Open-label Extension Study of Brazikumab in Ulcerative Colitis
Phase 2
Terminated
NCT04277546
| Condition | Ulcerative Colitis |
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| Phase | Phase 2 |
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| Sponsor | AstraZeneca |
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| Status | Terminated |
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| Enrollment | 57 participants |
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| Interventions | Brazikumab Maintenance Dose, Brazikumab Induction Dose |
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| Start date | Mar 3, 2020 |
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| Completion date | Oct 10, 2023 |
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| Results posted | Jun 23, 2026 |
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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/Brazikumab | 15 Participants |
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| Placebo/Brazikumab | 11 Participants |
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| Vedolizumab/Brazikumab | 2 Participants |
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Laboratory Values
Through Week 70 · Participants
| Brazikumab/Brazikumab | 1 Participants |
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| Placebo/Brazikumab | 0 Participants |
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| Vedolizumab/Brazikumab | 0 Participants |
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| Brazikumab/Brazikumab | 28 Participants |
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| Placebo/Brazikumab | 22 Participants |
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| Vedolizumab/Brazikumab | 2 Participants |
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Vital Signs
Through Week 70 · Participants
| Brazikumab/Brazikumab | 3 Participants |
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| Placebo/Brazikumab | 3 Participants |
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| Vedolizumab/Brazikumab | 0 Participants |
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| Brazikumab/Brazikumab | 0 Participants |
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| Placebo/Brazikumab | 0 Participants |
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| Vedolizumab/Brazikumab | 0 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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