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A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy (OSSIA)

2026年9月4日 更新者：Genentech, Inc.

A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous [IV], ocrelizumab IV) or PPMS (ocrelizumab IV).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 第四阶段

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

  • 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

研究联系人备份

  • 姓名：Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
  • 电话号码：888-662-6728 (U.S.)
  • 邮箱：global-roche-genentech-trials@gene.com

学习地点

  • 波多黎各
      • Guaynabo、波多黎各、00968
        • 招聘中
        • Caribbean Center for Clinical Research
  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30327
        • 招聘中
        • Atlanta Neuroscience Institute
    • Tennessee
      • Cordova、Tennessee、美国、38108
        • 招聘中
        • Neurology Clinic PC

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

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
  • Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
  • Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study
  • Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy

Exclusion Criteria:

  • Participants who have demonstrated suboptimal response to aCD20 therapy
  • Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy
  • Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
  • Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, human papillomavirus [HPV], tuberculosis [TB])
  • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
  • Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
  • Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
  • Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
  • Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
  • Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
  • Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening

Other protocol defined inclusion and exclusion criteria may apply.

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：OCR SC
Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.
药品：OCR SC
Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).
其他名称：
  • RO4964913
  • Ocrevus Zunovo® USPI;

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24
大体时间：Baseline, Week 24
Baseline, Week 24

次要结果测量

结果测量
措施说明
大体时间
有不良事件的参与者数量（AES）
大体时间：直到第48周
直到第48周
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24
大体时间：At Week 24
At Week 24
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48
大体时间：At Week 48
At Week 48
Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48
大体时间：Baseline, Weeks 24 and 48
Baseline, Weeks 24 and 48
Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II)
大体时间：At Day 1 (Baseline)
TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) responses with higher scores corresponding to higher satisfaction in that domain.
At Day 1 (Baseline)
Treatment Administration Satisfaction Score After Dose of OCR SC at Day 1 and Week 24, as Assessed Using Treatment Administration Satisfaction Questionnaire - Subcutaneous Injection (TASQ SC)
大体时间：At Day 1 (Baseline) and Week 24
TASQ SC is a 13-item questionnaire to evaluate participants' experience on their most recent OCR SC administration. The questionnaire consists of items related to SC injections, each rated on a 3- or 5-point Likert scale with higher scores corresponding to higher satisfaction and/or a more positive experience.
At Day 1 (Baseline) and Week 24
Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II
大体时间：At Weeks 24 and 48
TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) with higher scores corresponding to higher satisfaction in that domain.
At Weeks 24 and 48
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48
大体时间：Baseline, Weeks 24 and 48
MSIS-29 is a 29-item questionnaire to examine the impact of MS on physical and psychological functioning from a participant's perspective. Participants are asked to rate how much their functioning and well-being have been impacted over the past 14 days on a 4-point scale, from 1 = "Not at all" to 4 = "Extremely". The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.
Baseline, Weeks 24 and 48
Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching
大体时间：At Baseline
At Baseline

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

Genentech, Inc.

调查人员

  • 研究主任：Clinical Trials、Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2026年9月2日

初级完成 (估计的)

2029年2月28日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9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

  • ML46740

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

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

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

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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