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    Clinical Trial Results:
    A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

    Summary
    EudraCT number
    		 2017-004997-32
    Trial protocol
    		 ES   GB   NL   IE   DE   HU   IT  
    Global end of trial date
    12 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2023
    First version publication date
    28 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GA40209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche, Ltd.
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD).
    Protection of trial subjects
    This study is conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. All participants are required to read and sign an informed consent form prior to participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2019
    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
    Bulgaria: 2
    Country: Number of subjects enrolled
    Georgia: 2
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Moldova, Republic of: 4
    Country: Number of subjects enrolled
    Poland: 33
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Serbia: 15
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Ukraine: 56
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    143
    EEA total number of subjects
    56
    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)
    135
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All 143 patients were included in the intent-to-treat (ITT) population, with 128 patients allocated to study treatment and 15 patients that were not treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 UTTR1147A
    Arm description
    		 Participants received treatment with UTTR1147A until clinical remission was achieved.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A was administered based on disease status, as described in the protocol.

    Number of subjects in period 1
    		UTTR1147A
    Started
    143
    Completed
    82
    Not completed
    61
         Physician decision
    2
         Consent withdrawn by subject
    16
         Adverse event, non-fatal
    1
         Study Terminated By Sponsor
    16
         Not Specified
    9
         Lack of efficacy
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UTTR1147A
    Reporting group description
    		 Participants received treatment with UTTR1147A until clinical remission was achieved.

    Reporting group values
    		 UTTR1147A Total
    Number of subjects
    		 143 143
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 135 135
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.5 ± 12.4 -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 104 104
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        White
    		 142 142
    Race/Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 142 142
        Not Stated
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    UTTR1147A
    Reporting group description
    		 Participants received treatment with UTTR1147A until clinical remission was achieved.

    Primary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events [1]
    End point description
    Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0). The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.
    End point type
    Primary
    End point timeframe
    Up to 2 years
    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 analysis provided
    End point values
    		 UTTR1147A
    Number of subjects analysed
    128
    Units: Participants
        Serious Adverse Events
    9
        Non-Serious Adverse Events Reported
    52
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to 2 years
    Adverse event reporting additional description
    The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    UTTR1147A 60
    Reporting group description
    		 Participants received treatment with UTTR1147A until clinical remission was achieved.

    Serious adverse events
    		 UTTR1147A 60
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 128 (7.03%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Lipase increased
         subjects affected / exposed
    3 / 128 (2.34%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Amylase increased
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 UTTR1147A 60
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 128 (40.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 128 (6.25%)
         occurrences all number
    10
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 128 (11.72%)
         occurrences all number
    16
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    30 / 128 (23.44%)
         occurrences all number
    45
    Pruritus
         subjects affected / exposed
    8 / 128 (6.25%)
         occurrences all number
    13
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 128 (7.81%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2020
    Changes to study duration, eligibility

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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