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一项评估罗扎诺罗珠单抗在成人眼肌型重症肌无力患者中的疗效和安全性的研究 (MyVision)

2026年11月5日 更新者：UCB Biopharma SRL

一项评估罗扎诺洛昔单抗在成人眼肌型重症肌无力患者中的疗效和安全性的3期、随机、双盲、安慰剂对照研究

The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
招聘中

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
120

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

研究联系人备份

  • 姓名：UCB Cares
  • 电话号码：00184459922733 (UCB)
  • 邮箱：ucbcares@ucb.com

学习地点

  • 中国
      • Beijing、中国
        • 招聘中
        • Mg0038 31901
      • Beijing、中国
        • 招聘中
        • Mg0038 31912
      • Beijing、中国
        • 招聘中
        • Mg0038 31911
      • Chengdu、中国
        • 招聘中
        • Mg0038 31906
      • Chongqing、中国
        • 招聘中
        • Mg0038 31908
      • Nanchang、中国
        • 招聘中
        • Mg0038 31907
      • Suzhou、中国
        • 招聘中
        • Mg0038 31902
  • 乔治亚州
      • Sarajishvili、乔治亚州
        • 招聘中
        • Mg0038 21403
      • Tbilisi、乔治亚州
        • 招聘中
        • Mg0038 21402
  • 加拿大
      • Montreal、加拿大
        • 招聘中
        • Mg0038 10201
  • 德国
      • Rüdersdorf、德国
        • 招聘中
        • Mg0038 20405
  • 日本
      • Kobe、日本
        • 招聘中
        • Mg0038 31802
      • Minatoku、日本
        • 招聘中
        • Mg0038 31804
      • Sendai、日本
        • 招聘中
        • Mg0038 31805
  • 法国
      • Dijon、法国
        • 招聘中
        • Mg0038 20303
      • Nantes、法国
        • 招聘中
        • Mg0038 20304
      • Nice、法国
        • 招聘中
        • Mg0038 20301
      • Paris、法国
        • 招聘中
        • Mg0038 20302
      • Paris、法国
        • 招聘中
        • Mg0038 20305
  • 波兰
      • Katowice、波兰
        • 招聘中
        • Mg0038 21204
      • Krakow、波兰
        • 招聘中
        • Mg0038 21203
      • Lublin、波兰
        • 招聘中
        • Mg0038 21206
      • Warsaw、波兰
        • 招聘中
        • Mg0038 21202
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85251
        • 招聘中
        • Mg0038 10104
    • Illinois
      • O'Fallon、Illinois、美国、62269
        • 招聘中
        • Mg0038 10105
    • New York
      • Amherst、New York、美国、14226
        • 招聘中
        • Mg0038 10106
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • 招聘中
        • Mg0038 10102
      • Columbus、Ohio、美国、43210
        • 招聘中
        • Mg0038 10103
    • Wisconsin
      • Greenfield、Wisconsin、美国、53228
        • 招聘中
        • Mg0038 10108
  • 西班牙
      • Alicante、西班牙
        • 招聘中
        • Mg0038 20605
      • Barcelona、西班牙
        • 招聘中
        • Mg0038 20604
      • Barcelona、西班牙
        • 招聘中
        • Mg0038 20607
      • Madrid、西班牙
        • 招聘中
        • Mg0038 20611
      • Murcia、西班牙
        • 招聘中
        • Mg0038 20602
      • Málaga、西班牙
        • 招聘中
        • Mg0038 20606
      • Seville、西班牙
        • 招聘中
        • Mg0038 20603

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)

  • Participant has Myasthenia Gravis Foundation of America (MGFA) Class I with any ocular weakness at Screening through Baseline. The participant may have weakness in muscles of eye (ie, extraocular muscles that move the eyeball, including the medial rectus, lateral rectus, superior rectus, inferior rectus, superior oblique, and inferior oblique, orbicularis oculi muscles, and levator palpebrae superioris) but must have normal strength in all other facial, bulbar, and limb muscles.

  • Study participant has been diagnosed with Ocular Myasthenia Gravis (oMG) with consistent ocular clinical features at Screening and supported by:

  • Documented presence of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), OR

  • Documented absence of autoantibodies against AChR or MuSK; in this case, documented abnormal repetitive nerve stimulation (RNS) or single fiber electromyography (SFEMG) (as defined in the adjudication manual) and at least 1 of the following should be met:

    • Documented positive ice test (Ptosis recovers with the ice test [applied 2 minutes (min) to the ptotic lid] with >2mm improvement)
    • History of positive edrophonium chloride (Tensilon) test (or equivalent tests used to establish oMG diagnostic as per current practice)
    • Demonstrated objective improvement in oMG signs with acetylcholinesterase inhibitor (AChEIs), plasma exchange (PLEX), intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg) or corticosteroids (CSs)

  • Participant has an Myasthenia Gravis Impairment Index (MGII) ocular score (Patient-Reported Outcome (PRO) part) ≥6 with at least 2 ocular items with a score of ≥2 at both Screening and Baseline visits.

  • Participant reported ocular symptom(s) onset <3 years before Screening or ≥3 years provided they have demonstrated response (ie, improvement in ptosis or diploplia) to treatment (IVIg, PLEX, SCIg, pyridostigmine, and/or CSs) in the past year.

  • Participant has no pupillary abnormality except those resulting from prior localized eye disease or surgical intervention.

  • Participant who:

    • is currently receiving background treatment for oMG symptoms at the time of Screening and has been receiving treatment for oMG with a stable dose for at least 30 days prior to Screening, OR
    • is not receiving any background treatment at the time of Screening

  • Participant has a body weight ≥35kg at Baseline.

Exclusion Criteria:

  • Participant has any clinically significant medical or psychiatric condition (including an alcohol or drug use disorder), recent major surgery (including thymectomy [within 3 months of Screening], solid organ, stem cell or marrow transplant), planned major surgery (including thymectomy) during study participation, and/or significant laboratory abnormality that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
  • Participant has been diagnosed with other diseases that lead to eyelid dropping, peripheral muscle weakness, or diplopia, including other autoimmune diseases that would interfere with an accurate assessment of the oMG clinical symptoms or other neurological diseases, such as congenital myasthenic syndromes, mitochondrial diseases, and muscular dystrophies.
  • Participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication (including the excipient polysorbate 80) or has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.
  • Participant has active neoplastic disease or has received treatment for neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, carcinoma in situ of the breast, or incidental histological findings of prostate cancer [Tumor, Node, Metastasis (TNM) stage T1a or T1b] that has been definitely treated with standard of care approaches).
  • Participant has a clinically relevant active infection (eg, tuberculosis (TB) infection) or a history of serious infection (resulting in hospitalization or requiring intravenous (iv) antibiotic treatment) within 6 weeks before the Baseline Visit.
  • Participant has renal impairment, defined as glomerular filtration rate less than 30milliliter/min/1.73m2 at Screening.
  • Participant has been previously treated with FcRn inhibitors.
  • Participant has been treated with any of the immunosuppressive medications, biologics, or other therapies, in the specified prohibitive timeframe.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：Rozanolixizumab

After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive rozanolixizumab. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.
药品：Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion.

其他名称：
  • UCB7665
安慰剂比较：Placebo

After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive placebo. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.
药品：Placebo

Placebo will be administered by subcutaneous infusion.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome (PRO) part)
大体时间：At Day 43

MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week" ie, the last 7 days.
At Day 43

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score
大体时间：At Day 43

The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants will be asked to choose response option that best describes how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item.
At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score
大体时间：At Day 43

The MG-QoL15r is a brief survey, completed by the study participant, that is designed to assess some aspects of "quality of life" related to MG. The recall period that will be used is "past 7 days". When completing the 15-item MG-QoL15r, MG study participant should consider only how their MG affects these items.
At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular subdomain score
大体时间：At Day 43

The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability.

A positive change indicates worsening and a negative change indicates improvement.
At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Impairment Index (MGII) ocular score (Physical Examination part)
大体时间：At Day 43

MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week" ie, the last 7 days.
At Day 43
Incidence of treatment-emergent adverse events (TEAEs)
大体时间：Up to Week 13

Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.
Up to Week 13
Incidence of treatment-emergent serious adverse events (TESAEs)
大体时间：Up to Week 13

An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Up to Week 13
Incidence of TEAEs leading to permanent withdrawal of study treatment
大体时间：Up to Week 13

Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.
Up to Week 13

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
UCB Biopharma SRL

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2026年5月27日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2028年12月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2029年1月22日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年3月5日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年3月5日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年3月11日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月6日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月5日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • MG0038
  • 2025-524756-54-00 (克蒂斯)
  • CTR20262520 (注册表标识符：ChinaDrugTrials.org.cn)
  • U1111-1334-3276 (其他标识符：Universal Trial Number)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD 共享时间框架

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD 共享访问标准

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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