Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Anifrolumab: Anifrolumab pre-filled syringe
Anifrolumab: Anifrolumab solution for injection in pre-filled pen
Anifrolumab: Anifrolumab concentrate for solution for infusion
Study 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.
Eligibility
Primary outcome measure(s)
- SAEs and Non-Serious AEs — 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
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Los Angeles | California | |
| Research Site | Fort Lauderdale | Florida | |
| Research Site | Chicago | Illinois | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | New York | New York | |
| Research Site | Charleston | South Carolina | |
| Research Site | Graz | Austria | |
| Research Site | Graz | Austria | |
| Research Site | Ghent | Belgium | |
| Research Site | Salvador | Brazil | |
| Research Site | Sofia | Bulgaria | |
| Research Site | Bordeaux | France | |
| Research Site | Strasbourg | France | |
| Research Site | Toulouse | France | |
| Research Site | Chaïdári | Greece | |
| Research Site | Kolkata | India | |
| Research Site | Haifa | Israel | |
| Research Site | Milan | Italy | |
| Research Site | Sapporo | Japan | |
| Research Site | Iloilo City | Philippines | |
| Research Site | Lipa City | Philippines | |
| Research Site | Bydgoszcz | Poland | |
| Research Site | Kielce | Poland | |
| Research Site | Krakow | Poland | |
| Research Site | Iași | Romania | |
| Research Site | Kragujevac | Serbia | |
| Research Site | Piešťany | Slovakia | |
| Research Site | Seoul | South Korea | |
| Research Site | Barcelona | Spain | |
| Research Site | Granada | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Valencia | Spain | |
| Research Site | Kaohsiung City | Taiwan | |
| Research Site | Taichung | Taiwan | |
| Research Site | Bangkok | Thailand | |
| Research Site | Khon Kaen | Thailand | |
| Research Site | Fatih-Istanbul | Turkey (Türkiye) | |
| Research Site | London | United Kingdom | |
| Research Site | Newcastle upon Tyne | United Kingdom |
+ 1 more sites — see the full list on the official registry below.
On this site
📄 Saphnelo (anifrolumab) drug profile →More AstraZeneca trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07691970 on ClinicalTrials.gov ↗ ← All trials in Italy