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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2020-003507-34
    Trial protocol
    		 CZ   BE   FR   HU   PT   BG   IT  
    Global end of trial date
    19 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2025
    First version publication date
    04 Jul 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    APD334-210
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04607837
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 C5041011: C5041011
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    10 Apr 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the efficacy of etrasimod on clinical remission in participants with moderately active ulcerative colitis (UC) after 52 weeks of treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Belarus: 20
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    Georgia: 30
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Poland: 35
    Country: Number of subjects enrolled
    Russian Federation: 24
    Country: Number of subjects enrolled
    Ukraine: 17
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Worldwide total number of subjects
    233
    EEA total number of subjects
    84
    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)
    223
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants with moderately active ulcerative colitis (UC) were enrolled in the study.

    Pre-assignment
    Screening details
    		 A total of 234 participants were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This was a double-blind study. The treatment each participant received was not disclosed to the Investigator, study site staff, subject, Sponsor personnel involved with the conduct of the study (with the exception of the clinical supply staff and designated safety staff), or study vendors

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Etrasimod
    Arm description
    		 Participants with moderately active UC were randomised to receive Etrasimod 2 milligrams (mg) tablet orally once daily (QD) for 52-Week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etrasimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive Etrasimod 2 mg tablet orally daily.

    Arm title
    		 Placebo
    Arm description
    		 Participants with moderately active UC were randomised to receive placebo matched to Etrasimod tablet orally QD for 52-Week.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive placebo matching to Etrasimod tablet orally daily.

    Number of subjects in period 1
    		Etrasimod Placebo
    Started
    154
    79
    Safety set
    154
    79
    Primary analysis set
    127
    60
    Completed
    97
    34
    Not completed
    57
    45
         Consent withdrawn by subject
    8
    7
         Physician decision
    2
    -
         Adverse event, non-fatal
    8
    2
         Study termination by sponsor
    1
    -
         Disease worsening
    36
    36
         Lack of efficacy
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etrasimod
    Reporting group description
    		 Participants with moderately active UC were randomised to receive Etrasimod 2 milligrams (mg) tablet orally once daily (QD) for 52-Week.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with moderately active UC were randomised to receive placebo matched to Etrasimod tablet orally QD for 52-Week.

    Reporting group values
    		 Etrasimod Placebo Total
    Number of subjects
    		 154 79 233
    Age categorical
    Units: Subjects
        In Utero
    		 0 0 0
        Preterm newborn infants (gestional age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days - 23 months)
    		 0 0 0
        Children (2 - 11 years)
    		 0 0 0
        12 - 17 years
    		 0 0 0
        Adults (18 - 64 years)
    		 147 76 223
        From 65 - 84 years
    		 7 3 10
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.6 ( 13.15 ) 40.8 ( 13.00 ) -
    Gender categorical
    Units: Subjects
        Male
    		 91 39 130
        Female
    		 63 40 103
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 8 7 15
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 1 3
        White
    		 143 67 210
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 4 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 6 6 12
        Not Hispanic or Latino
    		 146 73 219
        Unknown or Not Reported
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Etrasimod
    Reporting group description
    		 Participants with moderately active UC were randomised to receive Etrasimod 2 milligrams (mg) tablet orally once daily (QD) for 52-Week.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with moderately active UC were randomised to receive placebo matched to Etrasimod tablet orally QD for 52-Week.

    Primary: Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS)

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    End point title
    		 Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS)
    End point description
    MMS assesses UC disease activity with three components: endoscopic score(ES),rectal bleeding(RB),stool frequency(SF).Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease.ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0(normal or inactive disease) to 3(severe disease [spontaneous bleeding, ulceration]).RB reported most severe amount of blood passed per rectum in 24-hour period, scores ranged from 0(no blood seen) to 3(blood alone passes).SF reported number of stools in 24-hour period relative to normal number of stools for that participant in same period,scores ranged from 0(normal number of stools) to 3(5 or more stools than normal).CR per FDA draft guidance defined as:SF=0 or 1 and no greater than baseline, RB=0,ES less than or equal to (<=)1(excluding friability).Percentage of participants achieving CR at Week 52 was evaluated. Primary analysis set was analysed.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    26.0
    18.3
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common risk difference using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the risk difference being 0.
    Comparison groups
    Placebo v Etrasimod
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2524
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    7.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.24
         upper limit
    		 19.94

    Secondary: Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS

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    End point title
    		 Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS
    End point description
    MMS assesses UC disease activity with three components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe); higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). RB reported the most severe amount of blood passed per rectum in a 24-hour period; scores ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance was defined as: SF=0 or =1 and no greater than baseline, RB=0, and ES <=1 (excluding friability). Percentage of participants achieving CR at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    28.3
    11.7
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0068
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.31
         upper limit
    		 26.91

    Secondary: Percentage of Participants Achieving Endoscopic Improvement at Week 52

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    End point title
    		 Percentage of Participants Achieving Endoscopic Improvement at Week 52
    End point description
    Endoscopic improvement was defined as ES <=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 52 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    32.3
    23.3
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2302
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.22
         upper limit
    		 21.71

    Secondary: Percentage of Participants Achieving Symptomatic Remission at Week 52

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    End point title
    		 Percentage of Participants Achieving Symptomatic Remission at Week 52
    End point description
    Symptomatic remission was defined as SF =0 (or = 1 with a >= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 52 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    37.0
    30.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3339
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    7.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.32
         upper limit
    		 21.55

    Secondary: Percentage of Participants Achieving Complete Symptomatic Remission at Week 52

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    End point title
    		 Percentage of Participants Achieving Complete Symptomatic Remission at Week 52
    End point description
    Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 52 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    20.5
    20.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9141
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.76
         upper limit
    		 13.13

    Secondary: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52

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    End point title
    		 Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52
    End point description
    Histologic-endoscopic mucosal improvement was defined as ES <=1 (excluding friability) with Geboes score <2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 52 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    25.2
    15.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1089
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.13
         upper limit
    		 21.25

    Secondary: Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS

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    End point title
    		 Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS
    End point description
    MMS assesses UC disease activity with three components: ES, RB, and SF. Each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe); higher scores=severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). RB reported most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes).SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR (per FDA draft guidance): SF=0 or =1 and no greater than baseline, RB=0, and ES <=1 (excluding friability). Percentage of participants who achieved CR at both the time points Week 12 and Week 52 [Combined] are reported. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 52 [Combined]
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    16.5
    5.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0104
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.63
         upper limit
    		 19.75

    Secondary: Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS

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    End point title
    		 Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS
    End point description
    MMS components: ES, RB and SF. Score ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe); higher scores=more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged=0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, scores ranged= 0 (no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in same period, scores ranged= 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1 (excluding friability). 12-week corticosteroid-free CR: CR at Week 52 and corticosteroid-free for >=12 weeks immediately prior to Week 52. Primary analysis set was analysed. Here, “Subjects Analysed” signifies participants evaluable for this outcome measure who received oral corticosteroids for UC at baseline.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    37
    18
    Units: Percentage of participants
        number (not applicable)
    16.2
    16.7
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9203
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.06
         upper limit
    		 19.92

    Secondary: Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS

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    End point title
    		 Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS
    End point description
    MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=12 weeks immediately prior to Week 52. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    25.2
    16.7
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1726
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.71
         upper limit
    		 20.68

    Secondary: Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS

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    End point title
    		 Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS
    End point description
    MMS components: ES, RB and SF. Score ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe); higher scores=more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged=0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, scores ranged= 0 (no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in same period, scores ranged= 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1 (excluding friability). 4-week corticosteroid-free CR: CR at Week 52 and corticosteroid-free for >=4 weeks immediately prior to Week 52. Primary analysis set was analysed. Here, “Subjects Analysed” signifies participants evaluable for this outcome measure who received oral corticosteroids for UC at baseline.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    20
    10
    Units: Percentage of participants
        number (not applicable)
    30.0
    30.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9272
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.31
         upper limit
    		 34.9

    Secondary: Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS

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    End point title
    		 Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS
    End point description
    MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=4 weeks immediately prior to Week 52. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    25.2
    16.7
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1726
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.71
         upper limit
    		 20.68

    Secondary: Percentage of Participants Achieving Clinical Response at Week 12 Using MMS

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    End point title
    		 Percentage of Participants Achieving Clinical Response at Week 12 Using MMS
    End point description
    Clinical response was defined as a >=2-point and >=30 percentage (%) decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore <=1 and is as per FDA draft guidance. MMS was used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). Percentage of participants achieving clinical response at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    55.9
    36.7
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0151
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    18.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.61
         upper limit
    		 33.67

    Secondary: Percentage of Participants Achieving Clinical Response at Week 52 Using MMS

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    End point title
    		 Percentage of Participants Achieving Clinical Response at Week 52 Using MMS
    End point description
    Clinical response was defined as a >=2-point and >=30 % decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore <=1 and is as per FDA draft guidance. MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component scores ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). Percentage of participants achieving clinical response at Week 52 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    44.1
    38.3
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4419
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.22
         upper limit
    		 21.13

    Secondary: Percentage of Participants Achieving Endoscopic Improvement at Week 12

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    End point title
    		 Percentage of Participants Achieving Endoscopic Improvement at Week 12
    End point description
    Endoscopic improvement was defined as ES <=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    44.1
    20.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    23.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.78
         upper limit
    		 36.89

    Secondary: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12

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    End point title
    		 Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12
    End point description
    Histologic-endoscopic mucosal improvement was defined as ES <=1 (excluding friability) with Geboes score <2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    29.1
    13.3
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0128
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    14.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.19
         upper limit
    		 26.79

    Secondary: Percentage of Participants Achieving Symptomatic Remission at Week 12

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    End point title
    		 Percentage of Participants Achieving Symptomatic Remission at Week 12
    End point description
    Symptomatic remission was defined as SF =0 (or = 1 with a >= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    36.2
    25.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1492
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    10.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.67
         upper limit
    		 24.14

    Secondary: Percentage of Participants Achieving Complete Symptomatic Remission at Week 12

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    End point title
    		 Percentage of Participants Achieving Complete Symptomatic Remission at Week 12
    End point description
    Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    20.5
    20.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9774
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.18
         upper limit
    		 12.53

    Secondary: Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12

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    End point title
    		 Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12
    End point description
    ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. RB: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. Percentage of participants with reduction from baseline in both ES and RB or in both ES and SF at Week 12 was evaluated in this endpoint. The baseline primary analysis set was balanced between treatment groups and representative of participants with mildly to moderately active UC. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    44.9
    21.7
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0011
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    22.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.17
         upper limit
    		 36.49

    Secondary: Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12

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    End point title
    		 Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12
    End point description
    Histologic response based on the Geboes grading system was defined as Geboes score <=3.1. The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving histologic response based on the Geboes grading system at week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    44.9
    33.3
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1513
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    10.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.95
         upper limit
    		 25.56

    Secondary: Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12

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    End point title
    		 Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12
    End point description
    RHI is an evaluative index, derived from the Geboes score, that is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. Histologic response based on RHI was defined as decrease in RHI of >=7 points from baseline. Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity), higher score = more severity. Percentage of participants achieving histologic response based on RHI at Week 12 was evaluated in this endpoint. Primary analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    127
    60
    Units: Percentage of participants
        number (not applicable)
    46.5
    35.0
    Statistical analysis title
    		 Etrasimod versus placebo
    Statistical analysis description
    Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.
    Comparison groups
    Etrasimod v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1823
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    10.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.73
         upper limit
    		 24.87

    Other pre-specified: Number of Participants With Adverse Events (AEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and all non-SAEs. Safety set included all randomised participants who received at least 1 dose of study treatment.
    End point type
    Other pre-specified
    End point timeframe
    From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    154
    79
    Units: Participants
    101
    49
    No statistical analyses for this end point

    Other pre-specified: Number of Participants With AEs Based on Severity

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    End point title
    		 Number of Participants With AEs Based on Severity
    End point description
    An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death related to AE. Only those categories in which at least 1 participant had data for any reporting group were reported. Safety set included all randomised participants who received at least 1 dose of study treatment.
    End point type
    Other pre-specified
    End point timeframe
    From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)
    End point values
    		 Etrasimod Placebo
    Number of subjects analysed
    154
    79
    Units: Participants
        Grade 1
    48
    23
        Grade 2
    42
    24
        Grade 3
    11
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)
    Adverse event reporting additional description
    Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety set included all randomised participants who received at least 1 dose of study treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants with moderately active UC were randomised to receive placebo matched to Etrasimod tablet orally QD for 52-Week.

    Reporting group title
    Etrasimod
    Reporting group description
    		 Participants with moderately active UC were randomised to receive Etrasimod 2 mg tablet orally QD for 52-Week.

    Serious adverse events
    		 Placebo Etrasimod
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 79 (1.27%)
    10 / 154 (6.49%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 154 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Post procedural infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Etrasimod
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 79 (60.76%)
    100 / 154 (64.94%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of bone
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Anogenital warts
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Eye naevus
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Haemangioma of liver
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Skin papilloma
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Lipoma
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    3
    Hypotension
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 154 (1.30%)
         occurrences all number
    1
    2
    Pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    4
    Hyperpyrexia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 79 (0.00%)
    5 / 154 (3.25%)
         occurrences all number
    0
    5
    Early satiety
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Chest pain
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Social circumstances
    Postmenopause
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    3
    Nasal inflammation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 79 (3.80%)
    0 / 154 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 79 (1.27%)
    13 / 154 (8.44%)
         occurrences all number
    1
    15
    Blood urine present
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 154 (1.95%)
         occurrences all number
    1
    4
    Blood bilirubin increased
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    2
    Blood cholesterol increased
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    4
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 79 (0.00%)
    5 / 154 (3.25%)
         occurrences all number
    0
    5
    Blood creatinine increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 154 (1.30%)
         occurrences all number
    1
    2
    Blood phosphorus increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    2
    Blood triglycerides increased
         subjects affected / exposed
    1 / 79 (1.27%)
    8 / 154 (5.19%)
         occurrences all number
    1
    9
    Blood uric acid increased
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 79 (1.27%)
    8 / 154 (5.19%)
         occurrences all number
    2
    10
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Heart rate decreased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Lung diffusion test decreased
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 154 (0.65%)
         occurrences all number
    2
    1
    Weight decreased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 79 (2.53%)
    13 / 154 (8.44%)
         occurrences all number
    2
    20
    Injury, poisoning and procedural complications
    Cataract operation complication
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Epicondylitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Face injury
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Immunisation reaction
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Radius fracture
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Bradycardia
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Arrhythmia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Bundle branch block right
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 79 (2.53%)
    5 / 154 (3.25%)
         occurrences all number
    2
    7
    Headache
         subjects affected / exposed
    3 / 79 (3.80%)
    9 / 154 (5.84%)
         occurrences all number
    3
    10
    Loss of consciousness
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Nerve compression
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    3
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Coagulopathy
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    6 / 79 (7.59%)
    4 / 154 (2.60%)
         occurrences all number
    6
    5
    Lymphadenopathy
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Splenic cyst
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Eye disorders
    Eye haemorrhage
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Eye irritation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Epiretinal membrane
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Blepharitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    2
    Eyelid thickening
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Floppy eyelid syndrome
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Macular degeneration
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Vitreoretinal traction syndrome
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Uveitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Macular oedema
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 154 (1.30%)
         occurrences all number
    3
    2
    Colitis ulcerative
         subjects affected / exposed
    8 / 79 (10.13%)
    19 / 154 (12.34%)
         occurrences all number
    9
    19
    Abdominal tenderness
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Abdominal pain lower
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 154 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    3 / 79 (3.80%)
    4 / 154 (2.60%)
         occurrences all number
    3
    4
    Abdominal distension
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Rectal polyp
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 154 (1.30%)
         occurrences all number
    1
    2
    Oesophageal polyp
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 154 (1.30%)
         occurrences all number
    2
    2
    Large intestine polyp
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 154 (1.95%)
         occurrences all number
    0
    4
    Intestinal polyp
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Gastric polyps
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 154 (1.30%)
         occurrences all number
    1
    2
    Duodenal polyp
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 154 (1.30%)
         occurrences all number
    2
    2
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Cholestasis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Acne
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 154 (1.30%)
         occurrences all number
    1
    2
    Alopecia
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 154 (0.65%)
         occurrences all number
    3
    1
    Dermal cyst
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Drug eruption
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Erythema nodosum
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Onychoclasis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    2 / 79 (2.53%)
    3 / 154 (1.95%)
         occurrences all number
    2
    3
    Skin fibrosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Skin irritation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Renal pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Urine abnormality
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    4
    Crystalluria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 79 (2.53%)
    5 / 154 (3.25%)
         occurrences all number
    2
    8
    Back pain
         subjects affected / exposed
    1 / 79 (1.27%)
    5 / 154 (3.25%)
         occurrences all number
    1
    5
    Costochondritis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Enthesopathy
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Osteochondrosis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Sacroiliitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Arthritis reactive
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Acute sinusitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Pyuria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 154 (1.30%)
         occurrences all number
    1
    2
    Pneumonia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Otitis externa
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 79 (3.80%)
    5 / 154 (3.25%)
         occurrences all number
    3
    6
    Intervertebral discitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 154 (2.60%)
         occurrences all number
    0
    4
    Infected bite
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    7 / 79 (8.86%)
    15 / 154 (9.74%)
         occurrences all number
    7
    16
    Conjunctivitis
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 154 (1.95%)
         occurrences all number
    1
    3
    Clostridium difficile infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 154 (1.30%)
         occurrences all number
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 79 (5.06%)
    3 / 154 (1.95%)
         occurrences all number
    5
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 154 (0.65%)
         occurrences all number
    1
    1
    Vaginal infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 154 (0.65%)
         occurrences all number
    2
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 154 (1.95%)
         occurrences all number
    2
    5
    Hyperuricaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 154 (0.00%)
         occurrences all number
    1
    0
    Hypovitaminosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1
    Increased appetite
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 154 (0.65%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Aug 2022
    Updated safety-related reporting guidance and procedures to align with Pfizer safety related reporting procedures.

    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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