Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
NCT07691970
Phase
Phase 3
Recruitment status
Not yet recruiting
Participants
1,072
Lead sponsor
AstraZeneca
Start date
2026-09-01
Number of sites
- Summary
- 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.
- Acronym
- ROSY-S
- Short title
- Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2032-12-31
- First posted
- 2026-07-09
- Registry last updated
- 2026-07-09
- Primary completion date
- 2032-12-31
- Start date
- 2026-09-01
- Participants
- 1,072
- Participant count basis
- Estimated
- Planned participants
- 1,072
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AstraZeneca
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07691970
- ClinicalTrials.gov ID
- NCT07691970
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
SAEs and Non-Serious AEs
Timeframe: 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
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 5 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
-
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.
- 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.
Sources for eligibility
- Research SiteLos Angeles, United States
- Research SiteFort Lauderdale, United States
- Research SiteChicago, United States
- Research SiteAnn Arbor, United States
- Research SiteNew York, United States
- Research SiteCharleston, United States
- Research SiteGraz, Austria
- Research SiteGraz, Austria
- Research SiteGhent, Belgium
- Research SiteSalvador, Brazil
- Research SiteSofia, Bulgaria
- Research SiteBordeaux, France
- Research SiteStrasbourg, France
- Research SiteToulouse, France
- Research SiteChaïdári, Greece
- Research SiteKolkata, India
- Research SiteHaifa, Israel
- Research SiteMilan, Italy
- Research SiteSapporo, Japan
- Research SiteIloilo City, Philippines
- Research SiteLipa City, Philippines
- Research SiteBydgoszcz, Poland
- Research SiteKielce, Poland
- Research SiteKrakow, Poland
- Research SiteIași, Romania
And 16 more, listed on the interactive page.
Sources for sites