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    Clinical Trial Results:
    A Two Part, Multi Centre, Randomized, Placebo Controlled, Double Blind Study of TRK 170 for the Treatment of Crohn's Disease

    Summary
    EudraCT number
    		 2011-000854-44
    Trial protocol
    		 SE   BE   NO   HU   NL   PL   CZ   BG   LV  
    Global end of trial date
    15 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    05 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    170CDT01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Toray Industries, Inc.
    Sponsor organisation address
    1-1, Nihonbashi-muromachi 2-chome, Chuo-ku, Tokyo, Japan, 103-8666
    Public contact
    Project leader - Anders Nilsson, TFS, +46 462801800, tfs.international@tfscro.com
    Scientific contact
    Project leader - Anders Nilsson, TFS, +46 462801800, tfs.international@tfscro.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
    15 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective: Part A To evaluate the effect of TRK-170 on mucosal healing as measured by Crohn's Disease Endoscopic Index of Severity (CDEIS) score based on ileocolonoscopy and use this evaluation to decide which dose(s) of TRK- 170 should be used in Part B Part B To evaluate the efficacy of TRK-170 in patients with active CD as measured by CDAI score After the interim analysis following completion of Part A, the decision was made not to conduct Part B
    Protection of trial subjects
    Patients were given anesthetics and sedatives as premedication for the colonoscopy procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Apr 2011
    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
    Poland: 92
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Bulgaria: 42
    Country: Number of subjects enrolled
    Czech Republic: 23
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Latvia: 9
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Serbia: 9
    Country: Number of subjects enrolled
    Ukraine: 28
    Worldwide total number of subjects
    237
    EEA total number of subjects
    200
    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)
    237
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place from 2011 to 2013. Recruitment took place at hospitals and gastroenterology clinics in Europe.

    Pre-assignment
    Screening details
    		 237 patients were screened of which 123 patients met the inclusion criteria and not the exclusion criteria.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    The IP code for each patient was contained in a sealed envelope with one envelope designated for each randomized study number. No envelope was opened unless it was critical to the treatment/outcome of an AE. All doses were administered with the same number of tablets, hence the patients were blinded both to treatment and dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TRK-170 12 mg
    Arm description
    		 Dosing of TRK-170 12 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRK-170
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 mg oral in tablet form, twice daily for 8 weeks.

    Arm title
    		 TRK-170 60 mg
    Arm description
    		 Dosing of TRK-170 60 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRK-170
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg oral in tablet form, twice daily for 8 weeks.

    Arm title
    		 TRK-170 120 mg
    Arm description
    		 Dosing of TRK-170 120 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRK-170
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg oral in tablet form, twice daily for 8 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Dosing with placebo.
    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
    Placebo, oral in tablet form, twice daily for 8 weeks.

    Number of subjects in period 1 [1]
    		TRK-170 12 mg TRK-170 60 mg TRK-170 120 mg Placebo
    Started
    31
    31
    31
    30
    Completed
    31
    31
    31
    30
    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: Two subjects did not take any IMP.
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The IP code for each patient was contained in a sealed envelope with one envelope designated for each randomized study number. No envelope was to opened unless it was critical to the treatment/outcome of an AE. All doses were to be administered with the same number of tablets, hence the patients were blinded both to treatment and dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TRK-170 12 mg
    Arm description
    		 Dosing of TRK-170 12 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRK-170
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 mg oral in tablet form, twice daily for 8 weeks.

    Arm title
    		 TRK-170 60 mg
    Arm description
    		 Dosing of TRK-170 60 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRK-170
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg oral in tablet form, twice daily for 8 weeks.

    Arm title
    		 TRK-170 120 mg
    Arm description
    		 Dosing of TRK-170 120 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRK-170
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg oral in tablet form, twice daily, for 8 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Dosing with Placebo
    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
    Placebo oral in tablet form for 8 weeks.

    Number of subjects in period 2 [2]
    		TRK-170 12 mg TRK-170 60 mg TRK-170 120 mg Placebo
    Started
    30
    31
    30
    30
    Completed
    25
    25
    27
    27
    Not completed
    5
    6
    3
    3
         Consent withdrawn by subject
    2
    2
    3
    1
         disease exacerbation
    -
    1
    -
    -
         Adverse event, non-fatal
    2
    2
    -
    2
         violation of inclusion/exclusion criteria
    -
    1
    -
    -
         Lost to follow-up
    1
    -
    -
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects withdrew during the treatment period due to reasons specified.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TRK-170 12 mg
    Reporting group description
    		 Dosing of TRK-170 12 mg

    Reporting group title
    TRK-170 60 mg
    Reporting group description
    		 Dosing of TRK-170 60 mg

    Reporting group title
    TRK-170 120 mg
    Reporting group description
    		 Dosing of TRK-170 120 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Dosing with placebo.

    Reporting group values
    		 TRK-170 12 mg TRK-170 60 mg TRK-170 120 mg Placebo Total
    Number of subjects
    		 31 31 31 30 123
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 31 31 31 30 123
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13 14 15 55
        Male
    		 18 18 17 15 68
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least 1 dose of the study drug.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who were diagnosed with CD, took at least 1 dose of the study drug, and had at least 1 post-baseline assessment of any efficacy data.

    Subject analysis sets values
    		 Safety Set Full Analysis Set
    Number of subjects
    121
    120
    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)
    121
    120
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    54
    54
        Male
    67
    66

    End points

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    End points reporting groups
    Reporting group title
    TRK-170 12 mg
    Reporting group description
    		 Dosing of TRK-170 12 mg

    Reporting group title
    TRK-170 60 mg
    Reporting group description
    		 Dosing of TRK-170 60 mg

    Reporting group title
    TRK-170 120 mg
    Reporting group description
    		 Dosing of TRK-170 120 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Dosing with placebo.
    Reporting group title
    TRK-170 12 mg
    Reporting group description
    		 Dosing of TRK-170 12 mg

    Reporting group title
    TRK-170 60 mg
    Reporting group description
    		 Dosing of TRK-170 60 mg

    Reporting group title
    TRK-170 120 mg
    Reporting group description
    		 Dosing of TRK-170 120 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Dosing with Placebo

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least 1 dose of the study drug.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who were diagnosed with CD, took at least 1 dose of the study drug, and had at least 1 post-baseline assessment of any efficacy data.

    Primary: CDEIS, change from baseline to end of treatment (week 8)

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    End point title
    		 CDEIS, change from baseline to end of treatment (week 8)
    End point description
    CDEIS was the primary efficacy variable in Part A. The numerical change from baseline to end of treatment was analysed using analysis of covariance (ANCOVA). Model includes adjustment for baseline CDEIS.
    End point type
    Primary
    End point timeframe
    Visit 2 (baseline) to Visit 6 (Week 8)
    End point values
    		 TRK-170 12 mg TRK-170 60 mg TRK-170 120 mg Placebo
    Number of subjects analysed
    23
    21
    20
    24
    Units: Change in CDEIS score
        arithmetic mean (standard deviation)
    -1.24 ± 6.02
    -1.31 ± 4.23
    -1.73 ± 9.77
    -1.14 ± 7.73
    Statistical analysis title
    		 12mg vs placebo (FAS)
    Statistical analysis description
    ANCOVA for Change from Baseline at Week 8 in CDEIS adjusted for baseline CDIES, TRK-170 12 mg vs Placebo (FAS)
    Comparison groups
    TRK-170 12 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.796
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - ANCOVA for Change from Baseline at Week 8 in CDEIS adjusted for baseline CDIES, TRK-170 12 mg vs Placebo (FAS)
    Statistical analysis title
    		 60mg vs placebo (FAS)
    Statistical analysis description
    ANCOVA for Change from Baseline at Week 8 in CDEIS adjusted for baseline CDIES, TRK-170 60 mg vs Placebo (FAS)
    Comparison groups
    TRK-170 60 mg v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.917
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - ANCOVA for Change from Baseline at Week 8 in CDEIS adjusted for baseline CDIES, TRK-170 60 mg vs Placebo (FAS)
    Statistical analysis title
    		 120mg vs placebo (FAS)
    Statistical analysis description
    ANCOVA for Change from Baseline at Week 8 in CDEIS adjusted for baseline CDIES, TRK-170 120 mg vs Placebo (FAS)
    Comparison groups
    TRK-170 120 mg v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.311
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - ANCOVA for Change from Baseline at Week 8 in CDEIS adjusted for baseline CDIES, TRK-170 120 mg vs Placebo (FAS)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All study subjects/patients were carefully monitored for the occurrence of AEs during the study period from the signing of informed consent to the completion of the follow up visit.
    Adverse event reporting additional description
    The Investigator or authorized designee collected AEs with a non leading question such as “have you experienced any new health problems or worsening of existing conditions” as well as reporting events directly observed or spontaneously volunteered by patients.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    TRK-170 12 mg
    Reporting group description
    		 Dosing of TRK-170 12 mg for 8 weeks.

    Reporting group title
    TRK-170 60 mg
    Reporting group description
    		 Dosing of TRK-170 60 mg for 8 weeks.

    Reporting group title
    TRK-170 120 mg
    Reporting group description
    		 Dosing, TRK-170 120 mg for 8 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Dosing with placebo for 8 weeks.

    Serious adverse events
    		 TRK-170 12 mg TRK-170 60 mg TRK-170 120 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TRK-170 12 mg TRK-170 60 mg TRK-170 120 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 30 (53.33%)
    8 / 31 (25.81%)
    11 / 30 (36.67%)
    13 / 30 (43.33%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 31 (9.68%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    3
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    0
    2
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 31 (3.23%)
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    4
    1
    Abdominal pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    3
    0
    0
    4
    Abdominal pain upper
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    0
    0
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2011
    Incorporation of changes requested by the Swedish Medical Products Agency. Amendment took place before inclusion of patients.
    20 May 2011
    Clarification of language used in inclusion/exclusion criteria. Addition of a reason for withdrawal. Addition of monitoring of early neurological symptoms of any developing disorders. Amendment took place before the inclusion of any patients.
    20 Jul 2011
    Addition of vital signs assessments to Visits 3, 4, 5, and 6. Amendment took place before inclusion of any patients.
    25 Nov 2011
    To align with the tablet standards in participating countires the limit for 5-ASA was increased to 2.5 g/day. CDAI collection at Visit 2 (Day 1) and Visit 6 (Week 8) were adjusted. The amendment took place after inclusion of patients.
    14 Nov 2013
    Changes in statistical definitions. The amendment took place after inclusion of patients.

    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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