NCT04006080

Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC). Patients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.

Detailed description

Primary objective \- To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC. Secondary objective (s) * To evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab. * To explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and UC disease activity and extent. * To determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of Th1/Th17 effector memory CD4+ T-cells (the key pathogenic subset in IBD) to the colon in UC.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Vedolizumab	Intravenously administered selective leukocyte adhesion molecule inhibitor

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2019-07-02
• Last updated: 2019-07-08

Locations

1 site across 1 country: United Kingdom