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    Clinical Trial Results:
    A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    		 2017-002350-36
    Trial protocol
    		 DE   GB   IE   HU   NL   BG   ES   GR   IT  
    Global end of trial date
    15 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2022
    First version publication date
    30 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GA39925
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03558152
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    Medical Communications, F. Hoffmann-La Roche AG, 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
    22 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: . Consensus ethical principles derived from international guidelines, including the Declaration of Helsinki . Applicable International Committee on Harmonisation (ICH) Good Clinical Practice Guidelines . Applicable laws and regulations
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2018
    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
    Bulgaria: 2
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Georgia: 4
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Moldova, Republic of: 7
    Country: Number of subjects enrolled
    Poland: 52
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    Serbia: 17
    Country: Number of subjects enrolled
    Ukraine: 64
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    195
    EEA total number of subjects
    86
    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)
    183
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients were assigned in a 1:1:1:1:1:1:2:1 ratio to one of eight treatment arms. Following completion of the screening period and after all patient eligibility requirements were confirmed, patients were assigned a patient number and randomly assigned to a treatment arm through an interactive voice or Web-based response system (IxRS).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
    Arm description
    		 Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A will be administered intravenously (IV) Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Arm title
    		 Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
    Arm description
    		 Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A will be administered intravenously (IV) Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Arm title
    		 Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
    Arm description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A will be administered intravenously (IV) Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Arm title
    		 Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
    Arm description
    		 Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A will be administered intravenously (IV) Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Arm title
    		 Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
    Arm description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A will be administered intravenously (IV) Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Arm title
    		 Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
    Arm description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UTTR1147A
    Investigational medicinal product code
    Other name
    Efmarodocokin alfa RO7021610 RG7880 IL-22Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    UTTR1147A will be administered intravenously (IV) Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Arm title
    		 Arm 4: Vedolizumab
    Arm description
    		 Parts A and B: Vedolizumab and UTTR1147A Placebo.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Entyvio
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab will be administered IV, as specified in the prescribing information.

    Arm title
    		 Arm 5: Placebo
    Arm description
    		 Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vedolizumab Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

    Investigational medicinal product name
    UTTR1147A Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

    Number of subjects in period 1
    		Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Started
    22
    21
    21
    23
    22
    21
    43
    22
    Completed
    7
    6
    8
    8
    3
    7
    21
    6
    Not completed
    15
    15
    13
    15
    19
    14
    22
    16
         Adverse event, serious fatal
    -
    -
    -
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    2
    3
    2
    1
    1
    1
    3
    2
         Mistake in calculation
    -
    -
    -
    1
    -
    -
    -
    -
         Physician decision
    -
    -
    -
    -
    -
    -
    1
    -
         Miscalculation in mmcs
    -
    -
    -
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    1
    1
    2
    1
    1
    -
         Rolled over in GA40209 due to worsening of disease
    1
    -
    -
    -
    -
    -
    -
    -
         Mistake in evaluation of disease status
    -
    -
    -
    -
    -
    -
    -
    1
         Lack of efficacy
    11
    11
    10
    11
    14
    12
    14
    13
         Protocol deviation
    1
    1
    -
    1
    1
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 195 195
    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)
    		 183 183
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 40.8 ( 13.2 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 60 60
        Male
    		 135 135
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 194 194
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 195 195
        Unknown or Not Reported
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Arm 1
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A at a dose of 30 ug/kg

    Subject analysis set title
    Arm 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A at a dose of 60 ug/kg

    Subject analysis set title
    Arm 3
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A at a dose of 90 ug/kg

    Subject analysis set title
    Arm 4
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Vedolizumab and UTTR1147A Placebo.

    Subject analysis set title
    Arm 5
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A Placebo and Vedolizumab Placebo.

    Subject analysis sets values
    		 Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Number of subjects
    43
    44
    43
    43
    22
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
        Adults (18-64 years)
    40
    42
    42
    39
    20
        From 65-84 years
    3
    1
    4
    2
        85 years and over
    0
    0
    0
    0
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    40.6 ( 13.2 )
    39.4 ( 12.1 )
    39.5 ( 12.3 )
    43.4 ( 14.8 )
    41.9 ( 14.0 )
    Sex: Female, Male
    Units: Participants
        Female
    15
    15
    11
    13
    6
        Male
    28
    29
    32
    30
    16
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    1
    0
    0
    0
        Asian
    0
    0
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
    0
    0
        Black or African American
    0
    0
    0
    0
    0
        White
    43
    43
    43
    43
    22
        More than one race
    0
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
    0
    0
        Not Hispanic or Latino
    43
    44
    43
    43
    22
        Unknown or Not Reported
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
    Reporting group description
    		 Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

    Reporting group title
    Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
    Reporting group description
    		 Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
    Reporting group description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

    Reporting group title
    Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
    Reporting group description
    		 Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
    Reporting group description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

    Reporting group title
    Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
    Reporting group description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    Arm 4: Vedolizumab
    Reporting group description
    		 Parts A and B: Vedolizumab and UTTR1147A Placebo.

    Reporting group title
    Arm 5: Placebo
    Reporting group description
    		 Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

    Subject analysis set title
    Arm 1
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A at a dose of 30 ug/kg

    Subject analysis set title
    Arm 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A at a dose of 60 ug/kg

    Subject analysis set title
    Arm 3
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A at a dose of 90 ug/kg

    Subject analysis set title
    Arm 4
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Vedolizumab and UTTR1147A Placebo.

    Subject analysis set title
    Arm 5
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received UTTR1147A Placebo and Vedolizumab Placebo.

    Primary: Percentage of Participants with Clinical Remission at Week 8

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    End point title
    		 Percentage of Participants with Clinical Remission at Week 8 [1] [2]
    End point description
    Clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
    End point type
    Primary
    End point timeframe
    8 weeks
    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 statistical analyses provided
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses provided
    End point values
    		 Arm 4: Vedolizumab Arm 5: Placebo Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    43
    22
    43
    44
    43
    Units: Participants
        Yes
    11
    2
    5
    4
    5
        No
    32
    20
    38
    40
    38
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Sustained Remission

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    End point title
    		 Percentage of Participants with Sustained Remission
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    Units: Percentage of Participants
    Notes
    [3] - Meaningful conclusions could not be made due to low enrollment
    [4] - Meaningful conclusions could not be made due to low enrollment
    [5] - Meaningful conclusions could not be made due to low enrollment
    [6] - Meaningful conclusions could not be made due to low enrollment
    [7] - Meaningful conclusions could not be made due to low enrollment
    [8] - Meaningful conclusions could not be made due to low enrollment
    [9] - Meaningful conclusions could not be made due to low enrollment
    [10] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration (Cmax) of UTTR1147A

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    End point title
    		 Maximum Serum Concentration (Cmax) of UTTR1147A
    End point description
    Due to low enrollment in Part B of the study, the PK data from pooled Arms 1-3 (1A + 1B; 2A + 2B; 3A + 3B) are summarized based on data up through Week 8 which is the primary efficacy assessment for Part A (Induction phase). A total of 130 patients who received at least one dose of efmarodocokin alfa and had measurable PK concentrations are included in the analysis.
    End point type
    Secondary
    End point timeframe
    Postdose at Baseline and Week 8
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    43
    44
    43
    Units: ng/mL
    arithmetic mean (standard deviation)
        Visit: Days 1 - 29
    449 ( 658 )
    590 ( 265 )
    837 ( 560 )
        Visit: Day 57
    426 ( 344 )
    693 ( 348 )
    1340 ( 883 )
    No statistical analyses for this end point

    Secondary: Minimum Serum Concentration (Cmin) of UTTR1147A

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    End point title
    		 Minimum Serum Concentration (Cmin) of UTTR1147A
    End point description
    Due to low enrollment in Part B of the study, the PK data from pooled Arms 1-3 (1A + 1B; 2A + 2B; 3A + 3B) are summarized based on data up through Week 8 which is the primary efficacy assessment for Part A (Induction phase). A total of 130 patients who received at least one dose of efmarodocokin alfa and had measurable PK concentrations are included in the analysis.
    End point type
    Secondary
    End point timeframe
    Postdose at Baseline and Week 8
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    39
    40
    42
    Units: ng/mL
    arithmetic mean (standard deviation)
        Days 1 - 29
    12.6 ( 9.55 )
    28.3 ( 17.1 )
    40.6 ( 27.7 )
        Visit: Day 57
    15.8 ( 11.7 )
    37.2 ( 35.2 )
    44.5 ( 28.1 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Clinical Response at Weeks 8 and 30

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    End point title
    		 Percentage of Participants with Clinical Response at Weeks 8 and 30
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    Units: Percentage of Participants
    Notes
    [11] - Meaningful conclusions could not be made due to low enrollment
    [12] - Meaningful conclusions could not be made due to low enrollment
    [13] - Meaningful conclusions could not be made due to low enrollment
    [14] - Meaningful conclusions could not be made due to low enrollment
    [15] - Meaningful conclusions could not be made due to low enrollment
    [16] - Meaningful conclusions could not be made due to low enrollment
    [17] - Meaningful conclusions could not be made due to low enrollment
    [18] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Endoscopic Healing at Weeks 8 and 30

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    End point title
    		 Percentage of Participants with Endoscopic Healing at Weeks 8 and 30
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    Units: Percentage of Participants
    Notes
    [19] - Meaningful conclusions could not be made due to low enrollment
    [20] - Meaningful conclusions could not be made due to low enrollment
    [21] - Meaningful conclusions could not be made due to low enrollment
    [22] - Meaningful conclusions could not be made due to low enrollment
    [23] - Meaningful conclusions could not be made due to low enrollment
    [24] - Meaningful conclusions could not be made due to low enrollment
    [25] - Meaningful conclusions could not be made due to low enrollment
    [26] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Endoscopic Remission at Weeks 8 and 30

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    End point title
    		 Percentage of Participants with Endoscopic Remission at Weeks 8 and 30
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    Units: Percentage of Participants
    Notes
    [27] - Meaningful conclusions could not be made due to low enrollment
    [28] - Meaningful conclusions could not be made due to low enrollment
    [29] - Meaningful conclusions could not be made due to low enrollment
    [30] - Meaningful conclusions could not be made due to low enrollment
    [31] - Meaningful conclusions could not be made due to low enrollment
    [32] - Meaningful conclusions could not be made due to low enrollment
    [33] - Meaningful conclusions could not be made due to low enrollment
    [34] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Change From Baseline in UC Bowel Movement Signs and Symptoms at Weeks 8 and 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score

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    End point title
    		 Change From Baseline in UC Bowel Movement Signs and Symptoms at Weeks 8 and 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    Units: Points on scale
    Notes
    [35] - Meaningful conclusions could not be made due to low enrollment
    [36] - Meaningful conclusions could not be made due to low enrollment
    [37] - Meaningful conclusions could not be made due to low enrollment
    [38] - Meaningful conclusions could not be made due to low enrollment
    [39] - Meaningful conclusions could not be made due to low enrollment
    [40] - Meaningful conclusions could not be made due to low enrollment
    [41] - Meaningful conclusions could not be made due to low enrollment
    [42] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Change From Baseline in UC Abdominal Signs and Symptoms at Weeks 8 and 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score

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    End point title
    		 Change From Baseline in UC Abdominal Signs and Symptoms at Weeks 8 and 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    0 [50]
    Units: Points on scale
    Notes
    [43] - Meaningful conclusions could not be made due to low enrollment
    [44] - Meaningful conclusions could not be made due to low enrollment
    [45] - Meaningful conclusions could not be made due to low enrollment
    [46] - Meaningful conclusions could not be made due to low enrollment
    [47] - Meaningful conclusions could not be made due to low enrollment
    [48] - Meaningful conclusions could not be made due to low enrollment
    [49] - Meaningful conclusions could not be made due to low enrollment
    [50] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Weeks 8 and 30

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    End point title
    		 Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Weeks 8 and 30 [51]
    End point description
    The evaluation of the secondary endpoints was affected by the proportion of patients in Part A who elected to enroll in the OLE study versus those who elected to participate in Part B. Meaningful conclusions could not be made due to low enrollment in Part B and therefore secondary endpoints were not discussed.
    End point type
    Secondary
    End point timeframe
    At Weeks 8 and 30
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses provided
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 4: Vedolizumab Arm 5: Placebo
    Number of subjects analysed
    0 [52]
    0 [53]
    0 [54]
    0 [55]
    0 [56]
    0 [57]
    Units: Points on scale
    Notes
    [52] - Meaningful conclusions could not be made due to low enrollment
    [53] - Meaningful conclusions could not be made due to low enrollment
    [54] - Meaningful conclusions could not be made due to low enrollment
    [55] - Meaningful conclusions could not be made due to low enrollment
    [56] - Meaningful conclusions could not be made due to low enrollment
    [57] - Meaningful conclusions could not be made due to low enrollment
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events

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    End point title
    		 Percentage of Participants with Adverse Events [58]
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 30 weeks
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses provided
    End point values
    		 Arm 4: Vedolizumab Arm 5: Placebo Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    43
    22
    43
    44
    43
    Units: Participants
        Non-Serious Adverse Events
    6
    4
    12
    11
    15
        Serious Adverse Events
    0
    0
    1
    1
    5
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration

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    End point title
    		 Percentage of Participants with Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration [59]
    End point description
    Participants in placebo group were not analysed for post-baseline Anti-Drug Antibodies (ADA)
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 weeks
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses provided
    End point values
    		 Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) Arm 5: Placebo
    Number of subjects analysed
    22
    21
    21
    23
    22
    21
    22
    Units: Partcipants
    number (not applicable)
        Patients with a positive sample at baseline
    14.55
    9.52
    4.76
    4.35
    4.55
    0
    4.62
        Patients with no positive samples at baseline
    95.45
    100
    94.24
    95.65
    95.45
    92.24
    95.38
        Patients positive for Treatment Emergent ADA
    0
    9.52
    4.76
    4.35
    9.09
    4.76
    0000
        Treatment-induced ADA
    0
    9.52
    4.76
    4.35
    9.09
    4.76
    0000
        Treatment-enhanced ADA
    0
    0
    0
    0
    0
    0
    0000
        Treatment unaffected
    4.55
    9.52
    4.76
    4.35
    14.55
    4.76
    0000
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Arm 1: UTTR1147A 30 ug/kgInduction
    Reporting group description
    		 Participants received UTTR1147A at a dose of 30 ug/kg

    Reporting group title
    Arm 2: UTTR1147A 60 ug/kgInduction
    Reporting group description
    		 Participants received UTTR1147A at a dose of 60 ug/kg

    Reporting group title
    Arm 3: UTTR1147A 90 ug/kg Induction
    Reporting group description
    		 Participants received UTTR1147A at a dose of 90 ug/kg

    Reporting group title
    Arm 4: VEDOLIZUMAB 300 mg Induction
    Reporting group description
    		 Participants received Vedolizumab and UTTR1147A Placebo.

    Reporting group title
    1A: UTTR1147A 30 + UTTR1147A 60Maintenance
    Reporting group description
    		 Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

    Reporting group title
    Arm 5: PLACEBOInduction
    Reporting group description
    		 Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    1B: UTTR1147A 30 + PLACEBOMaintenance
    Reporting group description
    		 Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    2A: UTTR1147A 60 + UTTR1147A 60Maintenance
    Reporting group description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

    Reporting group title
    2B: UTTR1147A 60 + PLACEBOMaintenance
    Reporting group description
    		 Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    3A: UTTR1147A 90 + UTTR1147A 60Maintenance
    Reporting group description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

    Reporting group title
    3B: UTTR1147A 90 + PLACEBO Maintenance
    Reporting group description
    		 Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

    Reporting group title
    ARM4: VEDOLIZUMAB 300 + VEDOLIZUMAB 300 Maintenance
    Reporting group description
    		 Parts A and B: Vedolizumab and UTTR1147A Placebo.

    Reporting group title
    ARM5: PLACEBO + PLACEBO Maintenance
    Reporting group description
    		 Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

    Serious adverse events
    		 Arm 1: UTTR1147A 30 ug/kgInduction Arm 2: UTTR1147A 60 ug/kgInduction Arm 3: UTTR1147A 90 ug/kg Induction Arm 4: VEDOLIZUMAB 300 mg Induction 1A: UTTR1147A 30 + UTTR1147A 60Maintenance Arm 5: PLACEBOInduction 1B: UTTR1147A 30 + PLACEBOMaintenance 2A: UTTR1147A 60 + UTTR1147A 60Maintenance 2B: UTTR1147A 60 + PLACEBOMaintenance 3A: UTTR1147A 90 + UTTR1147A 60Maintenance 3B: UTTR1147A 90 + PLACEBO Maintenance ARM4: VEDOLIZUMAB 300 + VEDOLIZUMAB 300 Maintenance ARM5: PLACEBO + PLACEBO Maintenance
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
    5 / 43 (11.63%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    1
    0
    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
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
    4 / 43 (9.30%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1: UTTR1147A 30 ug/kgInduction Arm 2: UTTR1147A 60 ug/kgInduction Arm 3: UTTR1147A 90 ug/kg Induction Arm 4: VEDOLIZUMAB 300 mg Induction 1A: UTTR1147A 30 + UTTR1147A 60Maintenance Arm 5: PLACEBOInduction 1B: UTTR1147A 30 + PLACEBOMaintenance 2A: UTTR1147A 60 + UTTR1147A 60Maintenance 2B: UTTR1147A 60 + PLACEBOMaintenance 3A: UTTR1147A 90 + UTTR1147A 60Maintenance 3B: UTTR1147A 90 + PLACEBO Maintenance ARM4: VEDOLIZUMAB 300 + VEDOLIZUMAB 300 Maintenance ARM5: PLACEBO + PLACEBO Maintenance
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 43 (27.91%)
    11 / 44 (25.00%)
    15 / 43 (34.88%)
    6 / 43 (13.95%)
    2 / 10 (20.00%)
    4 / 22 (18.18%)
    2 / 7 (28.57%)
    6 / 10 (60.00%)
    3 / 9 (33.33%)
    2 / 6 (33.33%)
    3 / 8 (37.50%)
    2 / 22 (9.09%)
    2 / 7 (28.57%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    8
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    2
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
    2 / 43 (4.65%)
    1 / 43 (2.33%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    2
    2
    6
    2
    0
    2
    0
    0
    0
    2
    0
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    2 / 43 (4.65%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    2
    0
    4
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Eosinophilia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    2
    0
    0
    0
    2
    0
    0
    0
    Reproductive system and breast disorders
    Epididymal cyst
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    3 / 43 (6.98%)
    5 / 44 (11.36%)
    9 / 43 (20.93%)
    1 / 43 (2.33%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    14
    28
    2
    0
    2
    0
    4
    0
    0
    0
    0
    0
    Hand dermatitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    0 / 10 (0.00%)
    2 / 22 (9.09%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    4
    0
    0
    0
    0
    4
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Herpes zoster infection neurological
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 44 (6.82%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    6
    2
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    2
    2
    2
    4
    0
    0
    0
    0
    0
    2
    0
    0
    2
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 22 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    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
    16 Nov 2017
    A placebo control arm was added to the study and the primary endpoint was updated accordingly.
    26 Jan 2018
    The purpose of this update was based on feedback from the FDA. Additional guidance on the management of patients with evidence of hepatotoxicity was added and randomization stratification factors were updated.
    28 Feb 2020
    The amendment represents a harmonization of v4 and v4 VHP. The protocol was amended to clarify that the randomization scheme within the IxRS was set up to enroll Clinical Study Report GA39925 Number 1116106 18 patients in the placebo arm for the entire duration of the study and not just within the first 150 patients.
    08 Apr 2021
    The purpose of this update was to address an urgent safety measure for COVID-19 infection. Guidance for the management of suspected or confirmed COVID-19 infections was added and suspected or confirmed COVID-19 infection was added to the list of AESIs.

    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
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