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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07430306

Public ClinicalTrials.gov record NCT07430306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 2, 2026, 3:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07430306
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
245 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 13, 2026 (Actual)
Primary completion
Jan 26, 2029 (Estimated)
Completion
Jan 26, 2029 (Estimated)
Last update posted
Sep 25, 2026

2026 – 2029

United States locations

U.S. sites
31
U.S. states
14
U.S. cities
27
Facility City State ZIP Site status
Research Site Anniston Alabama 36207 Withdrawn
Research Site Birmingham Alabama 35233 Not yet recruiting
Research Site Phoenix Arizona 85032 Not yet recruiting
Research Site Tucson Arizona 85748 Not yet recruiting
Research Site Fontana California 92335 Not yet recruiting
Research Site La Jolla California 92037 Not yet recruiting
Research Site La Palma California 90623 Recruiting
Research Site Menifee California 92586 Recruiting
Research Site San Leandro California 94578 Recruiting
Research Site Temecula California 92592 Recruiting
Research Site Brandon Florida 33511 Not yet recruiting
Research Site Miami Florida 33136 Not yet recruiting
Research Site Miami Florida 33145 Recruiting
Research Site Miami Florida 33180 Suspended
Research Site Willowbrook Illinois 60527 Recruiting
Research Site New Albany Indiana 47150 Recruiting
Research Site Lake Charles Louisiana 70605 Not yet recruiting
Research Site Silver Spring Maryland 20904 Not yet recruiting
Research Site Kansas City Missouri 64151 Not yet recruiting
Research Site West Long Branch New Jersey 07764 Not yet recruiting
Research Site Oklahoma City Oklahoma 73104 Not yet recruiting
Research Site Oklahoma City Oklahoma 73116 Recruiting
Research Site Memphis Tennessee 38104 Not yet recruiting
Research Site Memphis Tennessee 38119 Recruiting
Research Site Austin Texas 78745 Not yet recruiting
Research Site Baytown Texas 77521 Recruiting
Research Site Colleyville Texas 76034 Recruiting
Research Site Edinburg Texas 78550 Recruiting
Research Site Houston Texas 77054 Recruiting
Research Site Sugar Land Texas 77479 Recruiting
Research Site Spokane Washington 99204 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07430306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 25, 2026 · Synced Oct 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07430306 live on ClinicalTrials.gov.

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