BENITIONSClinical Trial Intelligence

Open-label Extension Study of Brazikumab in Ulcerative Colitis

2상 조기 종료 NCT04277546

대상 질환Ulcerative Colitis
임상 단계2상
스폰서AstraZeneca
상태조기 종료
참여자 수57 명
중재(약물)Brazikumab Maintenance Dose, Brazikumab Induction Dose
시작일2020년 3월 3일
완료일2023년 10월 10일
결과 공개일2026년 6월 23일

요약

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

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