Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus ErythematosusPhase 3ROSY-SNCT07691970
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
A Phase 3 study testing Anifrolumab in people with Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus, run by AstraZeneca at 128 sites in 35 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 128 sitesin 35 countries
- Study dates
- 31 Aug 2026to 30 Dec 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
128 sites in 35 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
128 sites in 35 countries
United States15 sites, 15 recruiting
- Not yet recruiting
Research Site
Ann Arbor, Michigan, 48109
- Not yet recruiting
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Boca Raton, Florida, 33486
- Not yet recruiting
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Charleston, South Carolina, 29425
- Not yet recruiting
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Charlotte, North Carolina, 28202
- Not yet recruiting
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Chicago, Illinois, 60611
- Not yet recruiting
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Cleveland, Ohio, 44195
- Not yet recruiting
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Fort Lauderdale, Florida, 33309
- Recruiting
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Los Angeles, California, 90045
- Not yet recruiting
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New York, New York, 10029
- Not yet recruiting
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Omaha, Nebraska, 68114
- Not yet recruiting
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Phoenix, Arizona, 85028
- Not yet recruiting
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Portland, Oregon, 97239
- Not yet recruiting
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Roanoke, Virginia, 24016
- Not yet recruiting
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Rochester, Minnesota, 55905
- Not yet recruiting
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San Francisco, California, 94115
Spain10 sites, 10 recruiting
- Not yet recruiting
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Barcelona, 08003
- Not yet recruiting
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Barcelona, 8041
- Not yet recruiting
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Castellon, 12004
- Not yet recruiting
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Granada, 18014
- Not yet recruiting
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Las Palmas de Gran Canaria, 35020
- Not yet recruiting
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Madrid, 28034
- Not yet recruiting
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Madrid, 28041
- Not yet recruiting
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Valencia, 46014
- Not yet recruiting
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Valencia, 46017
- Not yet recruiting
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Vigo, 36200
China8 sites, 8 recruiting
- Not yet recruiting
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Beijing, 100191
- Not yet recruiting
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Chongqing, 400010
- Not yet recruiting
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Guangzhou, 510080
- Not yet recruiting
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Jinan, 250022
- Not yet recruiting
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Lanzhou, 730000
- Not yet recruiting
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Shanghai, 200001
- Not yet recruiting
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Shenzhen, 518020
- Not yet recruiting
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Shenzhen, 518053
Italy7 sites, 7 recruiting
- Not yet recruiting
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Brescia, 25123
- Not yet recruiting
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Cona, 44124
- Not yet recruiting
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Florence, 50121
- Not yet recruiting
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Milan, 20122
- Not yet recruiting
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Milan, 20132
- Not yet recruiting
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Roma, 00144
- Not yet recruiting
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Roma, 00168
Germany6 sites, 6 recruiting
- Not yet recruiting
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Dresden, 1309
- Not yet recruiting
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Essen, 45122
- Not yet recruiting
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Kiel, 24105
- Not yet recruiting
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Mainz, 55131
- Not yet recruiting
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Marburg, 35043
- Not yet recruiting
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Tübingen, 72076
Poland6 sites, 6 recruiting
- Not yet recruiting
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Bydgoszcz, 85-168
- Not yet recruiting
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Katowice, 40-600
- Not yet recruiting
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Kielce, 25-316
- Not yet recruiting
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Krakow, 30-040
- Not yet recruiting
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Ossy, 40-027
- Not yet recruiting
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Warsaw, 00-807
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
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Cambridge, CB2 2QQ
- Not yet recruiting
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Leeds, LS7 4SA
- Not yet recruiting
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London, NW1 2BU
- Not yet recruiting
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London, SE5 9RS
- Not yet recruiting
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Newcastle upon Tyne, NE7 7DN
- Not yet recruiting
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Sheffield, S10 2JF
France5 sites, 5 recruiting
- Not yet recruiting
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Bordeaux, 33076
- Not yet recruiting
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Paris, 75014
- Not yet recruiting
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Paris, 75020
- Not yet recruiting
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Strasbourg, 67200
- Not yet recruiting
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Toulouse, 31300
Japan5 sites, 5 recruiting
- Not yet recruiting
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Kanazawa, 920-8641
- Not yet recruiting
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Maebashi, 371-8511
- Not yet recruiting
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Nagoya, 467-8602
- Not yet recruiting
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Sapporo, 060-8648
- Not yet recruiting
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Yokohama, 236-0004
Thailand5 sites, 5 recruiting
- Not yet recruiting
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Bangkok, 10330
- Not yet recruiting
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Bangkok, 10700
- Not yet recruiting
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Hat Yai, 90110
- Not yet recruiting
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Khon Kaen, 40002
- Not yet recruiting
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Klong Luang, 12120
Austria4 sites, 4 recruiting
- Not yet recruiting
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Graz, 8010
- Not yet recruiting
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Graz, 8036
- Not yet recruiting
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Linz, 4020
- Not yet recruiting
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Vienna, 1130
Brazil4 sites, 4 recruiting
- Not yet recruiting
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Rio de Janeiro, 22470-220
- Not yet recruiting
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Salvador, 40150-150
- Not yet recruiting
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Santa Efigênia, 30150-320
- Not yet recruiting
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São Paulo, 05403-000
India4 sites, 4 recruiting
- Not yet recruiting
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Hyderabad, 500082
- Not yet recruiting
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Kolkata, 700020
- Not yet recruiting
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New Delhi, 110060
- Not yet recruiting
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Pune, 411001
South Korea4 sites, 4 recruiting
- Not yet recruiting
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Seoul, 03080
- Not yet recruiting
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Seoul, 04401
- Not yet recruiting
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Seoul, 06973
- Not yet recruiting
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Seoul, 6591
Taiwan4 sites, 4 recruiting
- Not yet recruiting
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Kaohsiung City, 813414
- Not yet recruiting
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Kaohsiung City, 83301
- Not yet recruiting
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Taichung, 404327
- Not yet recruiting
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Taipei, 10449
Bulgaria3 sites, 3 recruiting
- Not yet recruiting
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Plovdiv, 4001
- Not yet recruiting
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Sofia, 1463
- Not yet recruiting
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Sofia, 1618
Mexico3 sites, 3 recruiting
- Not yet recruiting
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Guadalajara, 44650
- Not yet recruiting
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Guadalajara, 44950
- Not yet recruiting
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San Luis Potosí City, 78250
Philippines3 sites, 3 recruiting
- Not yet recruiting
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Iloilo City, 5000
- Not yet recruiting
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Lipa City, 4217
- Not yet recruiting
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Manila, 1000
Portugal3 sites, 3 recruiting
- Not yet recruiting
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Braga, 4710-367
- Not yet recruiting
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Lisbon, 1000-064
- Not yet recruiting
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Porto, 4099-001
Romania3 sites, 3 recruiting
- Not yet recruiting
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Bucharest, 011172
- Not yet recruiting
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Cluj-Napoca, 400006
- Not yet recruiting
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Iași, 700661
Argentina2 sites, 2 recruiting
- Not yet recruiting
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Quilmes, 1878
- Not yet recruiting
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San Miguel, 1663
Australia2 sites, 2 recruiting
- Not yet recruiting
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Melbourne, 3004
- Not yet recruiting
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Mitcham, 3132
Israel2 sites, 2 recruiting
- Not yet recruiting
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Haifa, 31048
- Not yet recruiting
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Kfar Saba, 4428164
Serbia2 sites, 2 recruiting
- Not yet recruiting
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Belgrade, 1100
- Not yet recruiting
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Kragujevac, 34000
Slovakia2 sites, 2 recruiting
- Not yet recruiting
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Košice, 4001
- Not yet recruiting
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Piešťany, 92101
Netherlands1 site, 1 recruiting
- Not yet recruiting
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Rotterdam, 3015 GD
South Africa1 site, 1 recruiting
- Not yet recruiting
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Johannesburg, 2193
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
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Fatih-Istanbul, 34098
About this study
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
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.
- Being tested
- Anifrolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabCombination product
Anifrolumab pre-filled syringe
AnifrolumabCombination product
Anifrolumab solution for injection in pre-filled pen
AnifrolumabDrug
Anifrolumab concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | 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. Receives: Combination Product: Anifrolumab; Drug: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From first dose administered and until 12 weeks after the last dose of Anifrolumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start31 Aug 2026
- Primary completion30 Dec 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The rationale of the ROSY-S study is to provide continuous access to study treatment for participants clinically benefiting from anifrolumab treatment upon completion of parent studies and monitoring long-term safety and tolerability of anifrolumab. Participants will be enrolled into this study based upon the parent study continuing to receive the same treatment dose and regimen throughout until they meet one of the treatment discontinuation criteria.
- Masking
- None (open label)
- Enrolment
- 1,072 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691970
- Sponsor's protocol ID
- D346BC00004
- Acronym
- ROSY-S
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.