Actively Recruiting
Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study of 2-HOBA in Systemic Lupus Erythematosus
Led by Vanderbilt University Medical Center · Updated on 2026-05-22
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of scavenging isolevuglandins (IsoLGs) with 2-HOBA on blood pressure and immune activation in patients with systemic lupus erythematosus (SLE), an autoimmune disease linked to high rates of hypertension and cardiovascular risks. This phase II randomized, placebo-controlled, double-blind, cross-over trial aims to understand the role of IsoLGs in SLE-related hypertension and immune responses. Participants will receive either placebo or 500mg of 2-HOBA acetate three times a day for 8 weeks, followed by a 4-week washout period, then switch to the other treatment for another 8 weeks. The study includes two treatment sequences: placebo first then 2-HOBA, or 2-HOBA first then placebo. This design allows comparison of blood pressure and immune activity changes between treatments. During the study, 42 women with stable SLE will undergo evaluations including 24-hour blood pressure monitoring and measurement of NETosis at baseline and at weeks 8, 12, and 20. Researchers will monitor immune activation and blood pressure changes to assess the impact of 2-HOBA compared to placebo. The total participation includes treatment periods and washout spanning 20 weeks.
CONDITIONS
Brief Title
2-HOBA in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Female (biological sex)
- Meet the 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for SLE
- No changes in immunosuppressant medications for at least 3 months
- Stable prednisone (or equivalent) dose of 20mg/day or less for at least 1 month
- Elevated blood pressure: systolic >120 and ≤160 mmHg or diastolic >80 and ≤110 mmHg at screening
- No changes in anti-hypertensive medication dose for at least 2 weeks
- Willingness to stop NSAIDs for at least 2 weeks before and throughout the study
- If of childbearing potential, willingness to use effective birth control during and 4 weeks after the study
You will not qualify if you...
- Pregnant or breastfeeding
- Male (biological sex)
- Active cancer except non-melanoma skin cancer
- History of liver cirrhosis or abnormal liver function tests (AST or ALT >1.5 times upper limit of normal or total bilirubin ≥1.5 mg/dl)
- Active infection requiring medical treatment
- Major surgery within the past 3 months
- Allergy to aspirin
- Use of monoamine oxidase inhibitors (MAO-I)
- Estimated kidney function (creatinine clearance) below 30 ml/min
- Known atrial fibrillation
- Severe other medical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive either 2-HOBA acetate or placebo three times daily for 8 weeks, followed by a 4-week washout, then switch to the other treatment for 8 weeks.
Visits at weeks 0, 8, 12, and 20 for assessments
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
P
Phicharmon Kulapatana (study coordinator)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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