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    Clinical Trial Results:
    A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC)

    Summary
    EudraCT number
    		 2018-002135-19
    Trial protocol
    		 HU   DE   PT   SK   FR   PL   ES   GR   BG   IT   RO  
    Global end of trial date
    27 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2022
    First version publication date
    26 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0164
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03920254
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 US IND Number: 128299
    Sponsors
    Sponsor organisation name
    Theravance Biopharma Ireland Limited
    Sponsor organisation address
    10 Earlsfort Terrace, Dublin, Ireland, D04 C5Y6
    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
    27 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of TD-1473 administered up to 3 years in participants with moderate to severe UC after participation in the Maintenance Study of Protocol 0157 (EudraCT number: 2018-002136-24).
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonization Harmonised Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jul 2020
    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: 9
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Georgia: 1
    Worldwide total number of subjects
    46
    EEA total number of subjects
    21
    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)
    40
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 46 out of the planned 500 participants were enrolled and received study drug between 23 July 2020 and 27 October 2021.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TD-1473 20mg
    Arm description
    		 Participants received TD-1473 orally at a dose of 20mg once daily.
    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 80mg
    Arm description
    		 Participants received TD-1473 orally at a dose of 80mg once daily.
    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 200mg
    Arm description
    		 Participants received TD-1473 orally at a dose of 200mg once daily.
    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
    		TD-1473 20mg TD-1473 80mg TD-1473 200mg
    Started
    13
    18
    15
    Completed
    0
    0
    0
    Not completed
    13
    18
    15
         Physician decision
    -
    1
    2
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    -
         Study Terminated By Sponsor
    12
    17
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TD-1473 20mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 20mg once daily.

    Reporting group title
    TD-1473 80mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 80mg once daily.

    Reporting group title
    TD-1473 200mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 200mg once daily.

    Reporting group values
    		 TD-1473 20mg TD-1473 80mg TD-1473 200mg Total
    Number of subjects
    		 13 18 15 46
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.31 ± 17.375 43.22 ± 15.869 46.13 ± 13.432 -
    Gender categorical
    Units: Subjects
        Female
    		 8 7 7 22
        Male
    		 5 11 8 24
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 2
        Not Hispanic or Latino
    		 12 17 15 44
        Unknown or Not Reported
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 1 3 1 5
        White
    		 12 15 13 40
        Unknown or Not Reported
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    TD-1473 20mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 20mg once daily.

    Reporting group title
    TD-1473 80mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 80mg once daily.

    Reporting group title
    TD-1473 200mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 200mg once daily.

    Primary: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

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    End point title
    		 Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) [1]
    End point description
    A TEAE was defined as any AE with a recorded start date on or after the date of the first dose of study drug up through 4 weeks after the last dose of study drug. Any clinically significant changes in laboratory safety tests, electrocardiograms (ECGs) and vital signs, were also recorded as TEAEs. Includes all participants from the Safety Analysis Set.
    End point type
    Primary
    End point timeframe
    Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180 days; TD-1473 200 mg - 158 days)
    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: No additional statistical analyses were pre-specified for this endpoint.
    End point values
    		 TD-1473 20mg TD-1473 80mg TD-1473 200mg
    Number of subjects analysed
    13
    18
    15
    Units: participants
    4
    5
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180 days; TD-1473 200 mg - 158 days)
    Adverse event reporting additional description
    Includes all participants from the Safety Analysis Set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    TD-1473 20mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 20mg once daily.

    Reporting group title
    TD-1473 80mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 80mg once daily.

    Reporting group title
    TD-1473 200mg
    Reporting group description
    		 Participants received TD-1473 orally at a dose of 200mg once daily.

    Serious adverse events
    		 TD-1473 20mg TD-1473 80mg TD-1473 200mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TD-1473 20mg TD-1473 80mg TD-1473 200mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 13 (30.77%)
    5 / 18 (27.78%)
    5 / 15 (33.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    1
    Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema asteatotic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Chlamydial infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea pedis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2018
    This protocol was amended to correct incorrect formatting , correct incorrect spelling, correct incorrect references to sections within the protocol, delete duplicated information, add updated information throughout, clarify wording, add updated results of a completed study, include minor administration changes.
    15 Feb 2021
    This protocol was amended to clarify some key points related to the inclusion and exclusion criteria. Additionally, some administrative updates were made along with some additional clarifications to provide operational guidance to sites on the appropriate implementation of key study activities. Lastly, typographical errors were corrected.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    The Sponsor notified all global clinical research sites in writing that screening of new participants was suspended initially for a period of 4 weeks (18 March 2020 to 17 April 2020) with planned reassessment thereafter. Participants already enrolled in the study screening period at the time of this notification could progress to randomization if they met safety criteria as specified by the Medical Director or per the study-specific COVID-19 mitigation plan.
    17 Apr 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study 0164 was terminated early because Study 0157 was terminated early and participation in Study 0164 was predicated on participation in Study 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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