Systemic Lupus ErythematosusPhase 3SUNFLOWERNCT07430306

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

A Phase 3 study testing Anifrolumab in people with Systemic Lupus Erythematosus, run by AstraZeneca at 107 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Anifrolumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 107 sitesin 9 countries
Study dates: 13 Apr 2026to 26 Jan 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged 18 to 70 years of age.
Participants who have a diagnosis of SLE confirmed by a rheumatologist.
ANA-positive per the Central Lab at screening:
ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)
Must be on the standard therapy regimen: antimalarials with or without OCSs
Must have at screening and baseline:

Show all 16Show fewer

Clinical SLEDAI-2K ≥ 4 points OR
Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)
Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis [TB]) or previous TB
Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).
No medical history or signs or symptoms of active TB prior to or during Screening.
Body weight ≥ 40.0 kg
Negative pregnancy test for females during screening
Normal HPV test result within 2 years prior to Week 0 (Day 1).
Willing and able to participate in all required study evaluations and procedures including completion of PROs.
Willing to not use any other forms of experimental treatment during the study.

Who cannot join

Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.
Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio [INR] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.
Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.
Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.
Subjects with a history of 3 or more unexplained consecutive pregnancy losses.
History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.

Show all 36Show fewer

Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.
Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.
Current diagnosis of, catastrophic antiphospholipid syndrome (APS).
History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).
Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.
Confirmed positive test for hepatitis B.
Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).
Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).
Severe HZ or recurrent HZ.
Malignancy. History of cancer, apart from:
Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).
Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).
Received any SLE-related therapies other than antimalarials and GCs.
History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.
History of an anaphylactic reaction to human proteins or mAbs.
Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.
Blood transfusion or receipt of blood products except albumin.
Received more than 2 investigational products for the SLE since time of diagnosis.
Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.
Concurrent enrollment in another clinical study with a study intervention.
Subjects with any abnormal lab result as specified in the protocol.
Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).
Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.
Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).
Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.
Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.
Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).
Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.

Trial locations and contacts

107 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

107 sites in 9 countries

United States31 sites, 29 recruiting

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

Other trials in United States

Poland15 sites, 15 recruiting

Research Site
Bydgoszcz, 85-065
Not yet recruiting
Research Site
Częstochowa, 42-217
Not yet recruiting
Research Site
Katowice, 40-611
Not yet recruiting
Research Site
Krakow, 30-688
Not yet recruiting
Research Site
Lodz, 90-368
Not yet recruiting
Research Site
Lublin, 20-607
Recruiting
Research Site
Nadarzyn, 05-830
Recruiting
Research Site
Nowa Sól, 67-100
Not yet recruiting
Research Site
Poznan, 60-681
Not yet recruiting
Research Site
Poznan, 60-693
Not yet recruiting
Research Site
Poznan, 61-397
Not yet recruiting
Research Site
Warsaw, 01-691
Recruiting
Research Site
Warsaw, 02-637
Not yet recruiting
Research Site
Warsaw, 05-077
Not yet recruiting
Research Site
Wroclaw, 53-673
Not yet recruiting

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Italy12 sites, 10 recruiting

Research Site
Brescia, 25123
Not yet recruiting
Research Site
Catania, 95123
Not yet recruiting
Research Site
Ferrara, 44121
Not yet recruiting
Research Site
Florence, 50141
Not yet recruiting
Research Site
Milan, 20122
Suspended
Research Site
Milan, 20122
Not yet recruiting
Research Site
Padova, 35128
Not yet recruiting
Research Site
Pisa, 56124
Not yet recruiting
Research Site
Roma, 00161
Not yet recruiting
Research Site
Roma, 00168
Suspended
Research Site
Rozzano, 20089
Not yet recruiting
Research Site
Udine, 33100
Not yet recruiting

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France11 sites, 11 recruiting

Research Site
Clermont-Ferrand, 63000
Not yet recruiting
Research Site
Lyon, 69437
Not yet recruiting
Research Site
Marseille, 13385
Not yet recruiting
Research Site
Paris, 75012
Not yet recruiting
Research Site
Paris, 75013
Recruiting
Research Site
Pessac, 33604
Not yet recruiting
Research Site
Saint-Denis, 97405
Not yet recruiting
Research Site
Saint-Pierre, 97448
Not yet recruiting
Research Site
Toulon, 83800, Cedex
Not yet recruiting
Research Site
Tours, 37044
Not yet recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
Not yet recruiting

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Spain11 sites, 10 recruiting

Research Site
Barcelona, 08035
Not yet recruiting
Research Site
Barcelona, 08036
Not yet recruiting
Research Site
Córdoba, 14004
Suspended
Research Site
Galdakao, 48960
Not yet recruiting
Research Site
Madrid, 28034
Not yet recruiting
Research Site
Madrid, 28046
Not yet recruiting
Research Site
Madrid, 28702
Not yet recruiting
Research Site
Sabadell, 08208
Not yet recruiting
Research Site
Santander, 39008
Not yet recruiting
Research Site
Seville, 41014
Not yet recruiting
Research Site
Valencia, 46026
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Taiwan10 sites, 10 recruiting

Research Site
Kaohsiung City, 813414
Not yet recruiting
Research Site
Kaohsiung City, 833
Not yet recruiting
Research Site
New Taipei City, 23561
Not yet recruiting
Research Site
Taichung, 40447
Not yet recruiting
Research Site
Taichung, 40705
Not yet recruiting
Research Site
Tainan, 70403
Not yet recruiting
Research Site
Tainan County, 71044
Not yet recruiting
Research Site
Taipei, 100
Not yet recruiting
Research Site
Taoyuan, 33305
Not yet recruiting
Research Site
Zhubei, 302
Not yet recruiting

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Mexico8 sites, 7 recruiting

Research Site
Culiacán, 80000
Not yet recruiting
Research Site
Durango, 34080
Not yet recruiting
Research Site
Guadalajara, 44160
Not yet recruiting
Research Site
Guadalajara, 44650
Not yet recruiting
Research Site
Guadalajara, 44690
Suspended
Research Site
Mérida, 97133
Not yet recruiting
Research Site
México, 03100
Not yet recruiting
Research Site
México, 14080
Not yet recruiting

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Canada5 sites, 5 recruiting

Research Site
Calgary, Alberta, T2T 5C7
Not yet recruiting
Research Site
Hamilton, Ontario, L8N 3Z5
Not yet recruiting
Research Site
Richmond, British Columbia, V6Z 1Y6
Not yet recruiting
Research Site
Toronto, M5T 2S8
Not yet recruiting
Research Site
Winnipeg, Manitoba, R3A 1M4
Not yet recruiting

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Germany4 sites, 4 recruiting

Research Site
Bad Abbach, 93077
Not yet recruiting
Research Site
Hamburg, 22763
Not yet recruiting
Research Site
Mainz, 55131
Not yet recruiting
Research Site
München, 80336
Not yet recruiting

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About this study

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)

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.

Read the detailed description

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:

Clinical SLEDAI 2K ≥4 points regardless of GC dose and disease duration.
Clinical SLEDAI-2K < 4 with GC ≥ 7.5 mg/day for > 5 weeks. After receiving the first dose of anifrolumab (week 0), the participant is allowed to increase the GC dose up until week 4, based on the investigator's recommendation. Between week 5 and week 40, participants taking >5 mg/day GC dose at study entry will attempt a protocolized taper to 5 mg/day over 12 weeks. Participants achieving DORIS remission for 2 consecutive visits will attempt complete withdrawal of GC following a 12-week tapering regimen. Starting week 41 until the end of the study (week 52), there will be no further reduction of GC dose.

Conditions: Systemic Lupus Erythematosus
Being tested: Anifrolumab
Keywords: Lupus, Immunosuppressant, Glucocorticoid, Anifrolumab, Remission
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnifrolumabDrug
Also called Saphnelo
Patients will receive Anifrolumab subcutaneous

Study groups in NCT07430306
Study group	Role	What they receive
Anifrolumab	Other	Participants will receive dose A of anifrolumab on X dosing schedule beginning on Day 1 for a maximum of 52 -week during the study Receives: Drug: Anifrolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At Week 52

Secondary outcomes (16)

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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At 52 Week
Adverse Events
Safety and tolerability of anifrolumab will be assessed.
Measured: 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.
Measured: At 52 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202626 Jan 2029

First posted24 Feb 2026
Study start13 Apr 2026
Primary completion26 Jan 2029 (estimated)
Study completion26 Jan 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: Multinational, Interventional, 52-week, Open-label, Single-arm Study
Masking: None (open label)
Enrolment: 245 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07430306
Sponsor's protocol ID: D3461C00040
Acronym: SUNFLOWER
Status last verified: Sep 2026
First submitted: 2 Feb 2026
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07430306
Acronym / sponsor ID: SUNFLOWER / D3461C00040
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus, Immunosuppressant, Glucocorticoid, Anifrolumab, Remission
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 245 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: ICON plc
Study start: 13 Apr 2026 (actual)
Primary completion: 26 Jan 2029 (estimated)
Study completion: 26 Jan 2029 (estimated)
First posted: 24 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Clinical SLEDAI 2K ≥4 points regardless of GC dose and disease duration.
Clinical SLEDAI-2K < 4 with GC ≥ 7.5 mg/day for > 5 weeks. After receiving the first dose of anifrolumab (week 0), the participant is allowed to increase the GC dose up until week 4, based on the investigator's recommendation. Between week 5 and week 40, participants taking >5 mg/day GC dose at study entry will attempt a protocolized taper to 5 mg/day over 12 weeks. Participants achieving DORIS remission for 2 consecutive visits will attempt complete withdrawal of GC following a 12-week tapering regimen. Starting week 41 until the end of the study (week 52), there will be no further reduction of GC dose.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multinational, Interventional, 52-week, Open-label, Single-arm Study

Arm	Type	Receives
Anifrolumab	Other	Drug: AnifrolumabParticipants will receive dose A of anifrolumab on X dosing schedule beginning on Day 1 for a maximum of 52 -week during the study

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Males or females aged 18 to 70 years of age.
Participants who have a diagnosis of SLE confirmed by a rheumatologist.
ANA-positive per the Central Lab at screening:
Must be on the standard therapy regimen: antimalarials with or without OCSs
Must have at screening and baseline:

Key exclusion criteria (36 listed)

Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.
Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio [INR] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.
Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.
Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.
Subjects with a history of 3 or more unexplained consecutive pregnancy losses.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AnifrolumabAlso: SaphneloPatients will receive Anifrolumab subcutaneous	Drug	Anifrolumab

Primary outcome

Attainment of DORIS remission
Time frame: At 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.

16 secondary outcomes

To assess the attainment of low level disease activity
Time frame: At Week 28 and 52
Time spent in DORIS remission, LLDAS or LLDAS-5
Time frame: At Week 52
Sustaining DORIS remission, LLDAS or LLDAS-5
Time frame: All subsequent visits including 52 Week
Sustaining DORIS remission, LLDAS or LLDAS-5
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
Time frame: Through Week 52
Daily GC dose
Time frame: At Week 40 and Week 52
Reduction in GC use
Time frame: From Week 4 to Week 40
Maintenance of reduction in GC dose
Time frame: During 52 Week
Cumulative GC dose
Time frame: Week 0 to Week 52
Attainment of DORIS-0
Time frame: From baseline over 52 Weeks
Time to first moderate-to-severe flare
Time frame: Through Week 52
Change in active skin manifestations
Time frame: At Week 4, Week 16, and Week 52
Change in joint activity
Time frame: At Week 28 and 52
Change in QoL and fatigue
Time frame: At 52 Week
Adverse Events
Time frame: Up to 52 Weeks
Change in QoL and fatigue
Time frame: At 52 Week

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Individual participant dataSharing planned: 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

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

107 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anifrolumab in people with Systemic Lupus Erythematosus, run by AstraZeneca at 107 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Poland, Italy, France, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attainment of DORIS remission (time frame: At Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07430306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.