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    Clinical Trial Results:
    A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)

    Summary
    EudraCT number
    		 2013-000366-11
    Trial protocol
    		 SE   IE   CZ   FI   GB   DK   BE   ES   PL   HU   LT   LV   BG   SK   RO  
    Global end of trial date
    17 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2017
    First version publication date
    04 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TP0503
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01903252
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tillotts Pharma AG
    Sponsor organisation address
    Baslerstrasse 15, Rheinfelden, Switzerland, 4310
    Public contact
    Dr. Robert Hofmann, Thillotts Pharma AG, +41 61 935 27 14, rhofmann@tillotts.com
    Scientific contact
    Dr. Robert Hofmann, Thillotts Pharma AG, +41 61 935 27 14, rhofmann@tillotts.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
    17 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Induction: The primary objective of the Induction phase is to determine if 8 weeks of treatment with 3.2 g/day of TP05 is not inferior to 3.2 g/day of Asacol™ in inducing clinical and endoscopic remission (a score ≤ 2 points on the Mayo scoring scale with no individual sub-score > 1 point) in subjects with active mild to moderate Ulcerative Colitis (UC). Open Label Extension (OLE): The primary objective of the OLE is to assess the safety and tolerability of TP05 over a 26-week period in subjects achieving endoscopic and clinical remission or exhibiting a response during the initial phase of TP0503. Maintenance of clinical remission by TP05 will also be assessed by determining the proportion of patients in clinical remission at the final visit.
    Protection of trial subjects
    No special protection of trial subjects
    Background therapy
    		 None
    Evidence for comparator
    		 Tillotts Pharma AG (Rheinfelden, Switzerland) manufactures and markets 400 mg mesalazine tablets (Asacol™) in over 30 countries in Europe and Asia.
    Actual start date of recruitment
    01 Jul 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 101
    Country: Number of subjects enrolled
    Belarus: 96
    Country: Number of subjects enrolled
    Canada: 32
    Country: Number of subjects enrolled
    Ukraine: 130
    Country: Number of subjects enrolled
    Serbia: 36
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 92
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    Belgium: 17
    Country: Number of subjects enrolled
    Bulgaria: 30
    Country: Number of subjects enrolled
    Czech Republic: 38
    Country: Number of subjects enrolled
    Denmark: 36
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Latvia: 44
    Country: Number of subjects enrolled
    Lithuania: 54
    Worldwide total number of subjects
    817
    EEA total number of subjects
    422
    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)
    755
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Up to 14 days screening period 179 study centres were activated, 49 centres did not screen or enrol any study subjects, 15 centres screened subjects, but did not enroll any subjects and 115 centres enrolled subjects into the study.

    Pre-assignment
    Screening details
    		 INCLUSION CRITERIA Subjects were required to meet the following criteria for enrollment into the study: 1. Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomisation, and must use a hormonal (oral, implantable or injectable) or ba

    Pre-assignment period milestones
    Number of subjects started
    		 1141 [1]
    Number of subjects completed
    		 817

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 10
    Reason: Number of subjects
    		 Protocol deviation: 314
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects that have started the pre-assignment period is the number of subjects screened, i.e 1141. The number of subjects enrolled is 817 which excludes 324 screen failures.
    Period 1
    Period 1 title
    Double-blind induction phase
    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
    		 TP05
    Arm description
    		 TP05 (Mesalamine) 1600 mg tablet, 3.2g/day once daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    TP05
    Investigational medicinal product code
    Other name
    Mesalamine
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3.2g/day once daily, with or without food

    Arm title
    		 Asacol 400mg
    Arm description
    		 Asacol 400mg, 3.2g/ day (1.6g in the morning and 1.6g in the evening)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Asacol 400 mg
    Investigational medicinal product code
    Other name
    Mesalamine, 5-ASA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3.2g/day, twice daily for 12 weeks

    Number of subjects in period 1
    		TP05 Asacol 400mg
    Started
    409
    408
    Completed
    370
    367
    Not completed
    39
    41
         Consent withdrawn by subject
    10
    13
         Physician decision
    2
    3
         Adverse event, non-fatal
    20
    18
         non-compliance
    7
    7
    Period 2
    Period 2 title
    Extended Induction Open Label (OLE)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Patients who failed to show a response in either arm at week 8 were withdrawn from the double-blind induction phase and put on an increased daily dose of 4.8g TP05.

    Arms
    Arm title
    		 TP05
    Arm description
    		 All patients received TP05, 4.8g/day once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    TP05
    Investigational medicinal product code
    Other name
    Mesalamine, 5-ASA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.8g/day, three tablets once daily

    Number of subjects in period 2 [2]
    		TP05
    Started
    243
    Completed
    220
    Not completed
    23
         Consent withdrawn by subject
    5
         Physician decision
    1
         Adverse event, non-fatal
    17
    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 who did not respond to the treatment after 8 weeks of the double-blind induction phase were withdrawn and started another 8 weeks on an increased daily dose of 4.8g (open-label extended induction)
    Period 3
    Period 3 title
    Maintenance Open Label (OLE)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Patients who completed either 12 weeks of the double-blind induction phase or the extended induction phase (OLE) enterd the maintenance Open Label phase

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 TP05 1.6g/day
    Arm description
    		 Patients who were in remission at week 12 of the double-blind induction phase, entered the maintenance OLE phase on a reduced daily dose of 1.6g (1 tablet a day)
    Arm type
    		 Experimental

    Investigational medicinal product name
    TP05
    Investigational medicinal product code
    Other name
    Mesalamine, 5-ASA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TP05 1.6g/ day, 1 tablet a day with or without food

    Arm title
    		 TP05 3.2g/day
    Arm description
    		 Patients who showed a response but not remission in the double-blind induction phase entered the maintenance OLE phase on the same dose as in the double-blind induction (3.2g/d, 2 tablets a day, OD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TP05
    Investigational medicinal product code
    Other name
    Mesalamine, 5-ASA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3.2g/d (2 tablets) once daily with or without food.

    Arm title
    		 TP05 4.8g/day
    Arm description
    		 Patients who lost response between week 8 and 12 of the double-blind induction phase and patients who showed no response at week 8 of the double-blind induction but responded after the extended induction phase (OLE), entered the maintenance OLE phase at a daily dose of 4.8g (3 tablets a day OD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TP05
    Investigational medicinal product code
    Other name
    Mesalamine, 5-ASA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.8g/day, 3 tablets once daily with or without food

    Number of subjects in period 3
    		TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Started
    202
    274
    199
    Completed
    196
    253
    181
    Not completed
    6
    21
    18
         Consent withdrawn by subject
    1
    6
    2
         unknown
    2
    6
    -
         Adverse event, non-fatal
    3
    9
    14
         Lack of efficacy
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TP05
    Reporting group description
    		 TP05 (Mesalamine) 1600 mg tablet, 3.2g/day once daily for 12 weeks

    Reporting group title
    Asacol 400mg
    Reporting group description
    		 Asacol 400mg, 3.2g/ day (1.6g in the morning and 1.6g in the evening)

    Reporting group values
    		 TP05 Asacol 400mg Total
    Number of subjects
    		 409 408 817
    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)
    		 378 377 755
        From 65-84 years
    		 31 31 62
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.97 ( 14.54 ) 43.3 ( 14.11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 171 178 349
        Male
    		 238 230 468
    Demographics
    Region of Enrolment
    Units: Subjects
        Belarus
    		 47 49 96
        Belgium
    		 9 8 17
        Bulgaria
    		 15 15 30
        Canada
    		 15 17 32
        Czech Republic
    		 20 18 38
        Denmark
    		 20 16 36
        Finland
    		 2 1 3
        Hungary
    		 17 11 28
        Ireland
    		 1 0 1
        Latvia
    		 22 22 44
        Lithuania
    		 26 28 54
        Norway
    		 4 5 9
        Poland
    		 44 48 92
        Romania
    		 2 1 3
        Russian Federation
    		 51 50 101
        Serbia
    		 18 18 36
        Slovakia
    		 2 3 5
        France
    		 23 16 39
        Ukraine
    		 59 71 130
        Spain
    		 0 2 2
        Sweden
    		 1 2 3
        United Kingdem
    		 11 7 18
    Mayo Score
    Mayo Clinic Score
    Units: Score
        arithmetic mean (standard deviation)
    		 7.7 ( 1.3 ) 7.6 ( 1.3 ) -
    Partial Mayo Score
    Partial Mayo Clinic Score
    Units: Score
        arithmetic mean (standard deviation)
    		 5.5 ( 1.1 ) 5.3 ( 1.1 ) -
    Subject analysis sets

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 817 randomised subjects

    Subject analysis sets values
    		 Baseline
    Number of subjects
    817
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    755
        From 65-84 years
    62
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.5 ( 14.3 )
    Gender categorical
    Units: Subjects
        Female
    349
        Male
    468
    Demographics
    Region of Enrolment
    Units: Subjects
        Belarus
    96
        Belgium
    17
        Bulgaria
    30
        Canada
    32
        Czech Republic
    38
        Denmark
    36
        Finland
    3
        Hungary
    28
        Ireland
    1
        Latvia
    44
        Lithuania
    45
        Norway
    9
        Poland
    92
        Romania
    3
        Russian Federation
    101
        Serbia
    36
        Slovakia
    5
        France
    39
        Ukraine
    130
        Spain
    2
        Sweden
    3
        United Kingdem
    18
    Mayo Score
    Mayo Clinic Score
    Units: Score
        arithmetic mean (standard deviation)
    7.7 ( 1.3 )
    Partial Mayo Score
    Partial Mayo Clinic Score
    Units: Score
        arithmetic mean (standard deviation)
    5.4 ( 1.1 )

    End points

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    End points reporting groups
    Reporting group title
    TP05
    Reporting group description
    		 TP05 (Mesalamine) 1600 mg tablet, 3.2g/day once daily for 12 weeks

    Reporting group title
    Asacol 400mg
    Reporting group description
    		 Asacol 400mg, 3.2g/ day (1.6g in the morning and 1.6g in the evening)
    Reporting group title
    TP05
    Reporting group description
    		 All patients received TP05, 4.8g/day once daily
    Reporting group title
    TP05 1.6g/day
    Reporting group description
    		 Patients who were in remission at week 12 of the double-blind induction phase, entered the maintenance OLE phase on a reduced daily dose of 1.6g (1 tablet a day)

    Reporting group title
    TP05 3.2g/day
    Reporting group description
    		 Patients who showed a response but not remission in the double-blind induction phase entered the maintenance OLE phase on the same dose as in the double-blind induction (3.2g/d, 2 tablets a day, OD).

    Reporting group title
    TP05 4.8g/day
    Reporting group description
    		 Patients who lost response between week 8 and 12 of the double-blind induction phase and patients who showed no response at week 8 of the double-blind induction but responded after the extended induction phase (OLE), entered the maintenance OLE phase at a daily dose of 4.8g (3 tablets a day OD).

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 817 randomised subjects

    Primary: Period 1: Clinical and Endoscopic Remission

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    End point title
    		 Period 1: Clinical and Endoscopic Remission
    End point description
    Mayo Score of <= 2 points with no individual sub-score > 1
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subject
    87
    95
    Statistical analysis title
    		 Non-Inferiority
    Statistical analysis description
    Non-inferiority, pre-defined non-inferiority margin 10%, a two-sided 95% confidence interval about the difference in proportion was contructed. If the lower limit of the confidence interval was no less than -10 it would be concluded that the test product is non-inferior to the comparator
    Comparison groups
    Asacol 400mg v TP05
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.1
         upper limit
    		 3.8
    Statistical analysis title
    		 Clinical and Endoscopic Remission
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.1
         upper limit
    		 3.8

    Primary: Period 2: Clinical Response

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    End point title
    		 Period 2: Clinical Response [1]
    End point description
    A decrease in the PMCS of >= 2 points and >= 30% from baseline, with a decrease in the rectal bleeding sub.score of >= 1 point or absolute rectal bleeding subscore of 1 or 0.
    End point type
    Primary
    End point timeframe
    week 16
    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: This is the open-label extended induction phase with one arm. The endpoint is the proportion of patients achievien clinical response. There was no comparison between arms and no p-value was established.
    End point values
    		 TP05
    Number of subjects analysed
    243
    Units: Number of Subject
    183
    No statistical analyses for this end point

    Primary: Period 3: Clinical Remission

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    End point title
    		 Period 3: Clinical Remission [2]
    End point description
    Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
    End point type
    Primary
    End point timeframe
    week 38
    Notes
    [2] - 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: This is the open-label part of the trial. There are three arms in Period 3 which differ from each other in the daily dose of TP05: 1.6g, 3.2g and 4.8g. The endpoint here is the proportion of patients achieving Clinical Remission in each arm separately. There was no comparison between the three arms and no p-value was established.
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    142
    93
    61
    No statistical analyses for this end point

    Primary: Period 1: Clinical Remission

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    End point title
    		 Period 1: Clinical Remission
    End point description
    End point type
    Primary
    End point timeframe
    Both week 8 and week 12
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    66
    80
    Statistical analysis title
    		 Clinical Remission
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.013
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 1.8

    Secondary: Period 1: Endoscopic Remission

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    End point title
    		 Period 1: Endoscopic Remission
    End point description
    End point type
    Secondary
    End point timeframe
    week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    36
    44
    Statistical analysis title
    		 Endoscopic Remission
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 2.2

    Secondary: Period 1: Endoscopic Response

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    End point title
    		 Period 1: Endoscopic Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Score
        number (not applicable)
    185
    196
    Statistical analysis title
    		 Endoscopic Response
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.026
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 3.9

    Secondary: Period 1: Clinical Remission

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    End point title
    		 Period 1: Clinical Remission
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    92
    110
    Statistical analysis title
    		 Clinical Remission
    Comparison groups
    Asacol 400mg v TP05
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.048
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.9
         upper limit
    		 1.4

    Secondary: Period 1: Rectal Bleeding Sub-Score of 0

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    End point title
    		 Period 1: Rectal Bleeding Sub-Score of 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    212
    226
    Statistical analysis title
    		 Rectal Bleeding = 0
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.042
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 3.1

    Secondary: Period 1: Clinical and Endoscopic Response

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    End point title
    		 Period 1: Clinical and Endoscopic Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    221
    236
    Statistical analysis title
    		 Clinical and Endoscopic Response
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.048
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 2.7

    Secondary: Period 1: Clinical Remission

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    End point title
    		 Period 1: Clinical Remission
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    93
    113
    Statistical analysis title
    		 Clinical Remission
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.068
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.5
         upper limit
    		 0.9

    Secondary: Period 1: Clinical Response

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    End point title
    		 Period 1: Clinical Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    223
    233
    Statistical analysis title
    		 Clinical Response
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.021
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 4

    Secondary: Period 1: Rectal Bleeding Sub-Score of 0

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    End point title
    		 Period 1: Rectal Bleeding Sub-Score of 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    193
    205
    Statistical analysis title
    		 Rectal Bleeding Score = 0
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.03
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 3.7

    Secondary: Period 1: Clinical Response

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    End point title
    		 Period 1: Clinical Response
    End point description
    End point type
    Secondary
    End point timeframe
    Both at week 8 and week 12
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    388
    386
    Units: Number of Subjects
    216
    230
    Statistical analysis title
    		 Clinical Response
    Comparison groups
    Asacol 400mg v TP05
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.042
    Method
    		 Newcombe
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 3

    Secondary: Period 1: Change in Mayo Score

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    End point title
    		 Period 1: Change in Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    371
    375
    Units: Score
        number (not applicable)
    3.1
    3.2
    Statistical analysis title
    		 Change in Mayo Score
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    746
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.557
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.3
    Variability estimate
    Standard deviation

    Secondary: Period 1: Change in Partial Mayo Score

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    End point title
    		 Period 1: Change in Partial Mayo Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    387
    383
    Units: Score
        number (not applicable)
    2.5
    2.5
    Statistical analysis title
    		 Change in Partial Mayo Score
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    770
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.987
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3

    Secondary: Period 1: Change in Stool Frequency

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    End point title
    		 Period 1: Change in Stool Frequency
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    387
    383
    Units: Score
        number (not applicable)
    0.9
    0.9
    Statistical analysis title
    		 Change in Stool Frequency
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    770
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.455
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.2

    Secondary: Period 1: Change in Rectal Bleeding

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    End point title
    		 Period 1: Change in Rectal Bleeding
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    387
    383
    Units: Score
        number (not applicable)
    0.9
    1.0
    Statistical analysis title
    		 Change in Rectal Bleeding
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    770
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.937
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.1

    Secondary: Period 1: Change in Physician Global Assessment

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    End point title
    		 Period 1: Change in Physician Global Assessment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    387
    383
    Units: Score
        number (not applicable)
    0.6
    0.7
    Statistical analysis title
    		 Change in Physician Global Assessment
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    770
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.357
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.1

    Secondary: Period 1: Change in Endoscopy Score

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    End point title
    		 Period 1: Change in Endoscopy Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 TP05 Asacol 400mg
    Number of subjects analysed
    371
    375
    Units: Score
        number (not applicable)
    0.5
    0.6
    Statistical analysis title
    		 Change in Endoscopy Score
    Comparison groups
    TP05 v Asacol 400mg
    Number of subjects included in analysis
    746
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.099
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0

    Secondary: Period 2: Clinical Remission

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    End point title
    		 Period 2: Clinical Remission
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 TP05
    Number of subjects analysed
    243
    Units: Number of Subjects
    53
    No statistical analyses for this end point

    Secondary: Period 2: Rectal Bleeding Score of 0

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    End point title
    		 Period 2: Rectal Bleeding Score of 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 TP05
    Number of subjects analysed
    243
    Units: Number of Subjects
    146
    No statistical analyses for this end point

    Secondary: Period 2: Stool Frequency Score of 0

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    End point title
    		 Period 2: Stool Frequency Score of 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 TP05
    Number of subjects analysed
    243
    Units: Number of Subjects
    64
    No statistical analyses for this end point

    Secondary: Period 2: Urgency

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    End point title
    		 Period 2: Urgency
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 TP05
    Number of subjects analysed
    243
    Units: Number of Subjects
    109
    No statistical analyses for this end point

    Secondary: Period 2: UC-Related Complications

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    End point title
    		 Period 2: UC-Related Complications
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 TP05
    Number of subjects analysed
    243
    Units: Number of Subjects
    0
    No statistical analyses for this end point

    Secondary: Period 3: Clinical and Endoscopic Remission

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    End point title
    		 Period 3: Clinical and Endoscopic Remission
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    133
    108
    59
    No statistical analyses for this end point

    Secondary: Period 3: Clinical Response

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    End point title
    		 Period 3: Clinical Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    190
    230
    156
    No statistical analyses for this end point

    Secondary: Period 3: Clinical and Endoscopic Response

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    End point title
    		 Period 3: Clinical and Endoscopic Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    181
    214
    138
    No statistical analyses for this end point

    Secondary: Period 3: Endoscopic Remission

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    End point title
    		 Period 3: Endoscopic Remission
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    76
    64
    27
    No statistical analyses for this end point

    Secondary: Period 3: Endoscopic Response

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    End point title
    		 Period 3: Endoscopic Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    149
    161
    106
    No statistical analyses for this end point

    Secondary: Period 3: Rectal Bleeding Sub-Score of 0

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    End point title
    		 Period 3: Rectal Bleeding Sub-Score of 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    178
    209
    149
    No statistical analyses for this end point

    Secondary: Period 3: Stool Frequency Score of 0

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    End point title
    		 Period 3: Stool Frequency Score of 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    148
    101
    66
    No statistical analyses for this end point

    Secondary: Period 3: Urgency

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    End point title
    		 Period 3: Urgency
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    41
    101
    90
    No statistical analyses for this end point

    Secondary: Period 3: UC-Related Complications

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    End point title
    		 Period 3: UC-Related Complications
    End point description
    End point type
    Secondary
    End point timeframe
    Week 38
    End point values
    		 TP05 1.6g/day TP05 3.2g/day TP05 4.8g/day
    Number of subjects analysed
    202
    274
    199
    Units: Number of Subjects
    3
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    July 2013 to May 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    TP05/TP05
    Reporting group description
    		 Subjects that were in the TP05 arm in the double-blind induction phase and received TP05 in the open-label phase

    Reporting group title
    TP05/Asacol
    Reporting group description
    		 Subject in the Asacol arm in the double-blind induction phase and on TP05 in the open-label-phase

    Serious adverse events
    		 TP05/TP05 TP05/Asacol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 409 (5.87%)
    18 / 408 (4.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Cryoglobulinaemia vasculitis
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Fading fetus
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deformation
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 409 (0.00%)
    2 / 408 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fruacture
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Artrial fibrilation
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unstable agina
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarctrion
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 409 (0.49%)
    2 / 408 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Chronic pancreatitis
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deterioration ulcerative colitis
         subjects affected / exposed
    9 / 409 (2.20%)
    6 / 408 (1.47%)
         occurrences causally related to treatment / all
    3 / 10
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis ulcerative
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute haemorrhagic cystitis
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Herniated disk
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chronic tonsillitis
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium dificile
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flue
         subjects affected / exposed
    1 / 409 (0.24%)
    0 / 408 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perichonditis
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 409 (0.24%)
    1 / 408 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes melitus
         subjects affected / exposed
    0 / 409 (0.00%)
    1 / 408 (0.25%)
         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
    		 TP05/TP05 TP05/Asacol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    131 / 409 (32.03%)
    108 / 408 (26.47%)
    Gastrointestinal disorders
    Ulcerative colitis deterioration
         subjects affected / exposed
    58 / 409 (14.18%)
    75 / 408 (18.38%)
         occurrences all number
    58
    75

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28568974
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