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RecruitingPhase 2

2-HOBA in Systemic Lupus Erythematosus

Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 2-HOBA changes blood pressure and immune system activity in adult biological females with stable lupus (SLE) and high blood pressure. Each person will take 2-HOBA and a placebo (a pill with no active drug) for 8 weeks each, with a 4-week break between them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join the study.
  • Be a biological female age 18 or older.
  • Have lupus that meets the study’s diagnostic rules.
  • Have no changes in medicines that lower immune activity for at least 3 months.
  • Take a steady dose of prednisone or a similar steroid, no more than 20 mg a day, for at least 1 month.
  • Have a top blood pressure number above 120 and up to 160, or a bottom number above 80 and up to 110. Blood pressure medicine doses must be unchanged for at least 2 weeks.
  • Be willing to stop NSAIDs, pain medicines such as ibuprofen, at least 2 weeks before and throughout the study.
  • If able to get pregnant, use effective birth control during the study and for 4 weeks afterward.

Who can't join

  • Be pregnant, breastfeeding, or a biological male.
  • Have active cancer, except non-melanoma skin cancer.
  • Have cirrhosis (liver scarring), AST or ALT liver blood tests above 1.5 times the normal limit, or total bilirubin of 1.5 mg/dL or higher.
  • Have an active infection that needs medical treatment, or have had major surgery within 3 months.
  • Have an aspirin allergy or take an MAO inhibitor, a type of medicine used for depression and other conditions.
  • Have very low kidney function: creatinine clearance below 30 mL/min.
  • Have known atrial fibrillation, a type of irregular heartbeat.
  • Have another severe health condition.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TN