A Phase 3 interventional study of Anifrolumab in Systemic Lupus Erythematosus, sponsored by AstraZeneca. Recruiting at 108 sites in 9 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
In this study, approximately 275 participants will be enrolled and the study duration will be up to approximately 69 weeks, including: A Screening Period lasting up to 35 days and A 52-week treatment period. Also, participants not continuing treatment with any preparation of anifrolumab after Week 52 will have additional safety follow up 12 weeks after last dose of anifrolumab. Anifrolumab will be administered SC via an aPFS during the 52-week Study.
The study population will comprise participants taking antimalarial with or without GCs (there is a recruitment cap of 50% of patients not on GC at baseline) who are IS-naïve and biologic-naïve and are not meeting LLDAS criteria, described by the following cohorts:
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 245 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ANA-positive per the Central Lab at screening:
(a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)
Must have at screening and baseline:
Exclusion Criteria:
. History of cancer, apart from:
(a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).
(a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive dose A of anifrolumab on X dosing schedule beginning on Day 1 for a maximum of 52 -week during the study
Drug: Anifrolumab
Patients will receive Anifrolumab subcutaneous
Also known as: Saphnelo
Attainment of DORIS remission
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.
Time frame: At Week 52
To assess the attainment of low level disease activity
Proportion of participants who are in LLDAS, or LLDAS-5 at Week 28 and 52 will be assessed. Low level disease activity as measured by LLDAS and LLDAS 5 * LLDAS criteria: SLEDAI 2K ≤ 4 without major organ involvement, no new disease activity, PGA ≤ 1 (0 - 3), prednisone 7.5 mg/day or less, and permitted use of the following medications: antimalarials, standard maintenance doses of ISs including biologics * LLDAS-5 criteria: SLEDAI-2K ≤ 4 without major organ involvement, no new disease activity, PGA ≤ 1 (0 - 3), prednisone 5.0 mg/day or less (this is modified LLDAS to include EULAR 2023 recommendations to lower daily maintenance GC ≤ 5.0 mg/day)
Time frame: At Week 28 and 52
Time spent in DORIS remission, LLDAS or LLDAS-5
Time spent in DORIS remission, LLDAS or LLDAS-5 for participants initiated on anifrolumab will be measured.
Time frame: At Week 52
Sustaining DORIS remission, LLDAS or LLDAS-5
The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 through to Week 52 will be measured.
Time frame: All subsequent visits including 52 Week
Sustaining DORIS remission, LLDAS or LLDAS-5
The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 for three or more consecutive visits will be measured. Consecutive visits' are defined as three back-to-back completed visits.
Time frame: At 3 consecutive visits occurring every 4 weeks during the 52 Week study
Time to attain and sustain DORIS, or LLDAS, or LLDAS-5
The time to attain and sustain DORIS, or LLDAS, or LLDAS-5 will be analyzed.
Time frame: Through Week 52
Daily GC dose
The daily GC dose at Week 40 and 52 in participants initiated on anifrolumab alongside a systematic approach to GC tapering and to assess the maintenance of this GC reduction through Week 52 will be assessed.
Time frame: At Week 40 and Week 52
Reduction in GC use
The reduction in GC use from Week 4 to Week 40 in participants initiated on anifrolumab alongside a systematic approach to GC tapering will be assessed
Time frame: From Week 4 to Week 40
Maintenance of reduction in GC dose
Maintenance of this percent reduction in GC dose through Week 52 will be assessed
Time frame: During 52 Week
Cumulative GC dose
The cumulative GC dose from Week 0 to Week 52 in participants initiated on anifrolumab alongside a systematic approach to GC tapering will be assessed.
Time frame: Week 0 to Week 52
Attainment of DORIS-0
Proportion of participants who attain DORIS-0 from baseline over 52 weeks. DORIS-0 is defined as DORIS criteria with prednisone 0 mg daily.
Time frame: From baseline over 52 Weeks
Time to first moderate-to-severe flare
Time to first moderate-to-severe flare through to Week 52 assessed based on MFI. Moderate-to-severe flare is defined as any one criterion present in the moderate or severe flare categories within the MFI will be assessed.
Time frame: Through Week 52
Change in active skin manifestations
The change in active skin manifestations of SLE measured by CLASI activity score in participants initiated on anifrolumab will be assessed.
Time frame: At Week 4, Week 16, and Week 52
Change in joint activity
The average change in number of active joints (swollen and tender joints) in participants initiated on anifrolumab compared to baseline will be assessed
Time frame: At Week 28 and 52
Change in QoL and fatigue
Change in QoL and fatigue in participants initiated on anifrolumab will be assessed using FACIT-F.
Time frame: At 52 Week
Adverse Events
Safety and tolerability of anifrolumab will be assessed.
Time frame: Up to 52 Weeks
Change in QoL and fatigue
Change in QoL and fatigue in participants initiated on anifrolumab will be assessed using PROMIS Lupus.
Time frame: At 52 Week
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Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Anifrolumab
Lupus Erythematosus, Systemic →