2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
2期
已完成
NCT05274243
| 适应症 | Rheumatoid Arthritis |
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| 分期 | 2期 |
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| 申办方 | Vanderbilt University Medical Center |
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| 状态 | 已完成 |
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| 受试者人数 | 32 人 |
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| 干预(药物) | 2-HOBA |
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| 开始日期 | 2022年8月9日 |
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| 完成日期 | 2025年5月28日 |
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| 结果公布日 | 2026年4月8日 |
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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-HOBA | 9 Participants |
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| Placebo | 9 Participants |
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Cellular Isolevuglandin (isoLG) Adducts
Baseline to 4 weeks · % isolevuglandin positive cells
| 2-HOBA | 8.8 ± 10.4 % isolevuglandin positive cells |
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| Placebo | 11.1 ± 8.9 % isolevuglandin positive cells |
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| 2-HOBA | 13.9 ± 10.6 % isolevuglandin positive cells |
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| Placebo | 12.7 ± 8.6 % isolevuglandin positive cells |
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| p-value | 0.35 |
| 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。