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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: ULCERATIVE COLITIS

Treatments: Drug: ADALIMUMAB; Drug: VEDOLIZUMAB

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02878083

RC15_0457

Details and patient eligibility

About

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.

Full description

Patients will be recruited before initiation of vedolizumab injections. The schedule for vedolizumab infusions will corresponding to the protocol follow-up visits (Week 0, W2, W6, W14, W22), and flexible sigmoidoscopy appointments will be performed at Week 0 and 22.

For responder patients, the end of the study will occured two weeks after the last vedolizumab infusion (W24).

At week 22, nonresponder patients to vedolizumab may be treated by adalimumab in the absence of contraindication and depending on the decision of the physician responsible for the patient. Patients will be treated every two weeks during 8 weeks. The protocol follow up will end 2 weeks after the fourth adalimumab injection.

During W0 and W22, colon biopsies will be collected. Blood samples will be collected on W0, W2, W6, W14, W22 (and W30 for non responder).

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

VEDOLIZUMAB

Experimental group

Description:

300 mg IV

Treatment:

Drug: VEDOLIZUMAB

Drug: ADALIMUMAB