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Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus ErythematosusChildren's healthCombination productDrugPhase 3

What this study is

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.

What's being tested

  • Anifrolumab

    Intervention · COMBINATION PRODUCT

    Anifrolumab pre-filled syringe

  • Anifrolumab

    Intervention · COMBINATION PRODUCT

    Anifrolumab solution for injection in pre-filled pen

  • Anifrolumab

    Intervention · DRUG

    Anifrolumab concentrate for solution for infusion

Study details

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
Sponsor
AstraZeneca
Conditions
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Enrolling
1,072 people
Starts
2026-08-31
Est. completion
2032-12-30
Design
Open-label, non-randomized, single group, Phase 3
Record
View on ClinicalTrials.gov ↗