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    Clinical Trial Results:
    Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFα) therapy, or intolerance to anti-TNFα therapy.

    Summary
    EudraCT number
    		 2018-004677-27
    Trial protocol
    		 BE   HU  
    Global end of trial date
    27 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2022
    First version publication date
    01 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABX464-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abivax
    Sponsor organisation address
    5 rue de la Baume, Paris, France, 75008
    Public contact
    VP Clinical Operations, Abivax, +33 0 15383 0961, paul.gineste@abivax.com
    Scientific contact
    VP Clinical Operations, Abivax, +33 0 15383 0961, paul.gineste@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
    22 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2021
    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 safety of ABX464 given at two different doses (100mg and 50 mg) vs placebo in combination with MTX when administered once daily in patients with moderate to severe active Rheumatoid Arthritis.
    Protection of trial subjects
    No specific protection
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2019
    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
    Poland: 35
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Hungary: 12
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    35
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on August 2019 in France, Belgium, Poland and Hungary

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

    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, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Bliniding implemented through IWRS

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABX464 50mg
    Arm description
    		 treatment with ABX464 50mg given once daily, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABX464
    Investigational medicinal product code
    ABX464
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule orally per day, in the morning

    Arm title
    		 ABX464 100mg
    Arm description
    		 Treatment with ABX464 100 mg given once daily, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABX464
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule orally per day, in the morning

    Arm title
    		 Placebo
    Arm description
    		 Matching Placebo given once daily, orally
    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
    One capsule orally per day, in the morning

    Number of subjects in period 1
    		ABX464 50mg ABX464 100mg Placebo
    Started
    21
    19
    20
    Completed
    18
    6
    19
    Not completed
    3
    13
    1
         Consent withdrawn by subject
    2
    3
    -
         Adverse event, non-fatal
    1
    9
    1
         Protocol deviation
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABX464 50mg
    Reporting group description
    		 treatment with ABX464 50mg given once daily, orally

    Reporting group title
    ABX464 100mg
    Reporting group description
    		 Treatment with ABX464 100 mg given once daily, orally

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo given once daily, orally

    Reporting group values
    		 ABX464 50mg ABX464 100mg Placebo Total
    Number of subjects
    		 21 19 20 60
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Mean Age value collected at baseline
    Units: years
        arithmetic mean (standard deviation)
    		 57.9 ( 11.4 ) 54.4 ( 10.6 ) 58.6 ( 11.0 ) -
    Gender categorical
    Number of female and male patients
    Units: Subjects
        Female
    		 15 11 11 37
        Male
    		 6 8 9 23

    End points

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    End points reporting groups
    Reporting group title
    ABX464 50mg
    Reporting group description
    		 treatment with ABX464 50mg given once daily, orally

    Reporting group title
    ABX464 100mg
    Reporting group description
    		 Treatment with ABX464 100 mg given once daily, orally

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo given once daily, orally

    Primary: number of treatment emergent adverse event

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    End point title
    		 number of treatment emergent adverse event
    End point description
    Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number of patients
    18
    18
    14
    Statistical analysis title
    		 analysis of all TEAEs 50 mg vs placebo
    Comparison groups
    ABX464 50mg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2212
    Method
    		 likelihood ratio chi-square test
    Confidence interval
         level
    		 90%
    Statistical analysis title
    		 analysis of all TEAEs 100mg vs placebo
    Comparison groups
    ABX464 100mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0351
    Method
    		 likelihood ratio chi-square test
    Confidence interval

    Secondary: ACR20/50/70 response

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    End point title
    		 ACR20/50/70 response
    End point description
    number of patients who achieved at least 20%, 50% or 70% improvement in the ACR response at week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number of patients
        ACR20
    9
    3
    4
        ACR50
    5
    2
    1
        ACR70
    4
    1
    1
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP)

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    End point title
    		 C-Reactive Protein (CRP)
    End point description
    Mean CRP change from Baseline to Week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: mg/L
        arithmetic mean (standard deviation)
    -4.31 ( 28.83 )
    0.62 ( 4.89 )
    -0.65 ( 18.74 )
    No statistical analyses for this end point

    Secondary: Tender Joint Count

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    End point title
    		 Tender Joint Count
    End point description
    Number of Tender Joint count (TJC) change from Baseline to week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -6.8 ( 6.4 )
    -4.1 ( 6.6 )
    -2.9 ( 3.8 )
    No statistical analyses for this end point

    Secondary: Swollen Joint Count

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    End point title
    		 Swollen Joint Count
    End point description
    number of swollen Joint count (SJC) change from Baseline to Week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -4.4 ( 4.2 )
    -3.2 ( 5.3 )
    -2.9 ( 3.8 )
    No statistical analyses for this end point

    Secondary: Pain-VAS

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    End point title
    		 Pain-VAS
    End point description
    Pain-Visaul Analog Scale change from baseline to Week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -2.63 ( 2.43 )
    -0.89 ( 1.97 )
    -0.78 ( 2.36 )
    No statistical analyses for this end point

    Secondary: Patient global assessment of disease

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    End point title
    		 Patient global assessment of disease
    End point description
    Patient global assessment of disease (Pt-GA) change from Baseline to Week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -1.44 ( 1.92 )
    -0.89 ( 1.93 )
    -0.36 ( 2.16 )
    No statistical analyses for this end point

    Secondary: Physician global assessment of disease

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    End point title
    		 Physician global assessment of disease
    End point description
    Physician global assessment of disease (Pr-GA) change from baseline to week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -3.26 ( 2.7 )
    -1.89 ( 2.95 )
    -1.63 ( 2.38 )
    No statistical analyses for this end point

    Secondary: HAQ Functional Disability Index

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    End point title
    		 HAQ Functional Disability Index
    End point description
    HAQ Functional Disability Index (HAQ-DI) change from Baseline to Week 12
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -0.435 ( 0.618 )
    -0.105 ( 0.344 )
    -0.181 ( 0.482 )
    No statistical analyses for this end point

    Secondary: Erythrocyte Sedimentation Rate (ESR)

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    End point title
    		 Erythrocyte Sedimentation Rate (ESR)
    End point description
    Change from Baseline in ESR
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -2.6 ( 19.3 )
    -0.3 ( 6.8 )
    -2.7 ( 16.6 )
    No statistical analyses for this end point

    Secondary: Disease activity score 28 joints (DAS28)

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    End point title
    		 Disease activity score 28 joints (DAS28)
    End point description
    Change From Baseline in DAS28-CRP (C-reactive protein) and DAS28-ESR
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
    arithmetic mean (standard deviation)
        DAS28-CRP
    -1.41 ( 1.45 )
    -0.72 ( 1.13 )
    -0.60 ( 0.98 )
        DAS28-ESR
    -1.43 ( 1.39 )
    -0.74 ( 1.11 )
    -0.59 ( 1.00 )
    No statistical analyses for this end point

    Secondary: Simplified disease activity index score (SDAI)

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    End point title
    		 Simplified disease activity index score (SDAI)
    End point description
    change from baseline in SDAI
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -20.21 ( 33.27 )
    -9.37 ( 14.44 )
    -7.58 ( 22.69 )
    No statistical analyses for this end point

    Secondary: Clinical Disease Activity Index Score (CDAI)

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    End point title
    		 Clinical Disease Activity Index Score (CDAI)
    End point description
    Chnage from baseline in CDAI
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number
        arithmetic mean (standard deviation)
    -15.89 ( 13.29 )
    -9.99 ( 15.85 )
    -6.93 ( 10.13 )
    No statistical analyses for this end point

    Secondary: DAS28-CRP EULAR response

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    End point title
    		 DAS28-CRP EULAR response
    End point description
    Numbe rof patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response measured as moderate/good European League Against Rheumatism (EULAR) response
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number of patients
    14
    6
    8
    No statistical analyses for this end point

    Secondary: Low Disease Activity (LDA)

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    End point title
    		 Low Disease Activity (LDA)
    End point description
    Number of patients Achieving Low Disease Activity (LDA) defined as DAS28-ESR <=3.2
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number of patients
    4
    2
    2
    No statistical analyses for this end point

    Secondary: Remission

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    End point title
    		 Remission
    End point description
    Number of patients achieving remmission: DAS28-ESR remission is defined as DAS2-ESR < 2.6 SDAI remission is considered achieved if the SDAI score ≤ 3.3 CDAI remission is considered achieved if the CDAI score ≤ 2.8 ACR/EULAR boolean-based remission based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ABX464 50mg ABX464 100mg Placebo
    Number of subjects analysed
    21
    19
    20
    Units: number of patients
        DAS28-ESR remission
    2
    0
    0
        SDAI remission
    1
    0
    0
        CDAI remission
    3
    0
    0
        Boolean remission
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    15 weeks : 12 weeks treatment period + 3 weeks safety period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    ABX464 50 mg treatment
    Reporting group description
    		 -

    Reporting group title
    ABX464 100 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 ABX464 50 mg treatment ABX464 100 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
    Additional description: atrial fibrillation reactive to hypokalemia secondary to diarrhea in the context of study drug treatment
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABX464 50 mg treatment ABX464 100 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 21 (71.43%)
    17 / 19 (89.47%)
    5 / 20 (25.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 21 (38.10%)
    10 / 19 (52.63%)
    4 / 20 (20.00%)
         occurrences all number
    19
    16
    6
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    5 / 21 (23.81%)
    4 / 19 (21.05%)
    1 / 20 (5.00%)
         occurrences all number
    6
    10
    1
    Diarrhoea
         subjects affected / exposed
    4 / 21 (19.05%)
    7 / 19 (36.84%)
    1 / 20 (5.00%)
         occurrences all number
    7
    11
    1
    Dyspepsia
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 19 (15.79%)
    0 / 20 (0.00%)
         occurrences all number
    1
    4
    0
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 19 (15.79%)
    0 / 20 (0.00%)
         occurrences all number
    2
    4
    0
    Abdominal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    3
    1
    0
    Nausea
         subjects affected / exposed
    3 / 21 (14.29%)
    9 / 19 (47.37%)
    0 / 20 (0.00%)
         occurrences all number
    4
    12
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    2
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    1
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2019
    Clarification on Data Safety Monitoring Board (DSMB) procedures Clarification on concomitant medication Clarfication about the infection exclusion criteria
    24 Oct 2019
    Addition of miR-124 assays and INR assessment Addition ofTruculture(R) samples for cytokines determination clarification of last dosing day procedure

    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.

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