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    Clinical Trial Results:
    A follow-up Phase 2a open-label study to evaluate the long-term safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis.

    Summary
    EudraCT number
    		 2019-001578-27
    Trial protocol
    		 HU   BE  
    Global end of trial date
    23 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Nov 2025
    First version publication date
    23 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABX464-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04049448
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abivax
    Sponsor organisation address
    7-11 Blvd Haussmann, Paris, France, 75009
    Public contact
    Study Director, Abivax, +33 (0)153830963, info@abivax.com
    Scientific contact
    Study Director, Abivax, +33 (0)153830963, 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
    06 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2023
    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 50mg once daily in patients with moderate to severe active Rheumatoid Arthritis.
    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
    25 Oct 2019
    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: 25
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Hungary: 6
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    29
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in Belgium: from 21Apr2020 to 27Apr2021 Recruitment in France: from 02Mar2020 to 01Mar2021 Recruitment in Hungary: from 07Apr2020 to 21Sep2020 Recruitment in Poland: from 25Oct2019 to 03Mar2021

    Pre-assignment
    Screening details
    		 Subjects were previously enrolled in the ABX464-301 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 104 weeks
    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
    40
    Completed
    15
    Not completed
    25
         Consent withdrawn by subject
    5
         Physician decision
    6
         subject's decision
    4
         Adverse event, non-fatal
    7
         worsening of rheumatoid arthritis
    2
         sponsor's decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study period
    Reporting group description
    		 -

    Reporting group values
    		 Overall study period Total
    Number of subjects
    		 40 40
    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)
    		 29 29
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.0 ( 10.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Observed Cases (OC) Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    all subjects who have received at least 1 dose of the study treatment. For the efficacy analysis, the denominator for each percentage was the number of subjects with non-missing observations.

    Subject analysis sets values
    		 Observed Cases (OC) Set
    Number of subjects
    40
    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)
    29
        From 65-84 years
    11
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    57.0 ( 10.8 )
    Gender categorical
    Units: Subjects
        Female
    25
        Male
    15

    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 104 weeks

    Subject analysis set title
    Observed Cases (OC) Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    all subjects who have received at least 1 dose of the study treatment. For the efficacy analysis, the denominator for each percentage was the number of subjects with non-missing observations.

    Primary: Number of subjects with adverse events emerging during treatment, categorized by severity

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    End point title
    		 Number of subjects with adverse events emerging during treatment, categorized by severity [1]
    End point description
    End point type
    Primary
    End point timeframe
    up to 108 weeks (104 weeks of treatment + 4 weeks of safety period)
    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: This is an open-label study. Only descriptive statistics were performed.
    End point values
    		 obefazimod 50mg Observed Cases (OC) Set
    Number of subjects analysed
    40
    40
    Units: participants
        Grade 1
    29
    29
        Grade 2
    24
    24
        Grade 3
    3
    3
        Grade 4
    1
    1
    No statistical analyses for this end point

    Secondary:  Number of patients achieving DAS28-ESR remission (DAS28 ESR < 2.6) at Week 52

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    End point title
    		  Number of patients achieving DAS28-ESR remission (DAS28 ESR < 2.6) at Week 52
    End point description
    The Disease Activity Score (DAS)28-Erythrocyte Sedimentation Rate (DAS28-ESR) components is a score calculated with the following formula: DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) o TJC28: tender/painful joint count (28), o SJC28: swollen joint count (28), o ESR: Erythrocyte Sedimentation Rate (in mm/h), and o PtGA: patient global assessment of disease expressed as a Visual Analog Scale (VAS) from 0 to 100 mm The DAS28-ESR remission is defined when the score is < 2.6
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 obefazimod 50mg Observed Cases (OC) Set
    Number of subjects analysed
    22 [2]
    22 [3]
    Units: participants
    7
    7
    Notes
    [2] - Subjects with non missing observations
    [3] - Subjects with non missing observations
    No statistical analyses for this end point

    Secondary:  Number of patients achieving DAS28-ESR remission (DAS28 ESR < 2.6) at Week 104

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    End point title
    		  Number of patients achieving DAS28-ESR remission (DAS28 ESR < 2.6) at Week 104
    End point description
    The Disease Activity Score (DAS)28-Erythrocyte Sedimentation Rate (DAS28-ESR) components is a score calculated with the following formula: DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) o TJC28: tender/painful joint count (28), o SJC28: swollen joint count (28), o ESR: Erythrocyte Sedimentation Rate (in mm/h), and o PtGA: patient global assessment of disease expressed as a Visual Analog Scale (VAS) from 0 to 100 mm The DAS28-ESR remission is defined when the score is < 2.6
    End point type
    Secondary
    End point timeframe
    At Week 104
    End point values
    		 obefazimod 50mg Observed Cases (OC) Set
    Number of subjects analysed
    11 [4]
    11 [5]
    Units: participants
    5
    5
    Notes
    [4] - Subjects with non missing observations
    [5] - Subjects with non missing observations
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 108 weeks (104 weeks of treatment period + 4 weeks of safety period)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Safety analysis
    Reporting group description
    		 -

    Serious adverse events
    		 Safety analysis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 40 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Emotional distress
         subjects affected / exposed
    1 / 40 (2.50%)
         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
    34 / 40 (85.00%)
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    30
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    12 / 40 (30.00%)
         occurrences all number
    31
    Dyspepsia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Bursitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Rheumatoid arthritis
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    COVID-19
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Nasopharyngitis
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Oral herpes
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    4
    Periodontitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2020
    Extension of study duration (from 52 to 104 weeks)
    16 Aug 2021
    Clarifications about discontinuation criteria and adverse events of special interest
    10 Feb 2022
    Update after Investigator's Brochure V7.0 release (changes in introduction and prohibited medications)
    08 Jun 2022
    change of pharmacovigilance service provider, addition of new available preclinical data and clarification in definitions of adverse events of special interest

    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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