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New treatment option for Systemic Lupus Erthematosus (SLE)
Official title 2-HOBA in Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07225543
What this study is testing
What is 2-HOBA acetate (2-Hydroxybenzlamine acetate)?
2-HOBA acetate (2-Hydroxybenzlamine acetate) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for systemic lupus erthematosus (sle).
Also referred to as 2-hydroxybenzylamine, 2-HOBA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Active infection requiring medical intervention
- Major surgery in ≤ 3 months
See the full eligibility 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 \ 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.