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    Clinical Trial Results:
    A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study

    Summary
    EudraCT number
    		 2014-002557-19
    Trial protocol
    		 CZ   HU   SK   NL   IT   PL  
    Global end of trial date
    24 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2018
    First version publication date
    24 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT-1303-E14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02389790
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mitsubishi Tanabe Pharma Corporation
    Sponsor organisation address
    17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, Japan, 103-8405
    Public contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd (MTPE), 0044 (0)2070655000, regulatory@mt-pharma-eu.com
    Scientific contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd (MTPE), 0044 (0)2070655000, regulatory@mt-pharma-eu.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
    12 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to evaluate the long term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's disease (CD). Secondary objectives were to evaluate the long term effects of MT-1303 on clinical outcomes in subjects with moderate to severe active CD and explore the pharmacodynamic effects of MT-1303 in subjects with moderate to severe active CD.
    Protection of trial subjects
    The study was conducted in accordance with the 2013 (Fortaleza) revision of the 1964 Declaration of Helsinki, Good Clinical Practice (GCP) as required by the International Conference on Harmonisation (ICH) guidelines, applicable regional and local legislation, and standard operating procedures in place at Mitsubishi Tanabe Pharma Europe Ltd (MTPE). Before implementing the study, the Protocol and all other appropriate documents were reviewed and approved by an Independent Ethics Committee (IEC) and regulatory authorities. The study was carefully designed to minimise the identified and potential risks to subjects; all subjects underwent screening procedures aimed at minimising the likelihood and impact of any such risks. In addition, regular safety monitoring during the treatment and safety Follow-up Periods for all subjects ensured that any unanticipated effects of study participation were identified promptly and managed appropriately. At the level of the individual subject, the Protocol stated well-defined criteria for intensive Cardiovascular Safety Monitoring, including extended monitoring and permanent discontinuation of study medication. In addition, an independent Data and Safety Monitoring Board (DSMB) reviewed selected data across the study, at regular, predefined intervals. The DSMB was empowered to make recommendations regarding continuation, termination or modification of the study, as appropriate. In particular, if it became clear that continuing treatment with MT-1303 was not clinically or ethically justified, the MT 1303-E14 study could be terminated. There were no guaranteed benefits for subjects; however, there was an expectation that subjects treated with MT-1303 would experience a selective reduction in lymphocytes which could be translated into clinical benefit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Aug 2015
    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
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Ukraine: 11
    Country: Number of subjects enrolled
    Japan: 4
    Worldwide total number of subjects
    46
    EEA total number of subjects
    30
    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)
    46
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a follow on study from a previous study MT-1303-E13

    Pre-assignment
    Screening details
    		 There was no screening period for this study. Subject eligibility was confirmed at Visit 7 (Week 14) in MT-1303-E13 and eligible subjects who wished to continue in the open-label extension were entered at Visit 1 (Week 0) in E14.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is an open label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MT-1303/MT-1303
    Arm description
    		 Subjects received once daily oral 0.4 mg MT-1303 capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MT-1303
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 0.4 mg MT-1303 capsule administered orally once daily

    Arm title
    		 placebo/MT-1303
    Arm description
    		 Subjects received once daily oral placebo capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MT-1303
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 0.4 mg MT-1303 capsule administered orally once daily

    Number of subjects in period 1
    		MT-1303/MT-1303 placebo/MT-1303
    Started
    21
    25
    Completed
    14
    12
    Not completed
    7
    13
         Consent withdrawn by subject
    3
    6
         Physician decision
    1
    -
         ALT/AST >5 x ULN, 2 or more consecutive visits
    -
    1
         Adverse event, non-fatal
    1
    2
         Pregnancy
    -
    1
         Insufficient control of disease condition
    1
    -
         Lack of efficacy
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MT-1303/MT-1303
    Reporting group description
    		 Subjects received once daily oral 0.4 mg MT-1303 capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.

    Reporting group title
    placebo/MT-1303
    Reporting group description
    		 Subjects received once daily oral placebo capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.

    Reporting group values
    		 MT-1303/MT-1303 placebo/MT-1303 Total
    Number of subjects
    		 21 25 46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 25 46
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.4 ± 8.5 34.9 ± 11.1 -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 17
        Male
    		 13 16 29

    End points

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    End points reporting groups
    Reporting group title
    MT-1303/MT-1303
    Reporting group description
    		 Subjects received once daily oral 0.4 mg MT-1303 capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.

    Reporting group title
    placebo/MT-1303
    Reporting group description
    		 Subjects received once daily oral placebo capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    The primary endpoint was safety and the data are provided in the AE section
    End point type
    Primary
    End point timeframe
    All of Study
    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: The primary endpoint was safety and the data are provided in the AE section
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    25
    Units: Adverse Events
    number (not applicable)
        subjects affected by serious adverse events
    1
    8
        subjects affected by non-serious adverse events
    12
    13
    No statistical analyses for this end point

    Secondary: Proportion of subjects who achieved a 70-point decrease from MT-1303-E13 baseline in CDAI score (CDAI 70) at Protocol scheduled visits

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    End point title
    		 Proportion of subjects who achieved a 70-point decrease from MT-1303-E13 baseline in CDAI score (CDAI 70) at Protocol scheduled visits
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    25
    Units: percent
    number (not applicable)
        week 0
    83.3
    86.4
        week 2
    84.2
    76.5
        week 4
    81
    81.0
        week 8
    70.6
    88.9
        week 12
    76.5
    81.3
        week 16
    82.4
    78.6
        week 20
    87.5
    92.3
        week 24
    93.8
    100.0
        week 28
    88.2
    100.0
        week 32
    92.9
    90.0
        week 36
    81.8
    80.0
    No statistical analyses for this end point

    Secondary: Proportion of subjects who achieved a 100-point decrease from MT-1303-E13 baseline in CDAI score (CDAI 100) at Protocol scheduled visits.

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    End point title
    		 Proportion of subjects who achieved a 100-point decrease from MT-1303-E13 baseline in CDAI score (CDAI 100) at Protocol scheduled visits.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    23
    Units: percent
    number (not applicable)
        week 0
    66.7
    81.8
        week 2
    68.4
    64.7
        week 4
    71.4
    76.2
        week 8
    64.7
    83.3
        week 12
    70.6
    81.3
        week 16
    76.5
    71.4
        week 20
    75
    92.3
        week 24
    87.5
    90
        week 28
    76.5
    91.7
        week 32
    85.7
    90
        week 36
    81.8
    80
    No statistical analyses for this end point

    Secondary: Proportion of subjects who achieve clinical remission (CDAI <150) at Protocol scheduled visits.

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    End point title
    		 Proportion of subjects who achieve clinical remission (CDAI <150) at Protocol scheduled visits.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    23
    Units: percent
    number (not applicable)
        week 0
    38.9
    72.7
        week 2
    47.4
    52.9
        week 4
    52.4
    47.6
        week 8
    52.9
    61.1
        week 12
    52.9
    75
        week 16
    58.8
    64.3
        week 20
    68.8
    69.2
        week 24
    75
    80
        week 28
    58.8
    75
        week 32
    85.7
    50
        week 36
    81.8
    70
    No statistical analyses for this end point

    Secondary: CDAI Score at Protocol scheduled visits

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    End point title
    		 CDAI Score at Protocol scheduled visits
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    23
    Units: score on scale
    arithmetic mean (standard deviation)
        week 0
    155.7 ± 77.7
    136.8 ± 82.9
        week 2
    162.8 ± 78.7
    127.7 ± 71.7
        week 4
    158.2 ± 84.3
    151.4 ± 73.2
        week 8
    162.8 ± 91.7
    113.7 ± 73.9
        week 12
    153.8 ± 78.8
    117.3 ± 67.1
        week 16
    144.7 ± 72.3
    117.1 ± 87
        week 20
    138.1 ± 78.2
    111.8 ± 62
        week 24
    126.8 ± 71.4
    110.2 ± 44.4
        week 28
    151.2 ± 75.3
    116.8 ± 51
        week 32
    112.6 ± 77
    124.7 ± 58.7
        week 36
    112.6 ± 87
    137 ± 67.7
    No statistical analyses for this end point

    Secondary: Proportion of subjects in corticosteroid free remission at End of Treatment.

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    End point title
    		 Proportion of subjects in corticosteroid free remission at End of Treatment.
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 36 Last observation carried forward (LOCF)
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    23
    Units: percent
    number (not applicable)
        week 0
    0.0
    25.0
        week 2
    0.0
    0.0
        week 4
    12.5
    0.0
        week 8
    28.6
    20.0
        week 12
    28.6
    25.0
        week 16
    14.3
    0.0
        week 20
    57.1
    33.3
        week 24
    42.9
    50.0
        week 28
    42.9
    33.3
        week 32
    50.0
    0.0
        week 36
    66.7
    50.0
        week 36 LOCF
    50.0
    25.0
    No statistical analyses for this end point

    Secondary: Lymphocyte counts at Protocol scheduled visits

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    End point title
    		 Lymphocyte counts at Protocol scheduled visits
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    23
    Units: X 10^9/L
    arithmetic mean (standard deviation)
        week 0
    0.656 ± 0.271
    1.708 ± 0.793
        week 2
    0.748 ± 0.307
    0.824 ± 0.314
        week 4
    0.772 ± 0.328
    0.704 ± 0.265
        week 8
    0.685 ± 0.307
    0.622 ± 0.247
        week 12
    0.728 ± 0.362
    0.568 ± 0.219
        week 16
    0.723 ± 0.358
    0.607 ± 0.274
        week 20
    0.767 ± 0.373
    0.612 ± 0.281
        week 24
    0.634 ± 0.18
    0.593 ± 0.302
        week 28
    0.694 ± 0.37
    0.645 ± 0.289
        week 32
    0.621 ± 0.184
    0.668 ± 0.368
        week 36
    0.628 ± 0.307
    0.579 ± 0.268
        week 40
    0.918 ± 0.282
    0.924 ± 0.418
        week 44
    1.182 ± 0.326
    1.131 ± 0.369
        week 48
    1.386 ± 0.313
    1.171 ± 0.489
    No statistical analyses for this end point

    Secondary: C-reactive protein at Protocol scheduled visits

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    End point title
    		 C-reactive protein at Protocol scheduled visits
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    24
    Units: mg/L
    median (full range (min-max))
        week 0
    3.45 (0.61 to 47.8)
    13.1 (0.20 to 49.90)
        week 2
    6.135 (0.76 to 30.60)
    8.25 (0.85 to 43.70)
        week 4
    6.82 (1.35 to 37.80)
    15.4 (0.25 to 72.60)
        week 8
    5.2 (1.11 to 41.50)
    9.155 (0.80 to 37.70)
        week 12
    6.29 (1.03 to 36.30)
    10.165 (3.97 to 55.70)
        week 16
    7.84 (1.00 to 55.00)
    9.87 (0.81 to 39.40)
        week 20
    4.3 (0.84 to 31.50)
    10.3 (0.55 to 33.80)
        week 24
    7.845 (0.80 to 33.5)
    10.135 (1.30 to 35.30)
        week 28
    10.3 (1.19 to 47.50)
    9.805 (1.25 to 45.60)
        week 32
    9.82 (0.95 to 24.60)
    7.295 (1.14 to 46.40)
        week 36
    14.50 (0.95 to 62.50)
    10.56 (0.87 to 36.50)
    No statistical analyses for this end point

    Secondary: Faecal calprotectin at Protocol scheduled visits

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    End point title
    		 Faecal calprotectin at Protocol scheduled visits
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 36
    End point values
    		 MT-1303/MT-1303 placebo/MT-1303
    Number of subjects analysed
    21
    24
    Units: mg/kg
    median (full range (min-max))
        week 12
    766 (30 to 2278)
    1356.5 (55 to 9546)
        week 36
    283 (30 to 2051)
    878 (30 to 3324)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events occurring from the signing of the informed consent form until the end of the safety Follow-up Period or the withdrawal of the subject from the study were documented, regardless of the relationship to study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    MT-1303/MT-1303
    Reporting group description
    		 Subjects received once daily oral 0.4 mg MT-1303 capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.

    Reporting group title
    placebo/MT-1303
    Reporting group description
    		 Subjects received once daily oral placebo capsules during the double-blind MT-1303-E13 study, and received once daily oral 0.4 mg MT-1303 capsules during the MT-1303-E14 extension study.

    Serious adverse events
    		 MT-1303/MT-1303 placebo/MT-1303
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    8 / 25 (32.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Endoscopy small intestine
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Vagal nerve stimulator removal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Granuloma skin
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MT-1303/MT-1303 placebo/MT-1303
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 21 (57.14%)
    13 / 25 (52.00%)
    Investigations
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 25 (8.00%)
         occurrences all number
    2
    3
    Protein urine present
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 25 (8.00%)
         occurrences all number
    6
    4
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Lymphopenia
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 25 (4.00%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 25 (12.00%)
         occurrences all number
    1
    3
    Anal fistula
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    4
    Aphthous ulcer
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Crohn's disease
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    Vomiting
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    4
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2015
    Inclusion criterion 1 was removed. Section 6.6.3, Section 8, Section 10.1, and were updated. Other minor administrative changes 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.
    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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