2-HOBA for Systemic Lupus Erythematosus
2-HOBA in Systemic Lupus Erythematosus
Recruiting
Phase 2
Interventional Study
Systemic Lupus Erthematosus (SLE)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 42 (estimated)
- Sponsor
- Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for women with stable systemic lupus erythematosus (SLE) to test a treatment called 2-HOBA. Participants will take either 2-HOBA or a placebo for 8 weeks, then switch to the other treatment after a break.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a woman and at least 18 years old.
- I have been diagnosed with systemic lupus erythematosus.
- I have not changed my immunosuppressants in the last 3 months.
- I have been taking a stable dose of prednisone for at least 1 month.
- I have elevated blood pressure at my screening visit.
- I have not changed my anti-hypertensive dose in the last 2 weeks.
- I am willing to stop taking NSAIDs for at least 2 weeks before and during the study.
- If I can get pregnant, I will use effective birth control during the study.
You may not be able to join if
- I am pregnant or breastfeeding.
- I am a man.
- I have active cancer besides non-melanoma skin cancer.
- I have been diagnosed with liver cirrhosis or have abnormal liver function tests.
- I have an active infection that needs medical treatment.
- I have had major surgery in the last 3 months.
- I am allergic to aspirin.
- I have known atrial fibrillation.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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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 th…
Trial Locations
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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/…
Contacts