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

NCT07430306 | Recruiting Phase 3 FDA Drug

• 1 other identifier: D3461C00040
• Study Type: interventional
• Target: 245
• Locations: 9 countries
• Sites: 73

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus; Immunosuppressant; Glucocorticoid; Anifrolumab; Remission

Outcome Measures

Primary Outcomes (1)

• 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.

  At Week 52

Secondary Outcomes (16)

• To assess the attainment of low level disease activity

  At Week 28 and 52

• Time spent in DORIS remission, LLDAS or LLDAS-5

  At Week 52

• Sustaining DORIS remission, LLDAS or LLDAS-5

  All subsequent visits including 52 Week

• Sustaining DORIS remission, LLDAS or LLDAS-5

  At 3 consecutive visits occurring every 4 weeks during the 52 Week study

• Time to attain and sustain DORIS, or LLDAS, or LLDAS-5

  Through Week 52

Study Arms (1)

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

Drug: Anifrolumab

Interventions

Anifrolumab DRUG

Patients will receive Anifrolumab subcutaneous

Also known as: Saphnelo

Anifrolumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• (a) 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:
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• AstraZeneca: lead
• ICON plc: collaborator

Study Sites (73)

Research Site

Anniston, Alabama, 36207, United States

WITHDRAWN

Research Site

Phoenix, Arizona, 85032, United States

NOT YET RECRUITING

Research Site

Fontana, California, 92335, United States

NOT YET RECRUITING

Research Site

La Palma, California, 90623, United States

NOT YET RECRUITING

Research Site

Menifee, California, 92586, United States

RECRUITING

Research Site

San Leandro, California, 94578, United States

NOT YET RECRUITING

Research Site

Temecula, California, 92592, United States

RECRUITING

Research Site

Miami, Florida, 33145, United States

NOT YET RECRUITING

Research Site

Miami, Florida, 33180, United States

SUSPENDED

Research Site

Willowbrook, Illinois, 60527, United States

NOT YET RECRUITING

Research Site

New Albany, Indiana, 47150, United States

NOT YET RECRUITING

Research Site

Kansas City, Missouri, 64151, United States

NOT YET RECRUITING

Research Site

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

Research Site

Memphis, Tennessee, 38104, United States

NOT YET RECRUITING

Research Site

Memphis, Tennessee, 38119, United States

RECRUITING

Research Site

Austin, Texas, 78745, United States

NOT YET RECRUITING

Research Site

Baytown, Texas, 77521, United States

NOT YET RECRUITING

Research Site

Colleyville, Texas, 76034, United States

NOT YET RECRUITING

Research Site

Edinburg, Texas, 78550, United States

NOT YET RECRUITING

Research Site

Houston, Texas, 77054, United States

NOT YET RECRUITING

Research Site

Spokane, Washington, 99204, United States

NOT YET RECRUITING

Research Site

Calgary, Alberta, T2T 5C7, Canada

NOT YET RECRUITING

Research Site

Winnipeg, Manitoba, R3A 1M4, Canada

NOT YET RECRUITING

Research Site

Hamilton, Ontario, L8N 3Z5, Canada

NOT YET RECRUITING

Research Site

Toronto, M5T 2S8, Canada

NOT YET RECRUITING

Research Site

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Research Site

Paris, 75012, France

NOT YET RECRUITING

Research Site

Paris, 75013, France

NOT YET RECRUITING

Research Site

Vandœuvre-lès-Nancy, 54511, France

NOT YET RECRUITING

Research Site

Hamburg, 22763, Germany

NOT YET RECRUITING

Research Site

Mainz, 55131, Germany

NOT YET RECRUITING

Research Site

München, 80336, Germany

NOT YET RECRUITING

Research Site

Brescia, 25123, Italy

NOT YET RECRUITING

Research Site

Catania, 95123, Italy

NOT YET RECRUITING

Research Site

Ferrara, 44121, Italy

NOT YET RECRUITING

Research Site

Florence, 50141, Italy

NOT YET RECRUITING

Research Site

Milan, 20122, Italy

SUSPENDED

Research Site

Milan, 20122, Italy

NOT YET RECRUITING

Research Site

Padova, 35128, Italy

NOT YET RECRUITING

Research Site

Pisa, 56124, Italy

NOT YET RECRUITING

Research Site

Roma, 00161, Italy

NOT YET RECRUITING

Research Site

Roma, 00168, Italy

SUSPENDED

Research Site

Rozzano, 20089, Italy

NOT YET RECRUITING

Research Site

Udine, 33100, Italy

NOT YET RECRUITING

Research Site

Culiacán, 80000, Mexico

NOT YET RECRUITING

Research Site

Durango, 34080, Mexico

NOT YET RECRUITING

Research Site

Guadalajara, 44160, Mexico

NOT YET RECRUITING

Research Site

Guadalajara, 44650, Mexico

NOT YET RECRUITING

Research Site

Guadalajara, 44690, Mexico

SUSPENDED

Research Site

México, 03100, Mexico

NOT YET RECRUITING

Research Site

México, 14080, Mexico

NOT YET RECRUITING

Research Site

Bydgoszcz, 85-065, Poland

NOT YET RECRUITING

Research Site

Krakow, 30-688, Poland

NOT YET RECRUITING

Research Site

Lodz, 90-368, Poland

NOT YET RECRUITING

Research Site

Lublin, 20-607, Poland

NOT YET RECRUITING

Research Site

Nadarzyn, 05-830, Poland

NOT YET RECRUITING

Research Site

Nowa Sól, 67-100, Poland

NOT YET RECRUITING

Research Site

Poznan, 60-693, Poland

NOT YET RECRUITING

Research Site

Poznan, 61-397, Poland

NOT YET RECRUITING

Research Site

Warsaw, 05-077, Poland

NOT YET RECRUITING

Research Site

Wroclaw, 53-673, Poland

NOT YET RECRUITING

Research Site

Córdoba, 14004, Spain

SUSPENDED

Research Site

Galdakao, 48960, Spain

NOT YET RECRUITING

Research Site

Madrid, 28034, Spain

NOT YET RECRUITING

Research Site

Madrid, 28046, Spain

NOT YET RECRUITING

Research Site

Sabadell, 08208, Spain

NOT YET RECRUITING

Research Site

Santander, 39008, Spain

NOT YET RECRUITING

Research Site

Valencia, 46026, Spain

NOT YET RECRUITING

Research Site

Kaohsiung City, 813414, Taiwan

NOT YET RECRUITING

Research Site

Kaohsiung City, 833, Taiwan

NOT YET RECRUITING

Research Site

Taichung, 40705, Taiwan

NOT YET RECRUITING

Research Site

Tainan, 70403, Taiwan

NOT YET RECRUITING

Research Site

Taoyuan, 33305, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multinational, Interventional, 52-week, Open-label, Single-arm Study

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 24, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): January 26, 2029
• Study Completion (Estimated): January 26, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

FR (4); ES (7); PL (10); US (21); DE (3); TW (5); ME (7); CA (4); IT (12)