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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA

    Summary
    EudraCT number
    2018-003365-34
    Trial protocol
    GB   IT  
    Global end of trial date
    26 Sep 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Oct 2020
    First version publication date
    04 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4V-MC-JAIV
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03742973
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial number: 17039
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    26 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of baricitinib 4-mg QD compared to placebo on PBC disease
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    0
    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)
    0
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Baricitinib Cohort A
    Arm description
    Participants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks.

    Arm title
    Placebo Cohort A
    Arm description
    Participants received placebo orally once daily (QD) 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
    Participants received placebo orally once daily (QD) for 12 weeks.

    Number of subjects in period 1
    Baricitinib Cohort A Placebo Cohort A
    Started
    1
    1
    Completed
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.

    Reporting group values
    Overall Study Total
    Number of subjects
    2 2
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    2 2
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    2 2
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Baricitinib Cohort A
    Reporting group description
    Participants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks.

    Reporting group title
    Placebo Cohort A
    Reporting group description
    Participants received placebo orally once daily (QD) for 12 weeks.

    Primary: Change From Baseline in Alkaline Phosphatase (ALP)

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    End point title
    Change From Baseline in Alkaline Phosphatase (ALP)
    End point description
    9999 is reported and represents no data available (NA). Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12.
    End point values
    Baricitinib Cohort A Placebo Cohort A
    Number of subjects analysed
    1 [1]
    1 [2]
    Units: 9999
        number (not applicable)
    1
    1
    Notes
    [1] - Zero participants reported in cohort A due to protection of personal identifiable information.
    [2] - Zero participants reported in cohort A due to protection of personal identifiable information.
    Statistical analysis title
    Statistical Analysis Cohort A
    Statistical analysis description
    Zero participants reported in cohort A due to protection of personal identifiable information.
    Comparison groups
    Baricitinib Cohort A v Placebo Cohort A
    Number of subjects included in analysis
    2
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    = 9999 [4]
    Method
    Other
    Parameter type
    9999
    Confidence interval
    Notes
    [3] - Zero participants reported in cohort A due to protection of personal identifiable information.
    [4] - Zero participants reported in cohort A due to protection of personal identifiable information.

    Secondary: Percentage of Participants With Alkaline Phosphatase (ALP) <1.67 x Upper Limit of Normal (ULN) (and at Least 15% Decrease From Baseline) and Total Bilirubin Level Less Than ULN

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    End point title
    Percentage of Participants With Alkaline Phosphatase (ALP) <1.67 x Upper Limit of Normal (ULN) (and at Least 15% Decrease From Baseline) and Total Bilirubin Level Less Than ULN
    End point description
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Baricitinib Cohort A Placebo Cohort A
    Number of subjects analysed
    1 [5]
    1 [6]
    Units: 9999
        number (not applicable)
    1
    1
    Notes
    [5] - Zero participants reported in cohort A due to protection of personal identifiable information.
    [6] - Zero participants reported in cohort A due to protection of personal identifiable information.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Itch Numeric Rating Scale (NRS)

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    End point title
    Change From Baseline in Itch Numeric Rating Scale (NRS)
    End point description
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Baricitinib Cohort A Placebo Cohort A
    Number of subjects analysed
    1 [7]
    1 [8]
    Units: 9999
        number (not applicable)
    1
    1
    Notes
    [7] - Zero participants reported in cohort A due to protection of personal identifiable information.
    [8] - Zero participants reported in cohort A due to protection of personal identifiable information.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fatigue NRS

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    End point title
    Change From Baseline in Fatigue NRS
    End point description
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Baricitinib Cohort A Placebo Cohort A
    Number of subjects analysed
    1 [9]
    1 [10]
    Units: 9999
        number (not applicable)
    1
    1
    Notes
    [9] - Zero participants reported in cohort A due to protection of personal identifiable information.
    [10] - Zero participants reported in cohort A due to protection of personal identifiable information.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 6 months
    Adverse event reporting additional description
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Baricitinib Cohort A
    Reporting group description
    Participants received 2 mg of Baricitinib tablet orally once a day for 12 weeks.

    Reporting group title
    Placebo Cohort A
    Reporting group description
    Participants received placebo orally once daily (QD) for 12 weeks.

    Serious adverse events
    Baricitinib Cohort A Placebo Cohort A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Baricitinib Cohort A Placebo Cohort A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Sep 2018
    The following changes were made to the protocol: Study population: A note was added on number system used for inclusion and exclusion criteria to avoid confusion to the numbering. Exclusion Criteria: Added clarifying language that cirrhosis should include complications. Method of Treatment Assignment: Changed method from stratification to dynamic minimization. Permanent discontinuation from study treatment: added discontinuation criterion of eFGR ≤40mL/min/1.73m2. Minor editorial changes for clarity were made.

    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.
    Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to study termination based on enrollment futility.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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