2-HOBA in Systemic Lupus Erythematosus
Recruiting · NCT07225543 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanderbilt University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a phase II randomized, placebo-controlled, double-blind, cross-over study to determine the effect of isolevuglandin (IsoLG) scavenging by 2-HOBA on blood pressure and immune activation in patients with SLE. 42 patients with stable SLE will be randomized to treatment sequence to receive placebo or 500mg 2-HOBA three times a day for 8 weeks followed by a 4 week washout and then 8 weeks of the other agent. Primary outcome measures include change in 24-hour blood pressure and NETosis. This study will provide mechanistic information on the role of IsoLGs in autoimmune disease-associated hypertension and immune activation.
Who can take part
Inclusion criteria
- Written informed consent
- Age ≥18 years
- Female (biological)
- Meeting the 2019 European League Against Rheumatism/ American College of Rheumatology classification criteria for SLE32
- No change in immunosuppressants ≥3 months
- Stable prednisone (or equivalent) dose ≤ 20mg/ day for ≥ 1 month
- Elevated blood pressure defined as \>120 and \< or = 160 mmHg systolic or \>80 and \< or = 110 mmHg diastolic blood pressure at screening visit
- No change in anti-hypertensive dose ≥2 weeks
- Willingness to stop NSAIDs for ≥2 weeks before and throughout the study
- If of childbearing potential, willingness to use effective birth control throughout the study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)
Exclusion criteria
- Pregnant or breastfeeding
- Male (biological)
- Active cancer except for non-melanoma skin cancer
- Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \>1.5x the upper limit of normal or total bilirubin ≥1.5 mg/dl
- Active infection requiring medical intervention
- Major surgery in ≤ 3 months
- Aspirin allergy
- Use of MAO-I
- Estimated creatinine clearance \<30 ml/min
- Known atrial fibrillation
- Severe comorbid condition
Where it is running
1 location listed across 1 US state.
- Vanderbilt University Medical Center - Nashville, Tennessee, United States