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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis

    Summary
    EudraCT number
    		 2014-002205-38
    Trial protocol
    		 IT  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    23 Mar 2018
    First version publication date
    23 Mar 2018
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    747-207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02177136
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Intercept Pharmaceuticals, Inc
    Sponsor organisation address
    4760 Eastgate Mall, San Diego, United States, 92121
    Public contact
    Kimberly Fowler, Senior Director, Clinical Operations , Intercept Pharmaceuticals, Inc, kfowler@interceptpharma.com
    Scientific contact
    Christian Weyer, M.D., M.A.S. Executive Vice President, R&D , Intercept Pharmaceuticals, Inc, christian.weyer@interceptpharma.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
    Interim
    Date of interim/final analysis
    07 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Mar 2017
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of oebticholic acid (OCA) on the following in subjects with PSC: - serum alkaline phosphatase (ALP) - safety
    Protection of trial subjects
    The study has been in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects have been also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Feb 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 73
    Worldwide total number of subjects
    77
    EEA total number of subjects
    4
    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)
    72
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started December 2014 and completed September 2016.

    Pre-assignment
    Screening details
    		 All subjects were required to undergo thorough screening procedures, to confirm they met the eligibility criteria, during the 30 day period preceding the first dose.

    Period 1
    Period 1 title
    Double-blind 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
    		 1.5 mg OCA Titrating to 3 mg OCA
    Arm description
    		 Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

    Arm title
    		 5 mg OCA Titrating to 10 mg OCA
    Arm description
    		 Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects randomized to placebo will take placebo daily for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to placebo will take placebo daily for 24 weeks.

    Number of subjects in period 1 [1]
    		1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Started
    25
    26
    25
    Completed
    19
    21
    21
    Not completed
    6
    5
    4
         Consent withdrawn by subject
    2
    -
    -
         Adverse event, non-fatal
    4
    5
    3
         Protocol deviation
    -
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 77 subjects were randomly allocated to treatment with placebo, 1.5 mg OCA titrated to 3 mg or 5 mg OCA titrated to 10 mg; however, 1 subject did not receive treatment. Therefore, the subject disposition, baseline analyses and efficacy analyses are based on the Intent-to-Treat Population of 76 subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1.5 mg OCA Titrating to 3 mg OCA
    Reporting group description
    		 Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

    Reporting group title
    5 mg OCA Titrating to 10 mg OCA
    Reporting group description
    		 Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomized to placebo will take placebo daily for 24 weeks.

    Reporting group values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo Total
    Number of subjects
    		 25 26 25 76
    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)
    		 24 23 24 71
        From 65-84 years
    		 1 3 1 5
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.6 ± 12.56 44.9 ± 14.28 43.7 ± 13.05 -
    Gender categorical
    Units: Subjects
        Female
    		 10 14 11 35
        Male
    		 15 12 14 41
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2 1 5
        Not Hispanic or Latino
    		 23 24 24 71
    Race
    Units: Subjects
        Asian
    		 1 0 0 1
        Black or african American
    		 3 4 3 10
        White
    		 21 22 22 65
    Alkaline phosphatase (ALP)
    Units: U/L
        arithmetic mean (standard deviation)
    		 422.5 ± 123.07 428.5 ± 178.19 562.8 ± 300.22 -
    Total bilirubin
    Units: umol/L
        arithmetic mean (standard deviation)
    		 16.3 ± 8.17 19.4 ± 10.94 20.9 ± 11.48 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 74.5 ± 12.51 73.6 ± 12.76 73.0 ± 12.95 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 174.4 ± 8.95 170.4 ± 11.61 172.6 ± 10.70 -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 24.6 ± 4.38 25.3 ± 3.74 24.5 ± 3.71 -
    International Normalized ratio (INR)
    Units: n/a
        arithmetic mean (standard deviation)
    		 1.0 ± 0.06 1.0 ± 0.10 1.0 ± 0.07 -

    End points

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    End points reporting groups
    Reporting group title
    1.5 mg OCA Titrating to 3 mg OCA
    Reporting group description
    		 Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

    Reporting group title
    5 mg OCA Titrating to 10 mg OCA
    Reporting group description
    		 Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomized to placebo will take placebo daily for 24 weeks.

    Primary: Week 24 Change from Baseline in ALP

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    End point title
    		 Week 24 Change from Baseline in ALP
    End point description
    The primary efficacy analysis will compare the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate.
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: U/L
        least squares mean (standard error)
    -105.05 ± 38.02
    -110.19 ± 33.77
    -26.76 ± 36.65
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The primary efficacy analysis will compare the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate.
    Comparison groups
    Placebo v 5 mg OCA Titrating to 10 mg OCA
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0434
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    1.5 mg OCA Titrating to 3 mg OCA v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0665
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Week 24 Change from baseline in alanine transaminase (ALT)

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    End point title
    		 Week 24 Change from baseline in alanine transaminase (ALT)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    -33.0 (-50.5 to 5)
    -5.5 (-30.0 to 4.5)
    -19.5 (-49.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Week 24 Change from Baseline in aspartate aminotransferase (AST)

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    End point title
    		 Week 24 Change from Baseline in aspartate aminotransferase (AST)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    -8.0 (-20.0 to 19.0)
    0.5 (-17.5 to 32.8)
    -14.0 (-35.5 to 8.0)
    No statistical analyses for this end point

    Secondary: Week 24 Change from Baseline in total bilirubin

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    End point title
    		 Week 24 Change from Baseline in total bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: umol/L
        median (inter-quartile range (Q1-Q3))
    0.8 (-1.7 to 4.3)
    1.3 (-1.3 to 6.9)
    0.0 (-5.1 to 4.3)
    No statistical analyses for this end point

    Secondary: Week 24 Change from Baseline in direct bilirubin

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    End point title
    		 Week 24 Change from Baseline in direct bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: umol/L
        median (inter-quartile range (Q1-Q3))
    0.8 (-0.9 to 0.9)
    0.9 (-0.9 to 6.4)
    0.0 (-1.7 to 4.3)
    No statistical analyses for this end point

    Secondary: Week 24 Change from Baseline in gamma-glutamyl transferase (GGT)

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    End point title
    		 Week 24 Change from Baseline in gamma-glutamyl transferase (GGT)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    -79.0 (-171.0 to -9.7)
    -78.5 (-235.5 to 14.0)
    -89.0 (-167.0 to 20.0)
    No statistical analyses for this end point

    Secondary: Week 24 Change from Baseline in fibroblast growth factor - 19 (FGF-19)

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    End point title
    		 Week 24 Change from Baseline in fibroblast growth factor - 19 (FGF-19)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    32.00 (-16.00 to 110.00)
    147.00 (-6.35 to 714.50)
    -19.50 (-79.56 to 28.00)
    No statistical analyses for this end point

    Secondary: Week 24 Change from baseline in C4

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    End point title
    		 Week 24 Change from baseline in C4
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Number of subjects analysed
    25
    26
    25
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    -2.80 (-7.50 to 0.55)
    -2.90 (-6.94 to -1.12)
    0.05 (-2.25 to 10.84)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to end of double-blind phase study participation
    Adverse event reporting additional description
    Adverse event reporting is based on safety population, where treatment group is defined by the treatment actually received. One (1) placebo subject actually received 5mg OCA titrating to 10mg OCA. All adverse event summaries are based on treatment-emergent adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    1.5 mg OCA Titrating to 3 mg OCA
    Reporting group description
    		 Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

    Reporting group title
    5 mg OCA Titrating to 10 mg OCA
    Reporting group description
    		 Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomized to placebo will take placebo daily for 24 weeks.

    Serious adverse events
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 25 (16.00%)
    4 / 27 (14.81%)
    2 / 24 (8.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 27 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 27 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cholangitis infective
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 25 (92.00%)
    26 / 27 (96.30%)
    21 / 24 (87.50%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    3
    0
    2
    Blood bilirubin increased
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 27 (11.11%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    0
    3
    0
    Headache
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    3
    2
    0
    Paraesthesia
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 27 (11.11%)
    2 / 24 (8.33%)
         occurrences all number
    2
    3
    2
    Oedema peripheral
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    3
    2
    0
    Pyrexia
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 27 (14.81%)
    1 / 24 (4.17%)
         occurrences all number
    5
    4
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    2
    0
    2
    Abdominal pain
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 27 (7.41%)
    4 / 24 (16.67%)
         occurrences all number
    2
    3
    5
    Abdominal pain upper
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
    4 / 24 (16.67%)
         occurrences all number
    2
    2
    4
    Ascites
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 27 (3.70%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    2
    Constipation
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    Crohn's disease
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    1
    Diarrhoea
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 27 (11.11%)
    2 / 24 (8.33%)
         occurrences all number
    1
    3
    3
    Frequent bowel movements
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 27 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    3
    Nausea
         subjects affected / exposed
    2 / 25 (8.00%)
    6 / 27 (22.22%)
    3 / 24 (12.50%)
         occurrences all number
    2
    7
    3
    Vomiting
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 27 (3.70%)
    4 / 24 (16.67%)
         occurrences all number
    1
    1
    4
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    Jaundice
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 27 (3.70%)
    3 / 24 (12.50%)
         occurrences all number
    1
    1
    3
    Nasal congestion
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 27 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 27 (11.11%)
    1 / 24 (4.17%)
         occurrences all number
    2
    3
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    15 / 25 (60.00%)
    18 / 27 (66.67%)
    11 / 24 (45.83%)
         occurrences all number
    31
    38
    17
    Urticaria
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 27 (11.11%)
    1 / 24 (4.17%)
         occurrences all number
    0
    3
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
    1 / 24 (4.17%)
         occurrences all number
    5
    1
    1
    Back pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 27 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    1
    0
    3
    Sinusitis
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 27 (11.11%)
    0 / 24 (0.00%)
         occurrences all number
    1
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
    2 / 24 (8.33%)
         occurrences all number
    2
    1
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 27 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2014
    Amendment 2
    26 Aug 2015
    Amendment 3
    08 Feb 2016
    Amendment 4
    18 Mar 2016
    Amendment 5

    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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    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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