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면역억제제 및 생물학적제제 미사용 전신성 홍반성 루푸스에서 피하 주사 아니프롤루맙 치료 결과 평가 연구 (SUNFLOWER)

2026년 9월 24일 업데이트: AstraZeneca

면역억제제 미사용 및 생물학적 제제 미사용 전신 홍반성 루푸스 환자에서 Anifrolumab 120mg 피하주사 주 1회 투여의 치료 결과를 평가하기 위한 다국적, 중재적, 52주, 개방형, 단일 군 연구 (SUNFLOWER)

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

245

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대만
      • Kaohsiung City, 대만, 833
        • 아직 모집하지 않음
        • Research Site
      • Kaohsiung City, 대만, 813414
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        • Research Site
      • New Taipei City, 대만, 23561
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        • Research Site
      • Taichung, 대만, 40705
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        • Research Site
      • Taichung, 대만, 40447
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        • Research Site
      • Tainan, 대만, 70403
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        • Research Site
      • Tainan County, 대만, 71044
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        • Research Site
      • Taipei, 대만, 100
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        • Research Site
      • Taoyuan, 대만, 33305
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        • Research Site
      • Zhubei, 대만, 302
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        • Research Site
  • 독일
      • Bad Abbach, 독일, 93077
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        • Research Site
      • Hamburg, 독일, 22763
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        • Research Site
      • Mainz, 독일, 55131
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      • München, 독일, 80336
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        • Research Site
  • 멕시코
      • Culiacán, 멕시코, 80000
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        • Research Site
      • Durango, 멕시코, 34080
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        • Research Site
      • Guadalajara, 멕시코, 44160
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      • Guadalajara, 멕시코, 44650
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        • Research Site
      • Guadalajara, 멕시코, 44690
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      • Mérida, 멕시코, 97133
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      • México, 멕시코, 14080
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      • México, 멕시코, 03100
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    • Alabama
      • Anniston, Alabama, 미국, 36207
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      • Birmingham, Alabama, 미국, 35233
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      • Phoenix, Arizona, 미국, 85032
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      • Tucson, Arizona, 미국, 85748
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    • California
      • Fontana, California, 미국, 92335
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      • La Jolla, California, 미국, 92037
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      • La Palma, California, 미국, 90623
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      • Menifee, California, 미국, 92586
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      • San Leandro, California, 미국, 94578
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        • Research Site
      • Temecula, California, 미국, 92592
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    • Florida
      • Brandon, Florida, 미국, 33511
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      • Miami, Florida, 미국, 33136
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      • Miami, Florida, 미국, 33145
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      • Miami, Florida, 미국, 33180
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    • Illinois
      • Willowbrook, Illinois, 미국, 60527
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    • Indiana
      • New Albany, Indiana, 미국, 47150
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    • Louisiana
      • Lake Charles, Louisiana, 미국, 70605
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    • Maryland
      • Silver Spring, Maryland, 미국, 20904
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    • Missouri
      • Kansas City, Missouri, 미국, 64151
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    • New Jersey
      • West Long Branch, New Jersey, 미국, 07764
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    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
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        • Research Site
      • Oklahoma City, Oklahoma, 미국, 73116
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    • Tennessee
      • Memphis, Tennessee, 미국, 38119
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        • Research Site
      • Memphis, Tennessee, 미국, 38104
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        • Research Site
    • Texas
      • Austin, Texas, 미국, 78745
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      • Baytown, Texas, 미국, 77521
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      • Colleyville, Texas, 미국, 76034
        • 모병
        • Research Site
      • Edinburg, Texas, 미국, 78550
        • 모병
        • Research Site
      • Houston, Texas, 미국, 77054
        • 모병
        • Research Site
      • Sugar Land, Texas, 미국, 77479
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        • Research Site
    • Washington
      • Spokane, Washington, 미국, 99204
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        • Research Site
  • 스페인
      • Barcelona, 스페인, 08035
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        • Research Site
      • Barcelona, 스페인, 08036
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      • Córdoba, 스페인, 14004
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      • Galdakao, 스페인, 48960
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      • Madrid, 스페인, 28046
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      • Madrid, 스페인, 28034
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        • Research Site
      • Madrid, 스페인, 28702
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      • Sabadell, 스페인, 08208
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        • Research Site
      • Santander, 스페인, 39008
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      • Seville, 스페인, 41014
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      • Valencia, 스페인, 46026
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  • 이탈리아
      • Brescia, 이탈리아, 25123
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        • Research Site
      • Catania, 이탈리아, 95123
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        • Research Site
      • Ferrara, 이탈리아, 44121
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        • Research Site
      • Florence, 이탈리아, 50141
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        • Research Site
      • Milan, 이탈리아, 20122
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        • Research Site
      • Milan, 이탈리아, 20122
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        • Research Site
      • Padova, 이탈리아, 35128
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        • Research Site
      • Pisa, 이탈리아, 56124
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        • Research Site
      • Roma, 이탈리아, 00161
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        • Research Site
      • Roma, 이탈리아, 00168
        • 정지된
        • Research Site
      • Rozzano, 이탈리아, 20089
        • 아직 모집하지 않음
        • Research Site
      • Udine, 이탈리아, 33100
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        • Research Site
  • 캐나다
      • Toronto, 캐나다, M5T 2S8
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    • Alberta
      • Calgary, Alberta, 캐나다, T2T 5C7
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        • Research Site
    • British Columbia
      • Richmond, British Columbia, 캐나다, V6Z 1Y6
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        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3A 1M4
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        • Research Site
    • Ontario
      • Hamilton, Ontario, 캐나다, L8N 3Z5
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        • Research Site
  • 폴란드
      • Bydgoszcz, 폴란드, 85-065
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        • Research Site
      • Częstochowa, 폴란드, 42-217
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        • Research Site
      • Katowice, 폴란드, 40-611
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        • Research Site
      • Krakow, 폴란드, 30-688
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        • Research Site
      • Lodz, 폴란드, 90-368
        • 아직 모집하지 않음
        • Research Site
      • Lublin, 폴란드, 20-607
        • 모병
        • Research Site
      • Nadarzyn, 폴란드, 05-830
        • 모병
        • Research Site
      • Nowa Sól, 폴란드, 67-100
        • 아직 모집하지 않음
        • Research Site
      • Poznan, 폴란드, 60-693
        • 아직 모집하지 않음
        • Research Site
      • Poznan, 폴란드, 61-397
        • 아직 모집하지 않음
        • Research Site
      • Poznan, 폴란드, 60-681
        • 아직 모집하지 않음
        • Research Site
      • Warsaw, 폴란드, 05-077
        • 아직 모집하지 않음
        • Research Site
      • Warsaw, 폴란드, 02-637
        • 아직 모집하지 않음
        • Research Site
      • Warsaw, 폴란드, 01-691
        • 모병
        • Research Site
      • Wroclaw, 폴란드, 53-673
        • 아직 모집하지 않음
        • Research Site
  • 프랑스
      • Clermont-Ferrand, 프랑스, 63000
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        • Research Site
      • Lyon, 프랑스, 69437
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        • Research Site
      • Marseille, 프랑스, 13385
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        • Research Site
      • Paris, 프랑스, 75013
        • 모병
        • Research Site
      • Paris, 프랑스, 75012
        • 아직 모집하지 않음
        • Research Site
      • Pessac, 프랑스, 33604
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        • Research Site
      • Saint-Denis, 프랑스, 97405
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        • Research Site
      • Saint-Pierre, 프랑스, 97448
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        • Research Site
      • Toulon, 프랑스, 83800, Cedex
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        • Research Site
      • Tours, 프랑스, 37044
        • 아직 모집하지 않음
        • Research Site
      • Vandœuvre-lès-Nancy, 프랑스, 54511
        • 아직 모집하지 않음
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참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Males or females aged 18 to 70 years of age.

  2. Participants who have a diagnosis of SLE confirmed by a rheumatologist.

  3. ANA-positive per the Central Lab at screening:

    (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)

  4. Must be on the standard therapy regimen: antimalarials with or without OCSs

  5. Must have at screening and baseline:

    1. Clinical SLEDAI-2K ≥ 4 points OR
    2. Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)

  6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis [TB]) or previous TB

  7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).

  8. No medical history or signs or symptoms of active TB prior to or during Screening.

  9. Body weight ≥ 40.0 kg

  10. Negative pregnancy test for females during screening

  11. Normal HPV test result within 2 years prior to Week 0 (Day 1).

  12. Willing and able to participate in all required study evaluations and procedures including completion of PROs.

  13. Willing to not use any other forms of experimental treatment during the study.

Exclusion Criteria:

  1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.

  2. 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.

  3. 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.

  4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.

  5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.

  6. 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.

  7. 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.

  8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.

  9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS).

  10. 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).

  11. 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.

  12. Confirmed positive test for hepatitis B.

  13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.

  14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).

  15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).

  16. Severe HZ or recurrent HZ.

  17. Malignancy. 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).

  18. Received any SLE-related therapies other than antimalarials and GCs.

  19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.

  20. History of an anaphylactic reaction to human proteins or mAbs.

  21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.

  22. Blood transfusion or receipt of blood products except albumin.

  23. Received more than 2 investigational products for the SLE since time of diagnosis.

  24. 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.

  25. Concurrent enrollment in another clinical study with a study intervention.

  26. Subjects with any abnormal lab result as specified in the protocol.

  27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).

  28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.

  29. 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).

  30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.

  31. 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.

  32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.

  33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).

  34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Anifrolumab

Participants will receive dose A of anifrolumab on X dosing schedule beginning on Day 1 for a maximum of 52 -week during the study
의약품: Anifrolumab

Patients will receive Anifrolumab subcutaneous

다른 이름들:
  • 사프넬로

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Attainment of DORIS remission
기간: 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.
At Week 52

2차 결과 측정

결과 측정
측정값 설명
기간
To assess the attainment of low level disease activity
기간: At Week 28 and 52

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)
At Week 28 and 52
Time spent in DORIS remission, LLDAS or LLDAS-5
기간: At Week 52

Time spent in DORIS remission, LLDAS or LLDAS-5 for participants initiated on anifrolumab will be measured.
At Week 52
Sustaining DORIS remission, LLDAS or LLDAS-5
기간: All subsequent visits including 52 Week

The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 through to Week 52 will be measured.
All subsequent visits including 52 Week
Sustaining DORIS remission, LLDAS or LLDAS-5
기간: At 3 consecutive visits occurring every 4 weeks during the 52 Week study

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.
At 3 consecutive visits occurring every 4 weeks during the 52 Week study
Time to attain and sustain DORIS, or LLDAS, or LLDAS-5
기간: Through Week 52

The time to attain and sustain DORIS, or LLDAS, or LLDAS-5 will be analyzed.
Through Week 52
Daily GC dose
기간: At Week 40 and Week 52

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.
At Week 40 and Week 52
Reduction in GC use
기간: From Week 4 to Week 40

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
From Week 4 to Week 40
Maintenance of reduction in GC dose
기간: During 52 Week

Maintenance of this percent reduction in GC dose through Week 52 will be assessed
During 52 Week
Cumulative GC dose
기간: Week 0 to Week 52

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.
Week 0 to Week 52
Attainment of DORIS-0
기간: From baseline over 52 Weeks

Proportion of participants who attain DORIS-0 from baseline over 52 weeks. DORIS-0 is defined as DORIS criteria with prednisone 0 mg daily.
From baseline over 52 Weeks
Time to first moderate-to-severe flare
기간: Through Week 52

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.
Through Week 52
Change in active skin manifestations
기간: At Week 4, Week 16, and Week 52

The change in active skin manifestations of SLE measured by CLASI activity score in participants initiated on anifrolumab will be assessed.
At Week 4, Week 16, and Week 52
Change in joint activity
기간: At Week 28 and 52

The average change in number of active joints (swollen and tender joints) in participants initiated on anifrolumab compared to baseline will be assessed
At Week 28 and 52
Change in QoL and fatigue
기간: At 52 Week

Change in QoL and fatigue in participants initiated on anifrolumab will be assessed using FACIT-F.
At 52 Week
Adverse Events
기간: Up to 52 Weeks

Safety and tolerability of anifrolumab will be assessed.
Up to 52 Weeks
Change in QoL and fatigue
기간: At 52 Week

Change in QoL and fatigue in participants initiated on anifrolumab will be assessed using PROMIS Lupus.
At 52 Week

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

ICON plc

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 13일

기본 완료 (추정된)

2029년 1월 26일

연구 완료 (추정된)

2029년 1월 26일

연구 등록 날짜

최초 제출

2026년 2월 2일

QC 기준을 충족하는 최초 제출

2026년 2월 18일

처음 게시됨 (실제)

2026년 2월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D3461C00040

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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