Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05440422
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-06-29
Brief Title:
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus SLE - IFN-CVD
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2024-09-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-PETCT 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
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-PETCT 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 Objective 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 Endpoints
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 Endpoints
Changes over time in biomarkers of cardiovascular riskimmune 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
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 Objective 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 Endpoints
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 Endpoints
Changes over time in biomarkers of cardiovascular riskimmune 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000682-AR | None | None | None |