Clinical Trial

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

Study acronym: ROSY-S
Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07691970
Lead Sponsor AstraZeneca
Conditions Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Enrollment 1,072 participants
Start Date 2026-09-01
Primary Completion 2032-12-31 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-09