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    Clinical Trial Results:
    A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-α] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.

    Summary
    EudraCT number
    		 2018-003558-26
    Trial protocol
    		 FR   SI   CZ   DE   SK   HU   PL   BE   GB   IT  
    Global end of trial date
    31 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2023
    First version publication date
    20 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ABX464-103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03760003
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ABIVAX
    Sponsor organisation address
    7-11 Boulevard Haussmann, Paris, France, 75009
    Public contact
    Clinical Operations, Abivax, +33 15383 0961, Paul.Gineste@abivax.com
    Scientific contact
    Clinical Operations, Abivax, +33 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
    31 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to determine an optimal ABX464 dose to be used in moderate to severe active ulcerative colitis patients who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab, JAK inhibitors and/or corticosteroids by comparing the mean change from baseline in the MMS at week 8 between each ABX464 group and placebo.
    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
    31 May 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 52 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 70
    Country: Number of subjects enrolled
    Slovakia: 18
    Country: Number of subjects enrolled
    Slovenia: 3
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Czechia: 14
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 22
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Ukraine: 32
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    254
    EEA total number of subjects
    210
    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)
    239
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 355 patients were enrolled in the study. Of these, 101 patients were screen failures and 1 patient was a Baseline failure (the patient signed informed consent but withdrew before the baseline visit).

    Period 1
    Period 1 title
    Randomized phase (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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 2 capsules of Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    once daily during a meal with a glass of water

    Arm title
    		 25mg ABX464
    Arm description
    		 1 capsule of 25mg ABX464 + 1 capsule of Placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    obefazimod
    Investigational medicinal product code
    ABX464
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Depending on the randomization, patients will be treated with a daily dose of either 25mg, 50mg or 100mg of ABX464 or matching placebo. All patients regardless of the treatment group will receive 2 capsules every day. Patients will be orally dosed in a fed condition (regular meal) in the morning with a glass of water.

    Arm title
    		 50mg ABX464
    Arm description
    		 1 capsule of 50mg ABX464 + 1 capsule of Placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    obefazimod
    Investigational medicinal product code
    ABX464
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Depending on the randomization, patients will be treated with a daily dose of either 25mg, 50mg or 100mg of ABX464 or matching placebo. All patients regardless of the treatment group will receive 2 capsules every day. Patients will be orally dosed in a fed condition (regular meal) in the morning with a glass of water

    Arm title
    		 100mg ABX464
    Arm description
    		 2 capsules of 50mg ABX464
    Arm type
    		 Experimental

    Investigational medicinal product name
    obefazimod
    Investigational medicinal product code
    ABX464
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Depending on the randomization, patients will be treated with a daily dose of either 25mg, 50mg or 100mg of ABX464 or matching placebo. All patients regardless of the treatment group will receive 2 capsules every day. Patients will be orally dosed in a fed condition (regular meal) in the morning with a glass of water.

    Number of subjects in period 1
    		Placebo 25mg ABX464 50mg ABX464 100mg ABX464
    Started
    64
    63
    63
    64
    FAS
    64
    61
    63
    64
    Completed
    57
    58
    53
    54
    Not completed
    7
    5
    10
    10
         Consent withdrawn by subject
    2
    -
    3
    5
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    4
    1
    6
    5
         Pregnancy
    -
    2
    -
    -
         Lost to follow-up
    -
    -
    1
    -
         Lack of efficacy
    1
    -
    -
    -
         Protocol deviation
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 2 capsules of Placebo

    Reporting group title
    25mg ABX464
    Reporting group description
    		 1 capsule of 25mg ABX464 + 1 capsule of Placebo

    Reporting group title
    50mg ABX464
    Reporting group description
    		 1 capsule of 50mg ABX464 + 1 capsule of Placebo

    Reporting group title
    100mg ABX464
    Reporting group description
    		 2 capsules of 50mg ABX464

    Reporting group values
    		 Placebo 25mg ABX464 50mg ABX464 100mg ABX464 Total
    Number of subjects
    		 64 63 63 64 254
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 60 58 60 61 239
        From 65-84 years
    		 4 5 3 3 15
    Age continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    		 41.1 ( 14.43 ) 41.5 ( 14.16 ) 40.2 ( 13.94 ) 42.2 ( 12.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 22 36 23 105
        Male
    		 40 41 27 41 149
    Subject analysis sets

    Subject analysis set title
    Full analysis set [FAS]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS contained all patients included in the study who had received at least 1 dose of the study treatment, and who had Baseline data for at least 1 efficacy variable.

    Subject analysis sets values
    		 Full analysis set [FAS]
    Number of subjects
    252
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    237
        From 65-84 years
    15
    Age continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    41.2 ( 13.67 )
    Gender categorical
    Units: Subjects
        Female
    104
        Male
    148

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 2 capsules of Placebo

    Reporting group title
    25mg ABX464
    Reporting group description
    		 1 capsule of 25mg ABX464 + 1 capsule of Placebo

    Reporting group title
    50mg ABX464
    Reporting group description
    		 1 capsule of 50mg ABX464 + 1 capsule of Placebo

    Reporting group title
    100mg ABX464
    Reporting group description
    		 2 capsules of 50mg ABX464

    Subject analysis set title
    Full analysis set [FAS]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS contained all patients included in the study who had received at least 1 dose of the study treatment, and who had Baseline data for at least 1 efficacy variable.

    Primary: Reduction from Baseline in MMS at Week 8.

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    End point title
    		 Reduction from Baseline in MMS at Week 8.
    End point description
    Change from baseline to week 8
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 Placebo 25mg ABX464 50mg ABX464 100mg ABX464
    Number of subjects analysed
    60
    59
    54
    58
    Units: Least squares mean
        least squares mean (confidence interval 95%)
    -1.9 (-2.4 to -1.5)
    -3.1 (-3.6 to -2.6)
    -3.2 (-3.7 to -2.7)
    -2.9 (-3.4 to -2.5)
    Statistical analysis title
    		 ANCOVA MODEL PLACEBO vs ABX464 25 mg
    Comparison groups
    Placebo v 25mg ABX464
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA MODEL PLACEBO vs ABX464 50 mg
    Comparison groups
    Placebo v 50mg ABX464
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA MODEL PLACEBO vs ABX464 100 mg
    Comparison groups
    100mg ABX464 v Placebo
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: CLINICAL RESPONSE

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    End point title
    		 CLINICAL RESPONSE
    End point description
    Number of patients with clinical response at week 8
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo 25mg ABX464 50mg ABX464 100mg ABX464 Full analysis set [FAS]
    Number of subjects analysed
    64
    61
    63
    64
    252
    Units: Number
        clinical reponse
    22
    38
    37
    32
    129
    No statistical analyses for this end point

    Secondary: CLINICAL REMISSION

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    End point title
    		 CLINICAL REMISSION
    End point description
    Number of patients in clinical remission at week 8
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo 25mg ABX464 50mg ABX464 100mg ABX464 Full analysis set [FAS]
    Number of subjects analysed
    64
    61
    63
    64
    252
    Units: Number of patients
        Clinical remission
    8
    16
    11
    16
    51
    Statistical analysis title
    		 Mantel-Haenszel Chi Square Test
    Comparison groups
    100mg ABX464 v 50mg ABX464 v 25mg ABX464 v Placebo v Full analysis set [FAS]
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.5
    Method
    		 Mantel-Haenszel
    Confidence interval

    Secondary: ENDOSCOPIC IMPROVEMENT

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    End point title
    		 ENDOSCOPIC IMPROVEMENT
    End point description
    Number of patients with endoscopic improvement
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo 25mg ABX464 50mg ABX464 100mg ABX464 Full analysis set [FAS]
    Number of subjects analysed
    64
    61
    63
    64
    252
    Units: Number of patients
        Endoscopic Improvement
    8
    20
    21
    24
    73
    No statistical analyses for this end point

    Secondary: ENDOSCOPIC REMISSION

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    End point title
    		 ENDOSCOPIC REMISSION
    End point description
    Number of patients with endoscopic remission
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo 25mg ABX464 50mg ABX464 100mg ABX464 Full analysis set [FAS]
    Number of subjects analysed
    64
    61
    63
    64
    252
    Units: Number of patients
        Endoscopic Remission
    5
    4
    5
    2
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    OVERALL
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Safety Analysis Set (SAF): Placebo treatment group The SAF included all randomized patients who received at least 1 dose of the study treatment. If there was any doubt whether a patient was treated or not, they were assumed treated for the purposes of analysis. The SAF was used for all safety analyses and patients were analyzed as treated.

    Reporting group title
    100 mg
    Reporting group description
    		 Safety Analysis Set (SAF): 100 mg ABX464 treatment group The SAF included all randomized patients who received at least 1 dose of the study treatment. If there was any doubt whether a patient was treated or not, they were assumed treated for the purposes of analysis. The SAF was used for all safety analyses and patients were analyzed as treated.

    Reporting group title
    50 mg
    Reporting group description
    		 Safety Analysis Set (SAF): 50 mg ABX464 treatment group The SAF included all randomized patients who received at least 1 dose of the study treatment. If there was any doubt whether a patient was treated or not, they were assumed treated for the purposes of analysis. The SAF was used for all safety analyses and patients were analyzed as treated.

    Reporting group title
    25 mg
    Reporting group description
    		 Safety Analysis Set (SAF): 25 mg ABX464 treatment group The SAF included all randomized patients who received at least 1 dose of the study treatment. If there was any doubt whether a patient was treated or not, they were assumed treated for the purposes of analysis. The SAF was used for all safety analyses and patients were analyzed as treated.

    Serious adverse events
    		 Placebo 100 mg 50 mg 25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 64 (6.25%)
    4 / 64 (6.25%)
    4 / 63 (6.35%)
    1 / 62 (1.61%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo 100 mg 50 mg 25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 64 (46.88%)
    45 / 64 (70.31%)
    38 / 63 (60.32%)
    33 / 62 (53.23%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    2
    2
    Fatigue
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    2
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pain
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Mite allergy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Breast cyst
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Affective disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Prothrombin time prolonged
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    2
    1
    2
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    2
    1
    Lipase increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    1
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Glutamate dehydrogenase increased
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Haematocrit decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Human chorionic gonadotropin increased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Troponin I increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Troponin increased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Troponin T increased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Myocardial infarction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 64 (7.81%)
    27 / 64 (42.19%)
    19 / 63 (30.16%)
    13 / 62 (20.97%)
         occurrences all number
    5
    29
    21
    14
    Burning sensation
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Migraine
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Syncope
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    1
    1
    Dysgeusia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Facial paralysis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Parosmia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    2
    1
    1
    2
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    0
    2
    Eye disorders
    Eczema eyelids
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 64 (6.25%)
    9 / 64 (14.06%)
    4 / 63 (6.35%)
    5 / 62 (8.06%)
         occurrences all number
    4
    9
    5
    5
    Abdominal pain upper
         subjects affected / exposed
    0 / 64 (0.00%)
    4 / 64 (6.25%)
    3 / 63 (4.76%)
    3 / 62 (4.84%)
         occurrences all number
    0
    4
    4
    4
    Colitis ulcerative
         subjects affected / exposed
    4 / 64 (6.25%)
    1 / 64 (1.56%)
    4 / 63 (6.35%)
    0 / 62 (0.00%)
         occurrences all number
    4
    1
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 64 (1.56%)
    5 / 64 (7.81%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    1
    5
    2
    1
    Proctalgia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Constipation
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    1
    1
    Abdominal distension
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Faeces discoloured
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Gastritis erosive
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intestinal fistula
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intestinal polyp
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pancreatitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis migration
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver injury
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 64 (3.13%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Rash
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Erythema nodosum
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pityriasis rosea
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal colic
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 64 (4.69%)
    5 / 64 (7.81%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    3
    6
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 64 (0.00%)
    5 / 64 (7.81%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    5
    0
    0
    Back pain
         subjects affected / exposed
    0 / 64 (0.00%)
    3 / 64 (4.69%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Coccydynia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteoporosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tendon disorder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    3 / 63 (4.76%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    3
    1
    COVID-19
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    0
    1
    Anal abscess
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Appendicitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatophytosis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyoderma
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    0
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    0
    1
    Folate deficiency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fluid retention
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperlipasaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Iron deficiency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2019
    Clinical response defined as reduction in Mayo score of greater than or equal to 3 points was changed to at least 2 points (Sections 2.0 and 8.2.2). For enrollment of patients in the study, moderately to severely active UC definition based on MMS range of 4 to 9 was modified to range 5 to 9 (Sections 2.0 and 9.3.1).
    07 Nov 2019
    Assessment of T3, T4 and TSH levels by local laboratory were added at Baseline, Day 57, Day 113 (Table 1).
    12 Dec 2019
    Addition of exclusion criterion: Patients who received live vaccine 30 days or fewer before first dose of study treatment and/or who is planning to receive such a vaccine during the study duration.
    11 Jan 2020
    US eligible patients were to be randomized only to once daily ABX464 50 mg, ABX464 25 mg, or placebo. US patients were not eligible to receive ABX464 100 mg once daily (Sections 9.1 and 9.4.3.1). Patients were required to have the following additional laboratory parameters obtained within 14 days prior to Baseline: creatinine clearance ≥90 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline, fibrinogen >0.9 × lower limit of normal and international normalized ratio ≤1.2 (if no anticoagulant therapy) (Section 9.3.1). Prohibited concomitant medications were updated to include drugs that inhibit or induce CYP1A2 and drugs that inhibit UGTIA9 activity and inhibitors or substrates of OATP1B1/1B3 transporters (Section 9.4.5). Patients enrolled in the US were not rolled over an open label extension study (ABX464-104). Patients were to be treated for 16 weeks and an end of study visit was to be performed within a week after last dosing (Section 9.1).
    01 Jun 2020
    The definition of clinical remission (a secondary endpoint) was changed (Sections 2.0 and 8.2.2). Exclusion criterion added: patients who received live vaccine 30 days or fewer before first dose of study treatment and/or who is planning to receive such a vaccine during the study duration (Section 9.3.2). Prohibited concomitant medications were updated to include drugs that inhibit or induce CYP1A2 and drugs that inhibit UGTIA9 activity and inhibitors of OATP1B1/1B3 transporters (Section 9.4.5).
    30 Jul 2020
    Similar to AMEND 2, (dated 01 june 2020)
    08 Oct 2020
    Similar to AMEND 2, (dated 01 june 2020)

    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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    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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