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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)

    Summary
    EudraCT number
    		 2020-005232-30
    Trial protocol
    		 HU   EE   DE   CZ   BG   SK   IT  
    Global end of trial date
    03 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AMUC-2023
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04857112
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Salix Pharmaceuticals
    Sponsor organisation address
    400 Somerset Corporate Boulevard, Bridgewater, United States, 08807
    Public contact
    Clinical Trial Manager, Salix Pharmaceuticals, Inc., alison.magnotti-nagel@bauschhealth.com
    Scientific contact
    Clinical Trial Manager, Salix Pharmaceuticals, Inc., alison.magnotti-nagel@bauschhealth.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
    03 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the efficacy and safety of oral amiselimod (MT-1303) compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC).
    Protection of trial subjects
    This study was conducted in compliance with the study protocol and in accordance with Good Clinical Practices (GCPs), as described in the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for GCP, the United States Code of Federal Regulations (CFR) dealing with clinical studies (21 CFR Parts 11, 50, 54, 56, and 312), the ethical principles in the Declaration of Helsinki, and applicable local regulations. Before undertaking any study-related procedures with patients, the purpose and nature of the study, as well as possible adverse effects, were explained to them in understandable terms, and written informed consent was obtained from each individual. Each informed consent form (ICF) was to be appropriately signed and dated by the patient and the person obtaining the consent. Each patient was to receive a copy of the signed ICF.
    Background therapy
    		 None
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    19 Feb 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
    Poland: 119
    Country: Number of subjects enrolled
    Slovakia: 7
    Country: Number of subjects enrolled
    Bulgaria: 6
    Country: Number of subjects enrolled
    Czechia: 18
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Belarus: 19
    Country: Number of subjects enrolled
    Georgia: 16
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Moldova, Republic of: 17
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Serbia: 28
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    322
    EEA total number of subjects
    179
    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)
    301
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in Australia, Belarus, Bulgaria, Czech Republic, Estonia, Georgia, Germany, Hungary, Italy, Japan, Moldova, Poland, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine, and the United States of America. A total of 185 sites were activated and 96 sites enrolled subjects. Date of first randomization: 28 Sep 2021.

    Pre-assignment
    Screening details
    		 Subjects were eligible if male or female, 18-75 years old at consent (inclusive), had stable vital signs, and had a diagnosis of active mild UC (mMS of 3 or 4) or moderate UC (mMS of 5 to 8). Subjects had to have an endoscopic subscore of ≥2 and evidence of active UC extending ≥15 cm from the anal verge, both confirmed by a screening colonoscopy.

    Period 1
    Period 1 title
    Double-Blind Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor
    Blinding implementation details
    For the Double-Blind Period, the 0.2 mg and 0.4 mg amiselimod capsules and placebo capsules looked identical to maintain the blind. In addition, all white blood cell (WBC) differential values (except total WBC count and absolute neutrophil count) remained blinded throughout the Double-Blind Period. Independent, unblinded, qualified medical professional(s) were responsible for monitoring absolute lymphocyte counts to identify subjects who reached the threshold for discontinuation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amiselimod Low Dose Group
    Arm description
    		 Subjects initially randomized to the amiselimod low dose group for the Double-Blind Period Study Treatment - loading dose: 0.4 mg amiselimod, orally, once daily; maintenance dose: 0.2 mg amiselimod, orally, once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amiselimod
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose (Days 1-14): Two 0.2 mg amiselimod capsules, orally, once daily Maintenance dose (Days 15-85): One 0.2 mg amiselimod capsule, orally, once daily

    Arm title
    		 Amiselimod High Dose Group
    Arm description
    		 Subjects initially randomized to the amiselimod high dose group for the Double-Blind Period Study Treatment - loading dose: 0.8 mg amiselimod, orally, once daily; maintenance dose: 0.4 mg amiselimod, orally, once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amiselimod
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose (Days 1-14): Two 0.4 mg amiselimod capsules, orally, once daily Maintenance dose (Days 15-85): One 0.4 mg amiselimod capsule, orally, once daily

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects initially randomized to the placebo group for the Double-Blind Period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose (Days 1-14): Two placebo capsules, orally, once daily Maintenance dose (Days 15-85): One placebo capsule, orally, once daily

    Number of subjects in period 1 [1]
    		Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group
    Started
    107
    107
    107
    Completed
    94
    96
    95
    Not completed
    13
    11
    12
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    5
    5
    7
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    5
    3
    2
         Other
    3
    -
    1
         Protocol deviation
    -
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was enrolled but did not receive any study treatment, so this person was not included in the summary tables.
    Period 2
    Period 2 title
    Open-label Extension (OLE) Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 OLE Overall Group
    Arm description
    		 Subjects who completed the Double-Blind Period of the study and who, in the opinion of the Investigator, would benefit from continued treatment, were permitted to participate in the OLE Period. Study Treatment - 0.4 mg amiselimod, orally, once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amiselimod
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 0.4 mg amiselimod capsule, orally, once daily

    Number of subjects in period 2 [2]
    		OLE Overall Group
    Started
    283
    Completed
    237
    Not completed
    46
         Physician decision
    5
         Consent withdrawn by subject
    23
         Adverse event, non-fatal
    9
         Other
    6
         Lost to follow-up
    1
         Protocol deviation
    2
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Two subjects completed the Double-Blind Period but did not enter the OLE Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Amiselimod Low Dose Group
    Reporting group description
    		 Subjects initially randomized to the amiselimod low dose group for the Double-Blind Period Study Treatment - loading dose: 0.4 mg amiselimod, orally, once daily; maintenance dose: 0.2 mg amiselimod, orally, once daily

    Reporting group title
    Amiselimod High Dose Group
    Reporting group description
    		 Subjects initially randomized to the amiselimod high dose group for the Double-Blind Period Study Treatment - loading dose: 0.8 mg amiselimod, orally, once daily; maintenance dose: 0.4 mg amiselimod, orally, once daily

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects initially randomized to the placebo group for the Double-Blind Period

    Reporting group values
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group Total
    Number of subjects
    		 107 107 107 321
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 98 101 101 300
        From 65-84 years
    		 9 6 6 21
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.6 ( 14.46 ) 41.6 ( 12.42 ) 40.5 ( 12.43 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 43 46 133
        Male
    		 63 64 61 188
    UC Severity
    Units: Subjects
        Mild UC (Modified Mayo Score of 3 or 4)
    		 21 22 22 65
        Moderate UC (Modified Mayo Score of 5 to 8)
    		 86 85 85 256
    History of Corticosteroids
    Units: Subjects
        Yes
    		 92 86 86 264
        No
    		 15 21 21 57
    History of Aminosalicylates
    Units: Subjects
        Yes
    		 102 106 104 312
        No
    		 5 1 3 9
    Previous Exposure to anti-TNF-α agents, anti-integrin, anti-IL, or JAK inhibitors
    Units: Subjects
        Yes
    		 36 31 33 100
        No
    		 71 76 74 221
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 16 10 9 35
        Black or African American
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        White
    		 89 97 98 284
        Not Reported
    		 2 0 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 1
        Not Hispanic or Latino
    		 104 106 107 317
        Not Reported
    		 3 0 0 3
    Time Since UC Symptom Onset
    Units: Years
        arithmetic mean (standard deviation)
    		 8.2227 ( 8.23754 ) 7.9766 ( 7.79472 ) 8.0499 ( 6.97550 ) -

    End points

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    End points reporting groups
    Reporting group title
    Amiselimod Low Dose Group
    Reporting group description
    		 Subjects initially randomized to the amiselimod low dose group for the Double-Blind Period Study Treatment - loading dose: 0.4 mg amiselimod, orally, once daily; maintenance dose: 0.2 mg amiselimod, orally, once daily

    Reporting group title
    Amiselimod High Dose Group
    Reporting group description
    		 Subjects initially randomized to the amiselimod high dose group for the Double-Blind Period Study Treatment - loading dose: 0.8 mg amiselimod, orally, once daily; maintenance dose: 0.4 mg amiselimod, orally, once daily

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects initially randomized to the placebo group for the Double-Blind Period
    Reporting group title
    OLE Overall Group
    Reporting group description
    		 Subjects who completed the Double-Blind Period of the study and who, in the opinion of the Investigator, would benefit from continued treatment, were permitted to participate in the OLE Period. Study Treatment - 0.4 mg amiselimod, orally, once daily

    Subject analysis set title
    Intent-to-Treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least 1 dose of study treatment. Subjects in the ITT Population were analyzed according to the study treatment assigned at randomization.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of study drug. Subjects in the Safety Population were analyzed according to study drug received. For subjects receiving placebo during the Double-Blind Period, the safety assessments obtained at Day 85 were used for Baseline during the OLE Period.

    Subject analysis set title
    OLE Period Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least 1 dose of study drug and were enrolled in the OLE period of the study. Analysis were according to study drug received.

    Primary: Change from Baseline in Modified Mayo Score (mMS) at Day 85

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    End point title
    		 Change from Baseline in Modified Mayo Score (mMS) at Day 85
    End point description
    The mMS consisted of the endoscopic (excluding friability), rectal bleeding, and stool frequency subscores. Change from baseline was calculated as Day 85 value — Baseline value. Subjects who discontinue prematurely for any reason and for whom a post-Baseline Mayo endoscopic subscore was not available at the Day 85/End of Treatment (EOT) Visit had the Baseline endoscopic categorization carried forward for purposes of this endpoint. For subjects who did not record diary data on stool frequency and rectal bleeding through Day 85/EOT, the value from the last available visit was to be carried forward for a last observation carried forward (LOCF) analysis of the primary endpoint. This endpoint was analyzed in the ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline to Day 85
    End point values
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group
    Number of subjects analysed
    107
    107
    107
    Units: Change in mMS
        arithmetic mean (standard deviation)
    -2.3 ( 2.18 )
    -2.3 ( 2.21 )
    -1.6 ( 2.17 )
    Statistical analysis title
    		 Amiselimod Low Dose Vs Placebo
    Comparison groups
    Amiselimod Low Dose Group v Placebo Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Means Difference
    Point estimate
    -0.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 -0.27
    Notes
    [1] - P-value was generated from an analysis of covariance (ANCOVA) model which included treatment, severity (mild or moderate UC), concurrent corticosteroid use (Y/N), and Baseline value as covariates.
    Statistical analysis title
    		 Amiselimod High Dose Vs Placebo
    Comparison groups
    Placebo Group v Amiselimod High Dose Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Means Difference
    Point estimate
    -0.76
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.23
         upper limit
    		 -0.29
    Notes
    [2] - P-value was generated from an ANCOVA model which included treatment, severity (mild or moderate UC), concurrent corticosteroid use (Y/N), and Baseline value as covariates.

    Secondary: Proportion of Subjects with Endoscopic Improvement at Day 85

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    End point title
    		 Proportion of Subjects with Endoscopic Improvement at Day 85
    End point description
    Endoscopic improvement was defined as a Mayo endoscopic subscore of ≤1. Endoscopic improvement subjects who discontinued prematurely for any reason and for whom a Mayo endoscopic subscore was not available at the Day 85 visit were categorized as Non-Responders for purposes of the endpoint. This endpoint was analyzed in the ITT Population.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 85
    End point values
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group
    Number of subjects analysed
    107 [3]
    107 [4]
    107 [5]
    Units: Subjects with endoscopic improvement
    44
    46
    25
    Notes
    [3] - Percentage with endoscopic improvement: 41.1%
    [4] - Percentage with endoscopic improvement: 43.0%
    [5] - Percentage with endoscopic improvement: 23.4%
    Statistical analysis title
    		 Amiselimod Low Dose vs Placebo
    Comparison groups
    Placebo Group v Amiselimod Low Dose Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    0.174
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.068
         upper limit
    		 0.28
    Notes
    [6] - P-value was generated by stratified Cochran-Mantel-Haenszel (CMH) test stratified by severity (mild UC or moderate UC) and concurrent corticosteroid use (Y/N).
    Statistical analysis title
    		 Amiselimod High Dose vs Placebo
    Comparison groups
    Placebo Group v Amiselimod High Dose Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    0.194
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.091
         upper limit
    		 0.298
    Notes
    [7] - P-value was generated by stratified CMH test stratified by severity (mild UC or moderate UC) and concurrent corticosteroid use (Y/N).

    Secondary: Change from Baseline in 2-Component Mayo Score at Day 85

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    End point title
    		 Change from Baseline in 2-Component Mayo Score at Day 85
    End point description
    The 2-component Mayo Score consisted of the endoscopic and rectal bleeding subscores. Change from baseline was calculated as Day 85 value – Baseline value. For subjects who did not record diary data on rectal bleeding through Day 85/EOT, the last recorded value in the diary was carried forward for an LOCF analysis of the primary endpoint. This endpoint was analyzed in the ITT Population.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 85
    End point values
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group
    Number of subjects analysed
    107
    107
    107
    Units: Change in 2-component Mayo Score
        arithmetic mean (standard deviation)
    -1.6 ( 1.58 )
    -1.6 ( 1.61 )
    -1.0 ( 1.51 )
    Statistical analysis title
    		 Amiselimod Low Dose Vs Placebo
    Comparison groups
    Amiselimod Low Dose Group v Placebo Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Means Difference
    Point estimate
    -0.61
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 -0.28
    Notes
    [8] - P-value was generated from an ANCOVA model which included treatment, severity (mild or moderate UC), concurrent corticosteroid use (Y/N), prior aminosalicylates use (Y/N), and Baseline value as covariates.
    Statistical analysis title
    		 Amiselimod High Dose Vs Placebo
    Comparison groups
    Placebo Group v Amiselimod High Dose Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Means Difference
    Point estimate
    -0.61
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 -0.28
    Notes
    [9] - P-value was generated from an ANCOVA model which included treatment, severity (mild or moderate UC), concurrent corticosteroid use (Y/N), prior aminosalicylates use (Y/N), and Baseline value as covariates.

    Secondary: Proportion of Subjects with Clinical Remission at Day 85 Based on the mMS with the April 2022 United States Food and Drug Administration (FDA) New UC Guideline Definition

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    End point title
    		 Proportion of Subjects with Clinical Remission at Day 85 Based on the mMS with the April 2022 United States Food and Drug Administration (FDA) New UC Guideline Definition
    End point description
    Clinical remission based on the FDA 2022 UC (draft) guidance was defined as follows: endoscopy subscore of ≤1 (excludes friability) + rectal bleeding subscore of 0 + stool frequency subscore of ≤1. This endpoint was analyzed in the ITT Population.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 85
    End point values
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group
    Number of subjects analysed
    107 [10]
    107 [11]
    107 [12]
    Units: Subjects with clinical remission
    35
    33
    19
    Notes
    [10] - Percentage with clinical remission: 32.7%
    [11] - Percentage with clinical remission: 30.8%
    [12] - Percentage with clinical remission: 17.8%
    Statistical analysis title
    		 Amiselimod Low Dose vs Placebo
    Comparison groups
    Amiselimod Low Dose Group v Placebo Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    0.146
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.048
         upper limit
    		 0.245
    Notes
    [13] - P-value was generated by stratified CMH test stratified by severity (mild UC or moderate UC) and concurrent corticosteroid use (Y/N).
    Statistical analysis title
    		 Amiselimod High Dose vs Placebo
    Comparison groups
    Placebo Group v Amiselimod High Dose Group
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion
    Point estimate
    0.129
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.033
         upper limit
    		 0.224
    Notes
    [14] - P-value was generated by stratified CMH test stratified by severity (mild UC or moderate UC) and concurrent corticosteroid use (Y/N).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events and serious adverse events (SAEs) were to be recorded from the signing of the informed consent through the End of Study Visit or 84 days after the last dose of investigation product (IP).
    Adverse event reporting additional description
    Double-Blind Period (up to 12 weeks of treatment): Results reported for the amiselimod low dose, amiselimod high dose, and placebo groups in the Safety Population. OLE Period (up to 36 additional weeks of treatment): Results reported for the OLE overall group in the OLE Safety Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Amiselimod Low Dose Group
    Reporting group description
    		 Subjects initially randomized to the amiselimod low dose group for the Double-Blind Period Study Treatment - loading dose: 0.4 mg amiselimod, orally, once daily; maintenance dose: 0.2 mg amiselimod, orally, once daily

    Reporting group title
    Amiselimod High Dose Group
    Reporting group description
    		 Subjects initially randomized to the amiselimod high dose for the Double-Blind Period Study Treatment - loading dose: 0.8 mg amiselimod, orally, once daily; maintenance dose: 0.4 mg amiselimod, orally, once daily

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects initially randomized to the placebo group for the Double-Blind Period

    Reporting group title
    OLE Overall Group
    Reporting group description
    		 Subjects who completed the Double-Blind Period of the study and who, in the opinion of the Investigator, would benefit from continued treatment, were permitted to participate in the OLE Period. Study Treatment - 0.4 mg amiselimod, orally, once daily

    Serious adverse events
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group OLE Overall Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 107 (1.87%)
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    16 / 283 (5.65%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
    Additional description: The pancreatic carcinoma in the OLE overall group was assessed by the Investigator as related to study treatment, but the Sponsor determined it was unrelated to treatment due to the presence of an abnormal pancreatic lesion prior to active treatment.
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    6 / 283 (2.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Campylobacter colitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Amiselimod Low Dose Group Amiselimod High Dose Group Placebo Group OLE Overall Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 107 (45.79%)
    59 / 107 (55.14%)
    44 / 107 (41.12%)
    202 / 283 (71.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenoma
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 107 (2.80%)
    4 / 107 (3.74%)
    3 / 107 (2.80%)
    6 / 283 (2.12%)
         occurrences all number
    3
    4
    3
    6
    Thrombophlebitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    7 / 283 (2.47%)
         occurrences all number
    2
    1
    0
    7
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    1
    1
    Asthenia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    0
    1
    Feeling cold
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    3 / 283 (1.06%)
         occurrences all number
    0
    1
    0
    3
    Neck pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    0
    1
    1
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    4 / 283 (1.41%)
         occurrences all number
    1
    1
    0
    5
    Epistaxis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Apnoea
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neurosis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    14 / 283 (4.95%)
         occurrences all number
    0
    0
    0
    19
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    7 / 283 (2.47%)
         occurrences all number
    1
    2
    0
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    4 / 283 (1.41%)
         occurrences all number
    1
    1
    0
    4
    Blood calcium decreased
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood potassium increased
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    1
    0
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    5 / 283 (1.77%)
         occurrences all number
    1
    0
    0
    9
    Clostridium test positive
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    0
    1
    Foot fracture
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    2 / 107 (1.87%)
    4 / 107 (3.74%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    1
    1
    0
    2
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bundle branch block left
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiomyopathy
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 107 (4.67%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    4 / 283 (1.41%)
         occurrences all number
    5
    2
    1
    4
    Paraesthesia
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    0
    1
    Dysgraphia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    3 / 283 (1.06%)
         occurrences all number
    0
    2
    0
    3
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    8 / 107 (7.48%)
    17 / 107 (15.89%)
    0 / 107 (0.00%)
    44 / 283 (15.55%)
         occurrences all number
    8
    21
    0
    51
    Anaemia
         subjects affected / exposed
    6 / 107 (5.61%)
    4 / 107 (3.74%)
    4 / 107 (3.74%)
    10 / 283 (3.53%)
         occurrences all number
    6
    5
    4
    11
    Neutropenia
         subjects affected / exposed
    2 / 107 (1.87%)
    6 / 107 (5.61%)
    0 / 107 (0.00%)
    12 / 283 (4.24%)
         occurrences all number
    2
    7
    0
    15
    Lymphopenia
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    80 / 283 (28.27%)
         occurrences all number
    0
    2
    0
    90
    Thrombocytopenia
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    3 / 283 (1.06%)
         occurrences all number
    2
    0
    0
    3
    Eosinophilia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    4 / 283 (1.41%)
         occurrences all number
    1
    0
    0
    5
    Dry eye
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    0
    1
    Macular fibrosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Retinal degeneration
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Visual impairment
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    6 / 107 (5.61%)
    2 / 107 (1.87%)
    3 / 107 (2.80%)
    27 / 283 (9.54%)
         occurrences all number
    6
    2
    3
    30
    Abdominal pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    4 / 107 (3.74%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    5
    1
    Food poisoning
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    3 / 107 (2.80%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Large intestine polyp
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    2 / 283 (0.71%)
         occurrences all number
    1
    2
    1
    2
    Diarrhoea
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    4 / 283 (1.41%)
         occurrences all number
    2
    0
    1
    4
    Nausea
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    1
    1
    Enteritis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Colitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dental dysaesthesia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eructation
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Faeces hard
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gingival swelling
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    2
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    3 / 283 (1.06%)
         occurrences all number
    0
    0
    1
    3
    Ileal ulcer
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    3 / 283 (1.06%)
         occurrences all number
    0
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 107 (0.00%)
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    2 / 283 (0.71%)
         occurrences all number
    0
    3
    1
    2
    Acne
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    1
    1
    Cold sweat
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    0
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    0
    1
    Pigmentation disorder
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    0
    1
    1
    Scar pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal cyst
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal colic
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    12 / 283 (4.24%)
         occurrences all number
    2
    1
    3
    12
    Back pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    3 / 283 (1.06%)
         occurrences all number
    1
    0
    0
    3
    Muscle spasms
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    5
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteonecrosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    1
    0
    0
    1
    Sacral pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    0
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Spinal pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 107 (3.74%)
    5 / 107 (4.67%)
    6 / 107 (5.61%)
    11 / 283 (3.89%)
         occurrences all number
    4
    5
    6
    11
    Nasopharyngitis
         subjects affected / exposed
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    4 / 107 (3.74%)
    10 / 283 (3.53%)
         occurrences all number
    3
    1
    4
    10
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    7 / 283 (2.47%)
         occurrences all number
    3
    1
    3
    9
    Influenza
         subjects affected / exposed
    2 / 107 (1.87%)
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    6 / 283 (2.12%)
         occurrences all number
    2
    3
    1
    7
    Urinary tract infection
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    1
    1
    1
    2
    Bronchitis
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    1
    1
    0
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    2
    1
    0
    2
    Bacteriuria
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    0
    1
    1
    Campylobacter infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    1
    2
    Escherichia infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    0
    1
    Mastitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    1
    2
    Rhinitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Salmonellosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    3 / 283 (1.06%)
         occurrences all number
    1
    0
    0
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Pharyngitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Tonsillitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    0
    0
    0
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    1
    1
    Iron deficiency
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    2 / 283 (0.71%)
         occurrences all number
    1
    1
    0
    2
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 283 (0.35%)
         occurrences all number
    0
    1
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypernatraemia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypochloraemia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 283 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    0 / 283 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 283 (0.35%)
         occurrences all number
    0
    0
    1
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2020
    •Changes made throughout the protocol related to addition of the OLE Period •Updates made to clarify inclusion criterion (IC) #3 (revised) and #4 (added) regarding endoscopic subscore •Clarification of exclusion criterion (EC) #36 for prior treatment with Sphingosine 1-Phosphates •Changed EC #16 to allow re-screening 7 days after treatment for C. difficile rather than 60 days •Text added to clarify period for hypothesis testing to be conducted after all subjects completed the Double-Blind Period •Clarification of EC #4 to state “history or evidence of any colonic resection or subtotal colectomy within 1 year prior to randomization” •Clarification of EC #26 to state “History or evidence of two or more failures with biologic treatment for UC (primary non-responders)” •For EC #28 and #29, clarified that immunosuppressants were not allowed within 28 days prior to randomization rather than 28 days prior to screening •Criteria for discontinuation modified to allow adequate time to collect second absolute lymphocyte count value, and alanine aminotransferase and/or aspartate aminotransferase value •Clarification that the 24-hour electrocardiograms (ECGs) were to begin within 1 hour prior to IP dose and to change the 24-hour ECGs to be collected for all subjects •Schedule for collection of colonoscopy adjusted to allow more time for collection (14 to 28 days prior to Baseline Visit) •Section added to include major adverse cardiac events (MACE) as an adverse event of special interest; text added to describe methods for the analysis of MACE
    03 Dec 2020
    •Clarified dosing: changed from “Group A (low dose): 0.4 mg amiselimod capsule + placebo” to “Group A (low dose): Two 0.2 mg amiselimod capsules, orally, QD” •Background section updated to match Investigator’s Brochure •History of tuberculosis deleted from EC #11 •History of hepatitis B virus (HBV) and hepatitis C virus (HCV) deleted and results of HBV and HCV updated in EC #12 •Requirements for progressive multifocal leukoencephalopathy (PML) EC #14 updated •Clarified EC #16 for previous or current C. difficile diagnoses; EC #47 updated to reflect change in C. difficile EC #16 •Updated requirement for stable dose of concomitant medications to within 28 days prior to randomization •New EC #45 added for diffusing capacity of the lungs for carbon monoxide (DLCO) assessment •Clarified requirements for Daily Symptoms Diary •Changed definition of laboratory results that were to be blinded/unblinded during the study; clarified that laboratory values are not blinded during the OLE Period •Added text on the DLCO assessment •Clarified use of combined subjective and objective PML checklist; instructions added on restarting IP in the case of a positive finding on the PML checklist •Clarified that urine alcohol and urine cotinine were not part of urine drug screen; urine drug screen was removed from Baseline Visit and added to Screening Visit; and added DLCO to pulmonary function tests (PFTs) •C-reactive protein was added to Day 421 visit •Prohibited use of drugs that prolong QT interval •Weight measurement added to Day 169 visit •Clarified how “normal” stool frequency was to be collected for scoring of Mayo stool frequency subscore •Added requirement to collect pharmacokinetics sample for a cardiac-related SAE •Clarified the recording of both local and central Mayo endoscopy subscores and determination of histological scoring at central laboratory •Clarified the timing of performing EuroQol 5-Dimension 3-Level and Patient Global Impression of Change surveys
    03 Mar 2022
    •Revised number of subjects from 175 to 189 and removed Africa •Revised Screening Period from up to 4 weeks to up to 35 days •Added a visit window for subjects that did not participate in the OLE Period; subjects were to be followed for 84 (±10) days in a Safety Follow-Up Period •Revised IC #2 to state subjects were eligible if they had “stable vital signs” rather than “normal vital signs”; changed IC ranges for heart rate (50-100 bpm), systolic blood pressure (>90 and <160 mmHg), and diastolic blood pressure (>50 and <100 mmHg) •Revised references to prednisolone dosing to “≤20 mg prednisolone equivalent per day;” clarified that tapering of prednisolone was allowed during the OLE period •Revised EC #12 from “previous shingles outbreak” to “history of disseminated herpes zoster” •Corrected the common standard deviation used in the sample size determination from 2.2 to 3.0 •Added details of a planned interim analysis •Clarified IC #7 regarding pregnancy testing to include “a urine pregnancy test at each subsequent study visit, and additionally at monthly intervals as applicable” •Corrected EC #11 regarding timing for any prior X-ray done in the 12 weeks prior to “Day 1” rather than “screening” •Revised EC #35 to specify non-oral (intravenous [IV] or rectal) corticosteroid use (“IV corticosteroid within 4 weeks of the Screening Visit; rectal corticosteroid within 2 weeks of the Screening Visit”) •Revised EC #40 to change the definition of low heart rate from “<55” to “<50" •Section added to allow and specify restrictions around re-screening •Revised timing of PFT testing in relation to the Baseline Visit (Day 1) •Clarified the timing for collection of stool sample and to loosen the associated restrictions •Revised timing of colonoscopy with colonic mucosal biopsy to allow for randomization of subjects in <14 days if the colonoscopy results were available sooner •Clarified that IP was to be dispensed at the Day 29 and Day 57 Visits

    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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