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.
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
At a glance
Conditions
Where it's being run
104 sites across 25 statesWho to contact
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What this trial measures
- 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.