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

NCT02878083 | Terminated

• 1 other identifier: RC15_0457
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

ULCERATIVE COLITIS

Keywords

vedolizumab,; confocal endomicroscopy; biomarker; ULCERATIVE COLITIS

Outcome Measures

Primary Outcomes (1)

• Demonstrate the feasibility of an ex vivo labeling of intestinal immune cells with a combination of two markers: vedolizumab-FITC and adalimumab-Alexa Fluor 647

  Presence of fluorescent cells by Cellvizio® examination field for each of the antibodies: FITCcoupled vedolizumab and Alexa Fluor 647-coupled adalimumab at week 0 for all the patients.

  week 0

Secondary Outcomes (11)

• Quantify, ex vivo, the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa of patients with moderate to severe UC that are associated with clinical remission at week 22 (W22) after the initiation of treatment with vedolizumab.

  Week 22

• Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of clinical response induced by treatment with a standard dose of vedolizumab

  week 22

• Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of endoscopic remission induced by treatment with a standard dose of vedolizumab

  week 22

• Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of histologic remission induced by treatment with a standard dose of vedolizumab

  week 22

• Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of clinical response induced by treatment with a standard dose of vedolizumab

  week 22

Study Arms (1)

VEDOLIZUMAB

EXPERIMENTAL

300 mg IV

Drug: VEDOLIZUMAB; Drug: ADALIMUMAB

Interventions

VEDOLIZUMAB DRUG

Infusion at week 0 week 2 week 6 week 14 for all patients Infusion at week 22 for responder patient only

Also known as: entyvio

VEDOLIZUMAB

ADALIMUMAB DRUG

For nonresponder patients only : Injection at week 22 week 24 week 26 and week 28

Also known as: HUMIRA

VEDOLIZUMAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Takeda: collaborator
• Mauna Kea Technologies: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (4)

Chu Angers

Angers, France

Location

Chd Vendee

La Roche-sur-Yon, France

Location

Chu Nantes

Nantes, France

Location

Chu Rennes

Rennes, France

Location

Related Publications (1)

• Queneherve L, Trang-Poisson C, Fantou A, Flamant M, Durand T, Bouguen G, Bregeon J, Oullier T, Amil M, Dewitte M, Bardot S, Blandin S, Braudeau C, Vibet MA, Josien R, Neunlist M, Bourreille A. Confocal laser endomicroscopy as predictive biomarker of clinical and endoscopic efficacy of vedolizumab in ulcerative colitis: The DETECT study. PLoS One. 2024 Apr 2;19(4):e0298313. doi: 10.1371/journal.pone.0298313. eCollection 2024.

  PMID: 38564601 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab; Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ARNAUD BOURREILLE, MD-PHD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 25, 2016
• Study Start: January 11, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)