2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Phase 2 Completed NCT05274243

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.

Safety/Tolerability (Adverse Events)

Baseline to 4 weeks · Participants

Cellular Isolevuglandin (isoLG) Adducts

Baseline to 4 weeks · % isolevuglandin positive cells

Open in BENITIONS View on ClinicalTrials.gov

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• Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life) — University of North Carolina, Chapel Hill
• Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With R — Alfasigma S.p.A.
• CD40L Antagonism in Rheumatoid Arthritis (RA) — National Institute of Allergy and Infectious Diseases (NIAID)
• A Study of Baricitinib in Participants With Rheumatoid Arthritis — Eli Lilly and Company
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