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NCT Number: NCT07691970

Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited 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.

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Key information

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Anifrolumab

Combination Product

Anifrolumab pre-filled syringe

Anifrolumab

Drug

Anifrolumab concentrate for solution for infusion

Primary outcomes

  1. SAEs and Non-Serious AEs

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

+1877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ROSY-S

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.