Phase 2
N=32
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT05274243 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Safety/Tolerability (Adverse Events) — 9; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2-HOBA (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety/Tolerability (Adverse Events) |
9; 9 | — |
| PRIMARY Cellular Isolevuglandin (isoLG) Adducts |
8.8; 11.1; 13.9; 12.7 | 0.35 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Age ≥18 years
- Meets 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid Arthritis classification criteria
- ≥ 4 tender or swollen joints
- No change in DMARDs, glucocorticoids in ≥ 4 weeks
- If of childbearing potential, willingness to use effective birth throughout study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)
- If using non-steroidal anti-inflammatory drugs (NSAIDs), willingness to discontinue use of NSAIDs for 2 weeks prior to the study and throughout the study
Exclusion Criteria
- Pregnant or breastfeeding
- Active cancer except non-melanoma skin cancer
- Active infection
- Concomitant inflammatory autoimmune disease
- Major surgery in ≤ 3 months
- Aspirin allergy
- Use of MAO-I
- Estimated creatinine clearance 1.5x the upper limit of normal or total bilirubin ≥1.5 mg/dl
Data sourced from ClinicalTrials.gov (NCT05274243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.