A Study to Assess the Safety and Efficacy of Oral Etrasim... | NCT04682639 | Trialant
NCT04682639
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 6, 2024Actual
Enrollment
108Actual
Phase
Phase 2
Conditions
Eosinophilic Esophagitis
Interventions
Etrasimod
Placebo
Etrasimod
Countries
United States
Australia
Belgium
Canada
Germany
Netherlands
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT04682639
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
APD334-206
Secondary IDs
ID
Type
Description
Link
C5041009
Other Identifier
Alias Study Number
2020-003226-23
EudraCT Number
Brief Title
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis
Acronym
VOYAGE
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
May 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 15, 2020Actual
Primary Completion Date
Sep 30, 2022Actual
Completion Date
Jun 30, 2023Actual
First Submitted Date
Dec 19, 2020
First Submission Date that Met QC Criteria
Dec 19, 2020
First Posted Date
Dec 24, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Sep 29, 2023
Results First Submitted that Met QC Criteria
Sep 29, 2023
Results First Posted Date
Oct 26, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 2, 2024
Last Update Posted Date
May 6, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Arena is a wholly owned subsidiary of Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.
Detailed Description
Not provided
Conditions Module
Conditions
Eosinophilic Esophagitis
Keywords
Eosinophilic esophagitis
Esophageal eosinophilia
Etrasimod
APD334
EoE
Eosinophilic oesophagitis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
108Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Etrasimod Dose 1
Experimental
Drug: Etrasimod
Etrasimod Dose 2
Experimental
Drug: Etrasimod
Placebo and Etrasimod
Placebo Comparator
Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.
Drug: Placebo
Drug: Etrasimod
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Etrasimod
Drug
Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.
Etrasimod Dose 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Baseline, Week 16
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16
The DSQ was used to measure the frequency and intensity of dysphagia to solid food. DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score = (Sum of points from questions 2+3 in the daily DSQ)×14 days/(Number of diaries reported with non-missing data). DSQ scores can range from 0 to 84, with a higher score indicating worse dysphagia.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AE is defined as an AE that started or worsened in severity on or after the first dose of study treatment. Severity is classified as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-Threatening, Grade 5: Death Related to AE.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils per high powered field (eos/hpf)
Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks during the Screening period
Inclusion Criteria for the Extension Treatment Period
Completion of the Week 24 study visit [including esophagogastroduodenoscopy (EGD)]
Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator
No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator
Willing to comply with all study visits and procedures for the Extension Treatment Period
Exclusion Criteria:
History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study
Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD
Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD
Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation:
Elemental diet
EoE food trigger elimination diet
Proton pump inhibitor (PPI) therapy
Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation
Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)
Use of any investigational agent or device within 12 weeks prior to Baseline
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
A total of 262 participants were screened in the study. Out of 262, 154 participants failed screening and 108 participants were randomized and treated.
Recruitment Details
The study consisted of a Double-Blind treatment period (24 weeks) and an Open Label Extension (OLE) period (28 weeks). Participants who were in the placebo group during the Double-Blind treatment period were re-randomized to etrasimod 1 milligram (mg) or etrasimod 2 mg at entry into the Open Label Extension period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
FG001
Experimental: Etrasimod 1 mg
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment Period (24 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 4, 2023
Sep 29, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Etrasimod Dose 2
APD334
Placebo
Drug
Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.
Placebo and Etrasimod
Etrasimod
Drug
Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.
Placebo and Etrasimod
APD334
Baseline, Week 16
Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Baseline, Week 16
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
Week 16
Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16
Week 16
Baseline, up to Week 24
Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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. Treatment-emergent are events between first dose of study drug and up to 24 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to etrasimod was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline up to Week 24
Birmingham
Alabama
35235
United States
Digestive Health Specialists
Dothan
Alabama
36301
United States
Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)
Dothan
Alabama
36301
United States
Dothan Surgery Center (Colonoscopy Location)
Dothan
Alabama
36301
United States
Pulmonary Associates (PFT Procedure Only, Second Location )
Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
FG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
FG003
OLE: Placebo Then Etrasimod 2 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
FG004
OLE: Placebo Then Etrasimod 1 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
FG00041 subjects
FG00139 subjects
FG00228 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00030 subjects
FG00131 subjects
FG00224 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00011 subjects
FG0018 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG0005 subjects
FG0015 subjects
FG0022 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-compliance
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
OLE Period (28 Weeks)
Type
Comment
Milestone Data
STARTED
FG00030 subjects
FG00131 subjects
FG0020 subjectsParticipants received placebo in Double-Blind treatment period were re-randomized into OLE Etrasimod 1 mg and Etrasimod 2 mg groups.
FG00312 subjectsParticipants received placebo in Double-Blind treatment period were re-randomized into OLE Etrasimod 1 mg and Etrasimod 2 mg groups.
FG00412 subjectsParticipants received placebo in Double-Blind treatment period were re-randomized into OLE Etrasimod 1 mg and Etrasimod 2 mg groups.
COMPLETED
FG00021 subjects
FG00124 subjects
FG0020 subjects
FG00311 subjects
FG004
NOT COMPLETED
FG0009 subjects
FG0017 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Non-compliance
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
All participants who were randomized to study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
BG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
BG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00041
BG00139
BG00228
BG003108
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00035.6± 9.80
BG00139.9± 12.87
BG00239.1± 11.65
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00117
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
The Full Analysis Set (FAS) will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Median
Inter-Quartile Range
Percent change
Baseline, Week 16
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Units
Counts
Participants
OG00033
OG00135
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-58.4(-86.21 to -26.25)
OG001-39.4(-71.08 to 78.95)
OG002-21.5(-57.20 to 55.42)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
0.0103
LS mean difference
-18.54
2-Sided
95
-32.60
-4.49
Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.
Other
OG001
OG002
ANCOVA
Secondary
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16
The DSQ was used to measure the frequency and intensity of dysphagia to solid food. DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score = (Sum of points from questions 2+3 in the daily DSQ)×14 days/(Number of diaries reported with non-missing data). DSQ scores can range from 0 to 84, with a higher score indicating worse dysphagia.
The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Secondary
Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
eos/hpf
Baseline, Week 16
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG002
Placebo Then Etrasimod Any Dose
Secondary
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Secondary
Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16
The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AE is defined as an AE that started or worsened in severity on or after the first dose of study treatment. Severity is classified as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-Threatening, Grade 5: Death Related to AE.
The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline, up to Week 24
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Other Pre-specified
Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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. Treatment-emergent are events between first dose of study drug and up to 24 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to etrasimod was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG001
Experimental: Etrasimod 1 mg
Time Frame
Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Description
Same event may appear as both non-SAE and a serious AE. 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 a serious and non-serious event during the study. All participants who receive any of the study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
41
0
41
30
41
EG001
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
39
0
39
27
39
EG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
28
0
28
23
28
EG003
OLE: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
30
0
30
16
30
EG004
OLE: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
31
0
31
19
31
EG005
OLE: Placebo Then Etrasimod 2 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
12
0
12
11
12
EG006
OLE: Placebo Then Etrasimod 1 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
0
12
1
12
7
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG0030 affected30 at risk
EG004
Fall
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0006 affected41 at risk
EG0013 affected39 at risk
EG0023 affected28 at risk
EG0032 affected30 at risk
EG0041 affected31 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected41 at risk
EG0011 affected39 at risk
EG0021 affected28 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0012 affected39 at risk
EG0021 affected28 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0025 affected28 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0021 affected28 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Eosinophilic oesophagitis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0023 affected28 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Bile acid malabsorption
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Oesophageal rupture
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
COVID-19
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0004 affected41 at risk
EG0014 affected39 at risk
EG0026 affected28 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0003 affected41 at risk
EG0012 affected39 at risk
EG0020 affected28 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0012 affected39 at risk
EG0020 affected28 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0012 affected39 at risk
EG0020 affected28 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Influenza
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Ear infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Epstein-Barr virus infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Viral infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0004 affected41 at risk
EG0014 affected39 at risk
EG0021 affected28 at risk
EG003
Headache
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0003 affected41 at risk
EG0012 affected39 at risk
EG0021 affected28 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hypoglossal nerve paralysis
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Migraine
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0021 affected28 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0003 affected41 at risk
EG0012 affected39 at risk
EG0020 affected28 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Blood pressure increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
C-reactive protein increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Heart rate decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Liver function test increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Transaminases increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Helicobacter test positive
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Pulmonary function test decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Blepharitis
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Blepharospasm
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Cataract
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Dry eye
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Eye irritation
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hypermetropia
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Photopsia
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Retinal degeneration
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Visual field defect
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Visual impairment
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Meibomian gland dysfunction
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Fatigue
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Influenza like illness
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected41 at risk
EG0010 affected39 at risk
EG0022 affected28 at risk
EG003
Chest discomfort
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0022 affected28 at risk
EG003
Chest pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Chills
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0012 affected39 at risk
EG0020 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Femoroacetabular impingement
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected41 at risk
EG0011 affected39 at risk
EG0022 affected28 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0012 affected39 at risk
EG0022 affected28 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0021 affected28 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Oropharyngeal spasm
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Limb fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0012 affected39 at risk
EG0020 affected28 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Excessive granulation tissue
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Breast discomfort
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0011 affected39 at risk
EG0020 affected28 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Skin odour abnormal
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Stress
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Pulmonary function test abnormal
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Hordeolum
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Acquired oesophageal web
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected41 at risk
EG0010 affected39 at risk
EG0020 affected28 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected41 at risk
EG0010 affected39 at risk
EG0021 affected28 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.
Other
OG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Units
Counts
Participants
OG00032
OG00136
OG00224
Title
Denominators
Categories
Title
Measurements
OG000-17.11± 2.247
OG001-14.78± 2.166
OG002-19.49± 2.602
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Linear mixed effects model
0.4894
LS mean difference
2.38
2-Sided
95
-4.43
9.19
Other
OG001
OG002
Linear mixed effects model
0.1671
LS mean difference
4.70
2-Sided
95
-2.00
11.41
Other
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Units
Counts
Participants
OG00033
OG00135
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-46.3± 17.46
OG001-5.7± 16.99
OG0028.3± 22.37
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
0.0565
LS mean difference
-54.53
2-Sided
95
-110.59
1.54
Other
OG001
OG002
ANCOVA
0.6193
LS mean difference
-13.95
2-Sided
95
-69.61
41.71
Other
Units
Counts
Participants
OG00041
OG00139
OG00228
Title
Denominators
Categories
Title
Measurements
OG00022.0
OG00112.8
OG0020
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mantel Haenszel
0.0007
Adjusted difference from placebo
21.90
2-Sided
95
9.23
34.57
Other
OG001
OG002
Mantel Haenszel
0.0121
Adjusted difference from placebo
13.85
2-Sided
95
3.03
24.66
Other
Units
Counts
Participants
OG00041
OG00139
OG00228
Title
Denominators
Categories
Title
Measurements
OG00012.2
OG0017.7
OG0020
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mantel Haenszel
0.0173
Adjusted difference from placebo
12.15
2-Sided
95
2.15
22.16
Other
OG001
OG002
Mantel Haenszel
0.0590
Adjusted difference from placebo
8.37
2-Sided
95
-0.32
17.07
Other
OG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
Units
Counts
Participants
OG00029
OG00127
OG00221
Title
Denominators
Categories
Title
Measurements
TEAE: Grade 1
OG00019
OG00115
OG0028
TEAE: Grade 2
OG0009
OG00112
OG00211
TEAE: Grade 3
OG0001
OG0010
OG0022
TEAE: Grade 4
OG0000
OG0010
OG0020
TEAE: Grade 5
OG0000
OG0010
OG0020
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
OG002
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.