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2-HOBA for Systemic Lupus Erythematosus

This study is looking at how a drug called 2-HOBA acetate affects blood pressure and immune system activity in people with Systemic Lupus Erythematosus (SLE), an autoimmune disease. Researchers believe that certain byproducts of stress in the body, called isolevuglandins (IsoLGs), might contribute to high blood pressure and immune problems in SLE. 2-HOBA acetate is thought to help by removing these IsoLGs. You might be able to join if you are a woman, at least 18 years old, have stable SLE, and have elevated blood pressure. The study will measure changes in your 24-hour blood pressure and NETosis (a type of immune cell activity) to see if 2-HOBA acetate is helpful. The current status of this study is unclear.

Study design
This is a randomized, placebo-controlled, double-blind, cross-over study involving 42 participants. This means participants will be randomly assigned to receive either 2-HOBA acetate or a placebo, and neither you nor your doctor will know which you are receiving.
What's involved
Participants will take two capsules of either 2-HOBA acetate or placebo three times a day for 8 weeks, followed by a 4-week break, and then 8 weeks of the other agent. Blood pressure and NETosis will be measured at the beginning and end of each phase (weeks 0, 8, 12, and 20).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 20 weeks, which includes the treatment phases and a washout period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07225543

2-HOBA in Systemic Lupus Erythematosus

Recruiting
PHASE2Ages 18+InterventionalTreatment
Vanderbilt University Medical Center
~42 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:2-HOBA acetate (2-Hydroxybenzlamine acetate)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24-hour systolic blood pressure
Measured over Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20.
+1 more outcome measured

Conditions

Systemic Lupus Erthematosus (SLE)

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Michelle J Ormseth, MD, MSCI · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Phicharmon Kulapatana (study coordinator)
[email protected]
615-936-5747
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • 24-hour systolic blood pressureMeasured at the beginning and end of each phase at weeks 0, 8, 12, and 20.

    Investigators will measure change in 24-hour systolic blood pressure

  • NETosisMeasured at beginning and end of each phase at weeks 0, 8, 12, and 20.

    Investigators will measure change in NETosis by ELISA assessing circulating NET concentration