2-HOBA in Systemic Lupus Erythematosus

NCT07225543 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2509441P01HL174442-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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 washout and then 4 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.

Conditions

Systemic Lupus Erthematosus (SLE)

Keywords

systemic lupus erythematosus; SLE; lupus; oxidative stress; hypertension; blood pressure; NETosis; isolevuglandins

Outcome Measures

Primary Outcomes (2)

• 24-hour systolic blood pressure

  Investigators will measure change in 24-hour systolic blood pressure

  Measured at the beginning and end of each phase at weeks 0, 4, 8, and 12.

• NETosis

  Investigators will measure change in NETosis by ELISA assessing circulating NET concentration

  Measured at beginning and end of each phase at weeks 0, 4, 8, and 12.

Study Arms (2)

Placebo First

EXPERIMENTAL

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

Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate); Drug: Placebo

2-HOBA First

EXPERIMENTAL

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

Drug: 2-HOBA acetate (2-Hydroxybenzlamine acetate); Drug: Placebo

Interventions

2-HOBA acetate (2-Hydroxybenzlamine acetate) DRUG

2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day

Also known as: 2-hydroxybenzylamine, 2-HOBA, salicylamine, IUPAC name: 2-(aminomethyl)phenol

2-HOBA First; Placebo First

Placebo DRUG

Placebo (provided as three capsules) three times per day

Also known as: indentical placebo

2-HOBA First; Placebo First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age ≥18 years
• 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)

You may not qualify if:

• Pregnant or breastfeeding
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Hypertension

Interventions

2-(aminomethyl)phenol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michelle J Ormseth, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phicharmon Kulapatana (study coordinator)

CONTACT

615-936-5747; phicharmon.kulapatana@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available upon publication of study results or end of the performance period, whichever comes first. The data shared will be archived and available on the Vivli platform for request by researchers for a minimum of 10 years after contribution.
• Access Criteria: The Vivli platform has multiple levels of protection for managing human participant data. Each user must sign a Data Use Agreement and there is an established policy for managing violations.

Locations

US (1)