Systemic Lupus Erthematosus (SLE)Phase 2NCT07225543
2-HOBA in Systemic Lupus Erythematosus
A Phase 2 study testing 2-HOBA acetate (2-Hydroxybenzlamine acetate) in people with Systemic Lupus Erthematosus (SLE), run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE)
- What is being tested?
- 2-HOBA acetate (2-Hydroxybenzlamine acetate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 31 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 11Show fewer
- Aspirin allergy
- Use of MAO-I
- Estimated creatinine clearance <30 ml/min
- Known atrial fibrillation
- Severe comorbid condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Phicharmon Kulapatana, 615-936-5747, phicharmon.kulapatana@vumc.org
About this study
Official title: Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study
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.
Read the detailed description
Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease with a markedly increased prevalence of not only hypertension but also resistant hypertension. Hypertension, along with other factors, leads to a 2 to 3-fold increase in risk of cardiovascular disease in SLE. Other than glucocorticoids and immunosuppression, there are few therapeutic options for patients with SLE and none that are known to have a beneficial effect on hypertension and cardiovascular disease; in fact, glucocorticoids have substantial deleterious effects. The increased prevalence of hypertension and its greater severity in SLE patients are unexplained; however, work from our group and others increasingly implicates activation of the immune system in the pathogenesis of hypertension. Moreover, our data suggest that downstream products of oxidative stress, specifically isolevuglandins (IsoLGs), drive immune activation and hypertension.
IsoLGs are highly reactive dicarbonyl products of oxidative stress that bind covalently to proteins causing conformational changes rendering them immunogenic and proinflammatory. Two decades of work at Vanderbilt led to the identification of 2-hydroxybenzylamine (2-HOBA) as a highly effective scavenger of reactive dicarbonyls such as IsoLGs. Scavenging reactive dicarbonyls is preferable to using antioxidants because reactive oxygen species are necessary for normal cellular function. In animal models of SLE, hypertension, and atherosclerosis 2-HOBA reduced inflammation, neutrophil extracellular traps (NETosis), blood pressure, and atherosclerosis, and in human phase I clinical studies with healthy volunteers it was well tolerated.
This is a mechanistic, proof-of-concept phase II study with a randomized, placebo-controlled, double-blind, cross-over design to determine the effect of 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. Comparing 2-HOBA and placebo arms, primary outcomes include change in 24-hour blood pressure and immune activation measured by NETosis.
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Being tested
- 2-HOBA acetate (2-Hydroxybenzlamine acetate), Placebo
- Keywords
- systemic lupus erythematosus, SLE, lupus, oxidative stress, hypertension, blood pressure, NETosis, isolevuglandins
- Medical subject headings
- Lupus Erythematosus, Systemic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-HOBA acetate (2-Hydroxybenzlamine acetate)Drug
Also called 2-hydroxybenzylamine, 2-HOBA, salicylamine, IUPAC name: 2-(aminomethyl)phenol
2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day
PlaceboDrug
Also called indentical placebo
Placebo (provided as two capsules) three times per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo First | Experimental | Placebo for first 8 weeks, then washout for 4 weeks, and then 2-HOBA acetate for 8 weeks Receives: Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate); Drug: Placebo |
| 2-HOBA First | Experimental | 2-HOBA acetate for first 8 weeks, then washout for 4 weeks, and then placebo for 8 weeks Receives: Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour systolic blood pressure
Investigators will measure change in 24-hour systolic blood pressure
Measured: 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
Measured: Measured at beginning and end of each phase at weeks 0, 8, 12, and 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start15 May 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erthematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michelle Ormseth, Vanderbilt University Medical Center
- Investigators
- Michelle J Ormseth, MD, MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225543
- Sponsor's protocol ID
- 250944
- Other IDs
- 1P01HL174442-01A1
- Status last verified
- May 2026
- First submitted
- 4 Nov 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data files will be produced: * Demographic/ clinical data such as age, race, sex, SLE disease activity measures, and medication use * Standard clinical laboratory measurements such as complete blood count, complete metabolic panel, complement C3 and C4, dsDNA antibody titer, erythrocyte sedimentation rate, urinalysis, spot urine protein and creatinine. * 24-hour blood pressure measurements * NETosis data * type 1 interferon signature Identifiable data will be de-identified and anonymized prior to sharing. Given the rarity of the disease, small geographic area of recruitment, and very specific manifestations of SLE in individual patients, the risk of re-identification of participants is real. Thus, to ensure privacy concordant with the requirements of the institutional review board, information on specific SLE manifestations will not be shared and demographic variables with few participants may be collapsed/ aggregated (e.g. age, race) to anonymize data.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study
- ClinicalTrials.gov ID
- NCT07225543
- Acronym / sponsor ID
- 250944
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Keywords
- systemic lupus erythematosus, SLE, lupus, oxidative stress, hypertension, blood pressure, NETosis, isolevuglandins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease with a markedly increased prevalence of not only hypertension but also resistant hypertension. Hypertension, along with other factors, leads to a 2 to 3-fold increase in risk of cardiovascular disease in SLE. Other than glucocorticoids and immunosuppression, there are few therapeutic options for patients with SLE and none that are known to have a beneficial effect on hypertension and cardiovascular disease; in fact, glucocorticoids have substantial deleterious effects. The increased prevalence of hypertension and its greater severity in SLE patients are unexplained; however, work from our group and others increasingly implicates activation of the immune system in the pathogenesis of hypertension. Moreover, our data suggest that downstream products of oxidative stress, specifically isolevuglandins (IsoLGs), drive immune activation and hypertension.
IsoLGs are highly reactive dicarbonyl products of oxidative stress that bind covalently to proteins causing conformational changes rendering them immunogenic and proinflammatory. Two decades of work at Vanderbilt led to the identification of 2-hydroxybenzylamine (2-HOBA) as a highly effective scavenger of reactive dicarbonyls such as IsoLGs. Scavenging reactive dicarbonyls is preferable to using antioxidants because reactive oxygen species are necessary for normal cellular function. In animal models of SLE, hypertension, and atherosclerosis 2-HOBA reduced inflammation, neutrophil extracellular traps (NETosis), blood pressure, and atherosclerosis, and in human phase I clinical studies with healthy volunteers it was well tolerated.
This is a mechanistic, proof-of-concept phase II study with a randomized, placebo-controlled, double-blind, cross-over design to determine the effect of 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. Comparing 2-HOBA and placebo arms, primary outcomes include change in 24-hour blood pressure and immune activation measured by NETosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo First | Experimental | Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate), Drug: PlaceboPlacebo for first 8 weeks, then washout for 4 weeks, and then 2-HOBA acetate for 8 weeks |
| 2-HOBA First | Experimental | Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate), Drug: Placebo2-HOBA acetate for first 8 weeks, then washout for 4 weeks, and then placebo for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-HOBA acetate (2-Hydroxybenzlamine acetate)Also: 2-hydroxybenzylamine, 2-HOBA, salicylamine, IUPAC name: 2-(aminomethyl)phenol2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day | Drug | 2-HOBA First, Placebo First |
| PlaceboAlso: indentical placeboPlacebo (provided as two capsules) three times per day | Drug | 2-HOBA First, Placebo First |
Primary outcome
24-hour systolic blood pressure
Time frame: Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20.
Investigators will measure change in 24-hour systolic blood pressure
NETosis
Time frame: Measured at beginning and end of each phase at weeks 0, 8, 12, and 20.
Investigators will measure change in NETosis by ELISA assessing circulating NET concentration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. The following data files will be produced: * Demographic/ clinical data such as age, race, sex, SLE disease activity measures, and medication use * Standard clinical laboratory measurements such as complete blood count, complete metabolic panel, complement C3 and C4, dsDNA antibody titer, erythrocyte sedimentation rate, urinalysis, spot urine protein and creatinine. * 24-hour blood pressure measurements * NETosis data * type 1 interferon signature Identifiable data will be de-identified and anonymized prior to sharing. Given the rarity of the disease, small geographic area of recruitment, and very specific manifestations of SLE in individual patients, the risk of re-identification of participants is real. Thus, to ensure privacy concordant with the requirements of the institutional review board, information on specific SLE manifestations will not be shared and demographic variables with few participants may be collapsed/ aggregated (e.g. age, race) to anonymize data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle J Ormseth, MD, MSCI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2-HOBA acetate (2-Hydroxybenzlamine acetate) in people with Systemic Lupus Erthematosus (SLE), run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phicharmon Kulapatana (study coordinator) (615-936-5747, phicharmon.kulapatana@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.