drugset / Trial / NCT05281614
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
Phase 0
Completed
20 enrolled
Benaroya Research Institute
University of California, San Diego · collab
RandomizedParallel-groupOpen-labelBasic science
Summary
The underlying hypothesis is that vedolizumab will modify immune cell trafficking in type 1 diabetes, and that this will be enhanced by pre-treatment with etanercept. This study will determine whether there is mechanistic evidence in support of this hypothesis and provide preliminary information about safety, efficacy, and tolerability of vedolizumab with and without pretreatment with etanercept in adults with type 1 diabetes (T1D)
Timeline
- Start
- 2022-09-21
- Primary completion
- 2024-01-10
- Completion
- 2024-01-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etanercept | Protein / enzyme biologic | — | — |
| Subject | Vedolizumab | Monoclonal antibody | — | — |