NCT05274243

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Completed Phase 2 Results posted Last updated 8 April 2026

What this trial tests

Phase 2 trial testing 2-HOBA in Rheumatoid Arthritis in 32 participants. Completed in 28 May 2025.

Timeline

9 August 2022

Primary endpoint
28 May 2025

28 May 2025

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	9 August 2022
Primary completion	28 May 2025
Estimated completion	28 May 2025
Sites	1 location across United States

Drugs / interventions tested

• 2-HOBA — full drug profile →
• Placebo

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety/Tolerability (Adverse Events) Primary · Baseline to 4 weeks

Rates of adverse events will be compared between active and placebo arms and presented as summary statistics. Number of participants having an adverse event are reported.

Group	Value	95% CI
2-HOBA	9
Placebo	9

Cellular Isolevuglandin (isoLG) Adducts Primary · Baseline to 4 weeks

Change in percentage of cellular isoLG adducts will be compared between active and placebo arms.

Baseline

Group	Value	95% CI
2-HOBA	8.8	± 10.4
Placebo	11.1	± 8.9

Week 4

Group	Value	95% CI
2-HOBA	13.9	± 10.6
Placebo	12.7	± 8.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2-HOBA

Serious: 0/16 (0%)

Deaths: 0/16

Placebo

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (13 terms — click to expand)

Reaction	System	2-HOBA	Placebo
GI upset	Gastrointestinal disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
RA flare	Musculoskeletal and connective tissue disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Acne	Skin and subcutaneous tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Numbness (hand)	Nervous system disorders	—	—
Elevated liver function tests (LFTs)	Investigations	—	—
Fatigue	General disorders	—	—
Dry mouth	General disorders	—	—

Data from ClinicalTrials.gov NCT05274243 adverse events section.

Sponsor's own description

This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks.

As primary outcome measures investigators will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes investigators will compare changes in markers of inflammation, DAS28 score, and 24-hour blood pressure in active and placebo arms. This pilot study will inform the feasibility and design of future studies to examine the efficacy of 2-HOBA in RA patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spermine oxidase promotes Helicobacter pylori-mediated gastric carcinogenesis through acrolein production.
   McNamara KM, Sierra JC, Latour YL, Hawkins CV, et al · · 2025 · cited 6× · PMID 39523394 · DOI 10.1038/s41388-024-03218-7
2. Epigenetic Regulation of Innate and Adaptive Immune Cells in Salt-Sensitive Hypertension.
   Mutchler AL, Haynes AP, Saleem M, Jamison S, et al · · 2025 · cited 5× · PMID 39819017 · DOI 10.1161/circresaha.124.325439