BENITIONSClinical Trial Intelligence

Open-label Extension Study of Brazikumab in Ulcerative Colitis

Phase 2 Terminated NCT04277546

ConditionUlcerative Colitis
PhasePhase 2
SponsorAstraZeneca
StatusTerminated
Enrollment57 participants
InterventionsBrazikumab Maintenance Dose, Brazikumab Induction Dose
Start dateMar 3, 2020
Completion dateOct 10, 2023
Results postedJun 23, 2026

Summary

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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