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    Clinical Trial Results:
    A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.

    Summary
    EudraCT number
    		 2017-003284-35
    Trial protocol
    		 BE   HU   PL   ES  
    Global end of trial date
    15 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Aug 2025
    First version publication date
    20 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABX464-102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abivax
    Sponsor organisation address
    7-11 Blvd Haussmann, Paris, France, 75009
    Public contact
    External Communication, Abivax, +33 1 53 83 09 63, info@abivax.com
    Scientific contact
    External Communication, Abivax, +33 1 53 83 09 63, info@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
    15 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2022
    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 the long-term safety of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
    Protection of trial subjects
    In the informed consent, subjects were asked to report all experienced adverse events to their study doctor. In case health problems occured, the study doctor asked subject to return to their facility for an unscheduled visit. If it was not possible to contact the study doctor or the site, subjects were asked to contact any healthcare professional or other competent person.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jan 2018
    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
    Poland: 10
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Hungary: 9
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    20
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment in Belgium: from 26Jan2018 to 23Apr2018 recruitment in Poland: from 24Apr2018 to 03Jul2018 recruitment in Hungary: from 09Apr2018 to 05Jul2018

    Pre-assignment
    Screening details
    		 Subjects were previously enrolled in the ABX464-101 clinical study (induction study) and were willing to continue their treatment

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

    Arms
    Arm title
    		 obefazimod 50mg
    Arm description
    		 All subjects receive ABX464 at 50 mg o.d for an overall period of 48 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    obefazimod
    Investigational medicinal product code
    ABX464
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The ABX464 investigational medicinal product (IMP) is a hard gelatin capsule intended for oral administration. Subjects are dosed with a daily dose of 50 mg that is 1 capsule every day.

    Number of subjects in period 1
    		obefazimod 50mg
    Started
    22
    Completed
    11
    Not completed
    11
         sponsor decision
    4
         Consent withdrawn by subject
    3
         Physician decision
    1
         Adverse event, non-fatal
    2
         worsening of UC
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    obefazimod 50mg
    Reporting group description
    		 All subjects receive ABX464 at 50 mg o.d for an overall period of 48 months.

    Reporting group values
    		 obefazimod 50mg Total
    Number of subjects
    		 22 22
    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)
    		 20 20
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 42.4 ( 14.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    Observed Cases (OC) set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Observed Cases (OC) Set was defined as those subjects included in the study, who had received at least one dose of the study treatment

    Subject analysis sets values
    		 Observed Cases (OC) set
    Number of subjects
    22
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    20
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    42.4 ( 14.3 )
    Gender categorical
    Units: Subjects
        Female
    9
        Male
    13

    End points

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    End points reporting groups
    Reporting group title
    obefazimod 50mg
    Reporting group description
    		 All subjects receive ABX464 at 50 mg o.d for an overall period of 48 months.

    Subject analysis set title
    Observed Cases (OC) set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Observed Cases (OC) Set was defined as those subjects included in the study, who had received at least one dose of the study treatment

    Primary: number of treatment emergent adverse event

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    End point title
    		 number of treatment emergent adverse event [1]
    End point description
    Only descriptive analysis was performed. For qualitative variable, count and percentage were presented.
    End point type
    Primary
    End point timeframe
    48 months
    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: Only descriptive analysis was performed. For qualitative variable, count and percentage were presented.
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of adverse events
    145
    No statistical analyses for this end point

    Secondary: Total Mayo Score

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    End point title
    		 Total Mayo Score
    End point description
    The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response.
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.0 ( 3.4 )
    No statistical analyses for this end point

    Secondary: Partial Mayo Score

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    End point title
    		 Partial Mayo Score
    End point description
    The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9. A higher (in negative) change from baseline shows a better clinical response.
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.2 ( 2.4 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Response at Month 48

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    End point title
    		 Number of Subjects With Clinical Response at Month 48
    End point description
    Clinical response was defined as: reduction in Total Mayo Score (TMS) of at least 2 points and >= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of >= 1 point or absolute rectal bleeding sub-score of <= 1 point.
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of subjects
    11
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Remission at Month 48

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    End point title
    		 Number of Subjects With Clinical Remission at Month 48
    End point description
    Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score: rectal bleeding sub-score = 0 central endoscopy sub-score <= 1 stool frequency sub-score <= 1
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of subjects
    9
    No statistical analyses for this end point

    Secondary: Number of Subject With Endoscopic Improvement at Month 48

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    End point title
    		 Number of Subject With Endoscopic Improvement at Month 48
    End point description
    Endoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1.
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of subjects
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects With Endoscopic Remission at Month 48

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    End point title
    		 Number of Subjects With Endoscopic Remission at Month 48
    End point description
    Endoscopic remission was defined as Mayo central endoscopic sub-score = 0
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of subjects
    6
    No statistical analyses for this end point

    Secondary: Fecal Calprotection levels

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    End point title
    		 Fecal Calprotection levels
    End point description
    The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: ug/g
        arithmetic mean (standard deviation)
    -299.69 ( 472.28 )
    No statistical analyses for this end point

    Secondary: CRP levels

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    End point title
    		 CRP levels
    End point description
    The change from Day 0 up to Month 48 in CRP levels
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: mg/L
        arithmetic mean (standard deviation)
    2.29 ( 4.82 )
    No statistical analyses for this end point

    Secondary: Number of Treatment-emergent Serious Adverse Events

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    End point title
    		 Number of Treatment-emergent Serious Adverse Events
    End point description
    The number of incidences of treatment-emergent serious adverse events
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of events
    3
    No statistical analyses for this end point

    Secondary: Number of Treatment-emergent Adverse Events of Special Interest

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    End point title
    		 Number of Treatment-emergent Adverse Events of Special Interest
    End point description
    The number of incidences of treatment-emergent adverse events of special interest
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of events
    15
    No statistical analyses for this end point

    Secondary: Number of Adverse Events Leading to Investigational Product Discontinuation

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    End point title
    		 Number of Adverse Events Leading to Investigational Product Discontinuation
    End point description
    The number of incidences of adverse events leading to investigational product discontinuation
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of events
    1
    No statistical analyses for this end point

    Secondary: Number of Specific Laboratory Abnormalities

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    End point title
    		 Number of Specific Laboratory Abnormalities
    End point description
    The number of incidences of specific laboratory abnormalities
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: number of events
    17
    No statistical analyses for this end point

    Secondary: SF-36 Quality of Life Questionnaire (SF-36 Physical Component)

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    End point title
    		 SF-36 Quality of Life Questionnaire (SF-36 Physical Component)
    End point description
    Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 physical component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.82 ( 4.23 )
    No statistical analyses for this end point

    Secondary: SF-36 Quality of Life Questionnaire (SF-36 Mental Component)

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    End point title
    		 SF-36 Quality of Life Questionnaire (SF-36 Mental Component)
    End point description
    Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 mental component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: unit on a scale
        arithmetic mean (standard deviation)
    6.38 ( 3.4 )
    No statistical analyses for this end point

    Secondary: Erythrocyte Sedimentation Rate (ESR) Levels

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    End point title
    		 Erythrocyte Sedimentation Rate (ESR) Levels
    End point description
    The change from Day 0 up to Month 48 in ESR levels
    End point type
    Secondary
    End point timeframe
    48 months
    End point values
    		 Observed Cases (OC) set
    Number of subjects analysed
    22
    Units: mm/hour
        arithmetic mean (standard deviation)
    2.9 ( 8.62 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Safety analysis
    Reporting group description
    		 The safety analysis used the Observed Cases (OC) Set defined as those subjects included in the study, who had received at least one dose of the study treatment

    Serious adverse events
    		 Safety analysis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 22 (13.64%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumor
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Enteropathic spondylitis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety analysis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 22 (81.82%)
    Nervous system disorders
    headache
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    5
    Dyspepsia
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    colitis ulcerative
         subjects affected / exposed
    7 / 22 (31.82%)
         occurrences all number
    11
    diarrhoea
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    10
    nausea
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    vomiting
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    oropharyngeal pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Infections and infestations
    nasopharyngitis
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2018
    Extension of overall study period from 12 months to 24 months
    12 Nov 2019
    Extension of overall study period from 24 months to 36 months
    21 Sep 2020
    Extension of overall study period from 36 months to 48 months
    18 Aug 2021
    End of study confirmation at M48 and possibility to enter a new long-term safety study (ABX464-108), addition of adverse event of special interest definition
    07 Feb 2022
    Update after investigator's brochure V7.0 release (prohibited medications, obefazimod previous clinical experience, study discontinuation criteria, safety updates), clarification of adverse event of special interest terms

    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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