Open-label Extension Study of Brazikumab in Ulcerative Colitis
2期
提前终止
NCT04277546
| 适应症 | Ulcerative Colitis |
|---|
| 分期 | 2期 |
|---|
| 申办方 | AstraZeneca |
|---|
| 状态 | 提前终止 |
|---|
| 受试者人数 | 57 人 |
|---|
| 干预(药物) | Brazikumab Maintenance Dose, Brazikumab Induction Dose |
|---|
| 开始日期 | 2020年3月3日 |
|---|
| 完成日期 | 2023年10月10日 |
|---|
| 结果公布日 | 2026年6月23日 |
|---|
摘要
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.
Adverse Events
Through Week 70 · Participants
| Brazikumab/Brazikumab | 15 Participants |
|---|
| Placebo/Brazikumab | 11 Participants |
|---|
| Vedolizumab/Brazikumab | 2 Participants |
|---|
Laboratory Values
Through Week 70 · Participants
| Brazikumab/Brazikumab | 1 Participants |
|---|
| Placebo/Brazikumab | 0 Participants |
|---|
| Vedolizumab/Brazikumab | 0 Participants |
|---|
| Brazikumab/Brazikumab | 28 Participants |
|---|
| Placebo/Brazikumab | 22 Participants |
|---|
| Vedolizumab/Brazikumab | 2 Participants |
|---|
Vital Signs
Through Week 70 · Participants
| Brazikumab/Brazikumab | 3 Participants |
|---|
| Placebo/Brazikumab | 3 Participants |
|---|
| Vedolizumab/Brazikumab | 0 Participants |
|---|
| Brazikumab/Brazikumab | 0 Participants |
|---|
| Placebo/Brazikumab | 0 Participants |
|---|
| Vedolizumab/Brazikumab | 0 Participants |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
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。