drugset / Trial / NCT02878083
Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)
Terminated
19 enrolled
Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France · collabMauna Kea Technologies · collabTakeda · collab
NaSingle-groupOpen-labelTreatment
Summary
The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine. This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.
Timeline
- Start
- 2017-01-11
- Primary completion
- 2020-01
- Completion
- 2021-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |
| Background | Adalimumab | Monoclonal antibody | — | — |