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    Clinical Trial Results:
    A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids.

    Summary
    EudraCT number
    2017-000937-30
    Trial protocol
    BE   HU   FR   DE   PL   ES   AT  
    Global end of trial date
    04 Feb 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Oct 2021
    First version publication date
    28 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABX464-101
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03093259
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ABIVAX
    Sponsor organisation address
    5 rue de la Baume, Paris, France, 75008
    Public contact
    Head of Clinical Operations , Abivax , +33 153830961, paul.gineste@abivax.com
    Scientific contact
    Chief Medical Officer, Abivax , +33 153830961, sophie.biguenet@abivax.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
    04 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate safety of ABX464 given at 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form (ICF).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Poland: 11
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    28
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    a total of 32 patients were enrolled a total of 30 patients completed the study a total of 17 patients achieved clinical response at week 8

    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
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ABX464 50mg
    Arm description
    ABX464 50mg
    Arm type
    Experimental

    Investigational medicinal product name
    ABX464
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Upon confirmation of eligibility, each subject was randomized using the electronic CRF (eCRF) in a 2:1 ratio to once daily oral 50 mg ABX464 added to background therapy for 8 weeks.

    Arm title
    Placebo
    Arm description
    Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Upon confirmation of eligibility, each subject was randomized using the electronic CRF (eCRF) in a 2:1 ratio to once daily oral 50 mg placebo added to background therapy for 8 weeks.

    Number of subjects in period 1
    ABX464 50mg Placebo
    Started
    23
    9
    Completed
    21
    9
    Not completed
    2
    0
         Adverse event, non-fatal
    1
    -
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    32 32
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    28 28
        From 65-84 years
    4 4
    Gender categorical
    Units: Subjects
        Female
    12 12
        Male
    20 20

    End points

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    End points reporting groups
    Reporting group title
    ABX464 50mg
    Reporting group description
    ABX464 50mg

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Primary: The number of incidences of treatment-emergent adverse events (TEAEs) in the ABX464-treated subjects compared to placebo

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    End point title
    The number of incidences of treatment-emergent adverse events (TEAEs) in the ABX464-treated subjects compared to placebo
    End point description
    The primary endpoint of this study is defined as the number of incidences of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo.
    End point type
    Primary
    End point timeframe
    week 8
    End point values
    ABX464 50mg Placebo
    Number of subjects analysed
    23
    9
    Units: 32
    18
    5
    Statistical analysis title
    primary endpoint statistical analysis
    Comparison groups
    ABX464 50mg v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.2096
    Method
    Chi-squared
    Confidence interval
         level
    90%
         sides
    1-sided
         lower limit
    -
         upper limit
    -
    Notes
    [1] - safety study

    Secondary: The proportion of subjects receiving ABX464 with clinical remission according to the Total Mayo Score at Week 8 compared to placebo (primary efficacy endpoint)

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    End point title
    The proportion of subjects receiving ABX464 with clinical remission according to the Total Mayo Score at Week 8 compared to placebo (primary efficacy endpoint)
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    ABX464 50mg Placebo
    Number of subjects analysed
    20
    9
    Units: 32
    7
    1
    Statistical analysis title
    statistical analysis secondary endpoint
    Comparison groups
    ABX464 50mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Post-hoc
    Analysis type
    other
    P-value
    = 0.1588
    Method
    Chi-squared
    Confidence interval
         level
    90%
         sides
    1-sided
         lower limit
    -
         upper limit
    -

    Secondary: The change from baseline in fecal calprotectin levels at Week 4 and Week 8 compared to placebo

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    End point title
    The change from baseline in fecal calprotectin levels at Week 4 and Week 8 compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 8
    End point values
    ABX464 50mg Placebo
    Number of subjects analysed
    20
    9
    Units: 32
    15
    8
    Statistical analysis title
    statistical analysis secondary endpoint
    Comparison groups
    ABX464 50mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Post-hoc
    Analysis type
    other
    P-value
    = 0.483
    Method
    ANCOVA
    Confidence interval

    Secondary: The change from screening in Total Mayo Score in subjects receiving ABX464 at Week 8 compared to placebo

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    End point title
    The change from screening in Total Mayo Score in subjects receiving ABX464 at Week 8 compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 8
    End point values
    ABX464 50mg Placebo
    Number of subjects analysed
    20
    9
    Units: Change in Total Mayo Score
        arithmetic mean (standard deviation)
    -4.6 ± 2.8
    -2.1 ± 2.5
    Statistical analysis title
    statistical analysis secondary endpoint
    Comparison groups
    ABX464 50mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Post-hoc
    Analysis type
    other
    P-value
    = 0.0742
    Method
    ANCOVA
    Confidence interval

    Secondary: The change from baseline in Partial Mayo Score in subjects receiving ABX464 at Week 4 and Week 8 compared to placebo

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    End point title
    The change from baseline in Partial Mayo Score in subjects receiving ABX464 at Week 4 and Week 8 compared to placebo
    End point description
    End point type
    Secondary
    End point timeframe
    week 8
    End point values
    ABX464 50mg Placebo
    Number of subjects analysed
    20
    9
    Units: Change in Partial Mayo Score
        arithmetic mean (standard deviation)
    -3.9 ± 2.2
    -1.8 ± 2.0
    Statistical analysis title
    statistical analysis secondary endpoint
    Comparison groups
    ABX464 50mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Post-hoc
    Analysis type
    other
    P-value
    = 0.0462
    Method
    ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 November 2017- 30 July 2018
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    ABX464 50mg
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    ABX464 50mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    ABX464 50mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 23 (78.26%)
    5 / 9 (55.56%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Investigations
    AST/ALT ratio
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 9 (0.00%)
         occurrences all number
    5
    0
    Poor quality sleep
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Influenza like illness
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 23 (17.39%)
    1 / 9 (11.11%)
         occurrences all number
    4
    1
    Abdominal pain upper
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Anal fissure
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Anorectal discomfort
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Nauseae
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Renal colic
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Skin discolouration
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 9 (22.22%)
         occurrences all number
    2
    2
    Iron deficiency
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitistis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Oral herpes
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Mar 2018
    Administrative changes and clarifications

    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
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