2-HOBA in Systemic Lupus Erythematosus (NCT07225543) | Clinical Trial Compass
RecruitingPhase 2
2-HOBA in Systemic Lupus Erythematosus
United States42 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24-hour systolic blood pressure
Timeframe: Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20.
2
NETosis
Timeframe: Measured at beginning and end of each phase at weeks 0, 8, 12, and 20.