A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
Key facts
- Where
- Bydgoszcz, Cracow, Częstochowa, Katowice, Lodz, Lublin, Nadarzyn, Nowa Sol, Poznan, Warsaw és Wroclaw, LengyelországSee the 15 sites
- Phase
- 3. fázis
Where in Lengyelország
- Medicover Integrated Clinical Services Sp. z o.o.Bydgoszcz, LengyelországTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországTaking people
- Pratia S.A.Częstochowa, LengyelországTaking people
- Provita Sp z o oKatowice, LengyelországTaking people
- Somed Cr Sp. z o.o. sp.k.Lodz, LengyelországTaking people
- Reumed Sp. z o.o.Lublin, LengyelországTaking people
- NZOZ Lecznica MAK MED S CNadarzyn, LengyelországTaking people
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.Nowa Sol, LengyelországTaking people
- Med Polonia Sp z o.o.Poznan, LengyelországTaking people
- Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel HrycajPoznan, LengyelországTaking people
- Termedia Sp. z o.o.Poznan, LengyelországTaking people
- Centrum medyczne Justmed Sp. z o.o.Warsaw, LengyelországTaking people
- Medicover Integrated Clinical Services Sp. z o.o.Warsaw, LengyelországTaking people
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, LengyelországTaking people
- Futuremeds Sp. z o.o.Wroclaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2025-523670-17-00
- Record updated
- 2026. szeptember 30.
- Original description
To describe the attainment of DORIS remission in IS-naïve and biologic-naïve participants with Systemic Lupus Erythematous (SLE) on antimalarials with or without (glucocorticoid) GC, initiated on anifrolumabRead full original descriptionShow less
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)
To describe the attainment of DORIS remission in IS-naïve and biologic-naïve participants with Systemic Lupus Erythematous (SLE) on antimalarials with or without (glucocorticoid) GC, initiated on anifrolumab
Inclusion: Males or females aged 18 to 70 years of age inclusive at the time of sigining the ICF; Participants who have a diagnosis of SLE, confirmed by a rheumatologist, for at least 3 months (≥ 12 weeks) prior to signing the ICF (SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria); ANA-positive as determined by a documented historical test result confirmed at Screening for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80) or at least one of the following determined at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm); Must be receiving the standard therapy regimen: antimalarials with or without OCSs; Must have at screening and baseline: (a) Clinical SLEDAI-2K ≥ 4 points OR (b) Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent); Additional details on inclusion criteria are described in protocol section 5.1 Inclusion Criteria.
Exclusion: Clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF; Clinically significant chronic infection within 8 weeks prior to signing the ICF; History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS) within one year prior to signing the ICF; History of, or current diagnosis of, a clinically significant non-SLE-related vasculitis syndrome ; Confirmed positive test for hepatitis B serology; Active hepatitis C infection; Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1); Malignancy. History of cancer; Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose are allowed if this is not the sole or the predominant feature of their SLE. Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit are excluded; 3.Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism are excluded. Subjects with a history of 3 or more unexplained consecutive pregnancy losses would also be excluded; Active severe SLE-driven renal disease where protocol-specified standard therapy is insufficient; History of recurrent infection requiring hospitalization and IV antibiotics; Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening; Severe Herpes Zostet (HZ) or recurrent HZ; History or evidence of suicidal ideation (severity of 4 or 5) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant; Active severe or unstable neuropsychiatric SLE.