Rollover Study for Participants Who Have Completed a Previous Clinical Study with Anifrolumab (Saphnelo) and Clinically Benefited from Continued Treatment.
Key facts
- Where
- A Coruña, Barcelona, Castello De La Plana, Granada, Las Palmas De Gran Canaria, Madrid, Valencia és Vigo. Pontevedra, SpanyolországSee the 10 sites
- Phase
- 3. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországToborzás még nem indult
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországToborzás még nem indult
- Hospital General Universitario De CastellonCastello De La Plana, SpanyolországToborzás még nem indult
- Hospital Universitario Virgen de las NievesGranada, SpanyolországToborzás még nem indult
- El Hospital Universitario De Gran Canaria Dr. NegrinLas Palmas De Gran Canaria, SpanyolországToborzás még nem indult
- Hospital Universitario 12 de OctubreMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario Ramón y CajalMadrid, SpanyolországToborzás még nem indult
- Consorcio Hospital General Universitario de ValenciaValencia, SpanyolországToborzás még nem indult
- Hospital Universitario Dr. Peset AleixandreValencia, SpanyolországToborzás még nem indult
- Complexo Hospitalario Universitario De VigoVigo. Pontevedra, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2026-526419-13-00
- Record updated
- 2026. október 26.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.