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    Clinical Trial Results:
    An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2020-003017-35
    Trial protocol
    		 SK   HU   CZ   BE   PL   LV  
    Global end of trial date
    09 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2023
    First version publication date
    12 Nov 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    J1P-MC-KFAH
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04677179
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17287
    Sponsors
    Sponsor organisation name
    Nektar Therapeutics
    Sponsor organisation address
    455 Mission Bay Blvd. South, San Francisco, United States, 94158
    Public contact
    Nektar Therapeutics, Clinical Trial Information Desk, Nektar Therapeutics, 1 855-482-8676, studyinquiry@nektar.com
    Scientific contact
    Nektar Therapeutics, Clinical Trial Information Desk, Nektar Therapeutics, 1 855-482-8676, studyinquiry@nektar.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
    09 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2021
    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
    Argentina: 4
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Czechia: 6
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Latvia: 5
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    Ukraine: 18
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    China: 1
    Worldwide total number of subjects
    81
    EEA total number of subjects
    26
    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)
    77
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study consisted of: -a 12-week induction treatment period: participants randomly received either high dose LY3471851 or low dose LY3471851 or placebo. -a 40-week maintenance/extension treatment period (final dose at week 50 and study assessments at week 52) (Continued..)

    Pre-assignment
    Screening details
    		 a 6-week post-treatment follow-up period: Following treatment completion or discontinuation, participants entered the follow-up period and were observed for safety. No treatments were administered.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High dose LY3471851 (Induction Treatment Period)
    Arm description
    		 Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3471851
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.

    Arm title
    		 Low dose LY3471851 (Induction Treatment Period)
    Arm description
    		 Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3471851
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.

    Arm title
    		 Placebo (Induction Treatment Period)
    Arm description
    		 Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.

    Number of subjects in period 1
    		High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Started
    32
    35
    14
    Received at Least One Dose of Study Drug
    32
    35
    14
    Completed
    19
    22
    12
    Not completed
    13
    13
    2
         Physician decision
    1
    -
    1
         Consent withdrawn by subject
    4
    1
    1
         Adverse event, non-fatal
    1
    -
    -
         Study terminated by sponsor
    7
    11
    -
         Protocol deviation
    -
    1
    -
    Period 2
    Period 2 title
    Maintenance/Extension Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 High Dose LY3471851 (Maintenance Treatment Period)
    Arm description
    		 Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3471851
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks with final dose at week 50.

    Arm title
    		 Low dose LY3471851 (Maintenance Treatment Period)
    Arm description
    		 Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3471851
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks with final dose at week 50.

    Arm title
    		 Placebo (Maintenance Treatment Period)
    Arm description
    		 Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of placebo every 2 weeks with final dose at week 50.

    Arm title
    		 High dose LY3471851 (Extension Treatment Period)
    Arm description
    		 Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3471851
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks with final dose at week 50. At week 26, non-responders were discontinued from treatment.

    Number of subjects in period 2
    		High Dose LY3471851 (Maintenance Treatment Period) Low dose LY3471851 (Maintenance Treatment Period) Placebo (Maintenance Treatment Period) High dose LY3471851 (Extension Treatment Period)
    Started
    8
    10
    5
    26
    Completed
    0
    0
    0
    0
    Not completed
    8
    10
    5
    26
         Consent withdrawn by subject
    1
    -
    -
    2
         Study terminated by sponsor
    7
    9
    5
    18
         Lack of efficacy
    -
    1
    -
    6
    Period 3
    Period 3 title
    Post-Treatment Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 High dose LY3471851 (Post-Treatment Follow-up Period)
    Arm description
    		 Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Low dose LY3471851 (Post-Treatment Follow-up Period)
    Arm description
    		 Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo (Post-Treatment Follow-up Period)
    Arm description
    		 Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		High dose LY3471851 (Post-Treatment Follow-up Period) Low dose LY3471851 (Post-Treatment Follow-up Period) Placebo (Post-Treatment Follow-up Period)
    Started
    25
    30
    11
    Completed
    0
    0
    0
    Not completed
    25
    30
    11
         Consent withdrawn by subject
    3
    1
    -
         Adverse event, non-fatal
    1
    -
    -
         Study terminated by sponsor
    18
    26
    11
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    2
    3
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    High dose LY3471851 (Induction Treatment Period)
    Reporting group description
    		 Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.

    Reporting group title
    Low dose LY3471851 (Induction Treatment Period)
    Reporting group description
    		 Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.

    Reporting group title
    Placebo (Induction Treatment Period)
    Reporting group description
    		 Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.

    Reporting group values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period) Total
    Number of subjects
    		 32 35 14 81
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.2 ± 12.5 44.5 ± 13.8 45.7 ± 15.2 -
    Gender categorical
    Units: Subjects
        Female
    		 10 9 6 25
        Male
    		 22 26 8 56
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 5 4 2 11
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 2 0 0 2
        White
    		 25 31 12 68
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Argentina
    		 2 1 1 4
        Australia
    		 0 1 0 1
        Belgium
    		 0 0 1 1
        Czechia
    		 2 4 0 6
        Hungary
    		 3 3 0 6
        Japan
    		 3 1 1 5
        South Korea
    		 1 3 1 5
        Latvia
    		 2 3 0 5
        Poland
    		 2 2 1 5
        Russia
    		 5 5 3 13
        Slovakia
    		 1 1 1 3
        Ukraine
    		 7 7 4 18
        United States
    		 3 4 1 8
        China
    		 1 0 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    High dose LY3471851 (Induction Treatment Period)
    Reporting group description
    		 Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.

    Reporting group title
    Low dose LY3471851 (Induction Treatment Period)
    Reporting group description
    		 Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.

    Reporting group title
    Placebo (Induction Treatment Period)
    Reporting group description
    		 Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
    Reporting group title
    High Dose LY3471851 (Maintenance Treatment Period)
    Reporting group description
    		 Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.

    Reporting group title
    Low dose LY3471851 (Maintenance Treatment Period)
    Reporting group description
    		 Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.

    Reporting group title
    Placebo (Maintenance Treatment Period)
    Reporting group description
    		 Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.

    Reporting group title
    High dose LY3471851 (Extension Treatment Period)
    Reporting group description
    		 Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
    Reporting group title
    High dose LY3471851 (Post-Treatment Follow-up Period)
    Reporting group description
    		 Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.

    Reporting group title
    Low dose LY3471851 (Post-Treatment Follow-up Period)
    Reporting group description
    		 Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.

    Reporting group title
    Placebo (Post-Treatment Follow-up Period)
    Reporting group description
    		 Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.

    Primary: Percentage of Participants Who Achieved Clinical Remission at Week 12

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    End point title
    		 Percentage of Participants Who Achieved Clinical Remission at Week 12
    End point description
    Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
    End point type
    Primary
    End point timeframe
    Week 12 Analysis Population Description (APD): All randomized participants who received at least one dose of study drug and had MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    17.2 (3.5 to 31)
    7.1 (0 to 16.7)
    14.3 (0 to 32.6)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.75
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 11.32
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.838
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 6.21

    Secondary: Percentage of Participants Who Achieved Clinical Response at Week 12

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    End point title
    		 Percentage of Participants Who Achieved Clinical Response at Week 12
    End point description
    Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    41.4 (23.5 to 59.3)
    39.3 (21.2 to 57.4)
    35.7 (10.6 to 60.8)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.563
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.3
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.759
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 3.64

    Secondary: Percentage of Participants Who Achieved Endoscopic Remission at Week 12

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    End point title
    		 Percentage of Participants Who Achieved Endoscopic Remission at Week 12
    End point description
    Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    24.1 (8.6 to 39.7)
    14.3 (1.3 to 27.2)
    28.6 (4.9 to 52.2)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.163
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 1.93
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.439
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 2.77

    Secondary: Percentage of Participants Who Achieved Endoscopic Response at Week 12

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    End point title
    		 Percentage of Participants Who Achieved Endoscopic Response at Week 12
    End point description
    Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    37.9 (20.3 to 55.6)
    32.1 (14.8 to 49.4)
    21.4 (0 to 42.9)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.821
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 9.88
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.572
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 5.49

    Secondary: Percentage of Participants Who Achieved Symptomatic Remission at week 12

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    End point title
    		 Percentage of Participants Who Achieved Symptomatic Remission at week 12
    End point description
    Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    27.6 (11.3 to 43.9)
    32.1 (14.8 to 49.4)
    21.4 (0 to 42.9)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.886
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 10.16
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.784
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 4.18

    Secondary: Percentage of Participants Who Achieved Symptomatic Response at Week 12

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    End point title
    		 Percentage of Participants Who Achieved Symptomatic Response at Week 12
    End point description
    Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    44.8 (26.7 to 62.9)
    42.9 (24.5 to 61.2)
    42.9 (16.9 to 68.8)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.331
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 2.43
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.407
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.52

    Secondary: Percentage of Participants Who Achieved Histologic Remission at Week 12

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    End point title
    		 Percentage of Participants Who Achieved Histologic Remission at Week 12
    End point description
    Histologic Remission is defined as Geboes score <2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had Geboes data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    10.3 (0.0 to 21.4)
    7.1 (0.0 to 16.7)
    7.1 (0.0 to 20.6)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.564
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 6
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.681
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 10.97

    Secondary: Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)

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    End point title
    		 Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)
    End point description
    HEMH is defined as Geboes score <2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants who received at least one dose of study drug and had Geboes, MMS data at week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    28
    14
    Units: percentage of participants
        number (confidence interval 95%)
    6.9 (0 to 16.1)
    3.6 (0 to 10.4)
    0 (0 to 0)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo (Induction Treatment Period) v Low dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.317
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 10.4
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.238
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 16.1

    Secondary: Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total score

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    End point title
    		 Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total score
    End point description
    IBDQ is a 32-item questionnaire that measures four aspects of participants’ lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes “not a problem at all” and 1 denotes “a very severe problem.” The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4 to 6] or [7 to 9]) and region (North America/Europe/Other) as fixed factors.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 APD: All randomized participants who received at least one dose of study drug and had IBDQ data at baseline, week 12.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Induction Treatment Period)
    Number of subjects analysed
    29
    26
    13
    Units: score on a scale
        least squares mean (standard error)
    25.76 ± 7.143
    36.42 ± 7.640
    26.71 ± 9.346
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Low dose LY3471851 (Induction Treatment Period) v Placebo (Induction Treatment Period)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.378
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    9.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.17
         upper limit
    		 31.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.935
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo (Induction Treatment Period) v High dose LY3471851 (Induction Treatment Period)
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.928
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.78
         upper limit
    		 19.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.406

    Secondary: Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at week 12

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    End point title
    		 Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at week 12 [1]
    End point description
    C-trough is the concentration of drug in the blood immediately before the next dose was administered.
    End point type
    Secondary
    End point timeframe
    Predose at week 12
    Notes
    [1] - 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: This outcome is specific to LY3471851 arms only.
    End point values
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period)
    Number of subjects analysed
    26
    26
    Units: microgram per milliliter (µg/mL)
        geometric mean (geometric coefficient of variation)
    139 ± 105
    91.3 ± 49
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Follow-up (Up To Week 58)
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    High dose LY3471851 (Induction Treatment Period)
    Reporting group description
    		 -

    Reporting group title
    Low dose LY3471851 (Induction Treatment Period)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Post-Treatment Follow-up Period)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Maintenance Treatment Period)
    Reporting group description
    		 -

    Reporting group title
    High dose LY3471851 (Extension Treatment Period)
    Reporting group description
    		 -

    Reporting group title
    High dose LY3471851 (Post-Treatment Follow-up Period)
    Reporting group description
    		 -

    Reporting group title
    Low dose LY3471851 (Post-Treatment Follow-up Period)
    Reporting group description
    		 -

    Reporting group title
    High dose LY3471851 (Maintenance Treatment Period)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Induction Treatment Period)
    Reporting group description
    		 -

    Reporting group title
    Low dose LY3471851 (Maintenance Treatment Period)
    Reporting group description
    		 -

    Serious adverse events
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Post-Treatment Follow-up Period) Placebo (Maintenance Treatment Period) High dose LY3471851 (Extension Treatment Period) High dose LY3471851 (Post-Treatment Follow-up Period) Low dose LY3471851 (Post-Treatment Follow-up Period) High dose LY3471851 (Maintenance Treatment Period) Placebo (Induction Treatment Period) Low dose LY3471851 (Maintenance Treatment Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    lower limb fracture
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    Nervous system disorders
    syncope
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Gastrointestinal disorders
    proctitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Infections and infestations
    vulval abscess
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 High dose LY3471851 (Induction Treatment Period) Low dose LY3471851 (Induction Treatment Period) Placebo (Post-Treatment Follow-up Period) Placebo (Maintenance Treatment Period) High dose LY3471851 (Extension Treatment Period) High dose LY3471851 (Post-Treatment Follow-up Period) Low dose LY3471851 (Post-Treatment Follow-up Period) High dose LY3471851 (Maintenance Treatment Period) Placebo (Induction Treatment Period) Low dose LY3471851 (Maintenance Treatment Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 32 (62.50%)
    15 / 35 (42.86%)
    1 / 11 (9.09%)
    1 / 5 (20.00%)
    5 / 26 (19.23%)
    0 / 25 (0.00%)
    1 / 30 (3.33%)
    4 / 8 (50.00%)
    5 / 14 (35.71%)
    6 / 10 (60.00%)
    Investigations
    body temperature increased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    11
    0
    0
    0
    0
    0
    0
    3
    0
    0
    Injury, poisoning and procedural complications
    injection related reaction
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    10
    0
    12
    Cardiac disorders
    extrasystoles
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 35 (2.86%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    0
    0
    0
    0
    0
    syncope
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 35 (5.71%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    0
    0
    1
    1
    neutropenia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 35 (2.86%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    application site reaction
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 35 (5.71%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    0
    0
    0
    6
    hyperthermia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    influenza like illness
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    injection site reaction
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    8 / 32 (25.00%)
    6 / 35 (17.14%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    21
    20
    0
    0
    9
    0
    0
    12
    0
    0
    malaise
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    pyrexia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    7 / 32 (21.88%)
    2 / 35 (5.71%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    2 / 8 (25.00%)
    1 / 14 (7.14%)
    1 / 10 (10.00%)
         occurrences all number
    9
    2
    0
    0
    0
    0
    0
    4
    1
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    colitis ulcerative
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    rhinorrhoea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    erythema
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 35 (2.86%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    5
    3
    0
    0
    0
    0
    0
    0
    0
    0
    rosacea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    back pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    myalgia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    erysipelas
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 35 (5.71%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    covid-19
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 35 (8.57%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    2
    3
    0
    1
    2
    0
    0
    1
    1
    0
    influenza
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 30 (3.33%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    tonsillitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 35 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2020
    Amendment (a): Modified the study entry criteria in response to Food and Drug Administration (FDA) feedback.

    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
    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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