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2-HOBA in Systemic Lupus Erythematosus

RecruitingPhase 2Ages 18 Years - anyFemaleVanderbilt University Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Written informed consent * Age โ‰ฅ18 years * Female (biological) * Meeting the 2019 European League Against Rheumatism/ American College of Rheumatology classification criteria for SLE32 * No change in immunosuppressants โ‰ฅ3 months * Stable prednisone (or equivalent) dose โ‰ค 20mg/ day for โ‰ฅ 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 โ‰ฅ2 weeks * Willingness to stop NSAIDs for โ‰ฅ2 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 โ‰ฅ1.5 mg/dl * Active infection requiring medical intervention * Major surgery in โ‰ค 3 months * Aspirin allergy * Use of MAO-I * Estimated creatinine clearance \<30 ml/min * Known atrial fibrillation * Severe comorbid condition
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What it tests

  • 2-HOBA acetate (2-Hydroxybenzlamine acetate)
  • Placebo
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Where

1 site
Vanderbilt University Medical Center
Nashville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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