), play a crucial role in the ITP pathogenesis by activating antibody-dependent cell-mediated cytotoxicity and antibody-dependent cell-mediated phagocytosis, leading to platelet destruction. In addition, recent insights highlight cytokine dysregulation, particularly involving interleukin (IL)-17, IL-6, and Interferon-gamma (IFN-γ), as contributing to disease persistence and immune dysfunction. We sought to evaluate the efficacy and safety of FcRn inhibitors for chronic or persistent ITP treatment. PubMed/Medline, Scopus, and Web of Science databases were systematically searched until January 16th, 2025. Preclinical and clinical studies with available full-text in English were included. Efgartigimod significantly improved platelet counts and reduced Immunoglobulin G (IgG) levels in refractory as well as chronic patients with minimal adverse effects. Rozanolixizumab also showed favorable outcomes in terms of platelet count elevation and IgG reduction in Phase 2 and Phase 3 clinical trials in cases who were unresponsive to ≥2 standard-of-care ITP treatments. These immunotherapeutic agents can effectively increase platelet counts and reduce IgG serum levels, addressing a critical need in patients who do not respond to corticosteroids, thrombopoietin receptor agonists (TPO-RAs), and rituximab. Further long-term studies are warranted to confirm these findings and explore their broader clinical implications.

2025-08-01·EUROPEAN JOURNAL OF NEUROLOGY

Improvement in Patient‐Reported Symptoms of Generalised Myasthenia Gravis With Rozanolixizumab in the Randomised Phase 3 MycarinG Study Using the MG Symptoms PRO

Article

作者: Sacconi, Sabrina ; Regnault, Antoine ; Hareendran, Asha ; Antozzi, Carlo ; Vissing, John ; Bril, Vera ; Pascuzzi, Robert M. ; Utsugisawa, Kimiaki ; Tarancón, Thaïs ; Kaminski, Henry J. ; Habib, Ali A. ; Grimson, Fiona

ABSTRACT:

Background:

In the Phase 3 MycarinG study (NCT03971422), rozanolixizumab improved myasthenia gravis (MG)‐specific outcomes versus placebo in patients with generalised MG, including those measured by the five independent MG Symptoms patient‐reported outcome (PRO) scales: Muscle Weakness Fatigability (MWF), Physical Fatigue (PF) and Bulbar Muscle Weakness (BMW) as secondary endpoints and Ocular Muscle Weakness and Respiratory Muscle Weakness (exploratory endpoints). This research aimed to provide further insights into these improvements.

Methods:

Post hoc analyses evaluated correlation (Pearson coefficient) between MG Symptoms PRO and subdomain scores of MG Activities of Daily Living (MG‐ADL) and Quantitative MG (QMG) at baseline. Proportions of responders reaching clinically meaningful thresholds and analyses at the item level (observed mean change and Rasch modelling of predicted change from baseline) are reported for MWF, PF, and BMW with rozanolixizumab versus placebo at Day 43.

Results:

Correlation coefficients between MG Symptoms PRO and MG‐ADL were strong (≥ 0.7) for ocular and bulbar scores and moderate (0.5 to < 0.7) for other scores. Correlations with clinician‐assessed QMG scores were generally weak (< 0.5). For MWF, PF, and BMW, greater proportions of responders were observed with rozanolixizumab 7 mg/kg (46.9%, 31.3% and 26.6%, respectively) or 10 mg/kg (56.5%, 48.4% and 32.3%) versus placebo (28.1%, 26.6% and 10.9%). Item‐level analyses demonstrated rozanolixizumab benefit at a symptom‐specific level.

Discussion:

MG Symptoms PRO scales correlate well with concepts in MG‐ADL while assessing additional concepts, such as PF and MWF. Results from the MG Symptoms PRO in MycarinG reflected improvements from baseline in patient‐relevant symptoms, including fatigue, with rozanolixizumab.

2025-07-01·CLINICAL NEUROLOGY AND NEUROSURGERY

Efficacy and safety of FcRn inhibitors in patients with Myasthenia gravis: An updated systematic review and meta‑analysis

Review

作者: Muzammil, Anam ; Farooqi, Hanzala Ahmed ; Hassan, Syed Muhammad ; Hanif, Ummara ; Akhtar, Muzamil ; Maryam, Ayesha ; Khan, Zarak ; Athar, Zoya ; Akhtar, Mehmood

BACKGROUND:

Myasthenia gravis (MG) is a chronic, complex autoimmune disorder characterized by the production of autoantibodies that destroy neuromuscular junctions. Blocking the neonatal Fc receptors (FcRn) enhances IgG catabolism, offering a novel therapeutic approach.

METHODS:

PubMed, Embase, and the Cochrane Library were searched up to February 2025, for RCTs evaluating FcRn inhibitors in MG. A random effects model to calculate pooled risk ratios (RR) and mean differences with 95 % confidence intervals (CI).

RESULTS:

873 patients from 8 randomized control trials (RCTs) were analyzed. Compared to placebo, FcRn inhibitors significantly reduced Myasthenia Gravis Activities of Daily Living (MG-ADL) scores (MD of -1.45 [95 % CI, -1.91 to -0.99]; P < 0.00001), Quantitative Myasthenia Gravis( QMG) scores (MD = -2.33 [95 % CI, -3.57 to -1.09]; P = 0.0002), and Myasthenia Gravis Composite (MGC) scores (MD = -2.96 [95 % CI, -4.29 to -1.63]; P < 0.0001). The FcRn inhibitors improved MG-ADL responder rates (RR = 1.60 [95 % CI, 1.27-2.02]; P < 0.0001), and Myasthenia Gravis Quality of Life (MGQoL15r) scores (MD = -2.18 [95 % CI, -3.35 to -1.00]; P = 0.0003). Serious adverse events were lower with the FcRn inhibitors (32/519) than the placebo (39/397). Subgroup analysis revealed that Rozanolixizumab and Nipocalimab improved MG-ADL scores, but had inferior responder rates. Additionally, Rozanolixizumab significantly improved MGC scores but had more adverse events.

CONCLUSION:

FcRn inhibitors demonstrated good efficacy and safety in MG, with efgartigimod and nipocalimab showing strong efficacy without added risk. Further research is required to evaluate long-term outcomes and optimize treatment.

153

项与罗泽利昔单抗相关的新闻（医药）

2025-08-26

·BioSpace

Argenx Eyes ‘Broadest Label’ for Vyvgart in Myasthenia Gravis After Positive Phase III Data

iStock, Deagreez Based on new data, argenx expects to the expansion of Vyvgart’s label into patients with generalized myasthenia gravis who are negative for antibodies against the AChR marker—an indication William Blair analysts called the broadest option in this disease space. Argenx’s Vyvgart significantly improved disease activity and daily life in certain patients with generalized myasthenia gravis in a Phase III study, setting the FcRn inhibitor up for a potential label expansion. Writing to investors on Monday, William Blair analysts said that with these new data, Vyvgart “represents the first FcRN inhibitor to demonstrate statistically significant clinical efficacy in AChR seronegative gMG [generalized myasthenia gravis] patients”—the specific population that the Phase III ADAPT SERON trial focused on. If cleared for this specific indication, Vyvgart would have “the broadest label of all FcRn antagonists approved in gMG,” they added. Argenx did not reveal specific data in its news release on Monday , noting only that Vyvgart elicited a “statistically significant and clinically meaningful improvement” in disease activity in patients with gMG who are seronegative for antibodies against the AChR marker. According to the biotech, this particular subpopulation represents about 20% of all gMG patients, a group that often experiences a heavier disease burden. With these findings, argenx is gearing up for a supplemental application to expand Vyvgart into patients negative for antibodies against AChR, covering all three subtypes: MuSK-positive, LRP4-positive and triple seronegative patients, as per its Monday release. The company expects to make its submission by the end of the year. If approved, Vyvgart would gain access to roughly 11,000 additional gMG patients beyond its current market, according to William Blair. Breaking into this patient population would also give Vyvgart an edge over its current competitors, including Johnson & Johnson’s Imaavy and UCB’s Rystiggo, both of which “are approved only in gMG patients with AChR-positive or MuSK-positive” disease, according to the analysts. Infused intravenously, Vyvgart is a human IgG1 antibody fragment that treats gMG by lowering the circulating levels of IgG. The therapy was first approved in 2021 but is currently only indicated for patients who are positive for antibodies against AChR. In June 2023, argenx secured an approval for a subcutaneous formulation of Vyvgart, called Vyvgart Hytrulo, for gMG. The under-the-skin injection has also been approved for chronic inflammatory demyelinating polyneuropathy . Last year, argenx reached more than 10,000 patients and brought in nearly $2.2 billion in sales from its Vygart line alone.

临床3期上市批准临床结果

2025-08-25

·FiercePharma

With late-stage trial win, Argenx preps FDA filing to push Vyvgart into broader myasthenia gravis population

If Argenx wins the seronegative myasthenia gravis nod it’s hoping for, Vyvgart would boast the “broadest label of all FcRn antagonists approved in gMG,” analysts at William Blair wrote to clients. Seeking to build out its pipeline-in-a-product Vyvgart, Argenx is returning to its roots with plans to pursue an expanded approval in the drug’s initial myasthenia gravis indication.On Monday, Argenx reported that its chief drug Vyvgart (efgartigimod) met the mark in a phase 3 trial assessing the FcRn blocker in certain patients with generalized myasthenia gravis (gMG).The late-stage study, dubbed ADAPT SERON, looked at Vyvgart’s safety and efficacy in the subset of gMG patients who are seronegative, meaning they do not have detectable antibodies against the proteins in their blood known as acetylcholine receptors (AChR), which help the body’s nerves and muscles communicate.In the topline data announcement from the trial, which met its primary endpoint, Argenx noted that Vyvgart—currently approved in the roughly 80% of gMG patients who are seropositive—helped a wide pool of seronegative patients achieve “statistically significant and clinically meaningful” improvements to their scores on the Myasthenia Gravis Activities of Daily Living (MG-ADL) test, a common metric of gMG symptoms.The drug appeared safe and well tolerated, too, with no new safety concerns cropping up during the trial, Argenx said in its press release.In turn, the Dutch drugmaker says it plans to submit Vyvgart for approval to the FDA by the end of the year across all three subtypes of seronegative gMG, which are known as MuSK-positive, LRP4-positive and triple seronegative. Argenx added that it plans to unveil detailed results from the ADAPT SERON trial at an upcoming medical conference.If Argenx wins the seronegative gMG label it’s hoping for, Vyvgart would boast the “broadest label of all FcRn antagonists approved in gMG,” analysts at William Blair wrote in a Monday note to clients. The seronegative nod could add around 11,000 new patients to Vyvgart’s current U.S. prescribing pool, the analysts added.Argenx won its first-ever approval when the FDA signed off on Vyvgart in adult gMG patients who test positive for AChR antibodies back in December of 2021. The green light also marked the first FDA nod for a neonatal Fc receptor (FcRn) inhibitor.From the jump, the company has touted Vyvgart’s potential to tackle a wide range of autoimmune diseases, while continuing to prioritize its gMG niche in parallel.In the base gMG indication, Argenx in June of 2023 won an FDA nod for a subcutaneous formulation of the drug known as Vyvgart Hytrulo. The medicine is now also approved in the U.S. to treat the rare peripheral nervous system disease, chronic inflammatory demyelinating polyneuropathy (CIDP).The ADAPT SERON trial in seronegative patients specifically assessed intravenous Vyvgart. Although myasthenia gravis is a rare disease, affecting an estimated 75,000 to 100,000 people in the U.S., the treatment space has become increasingly crowded in recent years.Just a few months after Argenx’s flagship Vyvgart nod, AstraZeneca’s Soliris successor Ultomiris picked up an FDA approval in gMG. Subsequently, UCB’s Rystiggo (rozanolixizumab) landed a 2023 U.S. green light in gMG, both for AChR antibody- and MuSK antibody-positive patients.As of late April, Johnson & Johnson has joined the fray, too, thanks to FDA sign off on nipocalimab, now marketed under the brand name Imaavy. That drug's approval covers its use in patients ages 12 and older who have detectable antibodies against AChR or MuSK. At the time of the nod, J&J touted Imaavy’s label as covering the “broadest population of people living with gMG.”

临床3期上市批准临床结果生物类似药

2025-08-11

·Biotech前瞻

荣昌生物泰它西普想实现高价BD，必须迈过的几道“坎”

点击蓝字关注我们本期看点随着中国生物医药创新进入快车道，荣昌生物（RC）凭借自主研发的BLyS/APRIL双靶融合蛋白—泰它西普（RC18，商品名“泰爱®”）成为国内免疫创新药领域的亮眼新星。2025年5月27日，NMPA正式批准泰它西普新增治疗抗乙酰胆碱受体抗体阳性成人全身型重症肌无力（gMG）适应症（继系统性红斑狼疮、类风湿关节炎后第三个获批适应症），也意味着这款药物有望成为国产免疫药向国际MNC（跨国药企）争取高价BD（对外授权合作）的重要筹码。然而，要想实现“高溢价”BD，泰它西普还必须踏过几道关键性“坎”。本期内容 01 泰它西普丨机制优势和数据解读 02 激烈的MNC市场布局 03 巴托利单抗的BD经验和潜在风险 04 总结与展望【01 泰它西普丨机制优势和数据解读】靶点与机制随着双抗/双功能融合蛋白赛道的火热，泰它西普定位于BLyS（B细胞活化因子）与APRIL（增殖诱导配体）双重靶点，通过阻断这两类B细胞存活和分化关键信号，从源头抑制致病性抗体产生。这种设计使得它在抑制B细胞异常增生和自身抗体生成方面具有更强的广谱调控能力： BLyS/BAFF路径：BLyS在B细胞成熟、存活和活化中扮演核心角色，过度表达与SLE、MG等自身免疫疾病高度相关； APRIL路径：APRIL对浆细胞生存（尤其是长期存活的记忆浆细胞）至关重要，可进一步维持异常自身抗体水平。相比单靶抗体，双靶融合蛋白能够同步削弱这两个信号通路，理论上实现更彻底且持久的抗体水平降低。这一双靶机制优势正是泰它西普在与国内外FcRn阻断剂、C5补体抑制剂竞争中最核心的区隔卖点。临床数据解读 2025年AAN大会公布的国内III期gMG研究（RC18-III）数据显示：主要疗效指标 MG-ADL评分下降≥3分的患者比例高达98.1%，对照组仅12%； QMG评分下降≥5分比例为87%，对照组仅16%； 24周时，泰它西普组MG-ADL平均下降5.74分（安慰剂0.91分）、QMG下降8.66分（安慰剂2.27分）。起效速度 4周时，泰它西普组已显现明显疗效，但4周MG-ADL平均改善幅度不及Agomab（FcRn抑制剂）。根据高盛研究，Agomab在4周时MG-ADL下降约4.6分，而同期泰它西普约为2.3分左右，比Agomab仅约一半水平；泰它西普真正达到与Agomab相当的疗效，约需12周时间才能实现MG-ADL与Agomab 4周时同幅度改善。安全性泰它西普治疗组感染性不良事件发生率45.6%，对照组59.6%；严重呼吸系统不良事件显著低于对照组，提示良好安全性。这些数据表明，泰它西普在深度缓解和持续疗效方面表现极其亮眼：长疗程下的高效降抗体能力与良好耐受性为其赢得慢性维持治疗市场奠定基础。但另一方面，与FcRn抑制剂相比具备更慢的起效速度，这将不可避免地影响急性发作或重症患者的首选偏好。在国际市场，急救及快速起效正是“抢占市场”首要因素。 02 激烈的MNC市场布局不要以为肿瘤治疗赛道卷，在部分疾病中，全球药企早已经实现布局。正如：赛诺菲95亿美元重金押注，罕见病，不再是“小众市场”一文提到的，即使在罕见病领域，也早已经出现红海市场的苗头。而在全球gMG治疗赛道上，已有多家重量级对手布局，详情可见强生加入阿斯利康、优时比行列，重磅FcRn抗体获FDA批准上市：阿斯利康Vyvgart（efgartigimod） 2021年底首获FDA批准，2024年Vyvgart全球销售额突破22亿美元，并预估2025年继续保持30%以上增长。自注射预充注射器形式：患者依从性更高；快速起效：4周时MG-ADL平均下降约4.8分；多适应症潜力：正在同步申请CIDP（慢性炎症性脱髓鞘性多发性神经病）等免疫适应症； UCB Rystiggo（rozanolixizumab） 2023年6月获FDA批准，是首款同时适用于抗AChR和抗MuSK阳性成人gMG患者的FcRn抑制剂；起效速度略低于Vyvgart，但同样在4周时MG-ADL下降约3.5分；已启动中国申报并纳入优先审评。 Alexion Zilbrysq（zilucoplan）基于C5补体抑制技术，获FDA批准用于抗AChR阳性gMG成人；以皮下自注射形式上市，具备方便性，但对比FcRn抑制剂，需关注患者适应性。此外，强生（J&J）尼卡利单抗（Nipocalimab，品牌名Imaavy）也于2025年3月在美国获批，覆盖年龄≥12岁的抗AChR/MuSK阳性gMG患者。其24周MG-ADL改善幅度约4.7分，较Rystiggo和Vyvgart均有优势；且已于4月在中国申报上市，并纳入优先审评。这意味着，到2025年底，国内市场将至少出现五款具有不同机制的获批gMG新药，竞争白热化也在所难免。 03 巴托利单抗的BD经验和潜在风险 batoclimab（HBM9161，巴托利单抗）是国产FcRn抗体出海的代表。其合作历程如下： 2018年，Immunovant将中国区权益授权给和铂医药； 2022年，和铂医药将该权益转授给石药集团，交易总金额超过10亿元人民币（预付款1.5亿+里程碑8.61亿+销售分成）；此次交易成为国内FcRn领域首个“亿元级”BD案例，提升了中国创新药在全球的影响力。这种转手交易，近期的康方蝴蝶效应，普米斯吃饱，施贵宝与BioNTech共同开发PD-L1/VEGF双抗新闻即可以看出，BioNTech早期押注普米斯，转手来了个大的BD。荣昌生物的房建民、普米斯的刘晓林、信达生物的俞德超，三者之间的渊源，谁曾想现在在各自赛道上成为弄潮儿。 batoclimab成功出海的几点启示：有差异化机制：相较传统FcRn抗体，其亲和力更高、抗体清除更持久；有扎实的国际数据：海外同步推进II/III期临床，大幅增强MNC信心；商业路径清晰：明确的NDA计划和上市后支持体系是加分项；合作伙伴背书强：石药具备成熟的本土商业化能力，是谈判中的关键保障。泰它西普高溢价BD面临的挑战 1）起效慢，难与竞品抗衡与Agomab（4周显效）相比，泰它西普需12周才能达到相同MG-ADL改善幅度；双靶机制是否能带来更快或更稳的疗效，仍缺乏有力证据。 2）缺乏海外临床数据目前仅有国内III期结果，尚未启动欧美注册研究。若无跨区域有效性/安全性数据，将影响MNC对其全球开发和申报的信心。 3）竞争激烈、节奏滞后强生Imaavy、UCB Rystiggo等竞品已布局欧美并申请上市；若泰它西普推进节奏慢，后发优势不足，难以获得“独家”定价逻辑支撑。 04 总结与展望在全球FcRn靶点竞争上，强生、优时比等企业已经在技术迭代。而Immunovant暂不提交巴托利单抗上市申请的决定，凸显了FcRn抑制剂赛道的激烈竞争，也揭示了跨国药企与本土玩家在全球权益布局中的深层博弈。荣昌生物不得不在全球竞争中去硬刚产品实力。这不是荣昌一家企业一家产品不得不的选择。而是随着全球药企开始纷纷布局押注中国医药行业产品春风下必然的内部竞争。 ★

临床3期临床成功

100 项与罗泽利昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14919

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
血小板减少症	加拿大	UCB SA	2025-03-01
重症肌无力	美国	UCB, Inc.	2023-06-26

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
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	美国	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	日本	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	澳大利亚	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	比利时	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	巴西	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	捷克	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	法国	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	德国	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	意大利	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	墨西哥	UCB Biopharma SRL	2022-02-02

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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


NCT04875975 (CTgov)	临床2期	桥本脑炎	12	Placebo	衊餘憲膚繭夢醖廠鹹醖 = 獵襯顧顧膚鏇窪壓獵遞夢獵憲齋艱醖網觸鬱襯 (蓋顧遞蓋襯衊壓廠網鑰, 繭鏇築築鏇壓糧獵艱餘 ~ 觸獵積醖鹽鏇簾鏇願淵) 更多	-	2025-05-31
NCT05681715 (CTgov)	临床3期	重症肌无力	62	RLZ SRD (Period 1: RLZ SRD)	艱膚壓膚襯顧構積鹹鏇 = 鹽獵餘鹽糧網願簾鹹觸憲艱網範窪積憲壓製襯 (顧壓範築襯繭遞醖製糧, 製艱醖鬱獵膚願製壓憲 ~ 膚夢淵製範膚鏇觸艱艱) 更多	-	2025-05-07
				RLZ (Period 1: RLZ MP)	艱膚壓膚襯顧構積鹹鏇 = 繭鏇顧齋範壓繭範簾築憲艱網範窪積憲壓製襯 (顧壓範築襯繭遞醖製糧, 觸壓艱願繭構衊衊衊齋 ~ 鑰鹽窪窪鹽獵醖網艱膚) 更多
NCT04650854 (CTgov)	临床3期	重症肌无力	165	Rozanolixizumab (Rozanolixizumab ~7 mg/kg)	淵鏇鑰願憲構繭衊構憲 = 蓋鏇餘鏇糧願構遞築繭憲遞鹹糧觸鬱糧範願鑰 (製壓糧壓膚齋艱衊艱觸, 顧鬱廠範壓繭觸糧製繭 ~ 膚觸簾壓鏇壓鹹壓顧構) 更多	-	2025-04-18
				Rozanolixizumab (Rozanolixizumab ~10 mg/kg)	淵鏇鑰願憲構繭衊構憲 = 觸繭範醖鹽艱糧膚願積憲遞鹹糧觸鬱糧範願鑰 (製壓糧壓膚齋艱衊艱觸, 鹽製糧艱襯蓋鹹鹹構鬱 ~ 鬱積構膚構簾夢窪衊選) 更多
NCT04124965 (MG0004, Pubmed \| J Neurol)	临床3期	重症肌无力 acetylcholine receptor \| muscle-specific tyrosine kinase autoantibody-positive	70	Rozanolixizumab 7mg/kg	艱獵醖糧壓鏇襯選製顧(糧積窪顧醖夢襯窪鏇製) = 11/70 [15.7%] 壓鏇遞願積簾觸願獵簾 (膚襯獵觸鏇艱齋範鏇壓 ) 更多	积极	2025-04-01
				Rozanolixizumab 10mg/kg
NCT04051944 \| NCT03861481 (CIDP04, Pubmed) 人工标引	临床2期	慢性炎症性脱髓鞘性多发性神经病维持	34	Rozanolixizumab 10 mg/kg	選衊糧衊鹹壓衊憲範壓(廠積築構齋廠醖獵構鬱) = 膚觸襯願蓋鹽鑰鹹觸簾蓋壓鹹鑰窪廠選鹽鹽膚 (憲憲網範鑰積獵願築範, 3.2) 更多	积极	2024-05-10
				Placebo	選衊糧衊鹹壓衊憲範壓(廠積築構齋廠醖獵構鬱) = 鏇顧範願願廠願簾構艱蓋壓鹹鑰窪廠選鹽鹽膚 (憲憲網範鑰積獵願築範, 2.6) 更多
AAN2024	N/A	睑板腺功能障碍	-	Rozanolixizumab 7mg/kg	製糧觸鬱憲網壓築窪鹹(窪範鏇積廠蓋壓淵蓋鹹) = 糧齋簾網艱繭壓願遞餘觸範憲獵醖選鑰遞獵繭 (觸顧獵築鬱衊廠遞憲齋 ) 更多	-	2024-04-09
				Rozanolixizumab 10mg/kg	製糧觸鬱憲網壓築窪鹹(窪範鏇積廠蓋壓淵蓋鹹) = 範網糧衊鏇鹽製艱夢壓觸範憲獵醖選鑰遞獵繭 (觸顧獵築鬱衊廠遞憲齋 ) 更多
AAN2024	N/A	重症肌无力	-	Rozanolixizumab 7mg/kg	壓蓋鏇鹽遞餘壓淵蓋顧(餘獵廠築齋網襯顧願餘) = mean reduction from baseline between Weeks 7–33 ranged from -2.6 to -5.4 (7mg/kg) and -4.2 to -6.2 points (10mg/kg) 壓蓋衊蓋鏇鑰觸艱鹹構 (衊蓋蓋鏇願淵襯製觸鹹 ) 更多	-	2024-04-09
				Rozanolixizumab 10mg/kg
AAN2024	N/A	重症肌无力	-	Rozanolixizumab	餘遞鏇鹹鏇願觸網範淵(餘選簾鹽壓醖積膚襯齋) = 鏇鏇窪構餘鑰膚遞窪獵鹽齋餘築積蓋構築蓋鬱 (製簾選襯壓蓋觸網鑰淵, 3.5) 更多	-	2024-04-09
NCT03971422 (MycarinG, AAN2024)	临床3期	重症肌无力	127	Rozanolixizumab 7mg/kg	餘艱襯遞繭遞淵夢積簾(獵膚鏇憲簾鹽鹽餘蓋鑰) = 衊獵簾製襯醖鑰遞簾簾艱窪壓遞艱齋廠簾壓齋 (製願築窪蓋範夢觸鹽範 ) 更多	积极	2024-04-09
				Rozanolixizumab 10mg/kg	餘艱襯遞繭遞淵夢積簾(獵膚鏇憲簾鹽鹽餘蓋鑰) = 壓鏇窪鬱鑰蓋願糧糧鹽艱窪壓遞艱齋廠簾壓齋 (製願築窪蓋範夢觸鹽範 ) 更多
NCT04828343 (CTgov)	临床1期	-	32	RLZ (Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg))	膚糧艱鬱艱夢繭遞獵艱 = 積積糧醖顧鹹範繭積淵衊鬱觸醖獵遞構餘膚鏇 (鑰鹽選艱窪簾艱顧積艱, 窪鬱遞淵淵製構壓獵觸 ~ 鏇遞艱顧夢壓膚壓願觸) 更多	-	2024-03-07
				placebo (PBO) (Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg))	膚糧艱鬱艱夢繭遞獵艱 = 艱餘顧鑰觸艱築鑰觸襯衊鬱觸醖獵遞構餘膚鏇 (鑰鹽選艱窪簾艱顧積艱, 窪醖顧顧衊繭鑰鏇醖衊 ~ 襯艱簾簾鬱廠壓鏇鬱構) 更多