BENITIONSClinical Trial Intelligence

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

第2相 完了 NCT05274243

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

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-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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