2-HOBA in Systemic Lupus Erythematosus
ConditionSystemic Lupus Erthematosus (SLE)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVanderbilt University Medical Center
About this trial
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 criteria
Qualifiers
Written informed consent
Age ≥18 years
Female (biological)
Meeting the 2019 European League Against Rheumatism/ American College of Rheumatology classification criteria for SLE32
Disqualifiers
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
Trial design
Treatments tested in this trial
- 2-HOBA acetate (2-Hydroxybenzlamine acetate)
- Placebo
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov