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    Clinical Trial Results:
    A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2018-002136-24
    Trial protocol
    		 FR   DE   SK   PT   BG   PL   GR   HU   ES   IT   RO  
    Global end of trial date
    20 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2022
    First version publication date
    06 Nov 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0157
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03758443
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 US IND: 128299
    Sponsors
    Sponsor organisation name
    Theravance Biopharma Ireland Limited
    Sponsor organisation address
    Ten Earlsfort Terrace, Dublin, Ireland, D02 T380
    Public contact
    Medical Monitor , Theravance Biopharma Ireland Limited, +1 855 633 8479, medinfo@theravance.com
    Scientific contact
    Medical Monitor , Theravance Biopharma Ireland Limited, +1 855 633 8479, medinfo@theravance.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
    20 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were as follows: Phase 2b Dose-Finding Induction Study -Assess the effect of TD-1473 taken daily for 8 weeks at daily doses of 20 mg, 80 mg, and 200 mg on the change from baseline in the total Mayo score -Assess the effect of TD-1473 on rates of clinical remission, endoscopic healing, clinical response, and mucosal healing -Select dose(s) of TD-1473 for evaluation in the Phase 3 dose-confirming Induction Study and the Phase 3 Maintenance Study Phase 3 Dose-Confirming Induction Study -Establish the clinical remission rate associated with TD-1473 compared to placebo treatment at Week 8 -To assess the safety and tolerability of TD-1473 when taken for up to 16 weeks Phase 3 Maintenance Study -Establish the clinical remission rate associated with TD-1473 compared to placebo treatment at Maintenance Week 44 -Establish the safety and tolerability of TD-1473 with up to 44 additional weeks of treatment
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Council for Harmonisation (ICH) Harmonised Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2019
    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: 53
    Country: Number of subjects enrolled
    Ukraine: 29
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Serbia: 10
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Georgia: 4
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    United States: 26
    Country: Number of subjects enrolled
    Israel: 9
    Country: Number of subjects enrolled
    South Africa: 1
    Worldwide total number of subjects
    239
    EEA total number of subjects
    120
    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)
    221
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 239 participants were enrolled at sites in Europe, Asia/Pacific, the United States, Israel, Australia, and South Africa between 11 March 2019 and 20 October 2021.

    Pre-assignment
    Screening details
    		 Participants were screened for eligibility over a 4-week period prior to randomization.

    Period 1
    Period 1 title
    Induction Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.
    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
    Received orally.

    Arm title
    		 TD-1473 20 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Arm title
    		 TD-1473 80 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Arm title
    		 TD-1473 200 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Number of subjects in period 1
    		Placebo TD-1473 20 mg TD-1473 80 mg TD-1473 200 mg
    Started
    61
    61
    59
    58
    Completed
    55
    54
    52
    50
    Not completed
    6
    7
    7
    8
         Physician decision
    1
    1
    3
    -
         Consent withdrawn by subject
    3
    2
    2
    4
         Adverse event, non-fatal
    2
    4
    2
    3
         Protocol deviation
    -
    -
    -
    1
    Period 2
    Period 2 title
    Extended Induction Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.
    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
    Received orally.

    Arm title
    		 TD-1473 20 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Arm title
    		 TD-1473 80 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Arm title
    		 TD-1473 200 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Number of subjects in period 2 [1]
    		Placebo TD-1473 20 mg TD-1473 80 mg TD-1473 200 mg
    Started
    42
    32
    32
    29
    Completed
    29
    29
    23
    22
    Not completed
    13
    3
    9
    7
         Physician decision
    2
    1
    2
    2
         Consent withdrawn by subject
    8
    1
    7
    3
         Adverse event, non-fatal
    1
    1
    -
    1
         Miscellaneous
    1
    -
    -
    -
         Lost to follow-up
    1
    -
    -
    -
         Protocol deviation
    -
    -
    -
    1
    Notes
    [1] - 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: The extended induction period included only participants who did not achieve clinical response at Week 8.
    Period 3
    Period 3 title
    Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.
    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
    Received orally.

    Arm title
    		 TD-1473 20 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Arm title
    		 TD-1473 80 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Arm title
    		 TD-1473 200 mg
    Arm description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-1473
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Received orally.

    Number of subjects in period 3
    		Placebo TD-1473 20 mg TD-1473 80 mg TD-1473 200 mg
    Started
    29
    31
    25
    22
    Completed
    13
    11
    12
    9
    Not completed
    16
    20
    13
    13
         Consent withdrawn by subject
    1
    -
    1
    1
         Adverse event, non-fatal
    1
    2
    -
    -
         Persistent Loss of Response During Maintenance
    3
    1
    2
    -
         Miscellaneous
    -
    -
    1
    -
         Study Terminated by Sponsor
    11
    16
    9
    11
         Lost to follow-up
    -
    -
    -
    1
         Protocol deviation
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 20 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 80 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 200 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group values
    		 Placebo TD-1473 20 mg TD-1473 80 mg TD-1473 200 mg Total
    Number of subjects
    		 61 61 59 58 239
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.92 ± 15.390 38.87 ± 14.576 42.02 ± 15.317 44.38 ± 14.122 -
    Gender categorical
    Units: Subjects
        Female
    		 27 17 20 29 93
        Male
    		 34 44 39 29 146
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 2 1 1 7
        Not Hispanic or Latino
    		 54 59 56 55 224
        Unknown or Not Reported
    		 4 0 2 2 8
    Race
    Units: Subjects
        White
    		 48 50 51 51 200
        Black or African American
    		 1 0 0 0 1
        Asian
    		 9 11 6 6 32
        Other
    		 3 0 2 1 6

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 20 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 80 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 200 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 20 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 80 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 200 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 20 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 80 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Reporting group title
    TD-1473 200 mg
    Reporting group description
    		 Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period. Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.

    Subject analysis set title
    Induction Period: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.

    Subject analysis set title
    Induction Period: TD-1473 20 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.

    Subject analysis set title
    Induction Period: TD-1473 80 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.

    Subject analysis set title
    Induction Period: TD-1473 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.

    Subject analysis set title
    Maintenance Period: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.

    Subject analysis set title
    Maintenance Period: TD-1473 20 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period.

    Subject analysis set title
    Maintenance Period: TD-1473 80 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period.

    Subject analysis set title
    Maintenance Period: TD-1473 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period.

    Primary: Change From Baseline in Total Mayo Score (tMS) at Week 8

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    End point title
    		 Change From Baseline in Total Mayo Score (tMS) at Week 8
    End point description
    Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician’s global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity. Modified Intent-to-Treat (mITT) Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline to Week 8
    End point values
    		 Induction Period: Placebo Induction Period: TD-1473 20 mg Induction Period: TD-1473 80 mg Induction Period: TD-1473 200 mg
    Number of subjects analysed
    56
    54
    53
    55
    Units: score on a scale
        least squares mean (standard error)
    -1.75 ± 0.341
    -2.02 ± 0.350
    -2.12 ± 0.351
    -2.40 ± 0.346
    Statistical analysis title
    		 Placebo v TD-1473 20 mg
    Statistical analysis description
    Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.
    Comparison groups
    Induction Period: TD-1473 20 mg v Induction Period: Placebo
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5809
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.22
         upper limit
    		 0.69
    Statistical analysis title
    		 Placebo v TD-1473 80 mg
    Statistical analysis description
    Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.
    Comparison groups
    Induction Period: Placebo v Induction Period: TD-1473 80 mg
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4501
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 0.59
    Statistical analysis title
    		 Placebo v TD-1473 200 mg
    Statistical analysis description
    Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.
    Comparison groups
    Induction Period: Placebo v Induction Period: TD-1473 200 mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1809
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.3

    Primary: Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44

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    End point title
    		 Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
    End point description
    Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders. mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
    End point type
    Primary
    End point timeframe
    mWeek 44
    End point values
    		 Maintenance Period: Placebo Maintenance Period: TD-1473 20 mg Maintenance Period: TD-1473 80 mg Maintenance Period: TD-1473 200 mg
    Number of subjects analysed
    9
    13
    11
    8
    Units: participants
    4
    3
    5
    3
    Statistical analysis title
    		 Placebo v TD-1473 20 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 20 mg
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3762
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 80 mg
    Comparison groups
    Maintenance Period: TD-1473 80 mg v Maintenance Period: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 200 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 200 mg
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8

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    End point title
    		 Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
    End point description
    Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. mITT Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Induction Period: Placebo Induction Period: TD-1473 20 mg Induction Period: TD-1473 80 mg Induction Period: TD-1473 200 mg
    Number of subjects analysed
    61
    61
    59
    58
    Units: participants
    6
    6
    4
    4
    Statistical analysis title
    		 Placebo v TD-1473 20 mg
    Statistical analysis description
    Difference in proportion estimates used Mantel-Haenszel stratum weights.
    Comparison groups
    Induction Period: Placebo v Induction Period: TD-1473 20 mg
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9542 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.104
         upper limit
    		 0.11
    Notes
    [1] - P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.
    Statistical analysis title
    		 Placebo v TD-1473 80 mg
    Statistical analysis description
    Difference in proportion estimates used Mantel-Haenszel stratum weights.
    Comparison groups
    Induction Period: Placebo v Induction Period: TD-1473 80 mg
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5863 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.126
         upper limit
    		 0.071
    Notes
    [2] - P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.
    Statistical analysis title
    		 Placebo v TD-1473 200 mg
    Statistical analysis description
    Difference in proportion estimates used Mantel-Haenszel stratum weights.
    Comparison groups
    Induction Period: Placebo v Induction Period: TD-1473 200 mg
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5408 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.131
         upper limit
    		 0.069
    Notes
    [3] - P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.

    Secondary: Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44

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    End point title
    		 Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
    End point description
    Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders. mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
    End point type
    Secondary
    End point timeframe
    Baseline to mWeek 44
    End point values
    		 Maintenance Period: Placebo Maintenance Period: TD-1473 20 mg Maintenance Period: TD-1473 80 mg Maintenance Period: TD-1473 200 mg
    Number of subjects analysed
    8
    13
    11
    8
    Units: participants
    5
    5
    8
    6
    Statistical analysis title
    		 Placebo v TD-1473 20 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 20 mg
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6656
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 80 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 80 mg
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6424
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 200 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 200 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6199
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44

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    End point title
    		 Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
    End point description
    Endoscopic remission was defined as an endoscopic subscore ≤ 1. Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity. mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
    End point type
    Secondary
    End point timeframe
    mWeek 44
    End point values
    		 Maintenance Period: Placebo Maintenance Period: TD-1473 20 mg Maintenance Period: TD-1473 80 mg Maintenance Period: TD-1473 200 mg
    Number of subjects analysed
    9
    13
    11
    8
    Units: participants
    3
    1
    3
    2
    Statistical analysis title
    		 Placebo v TD-1473 20 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 20 mg
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2643
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 80 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 80 mg
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 200 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 200 mg
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44

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    End point title
    		 Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
    End point description
    Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0. Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity. Participants with missing Week 44 values were imputed as non-responders. mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
    End point type
    Secondary
    End point timeframe
    mWeek 44
    End point values
    		 Maintenance Period: Placebo Maintenance Period: TD-1473 20 mg Maintenance Period: TD-1473 80 mg Maintenance Period: TD-1473 200 mg
    Number of subjects analysed
    9
    13
    11
    8
    Units: participants
    5
    7
    7
    5
    Statistical analysis title
    		 Placebo v TD-1473 20 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 20 mg
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 80 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 80 mg
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Placebo v TD-1473 200 mg
    Comparison groups
    Maintenance Period: Placebo v Maintenance Period: TD-1473 200 mg
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
    Adverse event reporting additional description
    The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Induction Period: Placebo
    Reporting group description
    		 Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.

    Reporting group title
    Induction Period: TD-1473 20 mg
    Reporting group description
    		 Participants who were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.

    Reporting group title
    Induction Period: TD-1473 80 mg
    Reporting group description
    		 Participants who were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.

    Reporting group title
    Induction Period: Placebo to TD-1473 80 mg
    Reporting group description
    		 Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.

    Reporting group title
    Induction Period: TD-1473 200 mg
    Reporting group description
    		 Participants who were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.

    Reporting group title
    Maintenance Period: Placebo
    Reporting group description
    		 Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.

    Reporting group title
    Maintenance Period: TD-1473 20 mg
    Reporting group description
    		 Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 20 mg TD-1473 for 44 weeks in the Maintenance Period.

    Reporting group title
    Maintenance Period: TD-1473 80 mg
    Reporting group description
    		 Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 80 mg TD-1473 for 44 weeks in the Maintenance Period.

    Reporting group title
    Maintenance Period: TD-1473 200 mg
    Reporting group description
    		 Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 200 mg TD-1473 for 44 weeks in the Maintenance Period.

    Serious adverse events
    		 Induction Period: Placebo Induction Period: TD-1473 20 mg Induction Period: TD-1473 80 mg Induction Period: Placebo to TD-1473 80 mg Induction Period: TD-1473 200 mg Maintenance Period: Placebo Maintenance Period: TD-1473 20 mg Maintenance Period: TD-1473 80 mg Maintenance Period: TD-1473 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 61 (6.56%)
    4 / 61 (6.56%)
    2 / 59 (3.39%)
    3 / 42 (7.14%)
    4 / 58 (6.90%)
    1 / 29 (3.45%)
    2 / 31 (6.45%)
    2 / 25 (8.00%)
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 42 (2.38%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    1 / 58 (1.72%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Large intestine operation
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    1 / 58 (1.72%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 61 (3.28%)
    3 / 61 (4.92%)
    1 / 59 (1.69%)
    1 / 42 (2.38%)
    2 / 58 (3.45%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 25 (4.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 42 (2.38%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Induction Period: Placebo Induction Period: TD-1473 20 mg Induction Period: TD-1473 80 mg Induction Period: Placebo to TD-1473 80 mg Induction Period: TD-1473 200 mg Maintenance Period: Placebo Maintenance Period: TD-1473 20 mg Maintenance Period: TD-1473 80 mg Maintenance Period: TD-1473 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 61 (11.48%)
    11 / 61 (18.03%)
    9 / 59 (15.25%)
    4 / 42 (9.52%)
    14 / 58 (24.14%)
    6 / 29 (20.69%)
    14 / 31 (45.16%)
    5 / 25 (20.00%)
    1 / 22 (4.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    1 / 42 (2.38%)
    2 / 58 (3.45%)
    1 / 29 (3.45%)
    2 / 31 (6.45%)
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    2
    1
    2
    1
    2
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 61 (3.28%)
    2 / 59 (3.39%)
    1 / 42 (2.38%)
    2 / 58 (3.45%)
    1 / 29 (3.45%)
    3 / 31 (9.68%)
    0 / 25 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    4
    2
    1
    2
    1
    5
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    2
    0
    0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 61 (4.92%)
    5 / 59 (8.47%)
    1 / 42 (2.38%)
    7 / 58 (12.07%)
    4 / 29 (13.79%)
    6 / 31 (19.35%)
    3 / 25 (12.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    4
    7
    1
    7
    4
    6
    3
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 42 (0.00%)
    0 / 58 (0.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 61 (1.64%)
    6 / 61 (9.84%)
    0 / 59 (0.00%)
    0 / 42 (0.00%)
    4 / 58 (6.90%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    6
    0
    0
    4
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    2 / 42 (4.76%)
    0 / 58 (0.00%)
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    1
    2
    0
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2018
    Changes were made to the following protocol sections: • Eligibility criteria • Study drugs • Study procedures • Statistical considerations
    09 Jan 2020
    Changes were made to the following protocol sections: • Objectives and endpoints • Eligibility criteria • Schedule of study procedures • Study procedures • Adverse events • Statistical considerations • Appendices
    29 May 2020
    Changes were made to the following protocol sections: • Study design • Eligibility criteria • Schedule of study procedures • Study drugs • Study procedures • Adverse events • Statistical considerations • Appendices

    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.
    Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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