2-HOBA Tested in Adults With Lupus
Tests 2-HOBA against placebo for blood pressure and immune activity in lupus.
Plain-language title generated from the registry record
Registry title: 2-HOBA in Systemic Lupus Erythematosus
Key facts
- Where
- Nashville, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vanderbilt University Medical Center
- Trial code
- NCT07225543
- Record updated
- 22 May 2026
- Original 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.Read full original descriptionShow less
Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study
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.
Inclusion: 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: Major surgery in ≤ 3 months; Active cancer except for non-melanoma skin cancer; Active infection requiring medical intervention; Aspirin allergy; Severe comorbid condition; 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; Estimated creatinine clearance <30 ml/min; Pregnant or breastfeeding; Male (biological); Use of MAO-I; Known atrial fibrillation.