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

Guy's and St Thomas' NHS Foundation Trust

Status and phase

Unknown

Phase 4

Conditions

Ulcerative Colitis

Treatments

Biological: Vedolizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04006080

2018-002794-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18 years or over, either male or female
Moderate-to-severe UC, defined as:
- SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 6 weeks of study enrollment
Commencing vedolizumab treatment
Sufficient English language skills to understand the patient information sheet and consent form

Exclusion criteria

Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)
Imminent need for colectomy (i.e. colectomy is being planned)
Previous ileoanal pouch formation
Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections