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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

    Summary
    EudraCT number
    2016-003817-80
    Trial protocol
    ES   GB   FR  
    Global end of trial date
    31 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Aug 2019
    First version publication date
    28 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GFT505B-216-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03124108
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Genfit SA
    Sponsor organisation address
    Parc Eurasante, avenue Eugene Avinee, France, 885
    Public contact
    Clinical Head, Genfit SA, clinicaltrial@genfit.com
    Scientific contact
    Clinical Head, Genfit SA, clinicaltrial@genfit.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 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the efficacy of elafibranor 80 milligram (mg) and 120 mg compared with placebo in subjects with primary biliary cholangitis (PBC) as measured by the relative change from baseline in serum alkaline phosphatase (ALP) levels.
    Protection of trial subjects
    This study was conducted in accordance with the principles laid down by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies, and the Good Clinical Practice (GCP) guideline (CHMP, 2016). This study also complied with applicable local regulatory requirements and laws of each country in which the study was performed, as well as any applicable guidelines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    United States: 23
    Worldwide total number of subjects
    45
    EEA total number of subjects
    22
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    34
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 68 subjects were screened, out of which 45 subjects were randomized, 15 subjects in each of the 3 treatment groups.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Elafibranor 80mg
    Arm description
    Subjects received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Elafibranor 80mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.

    Arm title
    Elafibranor 120mg
    Arm description
    Subjects received elafibranor 120 mg tablets orally once daily for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Elafibranor 120mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received elafibranor 120 mg tablets orally once daily for 12 weeks.

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo tablets orally once daily for 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo tablets orally once daily for 12 weeks.

    Number of subjects in period 1
    Elafibranor 80mg Elafibranor 120mg Placebo
    Started
    15
    15
    15
    Completed
    15
    14
    15
    Not completed
    0
    1
    0
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Elafibranor 80mg
    Reporting group description
    Subjects received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.

    Reporting group title
    Elafibranor 120mg
    Reporting group description
    Subjects received elafibranor 120 mg tablets orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo tablets orally once daily for 12 weeks.

    Reporting group values
    Elafibranor 80mg Elafibranor 120mg Placebo Total
    Number of subjects
    15 15 15 45
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    13 10 11 34
        From 65-84 years
    2 5 4 11
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.5 ± 8.7 60.4 ± 6.9 60.5 ± 8.6 -
    Gender categorical
    Units: Subjects
        Female
    14 15 14 43
        Male
    1 0 1 2

    End points

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    End points reporting groups
    Reporting group title
    Elafibranor 80mg
    Reporting group description
    Subjects received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.

    Reporting group title
    Elafibranor 120mg
    Reporting group description
    Subjects received elafibranor 120 mg tablets orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo tablets orally once daily for 12 weeks.

    Primary: Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)

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    End point title
    Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)
    End point description
    Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint. The modified Intent-to-Treat (mITT) analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percent change
        arithmetic mean (standard deviation)
    -48.264 ± 14.7676
    -40.640 ± 17.3624
    3.190 ± 14.8059
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Elafibranor 80mg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Difference in percentage
    Point estimate
    -52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -62.5
         upper limit
    -41.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.4
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Elafibranor 120mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Difference in percentage
    Point estimate
    -43.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -55.7
         upper limit
    -32.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    6

    Secondary: Percentage of subjects With Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction from Baseline to Endpoint)

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    End point title
    Percentage of subjects With Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction from Baseline to Endpoint)
    End point description
    Percentage of subjects with response defined by Composite Risk Scores (ALP Less than [<] 1.67 * ULN at endpoint, Total BIL within normal limits at endpoint, and > 15% ALP reduction from baseline to Endpoint) was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    66.7
    78.6
    6.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Defined by Composite Risk Scores (ALP < 2 * Upper Limit of Normal at Endpoint, Total Bilirubin Within Normal Limits at Endpoint, and > 40% ALP Reduction from Baseline to Endpoint)

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    End point title
    Percentage of subjects With Response Defined by Composite Risk Scores (ALP < 2 * Upper Limit of Normal at Endpoint, Total Bilirubin Within Normal Limits at Endpoint, and > 40% ALP Reduction from Baseline to Endpoint)
    End point description
    Percentage of subjects with response defined by composite risk scores (ALP < 2 * ULN at endpoint, Total BIL within normal limits at endpoint, and > 40% ALP reduction from baseline to endpoint) was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    73.3
    42.9
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Based on PARIS I Risk Score at Endpoint

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    End point title
    Percentage of subjects With Response Based on PARIS I Risk Score at Endpoint
    End point description
    Percentage of subjects with response based on Paris I risk score was defined as ALP less than or equal to (<=) 3 * ULN and aspartate aminotransferase (AST) <= 2 * ULN and bilirubin within normal limits. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    80.0
    78.6
    53.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Based on PARIS II Risk Score at Endpoint

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    End point title
    Percentage of subjects With Response Based on PARIS II Risk Score at Endpoint
    End point description
    Percentage of subjects with response based on Paris II risk score was defined as ALP <= 1.5 * ULN and AST <= 1.5 * ULN and bilirubin within normal limits. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    53.3
    50.0
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Based on Toronto I Risk Score at Endpoint

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    End point title
    Percentage of subjects With Response Based on Toronto I Risk Score at Endpoint
    End point description
    Percentage of subjects with response based on Toronto I risk score was defined as ALP <= 1.67 *ULN. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    66.7
    78.6
    6.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Based on Toronto II Risk Score at Endpoint

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    End point title
    Percentage of subjects With Response Based on Toronto II Risk Score at Endpoint
    End point description
    Percentage of subjects with response based on Toronto II risk scores was defined as ALP <= 1.75 * ULN. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    66.7
    78.6
    6.7
    No statistical analyses for this end point

    Secondary: Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint

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    End point title
    Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint
    End point description
    UK-PBC risk score at endpoint estimated that the median percentage risk that a subject treated with ursodeoxycholic acid (UDCA) will develop liver failure requiring liver transplant in 5, 10 and 15 years. UK-PBC score was calculated at each of the 3 survivor functions 1-baseline survival function^exp(0.0287854*[alpEPxuln-1.722136304] - 0.0422873*[{(altastEPxuln/10)^-1} - 8.675729006] + 1.4199 * [LN{bilEPxuln /10}+2.709607778] -1.960303*[albxlln-1.17673001]-0.4161954*[ pltxlln -1.873564875]). Where: Baseline survivor function=0. 982 (at 5 years); 0. 941 (at 10 years); 0.893 (at 15 years). alpEPxuln = ALP at endpoint/upper level normal ALP; altastEPxuln=(ALT, AST) at endpoint/ upper level normal of the value; bilEPxuln=bilirubin at endpoint/upper level normal bilirubin; albxlln=albumin at baseline/ albumin lower level normal; pltxlln=platelet count at baseline/ platelet count lower level normal. Population included mITT analysis set.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage risk
    median (full range (min-max))
        5 Years
    0.80 (0.1 to 6.0)
    0.95 (0.2 to 5.8)
    1.30 (0.1 to 3.7)
        10 Years
    2.60 (0.3 to 18.8)
    3.05 (0.8 to 18.1)
    4.40 (0.5 to 12.0)
        15 Years
    4.70 (0.6 to 32.1)
    5.55 (1.5 to 31.0)
    8.00 (0.9 to 21.1)
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase

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    End point title
    Percentage of subjects With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase
    End point description
    Percentage of subjects with response (defined by at least 10%, 20%, and 40% decrease in ALP from baseline to Endpoint) reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
    number (not applicable)
        10 Percent Reduction
    93.3
    92.9
    13.3
        20 Percent Reduction
    93.3
    92.9
    6.7
        40 Percent Reduction
    86.7
    57.1
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Defined by Normalized Alkaline Phosphatase Levels at Endpoint

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    End point title
    Percentage of subjects With Response Defined by Normalized Alkaline Phosphatase Levels at Endpoint
    End point description
    The response was defined by normalized ALP levels (ALP ULN 105 units per liter [U/L] for females, 129 U/L for males) at endpoint.The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    13.3
    21.4
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Defined by Normalized Bilirubin (BIL) at Endpoint

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    End point title
    Percentage of subjects With Response Defined by Normalized Bilirubin (BIL) at Endpoint
    End point description
    The response was defined by normalized BIL levels (BIL ULN <1.20 milligram per deciliter [mg/dL]) at endpoint.The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    86.7
    92.9
    93.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Response Defined by Normalized Albumin (ALB) Levels at Endpoint

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    End point title
    Percentage of subjects With Response Defined by Normalized Albumin (ALB) Levels at Endpoint
    End point description
    The response was defined by normalized ALB levels (3.5-5.2 gram per deciliter [g/dL] for ages 18-60 years; 3.2-4.6 g/ dL for ages 61-91 years) at endpoint. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Percentage of subjects
        number (not applicable)
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Change From Baseline in Alanine Aminotransferase (ALT) Levels at Endpoint

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    End point title
    Change From Baseline in Alanine Aminotransferase (ALT) Levels at Endpoint
    End point description
    Change from baseline in ALT levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: U/L
        arithmetic mean (standard deviation)
    -0.5 ± 57.38
    7.3 ± 29.13
    -1.2 ± 8.57
    No statistical analyses for this end point

    Secondary: Change From Baseline in Aspartate Aminotransferase (AST) Levels at Endpoint

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    End point title
    Change From Baseline in Aspartate Aminotransferase (AST) Levels at Endpoint
    End point description
    Change from baseline in AST levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: U/L
        arithmetic mean (standard deviation)
    6.0 ± 55.29
    11.1 ± 27.96
    -4.3 ± 7.97
    No statistical analyses for this end point

    Secondary: Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at Endpoint

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    End point title
    Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at Endpoint
    End point description
    Change from baseline in GGT levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: U/L
        arithmetic mean (standard deviation)
    -91.5 ± 95.30
    -61.9 ± 70.82
    0.6 ± 54.40
    No statistical analyses for this end point

    Secondary: Change From Baseline in 5 Prime (') Nucleotidase Levels at Endpoint

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    End point title
    Change From Baseline in 5 Prime (') Nucleotidase Levels at Endpoint
    End point description
    Change from baseline in 5' nucleotidase levels at endpoint was reported. 5’ nucleotidase is an enzyme used as a biomarker of hepatobiliary cholestasis and is less sensitive but more specific than GGT and ALP. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: U/L
        arithmetic mean (standard deviation)
    -7.81 ± 8.279
    -4.59 ± 13.067
    -0.47 ± 3.491
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Bilirubin (BIL) Levels at Endpoint

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    End point title
    Change From Baseline in Total Bilirubin (BIL) Levels at Endpoint
    End point description
    Change from baseline in total BIL levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: micromole per liter (mcmol/L)
        arithmetic mean (standard deviation)
    -0.23 ± 3.425
    -0.51 ± 2.821
    -0.01 ± 3.548
    No statistical analyses for this end point

    Secondary: Change From Baseline in Conjugated Bilirubin Levels at Endpoint

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    End point title
    Change From Baseline in Conjugated Bilirubin Levels at Endpoint
    End point description
    Change from baseline in conjugated bilirubin levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: mcmol/L
        arithmetic mean (standard deviation)
    0.34 ± 2.229
    -0.06 ± 0.596
    0.45 ± 1.526
    No statistical analyses for this end point

    Secondary: Change From Baseline in Albumin Levels at Endpoint

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    End point title
    Change From Baseline in Albumin Levels at Endpoint
    End point description
    Change from baseline in albumin levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: gram per liter (g/L)
        arithmetic mean (standard deviation)
    2.2 ± 2.54
    2.3 ± 2.73
    0.0 ± 2.20
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cholesterol Levels at Endpoint

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    End point title
    Change From Baseline in Cholesterol Levels at Endpoint
    End point description
    Change from baseline in cholesterol levels at endpoints was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: millimole per liter (mmol/L)
        arithmetic mean (standard deviation)
    -0.455 ± 0.7479
    -0.387 ± 0.6308
    0.043 ± 0.3706
    No statistical analyses for this end point

    Secondary: Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol Levels at Endpoint

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    End point title
    Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol Levels at Endpoint
    End point description
    Change from baseline in LDL-cholesterol at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.366 ± 0.5919
    -0.334 ± 0.4848
    0.061 ± 0.3272
    No statistical analyses for this end point

    Secondary: Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Levels at Endpoint

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    End point title
    Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Levels at Endpoint
    End point description
    Change from baseline in HDL-cholesterol levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.017 ± 0.3898
    0.059 ± 0.3391
    -0.007 ± 0.2988
    No statistical analyses for this end point

    Secondary: Change From Baseline in Triglycerides Levels at Endpoint

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    End point title
    Change From Baseline in Triglycerides Levels at Endpoint
    End point description
    Change from baseline in triglycerides levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.155 ± 0.3460
    -0.253 ± 0.2085
    -0.019 ± 0.3776
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Free Bile Acid Levels at Endpoint

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    End point title
    Change From Baseline in Total Free Bile Acid Levels at Endpoint
    End point description
    Change from baseline in total free bile acid levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: 10^-9 mole per liter (mol/L)
        arithmetic mean (standard deviation)
    -248.88 ± 2496.672
    -673.71 ± 2962.097
    -135.20 ± 6777.727
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Conjugated Bile Acid Levels at Endpoint

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    End point title
    Change From Baseline in Total Conjugated Bile Acid Levels at Endpoint
    End point description
    Change from baseline in total conjugated bile acid levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: 10^-9 mol/L
        arithmetic mean (standard deviation)
    5008.99 ± 17844.304
    -3280.16 ± 10941.769
    1873.22 ± 21795.349
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Bile Acid Levels at Endpoint

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    End point title
    Change From Baseline in Total Bile Acid Levels at Endpoint
    End point description
    Change from baseline in total bile acid levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: 10^-9 mol/L
        arithmetic mean (standard deviation)
    4760.11 ± 18919.661
    -3953.86 ± 12008.620
    1738.02 ± 26521.746
    No statistical analyses for this end point

    Secondary: Change From Baseline in 7 Alpha-hydroxy-4-cholesten-3-one Levels at Endpoint

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    End point title
    Change From Baseline in 7 Alpha-hydroxy-4-cholesten-3-one Levels at Endpoint
    End point description
    Change from baseline in 7 alpha-hydroxy-4-cholesten-3-one levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: 10^-9 mol/L
        arithmetic mean (standard deviation)
    -16.29 ± 27.584
    -10.04 ± 28.606
    5.22 ± 10.848
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fibroblast Growth Factor-19 Levels at Endpoint

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    End point title
    Change From Baseline in Fibroblast Growth Factor-19 Levels at Endpoint
    End point description
    Change from baseline in fibroblast growth factor-19 levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: nanogram per liter (ng/L)
        arithmetic mean (standard deviation)
    -21.67 ± 52.588
    -16.96 ± 38.933
    -47.08 ± 69.560
    No statistical analyses for this end point

    Secondary: Change From Baseline in Immunoglobulin M (IgM) Levels at Endpoint

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    End point title
    Change From Baseline in Immunoglobulin M (IgM) Levels at Endpoint
    End point description
    Change from baseline in IgM levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: g/L
        arithmetic mean (standard deviation)
    -0.339 ± 0.5846
    -0.472 ± 0.5507
    -0.076 ± 0.7227
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tumor Necrosis Factor Levels at Endpoint

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    End point title
    Change From Baseline in Tumor Necrosis Factor Levels at Endpoint
    End point description
    Change from baseline in tumor necrosis factor levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: ng/L
        arithmetic mean (standard deviation)
    0.066 ± 0.7829
    0.154 ± 1.1374
    0.053 ± 0.8329
    No statistical analyses for this end point

    Secondary: Change From Baseline in Transforming Growth Factor Beta Levels at Endpoint

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    End point title
    Change From Baseline in Transforming Growth Factor Beta Levels at Endpoint
    End point description
    Change from baseline in transforming growth factor beta levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: ng/L
        arithmetic mean (standard deviation)
    734.7 ± 2103.75
    297.2 ± 2762.61
    -1163.0 ± 4295.49
    No statistical analyses for this end point

    Secondary: Change From Baseline in Interleukin 6 Levels at Endpoint

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    End point title
    Change From Baseline in Interleukin 6 Levels at Endpoint
    End point description
    Change from baseline in interleukin 6 levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: ng/L
        arithmetic mean (standard deviation)
    -0.021 ± 0.8337
    -0.261 ± 0.5213
    -0.165 ± 0.5624
    No statistical analyses for this end point

    Secondary: Change From Baseline in Plasminogen Activator Inhibitor-1 Antigen (AG) Levels at Endpoint

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    End point title
    Change From Baseline in Plasminogen Activator Inhibitor-1 Antigen (AG) Levels at Endpoint
    End point description
    Change from baseline in plasminogen activator inhibitor-1 AG levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: microgram per liter (mcg/L)
        arithmetic mean (standard deviation)
    -0.483 ± 2.9839
    -1.739 ± 4.6587
    -1.456 ± 4.6448
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cytokeratin-18 Levels at Endpoint

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    End point title
    Change From Baseline in Cytokeratin-18 Levels at Endpoint
    End point description
    Change from baseline in cytokeratin-18 (M30 and M65) levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: picomole per liter (pmol/L)
    arithmetic mean (standard deviation)
        Cytokeratin-18 M30
    26.12 ± 472.247
    163.33 ± 499.500
    17.93 ± 307.531
        Cytokeratin-18 M65
    114.31 ± 627.068
    238.97 ± 611.520
    -53.16 ± 131.934
    No statistical analyses for this end point

    Secondary: Change From Baseline in Autotaxin Levels at Endpoint

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    End point title
    Change From Baseline in Autotaxin Levels at Endpoint
    End point description
    Change from baseline in autotaxin levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: mcg/L
        arithmetic mean (standard deviation)
    4.6 ± 156.92
    49.9 ± 77.25
    35.1 ± 161.58
    No statistical analyses for this end point

    Secondary: C-reactive Protein Level at Endpoint

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    End point title
    C-reactive Protein Level at Endpoint
    End point description
    C-reactive protein level at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: milligram per liter (mg/L)
        geometric mean (confidence interval 95%)
    2.74 (1.81 to 4.14)
    2.84 (1.68 to 4.78)
    4.01 (2.52 to 6.37)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Haptoglobin Levels at Endpoint

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    End point title
    Change From Baseline in Haptoglobin Levels at Endpoint
    End point description
    Change from baseline in haptoglobin levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: g/L
        arithmetic mean (standard deviation)
    -0.265 ± 0.4271
    -0.254 ± 0.1088
    0.025 ± 0.2244
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fibrinogen Levels at Endpoint

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    End point title
    Change From Baseline in Fibrinogen Levels at Endpoint
    End point description
    Change from baseline in fibrinogen levels at endpoint was reported. The mITT analysis set included all randomized subjects who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: g/L
        arithmetic mean (standard deviation)
    -0.865 ± 0.9472
    -0.452 ± 0.5780
    -0.072 ± 1.0936
    No statistical analyses for this end point

    Secondary: Change From Baseline in 5D Itch Scale Total Score

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    End point title
    Change From Baseline in 5D Itch Scale Total Score
    End point description
    5D-Itch Scale is reliable, multidimensional measure of itching that has been validated in subjects with chronic pruritus to detect changes over time. It consists of 5 domains: duration, degree, direction, disability, and distribution. Duration, degree and direction domains each include 1 item, while disability domain has 4 items (sleep, leisure/social, housework/errands, work/school). All items of first 4 domains were measured on a 5-point Likert scale. Distribution domain included 16 potential locations of itch, 15 body part items (head/scalp, soles, face, palms, chest, abdomen, back, buttocks, thighs, lower legs, tops of feet/toes, tops of hands/fingers, upper arms, groin, forearms) and 1 point of contact with clothing/bandages. Scores of each of 5 domains are achieved separately and then summed together to obtain total 5-D score. 5-D scores can range between 5 (no pruritus) and 25 (most severe pruritus). mITT population included. N= number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    12
    15
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.1 ± 5.15
    -0.1 ± 2.19
    0.8 ± 4.93
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score

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    End point title
    Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score
    End point description
    The VAS is a reliable and validated method of pruritus assessment. The VAS is adequate in assessing the severity of the symptom; it does not take into account other aspects of pruritus, such as the relative impact of pruritus on quality of life. The VAS, for pruritus assessment, requires the subject to use abstract thought processes to convert their itch severity to a mark on a continuum. A subject draws a line anywhere on the scale ranging from 0 to 10 (where 0 represents ‘no itching’ and 10 represents ‘worst possible itching’) that best represents the severity of subject’s itching and the scoring involves manual measuring of the mark with a ruler on range of 0 to 100 millimeter (mm). Higher scores indicate worse itching. mITT: randomized subjects received at least one study drug dose with available baseline value and at least one post baseline value for primary endpoint. Here 'N' (number of subjects analyzed) signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    14
    14
    15
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -4.4 ± 22.80
    -4.7 ± 11.81
    9.3 ± 35.93
    No statistical analyses for this end point

    Secondary: Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life Questionnaire Scores

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    End point title
    Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life Questionnaire Scores
    End point description
    PBC-40 QoL Questionnaire is patient-derived, disease-specific QoL measure developed and validated for use in PBC. It consists of 9 domains with total 40 questions: 1) digestion and diet (questions 1-3, with total score of 15); 2) experiences (questions 4-7, with total score of 20); 3) itching (questions 8-10, with total score of 15); 4) fatigue (questions 11-18, with total score of 40); 5) effort and planning (questions 19-21, with total score of 15); 6) memory and concentration (questions 22-27, with total score of 30); 7) affects you as person (questions 28-33, with total score of 30); 8) affects your social life (questions 34-37, with total score of 20); 9) overall impact on your life (questions 38-40, with total score of 15). PBC-40 QoL Questionnaire has 40 questions, each scored on scale of 1-5 (1=least impact, 5=greatest impact). For each domain, scoring involved summing individual question response scores. Higher scores indicate poorer quality of life. mITT population included.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (Endpoint)
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Digestion and Diet
    -0.3 ± 2.74
    -0.6 ± 2.24
    -0.6 ± 3.00
        Experiences
    0.6 ± 2.64
    -1.3 ± 1.77
    -0.7 ± 3.69
        Itching
    -0.9 ± 6.19
    -4.1 ± 6.56
    2.1 ± 5.78
        Fatigue
    -1.9 ± 4.10
    -1.4 ± 2.71
    -1.5 ± 5.04
        Effort and Planning
    -0.9 ± 2.03
    -0.8 ± 1.31
    -0.9 ± 1.98
        Memory and concentration
    0.1 ± 3.26
    -1.5 ± 3.33
    -0.5 ± 3.25
        Affecting you as a Person
    -1.8 ± 3.78
    -2.5 ± 2.85
    -1.3 ± 3.22
        Effects on your Social Life
    1.3 ± 3.08
    0.0 ± 1.47
    1.4 ± 4.79
        Impact on your Life
    -0.1 ± 3.04
    0.6 ± 0.63
    -1.0 ± 3.30
    No statistical analyses for this end point

    Secondary: Number of subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse

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    End point title
    Number of subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is another medically important condition. TEAEs is defined as it is not present when active phase of study begins and is not a chronic condition that is part of patient’s medical history, or it is present at start of active phase or as part of patient’s medical history, but severity/frequency increases during active phase. Safety Set included all randomized subjects who were administered at least one dose.
    End point type
    Secondary
    End point timeframe
    Up To Week 12
    End point values
    Elafibranor 80mg Elafibranor 120mg Placebo
    Number of subjects analysed
    15
    14
    15
    Units: subjects
    number (not applicable)
        TEAEs
    12
    13
    12
        Serious TEAEs
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 16 Weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Elafibranor 80mg
    Reporting group description
    subjects received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    subjects received matching placebo tablets orally once daily for 12 weeks.

    Reporting group title
    Elafibranor 120mg
    Reporting group description
    subjects received elafibranor 120 mg tablets orally once daily for 12 weeks.

    Serious adverse events
    Elafibranor 80mg Placebo Elafibranor 120mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural stroke
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic Stroke
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune Hepatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Elafibranor 80mg Placebo Elafibranor 120mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    12 / 15 (80.00%)
    13 / 15 (86.67%)
    Surgical and medical procedures
    Stent Removal
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    1
    0
    3
    Local Swelling
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral Swelling
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Sleep Disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Post-traumatic Neck Syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood Cholesterol Increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Bilirubin Increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Cystoscopy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Urine Present
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram Abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gammaglutamylctransferase Increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Liver Palpable
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Transaminases Increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Urine Albumin/Creatinine Ratio Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Urobilinogen Urine Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    White Blood Cells Urine
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Cerebral Amyloid Angiopathy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    3
    1
    2
    Lumbar Radiculopathy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Dry Eye
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Eye ulcer
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Scleral haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    2
    Dry Mouth
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
         occurrences all number
    0
    1
    3
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Albuminuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    3
    Chromaturia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Nitrituria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Polyuria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Renal Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Renal colic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Photosensitivity Reaction
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Alopecia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    3 / 15 (20.00%)
         occurrences all number
    3
    3
    3
    Skin Disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Bone Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis Externa
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Labyrinthitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    1
    0
    3
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    3
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2017
    The overall reason for this amendment was to include an end of study (EOS) visit for all subjects who completed the double-blind treatment period (at least 16 days but not more than 30 days after visit 5 [Week 12]), to clarify instructions for investigators and to add windows for pharmacokinetic (PK) sample collection.

    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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