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    Clinical Trial Results:
    A double blind, randomized placebo controlled crossover multiple dose study of LJN452 to assess safety, tolerability and efficacy in patients with primary bile acid diarrhea (pBAD)

    Summary
    EudraCT number
    		 2015-003192-30
    Trial protocol
    		 GB  
    Global end of trial date
    25 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2019
    First version publication date
    10 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLJN452X2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02713243
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    25 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety and tolerability of LJN452 in patients with primary bile acid diarrhea. To assess the effect of LJN452 on clinical symptoms experienced by patients with primary bile acid diarrhea.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 2016
    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 Kingdom: 12
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    20
    EEA total number of subjects
    12
    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)
    15
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In total, 20 patients were enrolled in this study and received at least one dose of LJN452 or matching placebo for 14 days in Period 1. There will be a washout period between 7 to 28 days followed by Period 2 drug if patient on LJN452 or Placebo in Period 1 they will take Placebo or LJN452 respectively in Period 2 for 14 days

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LJN452 followed by placebo
    Arm description
    		 Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to match LJN452
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match LJN453 daily for 14 days

    Investigational medicinal product name
    Tropifexor
    Investigational medicinal product code
    LJN452
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    LJN453 60 mcg daily for 14 days

    Arm title
    		 Placebo followed by LJN452
    Arm description
    		 Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Tropifexor
    Investigational medicinal product code
    LJN452
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    LJN453 60 mcg daily for 14 days

    Investigational medicinal product name
    Placebo to match LJN452
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match LJN453 daily for 14 days

    Number of subjects in period 1
    		LJN452 followed by placebo Placebo followed by LJN452
    Started
    10
    10
    Completed
    9
    8
    Not completed
    1
    2
         Abnormal laboratory value(s)#
    1
    -
         Protocol deviation
    -
    1
         Administrative problems
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LJN452 followed by placebo
    Reporting group description
    		 Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.

    Reporting group title
    Placebo followed by LJN452
    Reporting group description
    		 Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.

    Reporting group values
    		 LJN452 followed by placebo Placebo followed by LJN452 Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 9 6 15
        From 65-84 years
    		 1 4 5
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.4 ( 13.25 ) 57.9 ( 16.47 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 4 8 12
        Male
    		 6 2 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 10 10 20
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    LJN452 followed by placebo
    Reporting group description
    		 Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.

    Reporting group title
    Placebo followed by LJN452
    Reporting group description
    		 Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.

    Subject analysis set title
    LJN452 ALL Patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Patients on LJN452 in both Period 1 and Period 2

    Subject analysis set title
    Placebo ALL Patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Patients on Placebo in both Period 1 and Period 2

    Subject analysis set title
    LJN452 ALL Patients
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All Patients on LJN452 in both Period 1 and Period 2

    Primary: Number of patients reported with adverse events , serious adverse events and death.

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    End point title
    		 Number of patients reported with adverse events , serious adverse events and death. [1]
    End point description
    Number of patients reported with adverse events , serious adverse events and death. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
    End point type
    Primary
    End point timeframe
    up to Day 79
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
    End point values
    		 LJN452 ALL Patients Placebo ALL Patients
    Number of subjects analysed
    20
    20
    Units: count of participants
        AEs, Patients with AEs
    9
    14
        Study drug-related AEs
    0
    4
        Serious AEs
    0
    0
        Death
    0
    0
    No statistical analyses for this end point

    Primary: Stool frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined

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    End point title
    		 Stool frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
    End point description
    Stool frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
    End point type
    Primary
    End point timeframe
    Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
    End point values
    		 LJN452 ALL Patients Placebo ALL Patients
    Number of subjects analysed
    20
    20
    Units: stool frequency
    arithmetic mean (standard deviation)
        Baseline
    18.0 ( 9.39 )
    15.9 ( 6.92 )
        Week 1 (Period 1 & 2)
    20.0 ( 11.62 )
    16.2 ( 7.19 )
        Week 2 (Period 1 & 2)
    18.8 ( 9.68 )
    17.5 ( 10.88 )
        Week 1 & 2(Period 1 & 2)
    19.4 ( 10.56 )
    16.8 ( 9.11 )
    Statistical analysis title
    		 Stool Frequency Week 1 (Period 1 & 2)
    Statistical analysis description
    Week 1 (Period 1 & 2) -Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Comparison groups
    LJN452 ALL Patients v Placebo ALL Patients
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 7.11
    Statistical analysis title
    		 Stool Frequency Week 1&2 (Period 1 & 2)
    Statistical analysis description
    Week 1&2 (Period 1 & 2) Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Comparison groups
    LJN452 ALL Patients v Placebo ALL Patients
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.019
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 4.89
    Statistical analysis title
    		 Stool Frequency Week 2 (Period 1 & 2)
    Statistical analysis description
    Week 2 (Period 1 & 2) Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Comparison groups
    LJN452 ALL Patients v Placebo ALL Patients
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.401
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 4.38

    Primary: Stool form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined

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    End point title
    		 Stool form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
    End point description
    Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.
    End point type
    Primary
    End point timeframe
    Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
    End point values
    		 LJN452 ALL Patients Placebo ALL Patients
    Number of subjects analysed
    20
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.5 ( 0.87 )
    5.1 ( 0.94 )
        Week 1 (Period 1 & 2)
    5.3 ( 0.78 )
    5.3 ( 0.79 )
        Week 2 (Period 1 & 2)
    4.9 ( 0.82 )
    5.1 ( 1.01 )
        Week 1 & 2(Period 1 & 2)
    5.1 ( 0.81 )
    5.2 ( 0.90 )
    Statistical analysis title
    		 Stool Form Week 1 (Period 1 & 2)
    Statistical analysis description
    Week 1 (Period 1 & 2) Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Comparison groups
    LJN452 ALL Patients v Placebo ALL Patients
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.533
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.52
    Statistical analysis title
    		 Stool Form Week 1&2 (Period 1 & 2)
    Statistical analysis description
    Week 1&2 (Period 1 & 2) Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Comparison groups
    LJN452 ALL Patients v Placebo ALL Patients
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.916
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.3
    Statistical analysis title
    		 Stool Form Week 2 (Period 1 & 2)
    Statistical analysis description
    Week 2 (Period 1 & 2) Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Comparison groups
    LJN452 ALL Patients v Placebo ALL Patients
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.64
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.3

    Secondary: Area under the plasma concentration-time profile (AUCtau) of LJN452

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    End point title
    		 Area under the plasma concentration-time profile (AUCtau) of LJN452
    End point description
    AUCtau- is the area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume]
    End point type
    Secondary
    End point timeframe
    Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)
    End point values
    		 LJN452 ALL Patients
    Number of subjects analysed
    17
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        Day 1
    23.6 ( 7.24 )
        Day 12
    22.1 ( 4.83 )
    No statistical analyses for this end point

    Secondary: (Cmax) of LJN452

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    End point title
    		 (Cmax) of LJN452
    End point description
    Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume]
    End point type
    Secondary
    End point timeframe
    Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)
    End point values
    		 LJN452 ALL Patients
    Number of subjects analysed
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1
    1.63 ( 0.414 )
        Day 12
    1.82 ( 0.704 )
    No statistical analyses for this end point

    Secondary: Time to reach maximum concentration after drug administration (Tmax)

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    End point title
    		 Time to reach maximum concentration after drug administration (Tmax)
    End point description
    Tmax is the time to reach the maximum concentration after drug administration [time]
    End point type
    Secondary
    End point timeframe
    Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)
    End point values
    		 LJN452 ALL Patients
    Number of subjects analysed
    17
    Units: hr
    median (full range (min-max))
        Day 1
    5.00 (3.92 to 8.00)
        Day 12
    5.00 (1.83 to 8.00)
    No statistical analyses for this end point

    Secondary: Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined

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    End point title
    		 Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
    End point description
    Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined; Rescue Medication used was loperamide
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 (Period 1 & 2), Week 2 (Period 1 & 2), Week 1 & 2 combined
    End point values
    		 LJN452 ALL Patients Placebo ALL Patients
    Number of subjects analysed
    20
    20
    Units: mg
    arithmetic mean (standard deviation)
        Baseline
    0.9 ( 3.50 )
    1.3 ( 5.66 )
        Week 1 (Period 1 & 2)
    0.6 ( 1.75 )
    0.7 ( 2.06 )
        Week 2 (Period 1 & 2)
    0.5 ( 1.37 )
    0.7 ( 1.68 )
        Week 1 & 2(Period 1 & 2)
    0.6 ( 1.54 )
    0.7 ( 1.85 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    LJN452 60 ug
    Reporting group description
    		 LJN452 60 ug

    Serious adverse events
    		 Placebo LJN452 60 ug
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (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: 0%
    Non-serious adverse events
    		 Placebo LJN452 60 ug
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 19 (73.68%)
    9 / 17 (52.94%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    4 / 19 (21.05%)
    2 / 17 (11.76%)
         occurrences all number
    4
    2
    Tremor
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Abdominal distension
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Anal incontinence
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Bile acid malabsorption
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Biliary dyspepsia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2015
    Amendment 1:The purpose of this amendment was to address comments from the US FDA prior to start of the study. Specific limits for ALP and GGT were added that equate to the CTCAE grades within individual and stopping criteria.
    15 Aug 2016
    Amendment 2: The purpose of this amendment was to include new data from the embryo fetal developmental toxicity program. As a result of these new data, women of child bearing potential were allowed to participate in the study provided they utilized highly effective contraception. Changes were made to the inclusion criteria and to the assessment table with respect to optional pharmacokinetic and biomarker assessments to reduce patient burden.

    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.
    Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    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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