BENITIONSClinical Trial Intelligence

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

2상 완료 NCT05274243

대상 질환Rheumatoid Arthritis
임상 단계2상
스폰서Vanderbilt University Medical Center
상태완료
참여자 수32 명
중재(약물)2-HOBA
시작일2022년 8월 9일
완료일2025년 5월 28일
결과 공개일2026년 4월 8일

요약

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

2-HOBA9 Participants
Placebo9 Participants

Cellular Isolevuglandin (isoLG) Adducts

Baseline to 4 weeks · % isolevuglandin positive cells

2-HOBA8.8 ± 10.4 % isolevuglandin positive cells
Placebo11.1 ± 8.9 % isolevuglandin positive cells
2-HOBA13.9 ± 10.6 % isolevuglandin positive cells
Placebo12.7 ± 8.6 % isolevuglandin positive cells
p-value0.35
Mean Difference (Net)3.4 (95% CI -4.0–10.9)

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