2-HOBA in Systemic Lupus Erythematosus

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.

Eligibility

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

Conditions2

Interventions1

Locations1 site

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