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Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment (ROSY-S)

2026年7月7日 更新者：AstraZeneca

ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment

The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.

Study details include:

  • Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
  • The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
  • The participants will continue to receive anifrolumab the same way they received it in the parent trial
  • A participant is considered to have completed the study when they meet one of the discontinuation criteria.
  • Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1072

阶段

  • 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

学习地点

  • 以色列
      • Haifa、以色列、31048
        • Research Site
  • 保加利亚
      • Sofia、保加利亚、1618
        • Research Site
  • 印度
      • Kolkata、印度、700020
        • Research Site
  • 台湾
      • Kaohsiung City、台湾、83301
        • Research Site
      • Taichung、台湾、404327
        • Research Site
  • 土耳其（türkiye）
      • Fatih-Istanbul、土耳其（türkiye）、34098
        • Research Site
  • 塞尔维亚
      • Kragujevac、塞尔维亚、34000
        • Research Site
  • 奥地利
      • Graz、奥地利、8036
        • Research Site
      • Graz、奥地利、8010
        • Research Site
  • 巴西
      • Salvador、巴西、40150-150
        • Research Site
  • 希腊
      • Chaïdári、希腊、124 62
        • Research Site
  • 意大利
      • Milan、意大利、20122
        • Research Site
  • 斯洛伐克
      • Piešťany、斯洛伐克、92101
        • Research Site
  • 日本
      • Sapporo、日本、060-8648
        • Research Site
  • 比利时
      • Ghent、比利时、9000
        • Research Site
  • 法国
      • Bordeaux、法国、33076
        • Research Site
      • Strasbourg、法国、67200
        • Research Site
      • Toulouse、法国、31300
        • Research Site
  • 波兰
      • Bydgoszcz、波兰、85-168
        • Research Site
      • Kielce、波兰、25-316
        • Research Site
      • Krakow、波兰、30-040
        • Research Site
  • 泰国
      • Bangkok、泰国、10700
        • Research Site
      • Khon Kaen、泰国、40002
        • Research Site
  • 罗马尼亚
      • Iași、罗马尼亚、700661
        • Research Site
  • 美国
    • California
      • Los Angeles、California、美国、90045
        • Research Site
    • Florida
      • Fort Lauderdale、Florida、美国、33309
        • Research Site
    • Illinois
      • Chicago、Illinois、美国、60611
        • Research Site
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • Research Site
    • New York
      • New York、New York、美国、10029
        • Research Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Research Site
  • 英国
      • London、英国、SE5 9RS
        • Research Site
      • Newcastle upon Tyne、英国、NE7 7DN
        • Research Site
      • Sheffield、英国、S10 2JF
        • Research Site
  • 菲律宾
      • Iloilo City、菲律宾、5000
        • Research Site
      • Lipa City、菲律宾、4217
        • Research Site
  • 西班牙
      • Barcelona、西班牙、8041
        • Research Site
      • Granada、西班牙、18014
        • Research Site
      • Madrid、西班牙、28034
        • Research Site
      • Madrid、西班牙、28041
        • Research Site
      • Valencia、西班牙、46014
        • Research Site
  • 韩国
      • Seoul、韩国、6591
        • Research Site

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Participants are eligible to be included in the study only if all of the following criteria apply:

    1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study.

  • In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk.
  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants should continue following the contraception requirements as per Appendix B from study enrolment up to 16 weeks after the last dose of study treatment.
  • Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Capable of adhering to the treatment plan related to this ROSY-S study.

Exclusion Criteria:

  • Participant develops hypersensitivity to any of the components of anifrolumab.
  • Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study.
  • Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer.
  • Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting anifrolumab.
  • Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF.
  • Participants who are planning to use live/live-attenuated vaccines.
  • Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator.
  • Participants with any medical condition (such as cancer or viral infections [hepatitis]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.
  • Participants who discontinued the parent study prior to completion of all study visits.
  • Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.

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：非随机化
  • 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：Anifrolumab
This is a single arm open-label study with the primary objective of providing continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment and assessing long-term safety and tolerability of anifrolumab until participant meets one of the study discontinuation criteria.
组合产品：Anifrolumab
Anifrolumab pre-filled syringe
组合产品：Anifrolumab
Anifrolumab solution for injection in pre-filled pen
药品：Anifrolumab
Anifrolumab concentrate for solution for infusion

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
SAEs and Non-Serious AEs
大体时间：From first dose administered and until 12 weeks after the last dose of Anifrolumab
Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab
From first dose administered and until 12 weeks after the last dose of Anifrolumab

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

AstraZeneca

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 (估计的)

2026年9月1日

初级完成 (估计的)

2032年12月31日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • D346BC00004

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment. "Yes" indicates that AstraZeneca is accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability commitments in line with EFPIA/PhRMA Data Sharing Principles. For details of timelines, refer to AstraZeneca's disclosure commitment.

IPD 共享访问标准

When a request has been approved, AstraZeneca will provide access to anonymized individual patient-level data via a secure research environment (Vivli). A signed Data Usage Agreement must be in place before accessing the data.

IPD 共享支持信息类型

  • 研究方案

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

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.

Anifrolumab的临床试验

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医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

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地点

3
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