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
34 countries
124
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 Aug 2026
Longer than P75 for phase_3
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2032
October 2, 2026
September 1, 2026
6.3 years
June 23, 2026
September 29, 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 (128)
Research Site
Phoenix, Arizona, 85028, United States
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Los Angeles, California, 90045, United States
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San Francisco, California, 94115, United States
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Boca Raton, Florida, 33486, United States
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Fort Lauderdale, Florida, 33309, United States
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Chicago, Illinois, 60611, United States
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Ann Arbor, Michigan, 48109, United States
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Rochester, Minnesota, 55905, United States
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Omaha, Nebraska, 68114, United States
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New York, New York, 10029, United States
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Charlotte, North Carolina, 28202, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97239, United States
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Charleston, South Carolina, 29425, United States
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Roanoke, Virginia, 24016, United States
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Quilmes, 1878, Argentina
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San Miguel, 1663, Argentina
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Melbourne, 3004, Australia
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Mitcham, 3132, Australia
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Graz, 8010, Austria
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Graz, 8036, Austria
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Linz, 4020, Austria
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Vienna, 1130, Austria
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Ghent, 9000, Belgium
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Rio de Janeiro, 22470-220, Brazil
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Salvador, 40150-150, Brazil
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Santa Efigênia, 30150-320, Brazil
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São Paulo, 05403-000, Brazil
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Plovdiv, 4001, Bulgaria
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Sofia, 1463, Bulgaria
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Sofia, 1618, Bulgaria
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Québec, G1V 3M7, Canada
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Santiago, 7500571, Chile
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Beijing, 100191, China
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Chongqing, 400010, China
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Guangzhou, 510080, China
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Jinan, 250022, China
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Lanzhou, 730000, China
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Shanghai, 200001, China
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Shenzhen, 518020, China
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Shenzhen, 518053, China
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Bogotá, 110221, Colombia
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Prague, 12850, Czechia
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Bordeaux, 33076, France
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Paris, 75014, France
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Paris, 75020, France
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Strasbourg, 67200, France
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Toulouse, 31300, France
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Dresden, 1309, Germany
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Essen, 45122, Germany
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Kiel, 24105, Germany
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Mainz, 55131, Germany
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Marburg, 35043, Germany
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Tübingen, 72076, Germany
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Chaïdári, 124 62, Greece
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Hyderabad, 500082, India
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Kolkata, 700020, India
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New Delhi, 110060, India
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Pune, 411001, India
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Haifa, 31048, Israel
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Kfar Saba, 4428164, Israel
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Brescia, 25123, Italy
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Cona, 44124, Italy
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Florence, 50121, Italy
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Milan, 20122, Italy
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Milan, 20132, Italy
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Roma, 00144, Italy
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Roma, 00168, Italy
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Kanazawa, 920-8641, Japan
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Maebashi, 371-8511, Japan
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Nagoya, 467-8602, Japan
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Sapporo, 060-8648, Japan
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Yokohama, 236-0004, Japan
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Guadalajara, 44650, Mexico
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Guadalajara, 44950, Mexico
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San Luis Potosí City, 78250, Mexico
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Rotterdam, 3015 GD, Netherlands
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Iloilo City, 5000, Philippines
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Lipa City, 4217, Philippines
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Manila, 1000, Philippines
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Bydgoszcz, 85-168, Poland
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Katowice, 40-600, Poland
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Kielce, 25-316, Poland
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Krakow, 30-040, Poland
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Ossy, 40-027, Poland
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Warsaw, 00-807, Poland
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Braga, 4710-367, Portugal
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Lisbon, 1000-064, Portugal
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Porto, 4099-001, Portugal
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Bucharest, 011172, Romania
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Cluj-Napoca, 400006, Romania
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Iași, 700661, Romania
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Belgrade, 1100, Serbia
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Kragujevac, 34000, Serbia
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Košice, 4001, Slovakia
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Piešťany, 92101, Slovakia
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Johannesburg, 2193, South Africa
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Seoul, 03080, South Korea
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Seoul, 04401, South Korea
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Seoul, 06973, South Korea
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Seoul, 6591, South Korea
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Barcelona, 08003, Spain
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Barcelona, 8041, Spain
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Castellon, 12004, Spain
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Granada, 18014, Spain
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Las Palmas de Gran Canaria, 35020, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Valencia, 46014, Spain
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Valencia, 46017, Spain
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Vigo, 36200, Spain
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Kaohsiung City, 813414, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 404327, Taiwan
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Taipei, 10449, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Klong Luang, 12120, Thailand
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Fatih-Istanbul, 34098, Turkey (Türkiye)
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Cambridge, CB2 2QQ, United Kingdom
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Leeds, LS7 4SA, United Kingdom
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London, NW1 2BU, United Kingdom
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London, SE5 9RS, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Hà Nội, 100000, Vietnam
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
August 31, 2026
Primary Completion (Estimated)
December 30, 2032
Study Completion (Estimated)
December 30, 2032
Last Updated
October 2, 2026
Record last verified: 2026-09
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.