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   43871   clinical trials with a EudraCT protocol, of which   7290   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:
    A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease.

    Summary
    EudraCT number
    		 2016-002939-15
    Trial protocol
    		 CZ   DE   AT   HU   SK   NL   NO   GB  
    Global end of trial date
    08 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2021
    First version publication date
    12 Nov 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V56502
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02976129
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHsquared
    Sponsor organisation address
    1 Lower Court, Cambridge, United Kingdom, CB22 3GN
    Public contact
    Clinical Trial Information Desk, VHsquared Ltd, 0044 1223837650, info@vhsquared.com
    Scientific contact
    Clinical Trial Information Desk, VHsquared Ltd, 0044 1223837650, info@vhsquared.com
    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
    08 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy, safety and tolerability of 6 weeks treatment with V565 in subjects with active Crohn's Disease.
    Protection of trial subjects
    The study protocol, all study protocol amendments, written study subject information, informed consent form (ICF), Investigator’s Brochure and any other relevant documents were reviewed and approved by an Independent Ethics Committee (IEC) and Institutional Review Board (IRB) at each study site.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Feb 2017
    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: 9
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Ukraine: 34
    Country: Number of subjects enrolled
    Serbia: 6
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Czech Republic: 29
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 5
    Worldwide total number of subjects
    125
    EEA total number of subjects
    76
    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)
    121
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 125 subjects were recruited from 13 countries in North America and Europe.

    Pre-assignment
    Screening details
    		 Out of 330 screened subjects, 205 were considered screen failures. A total of 125 subjects were randomised and treated in the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V565
    Arm description
    		 V565 PO 555mg TID
    Arm type
    		 Experimental

    Investigational medicinal product name
    V565
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    V565 PO 555mg TID

    Arm title
    		 Placebo
    Arm description
    		 Placebo PO 3 capsules TID
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo 3 capsules TID

    Number of subjects in period 1
    		V565 Placebo
    Started
    82
    43
    Completed
    77
    41
    Not completed
    5
    2
         Physician decision
    -
    2
         Adverse event, non-fatal
    2
    -
         Missed primary endpoint visit
    1
    -
         Pregnancy
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    V565
    Reporting group description
    		 V565 PO 555mg TID

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO 3 capsules TID

    Reporting group values
    		 V565 Placebo Total
    Number of subjects
    		 82 43 125
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 78 43 121
        From 65-84 years
    		 4 0 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.7 ± 14.05 37.2 ± 12.08 -
    Gender categorical
    Units: Subjects
        Female
    		 32 19 51
        Male
    		 50 24 74
    CDAI score
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 316.34 ± 71.283 296.69 ± 64.344 -
    Baseline CRP
    Baseline CRP value for those subjects qualifying for the study based on CRP
    Units: mg/L
        arithmetic mean (standard deviation)
    		 21.9 ± 18.43 18.7 ± 14.56 -
    Baseline FCP
    Baseline FCP for those subjects qualifying for the study on FCP
    Units: µg/g
        arithmetic mean (standard deviation)
    		 1082.619 ± 804.2154 1091.217 ± 974.0855 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    V565
    Reporting group description
    		 V565 PO 555mg TID

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO 3 capsules TID

    Primary: Proportion of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from Baseline or CDAI score < 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP.

    		 Close Top of page
    End point title
    		 Proportion of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from Baseline or CDAI score < 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP.
    End point description
    End point type
    Primary
    End point timeframe
    Day 42
    End point values
    		 V565 Placebo
    Number of subjects analysed
    82
    43
    Units: Number of responders
    29
    16
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v V565
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Proportion of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42

    		 Close Top of page
    End point title
    		 Proportion of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 V565 Placebo
    Number of subjects analysed
    82
    43
    Units: Number of responders
    20
    9
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    V565 v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Confidence interval

    Other pre-specified: Proportion of subjects achieving CRP levels within normal limits at Day 14 and 42

    		 Close Top of page
    End point title
    		 Proportion of subjects achieving CRP levels within normal limits at Day 14 and 42
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 14 and 42
    End point values
    		 V565 Placebo
    Number of subjects analysed
    58
    31
    Units: Number of patients
    11
    4
    No statistical analyses for this end point

    Other pre-specified: Proportion of subjects achieving FCP levels within normal limits at Day 14 and 42

    		 Close Top of page
    End point title
    		 Proportion of subjects achieving FCP levels within normal limits at Day 14 and 42
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 14 and 42
    End point values
    		 V565 Placebo
    Number of subjects analysed
    23
    10
    Units: Number of subjects
    7
    3
    No statistical analyses for this end point

    Other pre-specified: Comparative assessment of endoscopic mucosal appearance

    		 Close Top of page
    End point title
    		 Comparative assessment of endoscopic mucosal appearance
    End point description
    Subjects with a pre-treatment endoscopy SES-CD of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.
    End point type
    Other pre-specified
    End point timeframe
    Day 42
    End point values
    		 V565 Placebo
    Number of subjects analysed
    32
    10
    Units: Proportion of subjects
    18
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first administration of IMP on Day 1 until the follow-up visit 2 weeks after the final dose, at Day 56.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    V565
    Reporting group description
    		 V565 PO 555mg TID

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO 3 capsules TID

    Serious adverse events
    		 V565 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 43 (4.65%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 V565 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 82 (36.59%)
    16 / 43 (37.21%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Seizure
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 82 (4.88%)
    4 / 43 (9.30%)
         occurrences all number
    6
    4
    Crohn's disease
    Additional description: Three of five cases occurred after end of treatment. One further case was a patient with improvement in lower GI CD, resulting in oesophageal CD becoming the primary problem and therefore an AE
         subjects affected / exposed
    5 / 82 (6.10%)
    0 / 43 (0.00%)
         occurrences all number
    5
    0
    Diarrhoea
         subjects affected / exposed
    2 / 82 (2.44%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    Vomiting
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Dyspepsia
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Abdominal distension
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Personality change
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Pulpitis dental
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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-Fri May 03 12:21:15 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA