A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Syste… (NCT07751848) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus
China417 participantsStarted 2026-09-04
Plain-language summary
This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines). Further, it aims to describe outcomes alongside a systematic approach to glucocorticoid (GC) tapering, in terms of effectively minimising GC use, as well as discontinuing GC use, thereby reducing GC exposure.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Capable of giving signed informed consent. Age
. Participant must be 18 to 70 years of age inclusive, at the time of signing the ICF.
. Participants who have a diagnosis of SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria (Appendix D), confirmed by a rheumatologist
. 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:
. Anti-dsDNA (b) Anti-Smith (anti-Sm) Note: Retesting of autoantibodies is allowed once during Screening.
. To be eligible a participant must have SLEDAI-2K ≥6 or clinical SLEDAI-2K ≥ 4 points:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients who achieve DORIS remission at week 52
. In order to qualify for SLEDAI-2K score for arthritis at Screening, participant must have at least 3 joints with tenderness AND swelling (same joints) due to SLE.
. In order to qualify for SLEDAI-2K score for rash at Screening, participant must have rash with significant erythema (not only faint pink erythema)
Exclusion criteria
. History of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome Vasculitis due to SLE is allowed in the study.
. Non-SLE diseases that potentially require systemic glucocorticoids (e.g. IV or oral), as determined by medical judgment, e.g. asthma, chronic obstructive pulmonary disease (COPD).
. 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, in the opinion of primary investigator or AstraZeneca, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
. Active severe SLE-driven renal disease where, in the opinion of the primary investigator or AstraZeneca, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease are excluded. Subjects with an overlap syndrome of SLE with rheumatoid arthritis are not excluded as long as they meet the criteria for the classification of SLE.
. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.) are excluded. Subjects with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
. History of, or current diagnosis of, catastrophic anti-phospholipid syndrome (APS) within one year prior to signing the ICF. 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 are excluded. Subjects with a history of 3 or more unexplained consecutive pregnancy losses would also be excluded. Participants with other degrees of APS adequately controlled by anticoagulants ((i.e., if on warfarin, an international normalized ratio \[INR\] target 2 to 3 or as appropriate for the clinical situation) or aspirin for at least 12 weeks can be recruited to the study.
. Current or history of Hypothalamic-Pituitary-Adrenal (HPA) axis related disease, Addison disease, adrenal haemorrhage etc.