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    Clinical Trial Results:
    A Phase 2/3, Two-Part Study to Evaluate the Efficacy and Long-term Safety with Oral Etrasimod, 2 mg, Once Daily in Adult Participants with Moderate-to-Severe Atopic Dermatitis with a History of Prior Systemic Treatment Failure

    Summary
    EudraCT number
    		 2022-003361-37
    Trial protocol
    		 CZ  
    Global end of trial date
    29 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2025
    First version publication date
    08 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C5041005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05732454
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 East Hudson boulevard, New York, United States, NY 10001
    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
    24 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Etrasimod is a sphingosine 1-phosphate receptor modulator (S1PRM) and was being developed as an oral treatment for patients with moderate-to-severe AD. Part 1 of this study evaluated efficacy of etrasimod therapy QD and long-term safety in participants with moderate-to-severe AD with a history of a prior systemic therapy failure. Part 2 of this study were planned to evaluate the long-term safety of etrasimod therapy QD in participants with moderate-to-severe AD with a history of a prior systemic therapy failure.
    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 Harmonisation (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
    18 Jan 2023
    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
    Canada: 4
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    58
    EEA total number of subjects
    34
    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)
    52
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study had 2 parts: Part 1 and Part 2. Part 2 was never initiated; hence no results are reported for it. All results are pertaining to Part 1 in the record. Part 1 of the study had 16-week double-blind (DB) treatment period and then 52-week part 1 open label extension (OLE) treatment period.

    Pre-assignment
    Screening details
    		 A total of 58 participants with moderate-to-severe atopic dermatitis (AD) were enrolled in Part 1- DB period and out of them 51 continued into the Part 1- OLE period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
    Arm description
    		 Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etrasimod 2 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received etrasimod 2 mg QD

    Arm title
    		 DB Placebo Then OLE Etrasimod 2 mg
    Arm description
    		 Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
    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 received placebo QD

    Number of subjects in period 1
    		DB Etrasimod 2 mg Then OLE Etrasimod 2 mg DB Placebo Then OLE Etrasimod 2 mg
    Started
    30
    28
    Completed
    27
    25
    Not completed
    3
    3
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    -
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Part 1: OLE Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
    Arm description
    		 Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etrasimod 2 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received etrasimod 2 mg QD

    Arm title
    		 DB Placebo Then OLE Etrasimod 2 mg
    Arm description
    		 Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etrasimod 2 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received etrasimod 2 mg QD

    Number of subjects in period 2 [1]
    		DB Etrasimod 2 mg Then OLE Etrasimod 2 mg DB Placebo Then OLE Etrasimod 2 mg
    Started
    27
    24
    Completed
    0
    0
    Not completed
    27
    24
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    -
    1
         Study Terminated by Sponsor
    25
    19
         Lack of efficacy
    -
    1
    Notes
    [1] - 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: The number of subjects starting is correct

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Reporting group title
    DB Placebo Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Reporting group values
    		 DB Etrasimod 2 mg Then OLE Etrasimod 2 mg DB Placebo Then OLE Etrasimod 2 mg Total
    Number of subjects
    		 30 28
    Age Categorical
    Units: Subjects
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 40.0 ( 14.78 ) 43.4 ( 18.18 ) -
    Gender categorical
    Units: Participants
        Female (F)
    		 21 9 30
        Male (M)
    		 9 19 28
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 3 0 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 1 4
        White
    		 24 27 51
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 5 10
        Not Hispanic or Latino
    		 25 23 48
        Unknown or Not Reported
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    DB Period: Etrasimod 2 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.

    Subject analysis set title
    DB Period: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.

    Subject analysis set title
    OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received etrasimod in DB period continued to receive etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.

    Subject analysis set title
    OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.

    Subject analysis sets values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects
    30
    28
    30
    28
    Age Categorical
    Units: Subjects
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Participants
        Female (F)
    0
    0
    0
    0
        Male (M)
    0
    0
    0
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
    0
    0
        Asian
    0
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
    0
        Black or African American
    0
    0
    0
    0
        White
    0
    0
    0
    0
        More than one race
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
    0
        Not Hispanic or Latino
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Reporting group title
    DB Placebo Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
    Reporting group title
    DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Reporting group title
    DB Placebo Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Subject analysis set title
    DB Period: Etrasimod 2 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.

    Subject analysis set title
    DB Period: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.

    Subject analysis set title
    OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received etrasimod in DB period continued to receive etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.

    Subject analysis set title
    OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.

    Primary: Part 1, DB Period: Percentage of Participants Achieving Investigator’s Global Assessment (IGA) Response at Week 16

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    End point title
    		 Part 1, DB Period: Percentage of Participants Achieving Investigator’s Global Assessment (IGA) Response at Week 16
    End point description
    IGA measured AD severity, based on a 5-point scale (0-4); 0= AD is clear, 1= AD is almost clear, 2= mild AD, 3= moderate AD and 4= severe AD. IGA response was defined as participants achieving IGA 0 (clear) or 1 (almost clear) and a reduction of >=2 points from baseline. FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Number of participants in FAS with baseline IGA>=2 was included in this analysis.
    End point type
    Primary
    End point timeframe
    DB Period: Week 16
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Percentage of Participants
        number (not applicable)
    3.3
    7.1
    Statistical analysis title
    		 CMH Normal Approximation to IGA Response Rate
    Statistical analysis description
    Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 [moderate], 4 [severe]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.
    Comparison groups
    DB Period: Etrasimod 2 mg v DB Period: Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.558
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    -3.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.36
         upper limit
    		 8.83

    Primary: Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality)

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    End point title
    		 Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period.
    End point type
    Primary
    End point timeframe
    DB Period: From first dose of study drug up to 16 Weeks of treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Participants
    16
    8
    No statistical analyses for this end point

    Primary: Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation

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    End point title
    		 Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation [2]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period.
    End point type
    Primary
    End point timeframe
    DB Period: From first dose of study drug up to 16 Weeks of treatment
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Participants
    1
    0
    No statistical analyses for this end point

    Primary: Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality)

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    End point title
    		 Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) [3]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period.
    End point type
    Primary
    End point timeframe
    DB Period: From first dose of study drug up to 16 Weeks of treatment
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)

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    End point title
    		 Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) [4]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, Atrioventricular (AV) conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections [including progressive multifocal leukoencephalopathy (PML)], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and bilirubin elevation); posterior reversible encephalopathy syndrome (PRES) and malignancies. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period.
    End point type
    Primary
    End point timeframe
    DB Period: From first dose of study drug up to 16 Weeks of treatment
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Participants
    2
    1
    No statistical analyses for this end point

    Primary: Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities

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    End point title
    		 Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities [5]
    End point description
    Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    DB Period: From first dose of study drug up to 16 Weeks of treatment
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    29
    27
    Units: Participants
    22
    13
    No statistical analyses for this end point

    Primary: Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and Atrioventricular (AV) Blocks

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    End point title
    		 Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and Atrioventricular (AV) Blocks [6]
    End point description
    Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval [increase (inc) or decrease (dec)], QTc corrected using Fridericia’s formula (QTcF), and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks [AV conduction: First degree AV Block (AV C:1st-degree AV Block)] are reported in this outcome measure. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, “Number Analyzed” = number of participants evaluable for specified timepoints.
    End point type
    Primary
    End point timeframe
    DB Period: Pre-dose and 4 hours (h) post-dose on Day 1/Week 0; Pre-dose and 4h post-dose on Day (D) 113/Week(W) 16
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Participants
        Predose/D1: AVC: 1st-degree AV Block(n=30,28)
    1
    0
        4h postdose/D1:QTCF,SB:>=450(M)/>=470(F)(n=30,28)
    1
    0
        4h postdose/D1: CFB in QT:>30 msec inc(30,28)
    9
    0
        4h postdose/D1:AVC:1st-degree AV Block(n=30,28)
    3
    0
        Predose/W16: CFB in QT: >30 msec inc(n=26, 24)
    1
    0
        Predose/W16:CFB in QT: >60 msec inc(n=26,24)
    1
    0
        Predose/W16: CFB in QTcF:>30 msec inc(n=26,24)
    2
    0
        4h postdose/W16:CFB in QTcF:>30 msec inc(n=25,24)
    2
    0
        4h postdose/W16:CFB in QT:>30 msec inc(n=25,24)
    2
    0
        4h postdose/W16:AVC:1st-degree AV Block(n=25,24)
    2
    0
    No statistical analyses for this end point

    Primary: Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Signs

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    End point title
    		 Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Signs [7]
    End point description
    Vital signs evaluation included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. Safety analysis set in DB period included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, “Number Analyzed”= number of participants evaluable for specified timepoints.
    End point type
    Primary
    End point timeframe
    DB Period: Pre-dose and 1, 2, 3, 4 hours (hrs) post-dose on Day 1/Week 0; Day 29/Week 4; Day 57/Week 8; Day 85/Week 12; Pre-dose and 1, 2, 3, 4, 5 and 6 hrs post-dose on Day 113/Week 16
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Participants
        Predose/D1: DBP >90 mmHg (n=30,28)
    0
    1
        Predose/D1: Pulse rate: <60 bpm(n=30,28)
    1
    3
        Predose/D1: Pulse rate >100 bpm(n=30,28)
    1
    0
        1h postdose/D1: SBP:Chg >=30 mmHg dec(n=30,28)
    0
    1
        1h postdose/D1: DBP>90 mmHg(n=30,28)
    2
    2
        1h postdose/D1:Pulse rate: <50 bpm (n=30,28)
    1
    0
        1h postdose/D1: Pulse rate: <60 bpm(n=30,28)
    7
    3
        2h postdose/D1: SBP: >150 mmHg(n=30,28)
    0
    2
        2h postdose/D1: DBP >90 mmHg (n=30,28)
    0
    1
        2h postdose/D1: Pulse rate: <60 bpm(n=30, 28)
    12
    5
        3h post-dose/D1:SBP >150 mmHg(n=30,28)
    0
    1
        3h postdose/D1: SBP: Chg>=30 mmHg dec(n=30, 28)
    1
    0
        3h postdose/D1: DBP:>90 mmHg (n=30, 28)
    0
    1
        3h postdose/D1: DBP: Chg>=20 mmHg dec(n=30, 28)
    2
    0
        3h postdose/D1: Pulse rate: <60 bpm (n=30, 28)
    11
    6
        4h postdose/D1: DBP: >90 mmHg (n=30, 28)
    1
    1
        4h post-dose/D1: Pulse rate: <60 bpm(n=30, 28)
    10
    5
        4h postdose/D1: Pulse rate: >100 bpm (n=30, 28)
    1
    0
        W4: DBP:>90 mmHg (n=29, 27)
    2
    3
        W4: Pulse rate: <60 bpm (n=28, 27)
    2
    1
        W4: Pulse rate: >100 bpm (n=28, 27)
    1
    0
        W8: SBP: >150 mmHg (n=28, 25)
    0
    1
        W8: DBP:>90 mmHg (n=28, 25)
    3
    3
        W8: DBP:Chg >=20 mmHg dec (n=28, 25)
    0
    1
        W8: Pulse rate: <60 bpm (n=28, 25)
    3
    1
        W12: SBP: >150 mmHg (n=27, 25)
    0
    1
        W12: DBP:>90 mmHg (n=27, 25)
    1
    3
        W12:Pulse rate: <60 bpm(n=27,25)
    1
    0
        W12: Pulse rate: >100 bpm (n=27,25)
    0
    2
        Predose/W16: SBP: >150 mmHg(n=26, 24)
    0
    1
        Predose/W16: DBP: >90 mmHg(n=26, 24)
    2
    0
        Predose/W16: Pulse rate: <60 bpm (n=26, 24)
    2
    2
        1h postdose/W16: SBP: >150 mmHg (n=26, 24)
    0
    1
        1h postdose/W16: SBP:Chg>=30 mmHg dec(n=26,24)
    0
    1
        1h postdose/W16: DBP: >90 mmHg(n=26, 24)
    2
    1
        1h postdose/W16: Pulse rate: <50 bpm (n=26, 24)
    1
    1
        1h postdose/W16: Pulse rate: <60 bpm(n=26, 24)
    3
    4
        2h postdose/W16: SBP: >150 mmHg (n=26, 24)
    0
    1
        2h postdose/W16: SBP:Chg>=30 mmHg dec(n=26,24)
    0
    2
        2h postdose/W16: DBP: >90 mmHg(n=26,24)
    2
    2
        2h postdose/W16: Pulse rate: <50 bpm (n=26, 24)
    0
    1
        2h postdose/W16: Pulse rate: <60 bpm (n=26, 24)
    3
    10
        3h postdose/W16:DBP: >90 mmHg (n=26, 24)
    2
    0
        3h postdose/W16: Pulse rate: <50 bpm (n=26, 24)
    0
    1
        3h postdose/W16: Pulse rate: <60 bpm (n=26, 24)
    3
    9
        4hpostdose/W16: SBP: >150 mmHg(n=26, 24)
    0
    1
        4h postdose/W16: DBP:>90 mmHg (n=26, 24)
    2
    0
        4h postdose/W16: DBP:Chg>=20 mmHg dec(n=26,24)
    0
    1
        4h postdose/W16:Pulse rate: <50 bpm(n=26, 24)
    0
    1
        4h postdose/W16:Pulse rate:<60 bpm (n=26, 24)
    1
    6
        5h postdose/W16:Pulse rate:<50 bpm (n=0,1)
    0
    1
        5h postdose/W16:Pulse rate:<60 bpm (n=0,1)
    0
    1
        6h postdose/W16:Pulse rate:<50 bpm (n=0,1)
    0
    1
        6h postdose/W16: Pulse rate:<60 bpm (n=0,1)
    0
    1
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With TEAEs (All Causality)

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    End point title
    		 Part 1, OLE Period: Number of Participants With TEAEs (All Causality) [8]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    30
    28
    Units: Participants
    9
    5
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation

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    End point title
    		 Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation [9]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    30
    28
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality)

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    End point title
    		 Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) [10]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator. Safety analysis set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    30
    28
    Units: Participants
    1
    0
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality)

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    End point title
    		 Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) [11]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections [including PML], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies. Safety analysis set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    30
    28
    Units: Participants
    1
    0
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities

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    End point title
    		 Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities [12]
    End point description
    Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. Safety analysis set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    28
    25
    Units: Participants
    20
    18
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and Atrioventricular (AV) Blocks

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    End point title
    		 Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and Atrioventricular (AV) Blocks [13]
    End point description
    Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia’s formula (QTcF), and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure. OLE period: Safety analysis set included all participants who received at least 1 dose of study drug in the OLE Period. Here, “Number Analyzed”= number of participants evaluable for specified timepoints.
    End point type
    Primary
    End point timeframe
    OLE Period: Day 169/Week 24
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    30
    28
    Units: Participants
        W24:QTCF,SB:>=450(M)/>=470(F) (n=14,11)
    1
    0
        Week 24:CFB in QTcF: >30 msec inc (n=14,11)
    1
    0
        Week 24:CFB in QT: >30 msec inc (n=14,11)
    2
    0
        Week 24:CFB in QT: >60 msec inc (n=14,11)
    1
    0
    No statistical analyses for this end point

    Primary: Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Signs

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    End point title
    		 Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Signs [14]
    End point description
    Vital signs evaluation included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. OLE period: Safety analysis set included all participants who received at least 1 dose of study drug in the OLE Period. Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for the specified endpoint.
    End point type
    Primary
    End point timeframe
    OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow up 1 (FU1); Follow up 2 (FU2)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was planned for this end point
    End point values
    		 OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Number of subjects analysed
    26
    23
    Units: Participants
        W20:SBP:>150 mmHg(n=26,23)
    1
    1
        W20:SBP: Change:>=30 mmHg dec (n=26,23)
    0
    1
        W20:DBP:>90 mmHg(n=26,23)
    2
    1
        W20:Pulse rate: <60 bpm(n=26,23)
    1
    0
        W24:SBP:>150 mmHg(n=25,21)
    0
    1
        W24:SBP: CFB:>=30 mmHg dec(n=25,21)
    0
    1
        W24:DBP:>90 mmHg(n=25,21)
    1
    1
        W24:DBP: CFB>=20 mmHg dec(n=25, 21)
    0
    1
        W24: Pulse rate: <60 bpm (n=25, 21)
    1
    1
        W32: DBP: >90 mmHg (n=11, 9)
    1
    0
        W40: DBP: >90 mmHg (n=4, 3)
    1
    0
        FU1: DBP: >90 mmHg (n=21, 18)
    2
    0
        FU1: Pulse rate: <60 bpm (n=21, 18)
    1
    2
        FU2: DBP: >90 mmHg (n=21, 19)
    2
    0
        FU2: Pulse rate: <60 bpm (n=21, 19)
    1
    2
    No statistical analyses for this end point

    Secondary: Part 1, DB Period: Percentage of Participants Who Achieved >=75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) at Week 16

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    End point title
    		 Part 1, DB Period: Percentage of Participants Who Achieved >=75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) at Week 16
    End point description
    EASI-75 response was defined as a 75% reduction or greater in EASI score from Baseline to Week 16. EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. FAS population were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    DB Period: Week 16
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Percentage of Participants
        number (not applicable)
    23.3
    14.3
    Statistical analysis title
    		 CMH Normal Approximation to EASI-75 Response Rate
    Statistical analysis description
    Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 [moderate], 4 [severe]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.
    Comparison groups
    DB Period: Etrasimod 2 mg v DB Period: Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3685
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    9.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.7
         upper limit
    		 28.85

    Secondary: Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16

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    End point title
    		 Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16
    End point description
    EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs.FAS population were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    DB Period: Baseline, Week 16
    End point values
    		 DB Period: Etrasimod 2 mg DB Period: Placebo
    Number of subjects analysed
    30
    28
    Units: Percent change
        least squares mean (standard error)
    -53.87 ( 9.007 )
    -24.65 ( 9.533 )
    Statistical analysis title
    		 Percent Change from Baseline in EASI Score
    Statistical analysis description
    Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin’s rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.
    Comparison groups
    DB Period: Etrasimod 2 mg v DB Period: Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0303
    Method
    		 Rubin's rule
    Parameter type
    		 Difference in Mean
    Point estimate
    -29.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.53
         upper limit
    		 -2.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
    Adverse event reporting additional description
    The same all-causality treatment-emergent event may appear as both SAE & non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious & non-serious event during study. Safety analysis set was evaluated.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    DB Period: Etrasimod 2 mg
    Reporting group description
    		 Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.

    Reporting group title
    DB Period: Placebo
    Reporting group description
    		 Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.

    Reporting group title
    OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
    Reporting group description
    		 Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.

    Reporting group title
    OLE Period: Etrasimod 2 mg (Placebo in DB Period)
    Reporting group description
    		 Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.

    Reporting group title
    DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Reporting group title
    DB Placebo Then OLE Etrasimod 2 mg
    Reporting group description
    		 Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator’s judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.

    Serious adverse events
    		 DB Period: Etrasimod 2 mg DB Period: Placebo OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period) DB Etrasimod 2 mg Then OLE Etrasimod 2 mg DB Placebo Then OLE Etrasimod 2 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DB Period: Etrasimod 2 mg DB Period: Placebo OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) OLE Period: Etrasimod 2 mg (Placebo in DB Period) DB Etrasimod 2 mg Then OLE Etrasimod 2 mg DB Placebo Then OLE Etrasimod 2 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    4 / 28 (14.29%)
    4 / 30 (13.33%)
    1 / 28 (3.57%)
    9 / 30 (30.00%)
    5 / 28 (17.86%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 28 (7.14%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    3 / 30 (10.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    2
    4
    0
    5
    2
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    2 / 30 (6.67%)
    2 / 28 (7.14%)
         occurrences all number
    2
    2
    0
    1
    2
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    0
    0
    2
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 May 2023
    Protocol Amendment 1: Updated Section 1.3. Schedule of Activities, Updated Section 7.1 Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal, Updated Section 7.1.1 Discontinuation after Part 1 DB (Week 16) due to a Clinically Significant Safety Concern, Updated Section 7.1.3 ECG Changes, Updated Section 8.4.8 Adverse Events of Special Interest, Section 10.10.2 Serious Infections Monitoring, Updated Section 10.10.3.2 Study Treatment Discontinuation Related to Post Dose Cardiac Monitoring, Updated Section 10.10.4 Pulmonary Function Monitoring, Updated Section 10.10.5 Ophthalmic Symptom Monitoring; Section 5.3.1 Contraception, Updated Section 10.4 Appendix 4: Contraceptive and Barrier Guidance-Contraception guidance regarding abstinence and pregnancy risk; Updated Section 10.10.1 Monitoring of Lymphocyte, Neutrophil, and White Blood Cell Counts- The safety follow-up approach for participants with lymphocyte declines; Updated Section 8.3.3. Electrocardiograms- Expanded section to emphasize ECG values of potential concern at Screening and Day 1, and further detailed investigator responsibility and process of ECG evaluation; Updated Section 1.1 Synopsis, Section 4.1 Overall Design, Section 7.1.1. Discontinuation after Part 1 DB (Week 16) due to a Clinically Significant Safety Concern; Updated Section 1.1 Synopsis and Section 3 – Objectives, Endpoints, and Estimands- Removed the detailed bullet of change from baseline in laboratory values for the listed parameters

    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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