Recruiting
Phase 2

2-HOBA

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07225543

Conditions

Systemic Lupus Erthematosus (SLE)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

2-HOBA acetate (2-Hydroxybenzlamine acetate)

Placebo

Study Details

Brief 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.

Conditions

Systemic Lupus Erthematosus (SLE)

Study ID

NCT07225543

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Placebo First

Placebo for first 8 weeks, then washout for 4 weeks, and then 2-HOBA acetate for 8 weeks

experimental: 2-HOBA First

2-HOBA acetate for first 8 weeks, then washout for 4 weeks, and then placebo for 8 weeks

Interventions

2-HOBA acetate (2-Hydroxybenzlamine acetate)

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

Placebo

Placebo (provided as two capsules) three times per day

Primary outcome measure

  • 24-hour systolic blood pressure [ Time Frame: Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20. ]
  • NETosis [ Time Frame: Measured at beginning and end of each phase at weeks 0, 8, 12, and 20. ]

Central Contacts and Locations

Central contacts

Phicharmon Kulapatana (study coordinator)

615-936-5747phicharmon.kulapatana@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Phicharmon Kulapatana

615-936-5747phicharmon.kulapatana@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • systemic lupus erythematosus
  • SLE
  • lupus
  • oxidative stress
  • hypertension
  • blood pressure
  • NETosis
  • isolevuglandins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-22.