Anifrolumab for Systemic Lupus Erythematosus (SUNFLOWER Study)

This study, called SUNFLOWER, is looking at how well a medication called anifrolumab works for people with Systemic Lupus Erythematosus (SLE), an autoimmune disease. You might be able to join if you are between 18 and 70 years old, have a confirmed SLE diagnosis, and have certain positive blood tests (ANA, anti-dsDNA, anti-Smith). You also need to be currently taking antimalarial medications, with or without steroids (OCS). The study will give anifrolumab as an injection under the skin once a week. Researchers want to see if anifrolumab can help you achieve "DORIS remission," which is a way to measure if your lupus symptoms are well-controlled, after 52 weeks. This study is for people who haven't used certain strong immunosuppressant or biologic medications before.

Study design
This interventional study plans to enroll approximately 245 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate in the study for about 69 weeks, including a screening period of up to 35 days and a 52-week treatment period where you receive anifrolumab injections weekly.
Compensation
Not stated in the trial record.
Follow-up
After the 52-week treatment period, if you stop taking anifrolumab, there will be an additional safety follow-up for 12 weeks after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07430306

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

Recruiting
PHASE3Ages 18–70InterventionalTreatment
AstraZeneca
~245 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Anifrolumab

At a glance

Recruiting sites
16 of 104 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Attainment of DORIS remission
Measured over At Week 52
Systemic Lupus Erythematosus
104 sites across 25 states
Poland15
Italy12
Spain11
France10
Taiwan10
Mexico7
California6
Texas6
AstraZeneca Clinical Study Information Center
Email the study team

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  • Attainment of DORIS remissionAt Week 52

    Proportion of participants who are in DORIS remission at Week 52 will be assessed. DORIS remission is defined as Clinical SLEDAI-2K (sum of all SLEDAI-2K items except for increased deoxyribonucleic acid \[DNA\] binding and low complement) = 0; PGA \[0-3\] \< 0.5, prednisone 5 mg/day or less, and stable antimalarials, ISs, and biologics.