BENITIONSClinical Trial Intelligence

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

2期 已完成 NCT05274243

适应症Rheumatoid Arthritis
分期2期
申办方Vanderbilt University Medical Center
状态已完成
受试者人数32 人
干预(药物)2-HOBA
开始日期2022年8月9日
完成日期2025年5月28日
结果公布日2026年4月8日

摘要

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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。