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2-HOBA in Systemic Lupus Erythematosus
Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the 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.
What is being tested
- 2-HOBA acetate (2-Hydroxybenzlamine acetate) (drug)
- Placebo (drug)
Sponsor: Vanderbilt University Medical Center · Participants: 42 · Started: May 15, 2026
Contact the study team
- Phicharmon Kulapatana (study coordinator) · Phone: 615-936-5747
Official record on ClinicalTrials.gov — NCT07225543
Locations in the U.S.
| Tennessee | Vanderbilt University Medical Center, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.