2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Фаза 2
Завершено
NCT05274243
| Заболевание | Rheumatoid Arthritis |
|---|
| Фаза | Фаза 2 |
|---|
| Спонсор | Vanderbilt University Medical Center |
|---|
| Статус | Завершено |
|---|
| Участники | 32 участн. |
|---|
| Вмешательство | 2-HOBA |
|---|
| Дата начала | 9.08.2022 |
|---|
| Дата завершения | 28.05.2025 |
|---|
| Публикация результатов | 8.04.2026 |
|---|
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-HOBA | 9 Participants |
|---|
| Placebo | 9 Participants |
|---|
Cellular Isolevuglandin (isoLG) Adducts
Baseline to 4 weeks · % isolevuglandin positive cells
| 2-HOBA | 8.8 ± 10.4 % isolevuglandin positive cells |
|---|
| Placebo | 11.1 ± 8.9 % isolevuglandin positive cells |
|---|
| 2-HOBA | 13.9 ± 10.6 % isolevuglandin positive cells |
|---|
| Placebo | 12.7 ± 8.6 % isolevuglandin positive cells |
|---|
| p-value | 0.35 |
| Mean Difference (Net) | 3.4 (95% CI -4.0–10.9) |
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Другие исследования по этому заболеванию
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.