Clinical Trial

A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus

Study acronym: SUNFLOWER
Recruiting Phase 3
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Summary
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.
Protocol Amendment History 4 changes
notable Trial sites expanded: 79 -> 101 locations 2026-06-30
notable Trial sites expanded: 73 -> 79 locations 2026-06-03
critical Recruitment opened 2026-05-06
notable Trial sites expanded: 0 -> 73 locations 2026-05-06
Trial Details
NCT Number NCT07430306
Lead Sponsor AstraZeneca
Collaborators: ICON plc
Conditions Systemic Lupus Erythematosus
Enrollment 245 participants
Start Date 2026-04-13
Primary Completion 2029-01-26 (estimated)
Study Completion 2029-01-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-23