drugset / Trial / NCT04277546
Open-label Extension Study of Brazikumab in Ulcerative Colitis
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-03-03
- Primary completion
- 2023-10-10
- Completion
- 2023-10-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brazikumab | Unknown | — | Subcutaneous |