Anifrolumab for Vascular Risk in Lupus (SLE)
This study is investigating if anifrolumab, a drug, can improve blood vessel health in people with systemic lupus erythematosus (SLE). People with SLE can have complications with their blood vessels, increasing their risk of heart attack or stroke. This study aims to see if anifrolumab can improve how your blood vessels work and reduce inflammation in them. We are looking for 45 participants, aged 18-80, who have SLE. Success in this study would mean seeing improvements in vascular function and reduced inflammation in the blood vessels after 8 months of treatment. The current recruitment status is unclear.
- Study design
- This is a double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving anifrolumab or a placebo (an inactive substance). The study plans to enroll 45 participants.
- What's involved
- You will have a physical exam, blood and urine tests, a heart function test, and a chest X-ray. You will also answer questions about your SLE symptoms. You will visit the clinic 9 times over 8 months, with visits every 4 weeks after an initial screening.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 8 months, which suggests the main follow-up period for treatment effects.
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NCT05440422
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
Recruiting
PHASE2Ages 18–80InterventionalTreatmentNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government-funded
~45 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:anifrolumabPlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
role of anifrolumab
Measured over 8 months
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Mariana J Kaplan, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Concurrent enrolment in another clinical study with an investigational product
Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.
Any of the following found at Screening:
Aspartate aminotransferase (AST) \>2.5 x upper limit of normal (ULN).
Alanine aminotransferase (ALT) \>2.0 x ULN.
Total bilirubin \>ULN (unless due to Gilbert's syndrome)
Serum creatinine \>2.5 mg/dL (or \>181 micromol/L)
Urine protein/creatinine ratio \>2.0 mg/mg (or \>226.30 mg/mmol)
Neutrophil count \<1000/microL (or \<1.0 x 109/L)
Platelet count \<25000/microL (or \<25 x 109/L)
Hemoglobin \<8 g/dL (or \<80 g/L), or \<7 g/dL (or \<70 g/L) if related to subject's SLE such as in active hemolytic anemia
Glycosylated hemoglobin (HbA1c) \>8% (or \>0.08) at screening (diabetic subjects only). Patients with HbA1c \>8% may be eligible for study if considered to be at low risk of infection and vascular complications at the discretion of study PI.
Positive SARS/Flu A/B/RSV (Panther), PCR - risk-based testing, only required if patient is symptomatic or has been exposed to someone with the virus.
Receipt of any of the following:
Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to week 0 (day 1), whichever is greater.
Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF
Receipt of B cell depleting therapy (including but not limited to belimumab, ocrelizumab, ofatumumab, atacicept, Obinutuzumab, or rituximab), \<26 weeks prior to the signing of the consent for all B-cell depleting therapy or \<40 weeks prior to the signing of the ICF for atacicept.
Receipt of any of the following: (a) Intra-articular, intramuscular or IV corticosteroids within 4 weeks prior to Day 1 (b) Any live or attenuated vaccine within 8 weeks prior to signing the ICF (administration of killed vaccines is acceptable)
History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months based on screening or at baseline.
Recent cardiac or stroke event (with in the last year prior to week 0 (day 1))
Active SLE disease with SLEDAI 2K \>6 at the time of 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; and mononeuritis multiplex:
Active severe SLE-driven renal disease where, in the opinion of the PI, protocol specified standard of care (SOC) is insufficient and utilization 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.
History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to signing the ICF. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable.
Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation.
Confirmed positive test for hepatitis B serology for:
Positive test for hepatitis C antibody along with detectable Hepatitis C viral RNA.
Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes (ever)
Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
Any of the following:
Any infection requiring oral antimicrobials (including antivirals) within 2 weeks prior to Day 1, except if taking antivirals/antimicrobials prophylactically.
History of cancer, apart from:
Pregnancy or lactation or intend to become pregnant anytime from initiation of Screening until completion of study.
Spontaneous or induced abortion, still or live birth, or pregnancy \<= 4 weeks prior to week 0 (day1)
Known allergic reactions to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy.
Tested positive for COVID-19 infection on the day of screening or up to 21 days prior to screening.
What this trial measures
- role of anifrolumab8 months
1.Change from Baseline (Week 0) to Week 28 in cardio-ankle vascular index (CAVI). 2. Change from Baseline to Week 28 in pulse wave velocity (PWV) using Sphygmocor. 3. Change from Baseline to Week 28 in vascular inflammation as measured by target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scans.