Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
ROSY-S
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
1 other identifier
interventional
1,072
22 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2032
Study Completion
Last participant's last visit for all outcomes
December 31, 2032
July 9, 2026
June 1, 2026
6.3 years
June 23, 2026
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
SAEs and Non-Serious AEs
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
Study Arms (1)
Anifrolumab
EXPERIMENTALThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Los Angeles, California, 90045, United States
Research Site
Fort Lauderdale, Florida, 33309, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
New York, New York, 10029, United States
Research Site
Charleston, South Carolina, 29425, United States
Research Site
Graz, 8010, Austria
Research Site
Graz, 8036, Austria
Research Site
Ghent, 9000, Belgium
Research Site
Salvador, 40150-150, Brazil
Research Site
Sofia, 1618, Bulgaria
Research Site
Bordeaux, 33076, France
Research Site
Strasbourg, 67200, France
Research Site
Toulouse, 31300, France
Research Site
Chaïdári, 124 62, Greece
Research Site
Kolkata, 700020, India
Research Site
Haifa, 31048, Israel
Research Site
Milan, 20122, Italy
Research Site
Sapporo, 060-8648, Japan
Research Site
Iloilo City, 5000, Philippines
Research Site
Lipa City, 4217, Philippines
Research Site
Bydgoszcz, 85-168, Poland
Research Site
Kielce, 25-316, Poland
Research Site
Krakow, 30-040, Poland
Research Site
Iași, 700661, Romania
Research Site
Kragujevac, 34000, Serbia
Research Site
Piešťany, 92101, Slovakia
Research Site
Seoul, 6591, South Korea
Research Site
Barcelona, 8041, Spain
Research Site
Granada, 18014, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28041, Spain
Research Site
Valencia, 46014, Spain
Research Site
Kaohsiung City, 83301, Taiwan
Research Site
Taichung, 404327, Taiwan
Research Site
Bangkok, 10700, Thailand
Research Site
Khon Kaen, 40002, Thailand
Research Site
Fatih-Istanbul, 34098, Turkey (Türkiye)
Research Site
London, SE5 9RS, United Kingdom
Research Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
Research Site
Sheffield, S10 2JF, United Kingdom
MeSH Terms
Interventions
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2026
First Posted
July 9, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 31, 2032
Study Completion (Estimated)
December 31, 2032
Last Updated
July 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 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.
- Access Criteria
- 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.
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.