Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

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

    Summary
    EudraCT number
    		 2018-002794-21
    Trial protocol
    		 GB  
    Global end of trial date
    29 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Apr 2026
    First version publication date
    08 Apr 2026
    Other versions
    Summary report(s)
    		 FAVOUR CSR v2.0_Final 01Nov25

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FAVOUR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE1 9RT
    Public contact
    Peter Irving, Guy's & St Thomas NHS Foundation trust, 44 02071882499, peter.irving@gstt.nhs.uk
    Scientific contact
    Peter Irving, Guy's & St Thomas NHS Foundation trust, 44 02071882499, peter.irving@gstt.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, cure, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawals can render the study un-interpretable; therefore, unnecessary withdrawal of patients should be avoided. Should a patient decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible. Should a patient withdraw from study drug only, efforts will be made to continue to obtain follow-up data, with the permission of the patient. Because this is a non-interventional trial there won’t be an interim analysis or premature termination of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    32
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 36
    Number of subjects completed
    		 36

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab will be administered in the standard manner, with 300mg intravenous infusions at weeks 0, 2, 6 and 8 weekly thereafter (as is standard of care). Our study will include data collected during the first 14 weeks (4 infusions).

    Number of subjects in period 1
    		Treatment Arm
    Started
    36
    Completed
    32
    Not completed
    4
         UC non-response
    3
         Lost to follow-up
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 36 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 32 32
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 23 23

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 -

    Primary: Vedolizumab loss

    		 Close Top of page
    End point title
    		 Vedolizumab loss [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline - 14 Weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Treatment Arm
    Number of subjects analysed
    36
    Units: Mean faecal vedolizumab level
    arithmetic mean (full range (min-max))
        Day 1
    3.9 (0.0 to 64.7)
        Day 2
    1.6 (0.0 to 21.6)
        Day 7
    0.8 (0.0 to 5.8)
        Week 2
    0.3 (0.1 to 1.3)
        Week 6
    1.9 (0.0 to 49.4)
        Week 14
    0.1 (0.0 to 1.8)
    No statistical analyses for this end point

    Secondary: SCCAI

    		 Close Top of page
    End point title
    		 SCCAI
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline - Week 14
    End point values
    		 Treatment Arm
    Number of subjects analysed
    36
    Units: Median SCCAI score
    arithmetic mean (full range (min-max))
        Baseline
    5 (1 to 12)
        Week 2
    4 (1 to 12)
        Week 6
    3 (1 to 12)
        Week 14
    1 (1 to 12)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline - Week 14
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: SAEs breakdown not present in CSR

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2019
    SA 01 - Changes to the RSI
    08 Mar 2020
    NSA02 - Protocol v2.0 Mar2020
    04 Nov 2021
    NSA3 - Protocol v3, Aug2021, SAP v2, 04Oct2021
    22 Nov 2021
    SA02 - RSI: section 4.8 of SmPC for Vedolizumab (Entyvio), dated 01Jun2021

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 08 10:08:25 CEST 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA