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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

2-HOBA acetate (2-Hydroxybenzlamine acetate)
Drug
2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day
Placebo
Drug
Placebo (provided as two capsules) three times per day

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: Placebo FirstExperimental treatment 2 interventions

Group B: 2-HOBA FirstExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

24-hour systolic blood pressure

Investigators will measure change in 24-hour systolic blood pressure

Time frame

Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20.

NETosis

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

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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