RecruitingPhase 3NCT07430306

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

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)


Sponsor

AstraZeneca

Enrollment

245 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anifrolumab for people with systemic lupus erythematosus. The study is currently recruiting participants at 79 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnifrolumab

Patients will receive Anifrolumab subcutaneous


Locations(79)

Research Site

Anniston, Alabama, United States

Research Site

Phoenix, Arizona, United States

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Fontana, California, United States

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La Palma, California, United States

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Menifee, California, United States

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San Leandro, California, United States

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Temecula, California, United States

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Brandon, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Willowbrook, Illinois, United States

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New Albany, Indiana, United States

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Lake Charles, Louisiana, United States

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Kansas City, Missouri, United States

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Oklahoma City, Oklahoma, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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Colleyville, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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Sugar Land, Texas, United States

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Spokane, Washington, United States

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Toronto, Canada

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Clermont-Ferrand, France

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Paris, France

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Paris, France

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Saint-Denis, France

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Vandœuvre-lès-Nancy, France

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Hamburg, Germany

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Mainz, Germany

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München, Germany

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Brescia, Italy

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Catania, Italy

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Ferrara, Italy

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Padova, Italy

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Pisa, Italy

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Roma, Italy

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Roma, Italy

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Rozzano, Italy

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Udine, Italy

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Culiacán, Mexico

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Durango, Mexico

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Guadalajara, Mexico

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Guadalajara, Mexico

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Guadalajara, Mexico

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México, Mexico

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México, Mexico

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Bydgoszcz, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Nadarzyn, Poland

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Nowa Sól, Poland

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Poznan, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Córdoba, Spain

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Galdakao, Spain

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Madrid, Spain

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Madrid, Spain

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Sabadell, Spain

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Santander, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taoyuan, Taiwan

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NCT07430306


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