2-HOBA in Systemic Lupus Erythematosus
Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study
Vanderbilt University Medical Center
42 participants
May 15, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria11
- 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
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Interventions
2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day
Placebo (provided as two capsules) three times per day
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07225543