Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis

Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis - FAVOUR

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002794-21-GB

Enrollment

Registered

2018-09-04

Start date

2018-09-11

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis (UC) MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Vedolizumab Product Name: Vedolizumab Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: 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 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.;Primary end point(s): Our primary endpoint is the identification and quantification of vedolizumab loss in faecal samples of patients with active UC. Following this, the correlation between faecal and serum vedolizumab concentrations will be evaluated; Secondary Objective: 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. ;Timepoint(s) of evaluation of this end point: Baseline, week 2, week 6 and week 14.	—

Measure

Time frame

Main Objective: To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.;Primary end point(s): Our primary endpoint is the identification and quantification of vedolizumab loss in faecal samples of patients with active UC. Following this, the correlation between faecal and serum vedolizumab concentrations will be evaluated; Secondary Objective: 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. ;Timepoint(s) of evaluation of this end point: Baseline, week 2, week 6 and week 14.

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Secondary

Measure	Time frame
Secondary end point(s): Assessment of the impact of faecal vedolizumab concentrations on rates of clinical and endoscopic response to induction therapy with vedolizumab. ;Timepoint(s) of evaluation of this end point: Baseline, weeks 2, 6 and 14	—

Countries

United Kingdom

Contacts

Public ContactPeter Irving

Guy's & St Thomas NHS Foundation trust

peter.irving@gstt.nhs.uk4402071882499

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026