NCT07225543 2-HOBA in Systemic Lupus Erythematosus
| NCT ID | NCT07225543 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Systemic Lupus Erthematosus (SLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2026-05-15 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michelle J Ormseth, MD, MSCI
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07225543 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Systemic Lupus Erthematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225543 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07225543 currently recruiting?
Yes, NCT07225543 is actively recruiting participants. Contact the research team at phicharmon.kulapatana@vumc.org for enrollment information.
Where is the NCT07225543 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07225543 clinical trial?
NCT07225543 is sponsored by Vanderbilt University Medical Center. The principal investigator is Michelle J Ormseth, MD, MSCI at Vanderbilt University Medical Center. The trial plans to enroll 42 participants.
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