NCT07691970尚未招募3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 1,072
- 试验地点
- 41
- 主要终点
- SAEs and Non-Serious AEs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
SAEs and Non-Serious AEs
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (41)
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