A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve… (NCT07430306) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
United States245 participantsStarted 2026-04-13
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males or females aged 18 to 70 years of age.
✓. Participants who have a diagnosis of SLE confirmed by a rheumatologist.
✓. ANA-positive per the Central Lab at screening:
✓. Must be on the standard therapy regimen: antimalarials with or without OCSs
✓. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \[TB\]) or previous TB
Exclusion criteria
✕. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.
✕. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \[INR\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.
✕. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.
✕. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.
✕. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.
✕. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.
✕. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.
✕. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.