Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

• Status: Terminated
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Mauna Kea Technologies; Takeda
• Treatments: Adalimumab; Vedolizumab

Criteria

Inclusion Criteria:

• Patients with moderate to severe UC defined by an overall Mayo score ≥ 5 and an endoscopic sub-score ≥ 2 points and rectal bleeding score ≥ 1 point

• Extension > 15 cm from the anal margin

• Requiring treatment with biotherapy and meeting the indications for the treatment

• Affiliated with a social security scheme

Exclusion Criteria:

• Crohn's disease or unclassified colitis

• Severe acute colitis

• Requirement for immediate surgical treatment

• Previous treatment with vedolizumab or anti-TNF-α

• Contraindication to the use of vedolizumab or an anti-TNF-α agent

• Contraindication to the use of adalimumab

• Corticosteroid therapy > 20 mg/day

• Corticosteroid therapy started within the previous two weeks

• Conventional Immunosppressor started within the previous month

• Colonic dysplasia or known cancer

• Likelihood to refuse two rectosigmoidoscopies, performed eighteen weeks apart

• Pregnant or lactating women