The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
- Conditions
- Premature AtherosclerosisCardiovascular DiseaseSystemic Lupus Erythematosus
- Interventions
- Other: Placebo
- Registration Number
- NCT05440422
- Lead Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Brief Summary
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.
- Detailed Description
Study Description:
This is a double blind placebo-controlled study to characterize whether blocking type I IFN receptor signaling with anifrolumab will lead to improvements in vascular function, decreases in vascular inflammation and modulation of biomarkers of vascular risk in patients with systemic lupus erythematosus (SLE).
Objectives:
Primary Objective:
To assess the role of anifrolumab in modulating vascular function and vascular inflammation in SLE patients with mild to moderate disease activity as determined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K\<= 6.
Secondary Objectives:
To assess the role of anifrolumab in modulating biomarkers of cardiovascular risk in SLE patients with mild to moderate disease activity as determined by SLEDAI 2K\<= 6. Assess safety and tolerability of short-term use of anifrolumab
Endpoints:
Primary:
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.
Secondary:
Changes over time in biomarkers of cardiovascular risk/immune dysregulation and metabolic dysfunction previously described in SLE. These biomarkers include but not limited to lipoprotein profiles and high-density lipoprotein cholesterol efflux capacity, immune cell types, endothelial progenitor cells, circulating neutrophil extracellular traps, serum cytokines, acute phase reactants, insulin resistance, transcriptomic analysis of peripheral immune cells.
Tertiary:
Safety, as assessed by severity and incidence of adverse events and the change over time from baseline in laboratory variables.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient placebo Placebo placebo Patient anifrolumab anifrolumab
- Primary Outcome Measures
Name Time Method role of anifrolumab 8 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.
- Secondary Outcome Measures
Name Time Method Role of anifrolumab 8 months in modulating biomarkers of cardiovascular risk in SLE patients with mild to moderate disease activity as determined by SLEDAI 2K= 6. Assess safety and tolerability of short-term use of anifrolumab
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States