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Status unknownNCT04006080FAVOURUpdated Jul 8, 2019

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

A Phase 4 interventional study of Vedolizumab in Ulcerative Colitis, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Vedolizumab

    Biological: Vedolizumab

Interventions

  • BiologicalVedolizumab

    Intravenously administered selective leukocyte adhesion molecule inhibitor

    Also known as: Entyvio

06

What researchers measure

Primary outcomes

  1. Change in vedolizumab concentrations in stool

    Evaluated using an enzyme-linked immunosorbent assay (ELISA)

    Time frame: Days 1, 4 and 7; and weeks 2, 6 and 14

Secondary outcomes

  1. UC endoscopic activity

    Evaluated using the Mayo Endoscopic Score: Mayo 0 = normal; Mayo 1= mild inflammation; Mayo 2 = moderate inflammation; Mayo 3 = severe inflammation

    Time frame: Baseline and week 14

  2. UC endoscopic activity

    Evaluated using the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score: Vascular pattern= Normal (0), patchy loss (1), obliterated (2); Bleeding = None (0), mucosal (1), luminal mild (2), luminal moderate (3); Erosions/ulcers = None (0), erosions (1), superfical ulcer (2), deep ulcer (3)

    Time frame: Baseline and week 14

  3. Clinical UC disease activity

    Evaluated using Patient Reported Outcome 2 (PRO2) Questionnaire: Stool frequency= normal (0), 1-2 more (1), 3-4 more (2), 5 or more stools than normal (3); Rectal bleeding= no blood (0), streaks of blood \<50% time (1), obvious blood \>50% time (2), blood alone passes (3)

    Time frame: Day 0, weeks 2, 6 and 14

  4. Vedolizumab serum concentrations

    Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)

    Time frame: Weeks 2, 6 and 14

  5. Vedolizumab anti-drug antibody levels

    Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)

    Time frame: Weeks 2, 6 and 14

  6. Faecal calprotectin

    Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)

    Time frame: Day 0, weeks 2, 6 and 14

  7. Serum CRP (mg/L)

    Time frame: Day 0, weeks 2, 6 and 14

  8. Serum albumin (g/L) [40-52g/L]

    Time frame: Day 0, weeks 2, 6 and 14

  9. Quality of life questionnaire

    IBD-Control questionnaire

    Time frame: Day 0, weeks 2, 6 and 14

  10. Clinical UC disease activity

    Evaluated using the Simple Clinical Colitis Activity Index score: Bowel frequency day= 0-3 (0), 4-6 (1), 7-9 (2), \>9 (3); Bowel frequency night= 0 (0), 1-3 (1), 4-6 (2); Urgency of defectation= None(0), Hurry (1), immediately (2), incontinence (3); Blood in stool = None (0), trace (1), occasional frank (2), usually frank (3); General well being= very well (0), slightly below par (1), poor (2), very poor (3), terrible (4); Extracolonic features (1 point for each) = arthritis, uveitis, erythema nodosum, pyoderma gangrenosum. Remission SCCAI ≤ 2; Response SCCAI ≤ 5, with a decrease by ≥ 2; Relapse SCCAI ≥ 5 (following a response)

    Time frame: Day 0, weeks 2, 6 and 14

  11. UC histological activity

    Evaluated using Nancy Histological Index

    Time frame: Day 0 and week 14

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available. PubMed 17258735 ↗
  • Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603. PubMed 3317057 ↗
  • Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Schnell P, Bernhardt CA, Mary JY, Sandborn WJ. Reliability and initial validation of the ulcerative colitis endoscopic index of severity. Gastroenterology. 2013 Nov;145(5):987-95. doi: 10.1053/j.gastro.2013.07.024. Epub 2013 Jul 25. PubMed 23891974 ↗
  • Jairath V, Khanna R, Zou GY, Stitt L, Mosli M, Vandervoort MK, D'Haens G, Sandborn WJ, Feagan BG, Levesque BG. Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials. Aliment Pharmacol Ther. 2015 Nov;42(10):1200-10. doi: 10.1111/apt.13408. Epub 2015 Sep 21. PubMed 26388424 ↗
  • Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lemann M, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Bernhardt CA, Mary JY, Sandborn WJ. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut. 2012 Apr;61(4):535-42. doi: 10.1136/gutjnl-2011-300486. Epub 2011 Oct 13. PubMed 21997563 ↗
  • Bodger K, Ormerod C, Shackcloth D, Harrison M; IBD Control Collaborative. Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-control questionnaire. Gut. 2014 Jul;63(7):1092-102. doi: 10.1136/gutjnl-2013-305600. Epub 2013 Oct 9. PubMed 24107590 ↗
  • Marchal-Bressenot A, Salleron J, Boulagnon-Rombi C, Bastien C, Cahn V, Cadiot G, Diebold MD, Danese S, Reinisch W, Schreiber S, Travis S, Peyrin-Biroulet L. Development and validation of the Nancy histological index for UC. Gut. 2017 Jan;66(1):43-49. doi: 10.1136/gutjnl-2015-310187. Epub 2015 Oct 13. PubMed 26464414 ↗
  • Globig AM, Hennecke N, Martin B, Seidl M, Ruf G, Hasselblatt P, Thimme R, Bengsch B. Comprehensive intestinal T helper cell profiling reveals specific accumulation of IFN-gamma+IL-17+coproducing CD4+ T cells in active inflammatory bowel disease. Inflamm Bowel Dis. 2014 Dec;20(12):2321-9. doi: 10.1097/MIB.0000000000000210. PubMed 25248005 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04006080
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Takeda
Responsible party
Sponsor
First posted
Jul 2, 2019
Start date
Jul 1, 2019
Primary completion
Mar 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jul 8, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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