Actively Recruiting
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2026-04-06
45
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Objective: To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE. Eligibility: People aged 18 to 80 years with SLE. Design: Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms. Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours. Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting. At some visits they will have additional tests: CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms. FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.
CONDITIONS
Official Title
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and available for the duration of the study
- Male or female, aged 18-80 years
- In good general health or diagnosed with SLE by American College of Rheumatology 1997 criteria
- Taking prednisone \u2264 10 mg/day for at least 2 weeks before screening and maintained through randomization
- Stable standard lupus therapies for at least 4 weeks before screening and maintained through randomization
- Abnormal cardio-ankle vascular index (CAVI) at screening or within 90 days prior
- Stable medications for diabetes, hypertension, and/or statins for at least 3 months
- Use of highly effective contraception during study and for 16 weeks after treatment (abstinence allowed)
- Confirmation of prior COVID-19 and Varicella Zoster vaccinations by verbal report and antibodies
You will not qualify if you...
- Any condition interfering with study evaluation or safety in the investigator's opinion
- Concurrent enrollment in another investigational clinical study
- Major surgery within 8 weeks before consent or planned during the study
- Abnormal liver enzymes (AST > 2.5x ULN, ALT > 2.0x ULN), total bilirubin > ULN (except Gilbert's)
- Serum creatinine >2.5 mg/dL or urine protein/creatinine ratio >2.0 mg/mg
- Low neutrophil count (<1000/microL), platelet count (<25000/microL), or hemoglobin (<8 g/dL or <7 g/dL if related to SLE)
- HbA1c >8% in diabetics at screening
- Positive PCR for SARS/Flu A/B/RSV
- Use of high-dose immunosuppressants or recent biologic agents within specified timeframes
- Recent corticosteroid injections or live vaccine administration
- History of suicidal ideation or behavior within past 6-12 months
- Cardiac or stroke event within 1 year before study start
- Active SLE with SLEDAI 2K >6
- Severe or unstable neuropsychiatric or renal SLE requiring aggressive therapy
- Recent severe infections or chronic infections requiring recent treatment
- History of certain cancers treated successfully
- Pregnancy, lactation, or recent pregnancy events
- Allergic reactions to investigational product components
- Positive COVID-19 test within 21 days before screening
- Positive tests for hepatitis B or C with active virus
- History of severe herpes infections or unresolved viral infections
- Known immunodeficiency, splenectomy, or HIV infection confirmed at screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Lubna K Hooda, R.N.
CONTACT
M
Mariana J Kaplan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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