2-HOBA for Lupus

Overseen By Phicharmon Kulapatana (study coordinator)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanderbilt University Medical Center

Must not be taking: NSAIDs, MAO-I

Disqualifiers: Pregnancy, Cancer, Liver cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 2-HOBA for people with lupus, a condition where the immune system attacks the body. The goal is to determine if 2-HOBA can lower blood pressure and reduce immune system activity in those with lupus. Participants will begin with either a placebo (a harmless pill with no treatment effect) or 2-HOBA for four weeks, take a break, and then switch to the other option. People with stable lupus who have high blood pressure and can manage without certain medications like NSAIDs (common painkillers) for a while might be suitable for this study. As a Phase 2 trial, this research measures how well 2-HOBA works in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

You will need to stop taking NSAIDs (non-steroidal anti-inflammatory drugs) for at least 2 weeks before and throughout the study. Other medications, like immunosuppressants and anti-hypertensives, should remain stable without changes for a specified period before joining the trial.

Is there any evidence suggesting that 2-HOBA is likely to be safe for humans?

Research has shown that 2-HOBA has been studied for its effects on stress and inflammation in healthy individuals. These studies found that 2-HOBA is generally well-tolerated, with most participants experiencing no major issues. No major safety concerns have been reported, and participants did not experience serious side effects, suggesting that 2-HOBA might be safe for further use.

This trial is in phase 2, indicating that the treatment has shown some safety in earlier research but is still being tested for effectiveness and safety in individuals with specific conditions, such as lupus. Although the results appear promising, further research is necessary to confirm them. It is crucial to consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Most treatments for lupus, like corticosteroids and immunosuppressants, work by broadly suppressing the immune system to reduce inflammation. But 2-HOBA is unique because it targets oxidative stress, a different mechanism that may contribute to lupus flare-ups. Researchers are excited about 2-HOBA because it has the potential to reduce damage to cells and tissues without the broad immune suppression seen in standard treatments. This could mean fewer side effects and a more targeted approach to managing lupus symptoms, offering new hope for patients seeking alternatives to current therapies.

What evidence suggests that 2-HOBA might be an effective treatment for lupus?

Research suggests that 2-HOBA, which participants in this trial may receive, may help manage lupus by targeting harmful substances in the body. This treatment removes isolevuglandins (IsoLGs), which are linked to inflammation and immune system activity in lupus patients. Earlier studies showed that 2-HOBA reduced signs of oxidative stress and inflammation in healthy people, both important factors in lupus. Additionally, studies indicate that IsoLGs can interfere with normal immune function, making 2-HOBA a promising option for reducing these issues. While more research is needed, these findings offer hope for its effectiveness in treating lupus symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Michelle J Ormseth, MD, MSCI

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with stable Systemic Lupus Erythematosus (SLE), who may also have high blood pressure. Participants will be given either a new treatment called 2-HOBA or a placebo to see if it affects their blood pressure and immune system activity.

Inclusion Criteria

I am 18 years old or older.

My immunosuppressant medication has been stable for 3 months.

I am willing to stop taking NSAIDs for 2 weeks before and during the study.

Exclusion Criteria

I am currently taking an MAO inhibitor.

I have active cancer, not including non-melanoma skin cancer.

I have liver cirrhosis or my liver tests are higher than normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or 750mg 2-HOBA three times a day for 4 weeks

4 weeks

Visits at weeks 0 and 4

Washout

Participants undergo a washout period to clear the effects of the first treatment

4 weeks

Visit at week 8

Crossover Treatment

Participants receive the alternate treatment (either 2-HOBA or placebo) for 4 weeks

4 weeks

Visit at week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 2-HOBA

Trial Overview The study tests the effects of 2-HOBA, which aims to reduce harmful compounds in the body that could worsen SLE symptoms. Patients take either 750mg of 2-HOBA or a placebo three times daily for four weeks, then switch after a break.

How Is the Trial Designed?

Group I: Placebo First Experimental Treatment 2 Interventions

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

Group II: 2-HOBA First Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225543

NCT07225543 | 2-HOBA in Systemic Lupus Erythematosus 42 patients with stable SLE will be randomized to treatment sequence to receive placebo or 750mg 2-HOBA three times a day for 4 weeks followed by a 4 week ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07225543?rank=8

NCT07225543 | 2-HOBA in Systemic Lupus Erythematosus Comparing 2-HOBA and placebo arms, primary outcomes include change in 24-hour blood pressure and immune activation measured by NETosis. Official ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10025056/

Inflammation Biomarker Response to Oral 2- ... In this study, we examined the potential beneficial effects of 2-HOBA on oxidative stress and inflammatory biomarkers in two cohorts of healthy ...

4. withpower.com withpower.com/trial/phase-2-lupus-erythematosus-systemic-4-2026-63c1a

2-HOBA for Lupus · Info for Participants Trial Overview The study tests the effects of 2-HOBA, which aims to reduce harmful compounds in the body that could worsen SLE symptoms.

5. insight.jci.org insight.jci.org/articles/view/136678/files/pdf

Isolevuglandins disrupt PU.1-mediated C1q expression ... We describe a mechanism responsible for systemic lupus erythematosus (SLE). In humans with. SLE and in 2 SLE murine models, there was marked ...

6. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/2-Hydroxybenzylamine-Cognitive-Vitality-For-Researchers.pdf

2-Hydroxybenzylamine In addition, these reports include evaluation of safety data ... Lupus: Systemic lupus erythematosus is an autoimmune condition involving inappropriate immune.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332222014810

The nutraceutical electrophile scavenger 2- ... Our goal was to investigate the effect of 2-HOBA on the pathogenesis of H. pylori infection. We used transgenic FVB/N insulin-gastrin (INS-GAS) mice as a model ...