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    Clinical Trial Results:
    A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

    Summary
    EudraCT number
    		 2019-000733-39
    Trial protocol
    		 SK   PL   AT   SI   BE   CZ   ES   HU   GB   FR   DE   IT  
    Global end of trial date
    23 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2026
    First version publication date
    19 Jul 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ABX464-104
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04023396
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abivax
    Sponsor organisation address
    7-11 Blvd. Haussmann, Paris, France, 75009
    Public contact
    Clinical Operations, ABIVAX, +33 630031132, laurence.desroys@abivax.com
    Scientific contact
    Clinical Operations, ABIVAX, +33 630031132, laurence.desroys@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
    29 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess in all patients the long-term efficacy of ABX464 given at 50 mg QD on clinical remission at Week 48 compared to the induction study (ABX464-103) baseline (ISB).
    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
    13 Jan 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 63
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Slovenia: 3
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Ukraine: 30
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Serbia: 5
    Worldwide total number of subjects
    217
    EEA total number of subjects
    177
    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)
    202
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 NOT APPLICABLE

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ABX464 50 mg
    Arm description
    		 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
    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
    All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

    Number of subjects in period 1
    		ABX464 50 mg
    Started
    217
    Completed
    164
    Not completed
    53
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    14
         Physician decision
    4
         Adverse event, non-fatal
    16
         e.g Ukraine crisis
    10
         Pregnancy
    4
         Lost to follow-up
    1
         Lack of efficacy
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 217 217
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 202 202
        From 65-84 years
    		 15 15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.1 ( 13.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 84 84
        Male
    		 133 133
    Subject analysis sets

    Subject analysis set title
    Full analysis set [FAS]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all patients in the study who received at least one dose of the study treatment, and who had BOLS (Baseline of the open-label study) data for at least one efficacy variable.

    Subject analysis set title
    Sustained endoscopic improvement at Week 8 of induction study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    At Week 8 of the induction study, endoscopic improvement was achieved by 70 patients

    Subject analysis set title
    Sustained endoscopic remission at Week 8 of induction study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    number of patients who achieved endoscopic remission at Week 8 (Induction Study)

    Subject analysis set title
    MMS baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Induction Study Baseline

    Subject analysis set title
    MMS baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Baseline of Open-Label Study

    Subject analysis set title
    MMS Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Week 48

    Subject analysis set title
    MMS Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Week 96

    Subject analysis set title
    pMMS baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Induction Study Baseline

    Subject analysis set title
    pMMS baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Baseline of Open Label Study.

    Subject analysis set title
    pMMS Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group: Week 4

    Subject analysis set title
    pMMS Week 8
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 8

    Subject analysis set title
    pMMS Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group: Week 12

    Subject analysis set title
    pMMS Week 16
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 16

    Subject analysis set title
    pMMS Week 20
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 20

    Subject analysis set title
    pMMS Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 24

    Subject analysis set title
    pMMS Week 28
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 28

    Subject analysis set title
    pMMS Week 32
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 32

    Subject analysis set title
    pMMS Week 36
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 36

    Subject analysis set title
    pMMS Week 40
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 40

    Subject analysis set title
    pMMS Week 44
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 44

    Subject analysis set title
    pMMS Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 48

    Subject analysis set title
    pMMS Week 60
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 60

    Subject analysis set title
    pMMS Week 72
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 72

    Subject analysis set title
    pMMS Week 84
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 84

    Subject analysis set title
    pMMS Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 96

    Subject analysis set title
    Stool frequency - Baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Baseline Induction Study Baseline

    Subject analysis set title
    Stool frequency - Baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Baseline of Open Label Study

    Subject analysis set title
    Stool Frequency - Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 4

    Subject analysis set title
    Stool Frequency - Week 8
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 8

    Subject analysis set title
    Stool Frequency - Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 12

    Subject analysis set title
    Stool Frequency - Week 16
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 16

    Subject analysis set title
    Stool Frequency - Week 20
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 20

    Subject analysis set title
    Stool Frequency - Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 24

    Subject analysis set title
    Stool Frequency - Week 28
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 28

    Subject analysis set title
    Stool Frequency - Week 32
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 32

    Subject analysis set title
    Stool Frequency - Week 36
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 36

    Subject analysis set title
    Stool Frequency - Week 40
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 40

    Subject analysis set title
    Stool Frequency - Week 44
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 44

    Subject analysis set title
    Stool Frequency - Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 48

    Subject analysis set title
    Stool Frequency - Week 60
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 60

    Subject analysis set title
    Stool Frequency - Week 72
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 72

    Subject analysis set title
    Stool Frequency - Week 84
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 84

    Subject analysis set title
    Stool Frequency - Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 96

    Subject analysis set title
    Rectal Bleeding Score - Baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore- Baseline Induction Study Baseline

    Subject analysis set title
    Rectal bleeding Score - BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Baseline of Open Label Study

    Subject analysis set title
    Rectal bleeding Score - Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 4

    Subject analysis set title
    Rectal bleeding Score - Week 8
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 8

    Subject analysis set title
    Rectal bleeding Score - Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - week 12

    Subject analysis set title
    Rectal bleeding Score - Week 16
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 16

    Subject analysis set title
    Rectal bleeding Score - Week 20
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 20

    Subject analysis set title
    Rectal bleeding Score - Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 24

    Subject analysis set title
    Rectal bleeding Score - Week 28
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 28

    Subject analysis set title
    Rectal bleeding Score - Week 32
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 32

    Subject analysis set title
    Rectal bleeding Score - Week 36
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 36

    Subject analysis set title
    Rectal bleeding Score - Week 40
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 40

    Subject analysis set title
    Rectal bleeding Score - Week 44
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 44

    Subject analysis set title
    Rectal bleeding Score - Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 48

    Subject analysis set title
    Rectal bleeding Score - Week 60
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore- Week 60

    Subject analysis set title
    Rectal bleeding Score - Week 72
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 72

    Subject analysis set title
    Rectal bleeding Score - Week 84
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 84

    Subject analysis set title
    Rectal bleeding Score - Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 96

    Subject analysis set title
    C- Reactive Protein - Baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    CRP by Induction Phase Treatment Group , Baseline - Baseline of Open Label Study

    Subject analysis set title
    C-Reactive Protein - Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    CRP by Induction Phase Treatment Group - Week 24

    Subject analysis set title
    C-Reactive Protein - Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    CRP by Induction Phase Treatment Group - Week 48

    Subject analysis sets values
    		 Full analysis set [FAS] Sustained endoscopic improvement at Week 8 of induction study Sustained endoscopic remission at Week 8 of induction study MMS baseline ISB MMS baseline BOLS MMS Week 48 MMS Week 96 pMMS baseline ISB pMMS baseline BOLS pMMS Week 4 pMMS Week 8 pMMS Week 12 pMMS Week 16 pMMS Week 20 pMMS Week 24 pMMS Week 28 pMMS Week 32 pMMS Week 36 pMMS Week 40 pMMS Week 44 pMMS Week 48 pMMS Week 60 pMMS Week 72 pMMS Week 84 pMMS Week 96 Stool frequency - Baseline ISB Stool frequency - Baseline BOLS Stool Frequency - Week 4 Stool Frequency - Week 8 Stool Frequency - Week 12 Stool Frequency - Week 16 Stool Frequency - Week 20 Stool Frequency - Week 24 Stool Frequency - Week 28 Stool Frequency - Week 32 Stool Frequency - Week 36 Stool Frequency - Week 40 Stool Frequency - Week 44 Stool Frequency - Week 48 Stool Frequency - Week 60 Stool Frequency - Week 72 Stool Frequency - Week 84 Stool Frequency - Week 96 Rectal Bleeding Score - Baseline ISB Rectal bleeding Score - BOLS Rectal bleeding Score - Week 4 Rectal bleeding Score - Week 8 Rectal bleeding Score - Week 12 Rectal bleeding Score - Week 16 Rectal bleeding Score - Week 20 Rectal bleeding Score - Week 24 Rectal bleeding Score - Week 28 Rectal bleeding Score - Week 32 Rectal bleeding Score - Week 36 Rectal bleeding Score - Week 40 Rectal bleeding Score - Week 44 Rectal bleeding Score - Week 48 Rectal bleeding Score - Week 60 Rectal bleeding Score - Week 72 Rectal bleeding Score - Week 84 Rectal bleeding Score - Week 96 C- Reactive Protein - Baseline BOLS C-Reactive Protein - Week 24 C-Reactive Protein - Week 48
    Number of subjects
    217
    70
    16
    217
    151
    182
    154
    217
    214
    214
    208
    203
    200
    196
    192
    191
    189
    188
    185
    182
    184
    175
    170
    169
    165
    217
    214
    214
    209
    203
    202
    198
    193
    192
    190
    189
    185
    182
    184
    176
    170
    169
    165
    217
    214
    208
    208
    203
    200
    196
    192
    191
    189
    188
    185
    182
    184
    175
    170
    169
    165
    216
    191
    183
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    202
        From 65-84 years
    15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.1 ( 13.77 )
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    Gender categorical
    Units: Subjects
        Female
    84
        Male
    133

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    ABX464 50 mg
    Reporting group description
    		 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

    Subject analysis set title
    Full analysis set [FAS]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all patients in the study who received at least one dose of the study treatment, and who had BOLS (Baseline of the open-label study) data for at least one efficacy variable.

    Subject analysis set title
    Sustained endoscopic improvement at Week 8 of induction study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    At Week 8 of the induction study, endoscopic improvement was achieved by 70 patients

    Subject analysis set title
    Sustained endoscopic remission at Week 8 of induction study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    number of patients who achieved endoscopic remission at Week 8 (Induction Study)

    Subject analysis set title
    MMS baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Induction Study Baseline

    Subject analysis set title
    MMS baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Baseline of Open-Label Study

    Subject analysis set title
    MMS Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Week 48

    Subject analysis set title
    MMS Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Modified Mayo Score by Induction Phase Treatment Group, Week 96

    Subject analysis set title
    pMMS baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Induction Study Baseline

    Subject analysis set title
    pMMS baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Baseline of Open Label Study.

    Subject analysis set title
    pMMS Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group: Week 4

    Subject analysis set title
    pMMS Week 8
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 8

    Subject analysis set title
    pMMS Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group: Week 12

    Subject analysis set title
    pMMS Week 16
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 16

    Subject analysis set title
    pMMS Week 20
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 20

    Subject analysis set title
    pMMS Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 24

    Subject analysis set title
    pMMS Week 28
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 28

    Subject analysis set title
    pMMS Week 32
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 32

    Subject analysis set title
    pMMS Week 36
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 36

    Subject analysis set title
    pMMS Week 40
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 40

    Subject analysis set title
    pMMS Week 44
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 44

    Subject analysis set title
    pMMS Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 48

    Subject analysis set title
    pMMS Week 60
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 60

    Subject analysis set title
    pMMS Week 72
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 72

    Subject analysis set title
    pMMS Week 84
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 84

    Subject analysis set title
    pMMS Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Partial Modified Mayo Score by Induction Phase Treatment Group, Week 96

    Subject analysis set title
    Stool frequency - Baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Baseline Induction Study Baseline

    Subject analysis set title
    Stool frequency - Baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Baseline of Open Label Study

    Subject analysis set title
    Stool Frequency - Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 4

    Subject analysis set title
    Stool Frequency - Week 8
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 8

    Subject analysis set title
    Stool Frequency - Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 12

    Subject analysis set title
    Stool Frequency - Week 16
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 16

    Subject analysis set title
    Stool Frequency - Week 20
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 20

    Subject analysis set title
    Stool Frequency - Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 24

    Subject analysis set title
    Stool Frequency - Week 28
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 28

    Subject analysis set title
    Stool Frequency - Week 32
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 32

    Subject analysis set title
    Stool Frequency - Week 36
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 36

    Subject analysis set title
    Stool Frequency - Week 40
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 40

    Subject analysis set title
    Stool Frequency - Week 44
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 44

    Subject analysis set title
    Stool Frequency - Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 48

    Subject analysis set title
    Stool Frequency - Week 60
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 60

    Subject analysis set title
    Stool Frequency - Week 72
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 72

    Subject analysis set title
    Stool Frequency - Week 84
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 84

    Subject analysis set title
    Stool Frequency - Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Stool Frequency Subscore, Week 96

    Subject analysis set title
    Rectal Bleeding Score - Baseline ISB
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore- Baseline Induction Study Baseline

    Subject analysis set title
    Rectal bleeding Score - BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Baseline of Open Label Study

    Subject analysis set title
    Rectal bleeding Score - Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 4

    Subject analysis set title
    Rectal bleeding Score - Week 8
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 8

    Subject analysis set title
    Rectal bleeding Score - Week 12
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - week 12

    Subject analysis set title
    Rectal bleeding Score - Week 16
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 16

    Subject analysis set title
    Rectal bleeding Score - Week 20
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 20

    Subject analysis set title
    Rectal bleeding Score - Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 24

    Subject analysis set title
    Rectal bleeding Score - Week 28
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 28

    Subject analysis set title
    Rectal bleeding Score - Week 32
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 32

    Subject analysis set title
    Rectal bleeding Score - Week 36
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 36

    Subject analysis set title
    Rectal bleeding Score - Week 40
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 40

    Subject analysis set title
    Rectal bleeding Score - Week 44
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 44

    Subject analysis set title
    Rectal bleeding Score - Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 48

    Subject analysis set title
    Rectal bleeding Score - Week 60
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore- Week 60

    Subject analysis set title
    Rectal bleeding Score - Week 72
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 72

    Subject analysis set title
    Rectal bleeding Score - Week 84
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 84

    Subject analysis set title
    Rectal bleeding Score - Week 96
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rectal Bleeding Subscore - Week 96

    Subject analysis set title
    C- Reactive Protein - Baseline BOLS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    CRP by Induction Phase Treatment Group , Baseline - Baseline of Open Label Study

    Subject analysis set title
    C-Reactive Protein - Week 24
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    CRP by Induction Phase Treatment Group - Week 24

    Subject analysis set title
    C-Reactive Protein - Week 48
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    CRP by Induction Phase Treatment Group - Week 48

    Primary: Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103)

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    End point title
    		 Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103) [1]
    End point description
    Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
    End point type
    Primary
    End point timeframe
    week 48
    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: Descriptive Statistics were done.
    End point values
    		 ABX464 50 mg Full analysis set [FAS]
    Number of subjects analysed
    217
    217
    Units: participants
    119
    119
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study

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    End point title
    		 Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study
    End point description
    Proportion of patients with clinical response at week 48 Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
    End point type
    Secondary
    End point timeframe
    Weeks 48 and 96
    End point values
    		 ABX464 50 mg Full analysis set [FAS]
    Number of subjects analysed
    217
    217
    Units: participants
        Week 48
    177
    177
        Week 96
    158
    158
    No statistical analyses for this end point

    Secondary: Endoscopic Improvement at Weeks 48 and 96

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    End point title
    		 Endoscopic Improvement at Weeks 48 and 96
    End point description
    Proportion of patients with endoscopic improvement at week 48 among all patients. Proportion of patients with endoscopic improvement at week 96 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability).
    End point type
    Secondary
    End point timeframe
    week 48 and week 96
    End point values
    		 ABX464 50 mg Full analysis set [FAS]
    Number of subjects analysed
    217
    217
    Units: participants
        Week 48
    133
    133
        Week 96
    128
    128
    No statistical analyses for this end point

    Secondary: Endoscopic Remission at Weeks 48 and 96

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    End point title
    		 Endoscopic Remission at Weeks 48 and 96
    End point description
    Proportion of patients with endoscopic remission at week 48 among all patients. Proportion of patients with endoscopic remission at week 96 among all patients. Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
    End point type
    Secondary
    End point timeframe
    week 48 and week 96
    End point values
    		 ABX464 50 mg Full analysis set [FAS]
    Number of subjects analysed
    217
    217
    Units: participants
        Week 48
    72
    72
        Week 96
    78
    78
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    Participants recorded stool frequency using a paper subject diary on a daily basis. The stool frequency subscore ranges from 0 to 3 according to the following scale: Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal
    End point type
    Secondary
    End point timeframe
    Baseline ISB
    End point values
    		 Stool frequency - Baseline ISB
    Number of subjects analysed
    217
    Units: score on a scale
    arithmetic mean (standard deviation)
        Stool frequency - Baseline ISB
    2.6 ( 0.66 )
    No statistical analyses for this end point

    Secondary: miRNA-124 Expression

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    End point title
    		 miRNA-124 Expression
    End point description
    Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
    End point type
    Secondary
    End point timeframe
    baseline, week 24 and week 48
    End point values
    		 ABX464 50 mg Full analysis set [FAS]
    Number of subjects analysed
    217
    217
    Units: copy number/cell
    arithmetic mean (standard deviation)
        miR-124 - Rectal - Baseline
    0.0065 ( 0.00211 )
    0.00065 ( 0.00211 )
        miR-124 - Rectal - Week 48
    0.00255 ( 0.00252 )
    0.00255 ( 0.00252 )
        miR-124 - Sigmoidal- Baseline
    0.00035 ( 0.00050 )
    0.00035 ( 0.00050 )
        miR-124 - Sigmoidal- Week 48
    0.00225 ( 0.00216 )
    0.00225 ( 0.00216 )
        miR-124 - Blood- Baseline
    0.00000 ( 0.00000 )
    0.00000 ( 0.00000 )
        miR-124 - Blood- Week 24
    0.00011 ( 0.00015 )
    0.00011 ( 0.00015 )
        miR-124 - Blood- Week 48
    0.00013 ( 0.00026 )
    0.00013 ( 0.00026 )
    No statistical analyses for this end point

    Secondary: Incidence and Description of Adverse Events

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    End point title
    		 Incidence and Description of Adverse Events
    End point description
    Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity. Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days. Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 ABX464 50 mg Full analysis set [FAS]
    Number of subjects analysed
    217
    217
    Units: participants
        AEs
    149
    149
        TEAEs
    148
    148
        Related TEAEs
    54
    54
        SAEs
    18
    18
        TESAEs
    18
    18
        TEAEs leading to discontinuation of IP
    26
    26
        TEAEs leading to study discontinuation
    17
    17
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline BOLS
    End point values
    		 Stool frequency - Baseline BOLS
    Number of subjects analysed
    214
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.4 ( 0.94 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Stool Frequency - Week 4
    Number of subjects analysed
    214
    Units: score on scale
        arithmetic mean (standard deviation)
    1.2 ( 0.89 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Stool Frequency - Week 8
    Number of subjects analysed
    213
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.2 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Stool Frequency - Week 12
    Number of subjects analysed
    203
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.1 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Stool Frequency - Week 16
    Number of subjects analysed
    202
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.1 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 Stool Frequency - Week 20
    Number of subjects analysed
    198
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.0 ( 0.92 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Stool Frequency - Week 24
    Number of subjects analysed
    193
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.0 ( 0.83 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

    		 Close Top of page
    End point title
    		 Stool Frequency Subscore
    End point description
    Stool Frequency - Week 28
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Stool Frequency - Week 28
    Number of subjects analysed
    192
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.9 ( 0.87 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 32
    End point values
    		 Stool Frequency - Week 32
    Number of subjects analysed
    190
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.9 ( 0.78 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 Stool Frequency - Week 40
    Number of subjects analysed
    185
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.8 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

    		 Close Top of page
    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Stool Frequency - Week 36
    Number of subjects analysed
    182
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.9 ( 0.82 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 44
    End point values
    		 Stool Frequency - Week 44
    Number of subjects analysed
    182
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.8 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Stool Frequency - Week 48
    Number of subjects analysed
    184
    Units: score on scale
        arithmetic mean (standard deviation)
    0.7 ( 0.79 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 60
    End point values
    		 Stool Frequency - Week 60
    Number of subjects analysed
    176
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.73 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 72
    End point values
    		 Stool Frequency - Week 72
    Number of subjects analysed
    170
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.76 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 84
    End point values
    		 Stool Frequency - Week 84
    Number of subjects analysed
    169
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.77 )
    No statistical analyses for this end point

    Secondary: Stool Frequency Subscore

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    End point title
    		 Stool Frequency Subscore
    End point description
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Stool Frequency - Week 96
    Number of subjects analysed
    165
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.6 ( 0.73 )
    No statistical analyses for this end point

    Secondary: C-Reactive Protein levels

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    End point title
    		 C-Reactive Protein levels
    End point description
    Change to baseline in C-Reactive Protein levels. Number analyzed correspond to number of patients analysed in the relevant week
    End point type
    Secondary
    End point timeframe
    Baseline BOLS
    End point values
    		 ABX464 50 mg
    Number of subjects analysed
    216
    Units: mg/L
        arithmetic mean (standard deviation)
    6.66 ( 12.17 )
    No statistical analyses for this end point

    Secondary: C-Reactive Protein levels

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    End point title
    		 C-Reactive Protein levels
    End point description
    Change to baseline in C-Reactive Protein levels. Number analyzed correspond to number of patients analysed in the relevant week.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 C-Reactive Protein - Week 24
    Number of subjects analysed
    191
    Units: mg/L
        arithmetic mean (standard deviation)
    5.07 ( 10.43 )
    No statistical analyses for this end point

    Secondary: C-Reactive Protein levels

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    End point title
    		 C-Reactive Protein levels
    End point description
    Change to baseline in C-Reactive Protein levels. Number analyzed correspond to number of patients analysed in the relevant week
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 C-Reactive Protein - Week 48
    Number of subjects analysed
    183
    Units: mg/L
        arithmetic mean (standard deviation)
    5.01 ( 11.31 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    Participants recorded rectal bleeding in a paper subject diary on a daily basis. Rectal bleeding score is taken as the worst subscore of the three most recent scores within 7 days prior to the visit. The rectal bleeding subscore ranges from 0 to 3 according to the following scale: Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding.
    End point type
    Secondary
    End point timeframe
    Baseline - ISB
    End point values
    		 Rectal Bleeding Score - Baseline ISB
    Number of subjects analysed
    217
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.6 ( 0.72 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline - BOLS
    End point values
    		 Rectal bleeding Score - BOLS
    Number of subjects analysed
    214
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.4 ( 0.66 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Rectal bleeding Score - Week 4
    Number of subjects analysed
    214
    Units: score on scale
        arithmetic mean (standard deviation)
    0.2 ( 0.49 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Stool Frequency - Week 8
    Number of subjects analysed
    208
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.2 ( 0.56 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Rectal bleeding Score - Week 12
    Number of subjects analysed
    203
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.2 ( 0.50 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Rectal bleeding Score - Week 16
    Number of subjects analysed
    200
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.2 ( 0.51 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 Rectal bleeding Score - Week 20
    Number of subjects analysed
    196
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.2 ( 0.49 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Rectal bleeding Score - Week 24
    Number of subjects analysed
    192
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.2 ( 0.46 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Rectal bleeding Score - Week 28
    Number of subjects analysed
    191
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.1 ( 0.42 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 32
    End point values
    		 Rectal bleeding Score - Week 32
    Number of subjects analysed
    189
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.1 ( 0.39 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Rectal bleeding Score - Week 36
    Number of subjects analysed
    188
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.1 ( 0.38 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

    		 Close Top of page
    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 40
    End point values
    		 Rectal bleeding Score - Week 40
    Number of subjects analysed
    185
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.1 ( 0.37 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 44
    End point values
    		 Rectal bleeding Score - Week 44
    Number of subjects analysed
    182
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.1 ( 0.37 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Rectal bleeding Score - Week 48
    Number of subjects analysed
    184
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.0 ( 0.23 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 60
    End point values
    		 Rectal bleeding Score - Week 60
    Number of subjects analysed
    175
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.0 ( 0.24 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 72
    End point values
    		 Rectal bleeding Score - Week 72
    Number of subjects analysed
    170
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.0 ( 0.24 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 84
    End point values
    		 Rectal bleeding Score - Week 84
    Number of subjects analysed
    169
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.1 ( 0.36 )
    No statistical analyses for this end point

    Secondary: Rectal Bleeding Score

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    End point title
    		 Rectal Bleeding Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Rectal bleeding Score - Week 96
    Number of subjects analysed
    165
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.0 ( 0.22 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    Change in Modified Mayo Score (MMS) at weeks 48 and 96 and in partial Modified Mayo Score (pMMS) MMS is a composite score of UC disease activity calculated as the sum of the following 3 subscores: 1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic evaluation, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. pMMS is a composite score of UC disease activity calculed as the sum of the following 2 subscores: 1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). The overall pMMS ranges from 0 to 6 where higher scores represent more severe disease.
    End point type
    Secondary
    End point timeframe
    MMS Baseline ISB
    End point values
    		 MMS baseline ISB
    Number of subjects analysed
    217
    Units: units on a scale
        arithmetic mean (standard deviation)
    7.0 ( 1.07 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    MMS baseline BOLS
    End point values
    		 MMS baseline BOLS
    Number of subjects analysed
    151
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.0 ( 2.02 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    MMS Week 48
    End point values
    		 MMS Week 48
    Number of subjects analysed
    182
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.8 ( 1.47 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    MMS Week 96
    End point values
    		 MMS Week 96
    Number of subjects analysed
    154
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.5 ( 1.48 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS baseline ISB
    End point values
    		 pMMS baseline ISB
    Number of subjects analysed
    217
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.2 ( 1.01 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS baseline BOLS
    End point values
    		 pMMS baseline BOLS
    Number of subjects analysed
    214
    Units: units on a cale
        arithmetic mean (standard deviation)
    1.8 ( 1.31 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 4
    End point values
    		 pMMS Week 4
    Number of subjects analysed
    214
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.4 ( 1.17 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 8
    End point values
    		 pMMS Week 8
    Number of subjects analysed
    208
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.4 ( 1.24 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 12
    End point values
    		 pMMS Week 12
    Number of subjects analysed
    203
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.3 ( 1.22 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 16
    End point values
    		 pMMS Week 16
    Number of subjects analysed
    200
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.3 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 20
    End point values
    		 pMMS Week 20
    Number of subjects analysed
    196
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.2 ( 1.14 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 24
    End point values
    		 pMMS Week 24
    Number of subjects analysed
    192
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.1 ( 1.06 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 28
    End point values
    		 pMMS Week 28
    Number of subjects analysed
    191
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.1 ( 1.09 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 32
    End point values
    		 pMMS Week 32
    Number of subjects analysed
    189
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.0 ( 1.00 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 36
    End point values
    		 pMMS Week 36
    Number of subjects analysed
    188
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.0 ( 0.98 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 40
    End point values
    		 pMMS Week 40
    Number of subjects analysed
    185
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.9 ( 0.94 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 44
    End point values
    		 pMMS Week 44
    Number of subjects analysed
    182
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.9 ( 0.98 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    Stool Frequency - Week 48
    End point values
    		 Stool Frequency - Week 48
    Number of subjects analysed
    184
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.8 ( 0.88 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 60
    End point values
    		 pMMS Week 60
    Number of subjects analysed
    175
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.80 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 72
    End point values
    		 pMMS Week 72
    Number of subjects analysed
    170
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.84 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 84
    End point values
    		 pMMS Week 84
    Number of subjects analysed
    169
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Change in Modified Mayo Score and in Partial Modified Mayo Score

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    End point title
    		 Change in Modified Mayo Score and in Partial Modified Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    pMMS Week 96
    End point values
    		 pMMS Week 96
    Number of subjects analysed
    165
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.7 ( 0.79 )
    No statistical analyses for this end point

    Secondary: Sustained Endoscopic Changes at Week 48 and Week 96

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    End point title
    		 Sustained Endoscopic Changes at Week 48 and Week 96
    End point description
    Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).
    End point type
    Secondary
    End point timeframe
    weeks 48
    End point values
    		 Sustained endoscopic improvement at Week 8 of induction study
    Number of subjects analysed
    70
    Units: participants
        Sustained endoscopic improvement at Week 8 of indu
    53
    No statistical analyses for this end point

    Secondary: Sustained Endoscopic Changes at Week 48 and Week 96

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    End point title
    		 Sustained Endoscopic Changes at Week 48 and Week 96
    End point description
    End point type
    Secondary
    End point timeframe
    week 96
    End point values
    		 Sustained endoscopic improvement at Week 8 of induction study
    Number of subjects analysed
    70
    Units: participants
    50
    No statistical analyses for this end point

    Secondary: Sustained Endoscopic Changes at Week 48 and Week 96

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    End point title
    		 Sustained Endoscopic Changes at Week 48 and Week 96
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 Sustained endoscopic remission at Week 8 of induction study
    Number of subjects analysed
    16
    Units: participants
    13
    No statistical analyses for this end point

    Secondary: Sustained Endoscopic Changes at Week 48 and Week 96

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    End point title
    		 Sustained Endoscopic Changes at Week 48 and Week 96
    End point description
    End point type
    Secondary
    End point timeframe
    week 96
    End point values
    		 Sustained endoscopic remission at Week 8 of induction study
    Number of subjects analysed
    16
    Units: participants
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    96 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    ABX464 50 mg
    Reporting group description
    		 -

    Serious adverse events
    		 ABX464 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 217 (8.29%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma malignant
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Facial paresis
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischemic stroke
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colon dysplasia
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctitis
         subjects affected / exposed
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Apendicitis
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneunomia
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 ABX464 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    148 / 217 (68.20%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    8 / 217 (3.69%)
         occurrences all number
    10
    C-reactive protein increased
         subjects affected / exposed
    6 / 217 (2.76%)
         occurrences all number
    7
    Low density lipoprotein increased
         subjects affected / exposed
    5 / 217 (2.30%)
         occurrences all number
    7
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    6
    Neutrophil count increased
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    4
    Thyroxine increased
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Lipase increased
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Platelet count decreased
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    SARS-CoV-2 test positive
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Fecal calprotectin increased
         subjects affected / exposed
    10 / 217 (4.61%)
         occurrences all number
    11
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    5 / 217 (2.30%)
         occurrences all number
    12
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 217 (3.69%)
         occurrences all number
    8
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 217 (11.52%)
         occurrences all number
    35
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    5
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    17 / 217 (7.83%)
         occurrences all number
    20
    Abdominal pain
         subjects affected / exposed
    8 / 217 (3.69%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    8 / 217 (3.69%)
         occurrences all number
    8
    Hemorrhoids
         subjects affected / exposed
    7 / 217 (3.23%)
         occurrences all number
    7
    Diarrhea
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    5
    Gastroesophageal reflux disease
         subjects affected / exposed
    5 / 217 (2.30%)
         occurrences all number
    5
    Abdominal distension
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 217 (5.07%)
         occurrences all number
    15
    Back pain
         subjects affected / exposed
    12 / 217 (5.53%)
         occurrences all number
    13
    Pain in extremity
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    6
    Myalgia
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    5
    Osteoarthritis
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    5
    Bursitis
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    31 / 217 (14.29%)
         occurrences all number
    34
    Nasopharyngitis
         subjects affected / exposed
    15 / 217 (6.91%)
         occurrences all number
    23
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 217 (2.76%)
         occurrences all number
    7
    Pharyngitis
         subjects affected / exposed
    4 / 217 (1.84%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Ear infection
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hypophosphatemia
         subjects affected / exposed
    5 / 217 (2.30%)
         occurrences all number
    7
    Folate deficiency
         subjects affected / exposed
    6 / 217 (2.76%)
         occurrences all number
    6
    Hypercholesterolemia
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3
    Vitamin D deficiency
         subjects affected / exposed
    3 / 217 (1.38%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2019
    The protocol was amended to add Geboes and Nancy Histology Scoring Scales, increase period of contraception use to 6 months, updated allowed doses of prednisone or equivalent and budesonide MMX to reflect standard doses used in participating countries, updated blood sample tubes and volumes, added annex 13 of the EudraLex guidelines for Good Manufacturing Practices.
    10 Sep 2020
    The protocol was amended to change from a 48-week to a 96-week study treatment schedule, change clinical response definition based on MMS, add sustained endoscopic remission endpoint, change clinical remission definition, add study endpoints regarding study treatment period extension, add inclusion criteria regarding second year of study treatment, add prohibited concomitant medications, include DSMB review study safety every 2 months, remove lifestyle guidelines, and add urine pregnancy tests monthly from Week 48 onward.
    16 Aug 2021
    The protocol was amendment to add miRNA dosage at Week 96, include eligibility check and signature of ICF at Week 48, add possibility to take part in long-term follow-up safety study (ABX464-108), add echocardiography measurements and add reason for discontinuation for patients with history of cardiac ischemic disease and/or congestive heart failure, implement designated independent cardiovascular safety adjudication committee, and to remove exclusion criteria 1: patients who had protocol deviation(s) in the induction study assessed as major by the investigator or Sponsor.
    08 Sep 2021
    The protocol was amended to include administration changes, and the addition of EU Regulation 536/2014 of the European Parliament and of Council, which introduces the Clinical Trials Information System (CTIS) that harmonizes the submission, assessment, and supervision process for clinical trials throughout Europe.
    11 Jul 2022
    The protocol was amended to align with the IB v8.0, clarify that only 2-dimensional echocardiography will be performed by sites, clarify local read results could be used at Week 96 to assess eligibility of patient to enter ABX464-108 study if central read results are not available, and add definitions and reporting of SAE/AESI during the study. 9.8.2

    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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