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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04006080
• Date of registration: 13/02/2019
• Prospective Registration: Yes
• Primary sponsor: Guy's and St Thomas' NHS Foundation Trust
• Public title: Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis FAVOUR
• Scientific title: Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis
• Date of first enrolment: July 1, 2019
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04006080
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Georgina Cunningham, MBBS

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: Vedolizumab

Primary Outcome(s)

Change in vedolizumab concentrations in stool [Time Frame: Days 1, 4 and 7; and weeks 2, 6 and 14]

Secondary Outcome(s)

Quality of life questionnaire [Time Frame: Day 0, weeks 2, 6 and 14]

Serum CRP (mg/L) [Time Frame: Day 0, weeks 2, 6 and 14]

Clinical UC disease activity [Time Frame: Day 0, weeks 2, 6 and 14]

Faecal calprotectin [Time Frame: Day 0, weeks 2, 6 and 14]

Serum albumin (g/L) [40-52g/L] [Time Frame: Day 0, weeks 2, 6 and 14]

UC histological activity [Time Frame: Day 0 and week 14]

Vedolizumab serum concentrations [Time Frame: Weeks 2, 6 and 14]

Vedolizumab anti-drug antibody levels [Time Frame: Weeks 2, 6 and 14]

UC endoscopic activity [Time Frame: Baseline and week 14]

Secondary ID(s)

2018-002794-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda