Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease

Phase 1

• Conditions: lcerative colitis (UC) and Crohn disease (CD); MedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003270-32-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Key Inclusion Criteria (IBD patients):
Patients with Crohn´s disease and ulcerative colitis qualified for vedolizumab therapy can be included.

Key Inclusion Criteria (healthy controls):
Healthy subject between 18 and 80 years old doing colonoscopy either for colorectal cancer screening or gastrointestinal symptoms

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Key Exclusion Criteria (IBD patients):
1.Subjects <18 years or > 80 years
2.History of malignancy in the previous 5 years
3.Serious infections within 4 weeks prior to baseline or active chronic infections
4.Pregnancy or lactation
5.Any medical condition that could negatively impact on the participation to the study
6.Therapy with any investigational or approved biologics within the last 60 days

Key Exclusion Criteria (healthy controls):
1.Subjects <18 years or > 80 years
2.Serious infections within 4 weeks prior to baseline or active chronic infections
3.Pregnancy or lactation
4.Any medical condition that could negatively impact on the participation to the study, in particular previous diagnosis of cancer or IBD.
5.Endoscopic signs of intestinal inflammation at baseline endoscopy, or detection of adenoma or colorectal cancer at screening endoscopy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the expression of a4ß7 heterodimer in circulating T lymphocytes (CD4 and CD8) from active IBD patients and healthy controls, in combination with chemokine receptors known to define specific inflammatory and regulatory T cell subsets (Th1,Th17,Th1-17,Tc1,Tc17,Tregs);Secondary Objective: To evaluate the expression of a4ß7 in gut-infiltrating T lymphocytes (CD4 and CD8 subsets) of active IBD patients and controls and to correlate the relative frequencies of circulating and gut-infiltrating a4ß7-expressing T cell subsets at baseline with the short-term (14 week) clinical and endoscopical response to Vedolizumab ;Primary end point(s): to correlate the relative frequencies of circulating and gut-infiltrating a4ß7-expressing T cell subsets at baseline with the short-term (14 week) clinical and endoscopical response to Vedolizumab;Timepoint(s) of evaluation of this end point: 14 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): to evaluate the expression of a4ß7 in gut-infiltrating T lymphocytes (CD4 and CD8 subsets) of active IBD patients and controls;;Timepoint(s) of evaluation of this end point: 14 weeks