2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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 we will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes we 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Phenol

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, corticosteroids 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)

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 <30 ml/min