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Not yet taking people in RomaniaPhase 3

Continued anifrolumab treatment for people with lupus, systemic sclerosis or myopathies

Offers anifrolumab to people who finished an earlier study and are still helped.

Key facts

Who runs it
AstraZeneca AB
Where
Bucharest, RomaniaSee the siteAlso in 12 other countries, 50 sites
Registry title
Rollover Study for Participants Who Have Completed a Previous Clinical Study with Anifrolumab (Saphnelo) and Clinically Benefited from Continued Treatment.
Status
Not yet recruiting
Phase
Phase 3
People taking part
340 people, planned
Started
1 Sept 2026
Expected to end
31 Dec 2032
Type of study
Interventional
Record updated
26 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who finished an earlier anifrolumab (Saphnelo) study, got at least one dose, and whose doctor thinks continuing the drug is worth the risk.

Sex
All sexes can join.
Earlier treatment
Must have completed the whole earlier anifrolumab study and received at least one dose of anifrolumab in it.

Main reasons for not taking part

  • Allergic reaction to any component of anifrolumab
  • Approved, reimbursed anifrolumab is available locally for the condition
  • Breastfeeding, pregnant, or planning pregnancy during the study
  • Taking part in another investigational study within 30 days or 5 half-lives before enrolment
  • Stopped the earlier study before finishing all visits

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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 take part

  • Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation
  • 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 who discontinued the parent study prior to completion of all study visits
  • Participant develops hypersensitivity to any of the components of anifrolumab
  • 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
  • Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study

Where in Romania

Also in 12 other countries, 50 sites

  • Saint Maria HospitalBucharest, RomaniaNot yet recruiting

About the trial

What the trial wants to find out

To provide study treatment to participants who continue to benefit at the end of the parent clinical study while monitoring long-term safety and tolerability of anifrolumab.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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
Plain-language title
Continued anifrolumab treatment for people with lupus, systemic sclerosis or myopathiesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
26 October 2026