2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

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.

Timeline

Start

2022-08-09

Primary completion

2025-05-28

Completion

2025-05-28

Outcome

Missed primary endpoint

registry analysis (superiority test); 2-HOBA vs Placebo; p = 0.35; Mean Difference (Net) 3.4 (95% CI -4.0 to 10.9); Mixed Models Analysis NCT05274243 ↗

Drugs

Indications