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NCT05440422 · ClinicalTrials.gov registry record · Phase 2
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
A Phase 2 study of Cardiovascular Disease and Systemic Lupus Erythematosus, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT05440422: Recruiting Phase 2 study of Cardiovascular Disease and Systemic Lupus Erythematosus, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT05440422 is a Phase 2 study of Cardiovascular Disease and Systemic Lupus Erythematosus that is actively recruiting participants, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 45 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05440422, a Phase 2 study of Cardiovascular Disease and Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG anifrolumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2023-12-07 |
| Est. Completion | 2027-08-02 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What NCT05440422 shows while recruiting
NCT05440422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05440422 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05440422 about?
NCT05440422 is a clinical study titled "The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD". 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 (anifr...
What is the current status of trial NCT05440422?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2023-12-07. Estimated completion is 2027-08-02.
What conditions does trial NCT05440422 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Systemic Lupus Erythematosus, Premature Atherosclerosis.
What interventions are being tested in trial NCT05440422?
The interventions under investigation include: Placebo (OTHER), anifrolumab (DRUG).
Who is sponsoring clinical trial NCT05440422?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05440422 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05440422's enrollment target sits among peer trials
45 111th of 137 higher than 27 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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