The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus, Cardiovascular Disease, Premature Atherosclerosis

In brief

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.

Key facts

Study ID

NCT05440422

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

45

Starts

2023-12-07

Expected to finish

2027-08-02

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this
• study:
• 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)
• Positive SARS/Flu A/B/RSV (Panther), PCR
• Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.
• Receipt of any of the following:
• Azathioprine >200 mg/day
• Mycophenolate mofetil > 3 g/day or mycophenolic acid >2.16 g/day
• Oral, SC, or intramuscular methotrexate >25 mg/week
• Mizoribine >150 mg/day. Leflunomide more than 20 mg and any other immunosuppressant usage at the discretion of the PI.
• 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.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.