BENITIONSClinical Trial Intelligence

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/Brazikumab15 Participants
Placebo/Brazikumab11 Participants
Vedolizumab/Brazikumab2 Participants

Laboratory Values

Through Week 70 · Participants

Brazikumab/Brazikumab1 Participants
Placebo/Brazikumab0 Participants
Vedolizumab/Brazikumab0 Participants
Brazikumab/Brazikumab28 Participants
Placebo/Brazikumab22 Participants
Vedolizumab/Brazikumab2 Participants

Vital Signs

Through Week 70 · Participants

Brazikumab/Brazikumab3 Participants
Placebo/Brazikumab3 Participants
Vedolizumab/Brazikumab0 Participants
Brazikumab/Brazikumab0 Participants
Placebo/Brazikumab0 Participants
Vedolizumab/Brazikumab0 Participants

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。