NCT07225543 · Vanderbilt University Medical Center
2-HOBA in Systemic Lupus Erythematosus
What this study is about
This is a phase II randomly assigned, compared against an inactive treatment, where neither patients nor doctors know which treatment is given, cross-over study to determine the effect of isolevuglandin (IsoLG) scavenging by 2-HOBA on blood pressure and immune activation in patients with SLE.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations