2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
第2相
完了
NCT05274243
| 対象疾患 | Rheumatoid Arthritis |
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| 相 | 第2相 |
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| スポンサー | Vanderbilt University Medical Center |
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| ステータス | 完了 |
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| 参加者数 | 32 名 |
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| 介入(薬剤) | 2-HOBA |
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| 開始日 | 2022年8月9日 |
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| 完了日 | 2025年5月28日 |
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| 結果公開日 | 2026年4月8日 |
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概要
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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