BENITIONSClinical Trial Intelligence

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Фаза 2 Завершено NCT05274243

ЗаболеваниеRheumatoid Arthritis
ФазаФаза 2
СпонсорVanderbilt University Medical Center
СтатусЗавершено
Участники32 участн.
Вмешательство2-HOBA
Дата начала9.08.2022
Дата завершения28.05.2025
Публикация результатов8.04.2026

Кратко

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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