Eosinophilic Esophagitis
Conditions
Keywords
Eosinophilic esophagitis, Esophageal eosinophilia, Etrasimod, APD334, EoE, Eosinophilic oesophagitis
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.
Interventions
DRUGEtrasimod
Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.
DRUGPlacebo
Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.
Sponsors
Arena is a wholly owned subsidiary of Pfizer
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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: 1. Elemental diet 2. EoE food trigger elimination diet 3. 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 * Females who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | Baseline, 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. |
| Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Baseline, 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. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | Baseline, up to Week 24 | 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. |
| 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 | Baseline up to Week 24 | 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. |
Countries
Australia, Belgium, Canada, Germany, Netherlands, Spain, Switzerland, United States
Participant flow
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.
Pre-assignment details
A total of 262 participants were screened in the study. Out of 262, 154 participants failed screening and 108 participants were randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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. | 39 |
| 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. | 28 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-Blind Treatment Period (24 Weeks) | Adverse Event | 1 | 0 | 1 | 0 | 0 |
| Double-Blind Treatment Period (24 Weeks) | Lack of Efficacy | 1 | 1 | 1 | 0 | 0 |
| Double-Blind Treatment Period (24 Weeks) | Lost to Follow-up | 2 | 1 | 0 | 0 | 0 |
| Double-Blind Treatment Period (24 Weeks) | Non-compliance | 2 | 0 | 0 | 0 | 0 |
| Double-Blind Treatment Period (24 Weeks) | Pregnancy | 0 | 1 | 0 | 0 | 0 |
| Double-Blind Treatment Period (24 Weeks) | Withdrawal by Subject | 5 | 5 | 2 | 0 | 0 |
| OLE Period (28 Weeks) | Adverse Event | 3 | 0 | 0 | 1 | 0 |
| OLE Period (28 Weeks) | Lack of Efficacy | 2 | 1 | 0 | 0 | 0 |
| OLE Period (28 Weeks) | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
| OLE Period (28 Weeks) | Non-compliance | 1 | 0 | 0 | 0 | 1 |
| OLE Period (28 Weeks) | Other | 1 | 2 | 0 | 0 | 1 |
| OLE Period (28 Weeks) | Withdrawal by Subject | 1 | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Experimental: Etrasimod 2 mg | Experimental: Etrasimod 1 mg | Placebo Then Etrasimod Any Dose |
|---|---|---|---|---|
| Age, Continuous | 38.1 Years STANDARD_DEVIATION 11.52 | 35.6 Years STANDARD_DEVIATION 9.8 | 39.9 Years STANDARD_DEVIATION 12.87 | 39.1 Years STANDARD_DEVIATION 11.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 4 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 36 Participants | 34 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 105 Participants | 39 Participants | 38 Participants | 28 Participants |
| Sex: Female, Male Female | 51 Participants | 20 Participants | 17 Participants | 14 Participants |
| Sex: Female, Male Male | 57 Participants | 21 Participants | 22 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 | 0 / 28 | 0 / 30 | 0 / 31 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 30 / 41 | 27 / 39 | 23 / 28 | 16 / 30 | 19 / 31 | 11 / 12 | 7 / 12 |
| serious Total, serious adverse events | 0 / 41 | 0 / 39 | 0 / 28 | 0 / 30 | 0 / 31 | 0 / 12 | 1 / 12 |
Outcome results
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.
Time frame: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Etrasimod 2 mg | Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | -58.4 Percent change |
| Experimental: Etrasimod 1 mg | Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | -39.4 Percent change |
| Placebo Then Etrasimod Any Dose | Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | -21.5 Percent change |
p-value: 0.010395% CI: [-32.6, -4.49]ANCOVA
p-value: 0.286195% CI: [-21.48, 6.42]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.
Time frame: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Etrasimod 2 mg | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | -17.11 Units on a scale | Standard Error 2.247 |
| Experimental: Etrasimod 1 mg | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | -14.78 Units on a scale | Standard Error 2.166 |
| Placebo Then Etrasimod Any Dose | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | -19.49 Units on a scale | Standard Error 2.602 |
p-value: 0.489495% CI: [-4.43, 9.19]Linear mixed effects model
p-value: 0.167195% CI: [-2, 11.41]Linear mixed effects model
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.
Time frame: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Etrasimod 2 mg | Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | -46.3 eos/hpf | Standard Error 17.46 |
| Experimental: Etrasimod 1 mg | Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | -5.7 eos/hpf | Standard Error 16.99 |
| Placebo Then Etrasimod Any Dose | Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | 8.3 eos/hpf | Standard Error 22.37 |
p-value: 0.056595% CI: [-110.59, 1.54]ANCOVA
p-value: 0.619395% CI: [-69.61, 41.71]ANCOVA
Secondary
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
Time frame: Week 16
Population: The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Etrasimod 2 mg | Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | 22.0 Percentage of participants |
| Experimental: Etrasimod 1 mg | Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | 12.8 Percentage of participants |
| Placebo Then Etrasimod Any Dose | Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | 0 Percentage of participants |
p-value: 0.000795% CI: [9.23, 34.57]Mantel Haenszel
p-value: 0.012195% CI: [3.03, 24.66]Mantel Haenszel
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
Time frame: Week 16
Population: The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Etrasimod 2 mg | Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | 12.2 Percentage of participants |
| Experimental: Etrasimod 1 mg | Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | 7.7 Percentage of participants |
| Placebo Then Etrasimod Any Dose | Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | 0 Percentage of participants |
p-value: 0.017395% CI: [2.15, 22.16]Mantel Haenszel
p-value: 0.05995% CI: [-0.32, 17.07]Mantel Haenszel
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.
Time frame: Baseline up to Week 24
Population: The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Etrasimod 2 mg | 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 | TEAEs leading to death | 0 Participants |
| Experimental: Etrasimod 2 mg | 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 | TEAEs leading to study treatment discontinuation | 1 Participants |
| Experimental: Etrasimod 2 mg | 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 | Serious TEAEs | 0 Participants |
| Experimental: Etrasimod 1 mg | 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 | TEAEs leading to study treatment discontinuation | 0 Participants |
| Experimental: Etrasimod 1 mg | 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 | Serious TEAEs | 0 Participants |
| Experimental: Etrasimod 1 mg | 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 | TEAEs leading to death | 0 Participants |
| Placebo Then Etrasimod Any Dose | 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 | Serious TEAEs | 0 Participants |
| Placebo Then Etrasimod Any Dose | 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 | TEAEs leading to death | 0 Participants |
| Placebo Then Etrasimod Any Dose | 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 | TEAEs leading to study treatment discontinuation | 1 Participants |
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.
Time frame: Baseline, up to Week 24
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Etrasimod 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 3 | 1 Participants |
| Experimental: Etrasimod 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 2 | 9 Participants |
| Experimental: Etrasimod 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 5 | 0 Participants |
| Experimental: Etrasimod 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 1 | 19 Participants |
| Experimental: Etrasimod 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 4 | 0 Participants |
| Experimental: Etrasimod 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 4 | 0 Participants |
| Experimental: Etrasimod 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 1 | 15 Participants |
| Experimental: Etrasimod 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 2 | 12 Participants |
| Experimental: Etrasimod 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 3 | 0 Participants |
| Experimental: Etrasimod 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 5 | 0 Participants |
| Placebo Then Etrasimod Any Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 5 | 0 Participants |
| Placebo Then Etrasimod Any Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 3 | 2 Participants |
| Placebo Then Etrasimod Any Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 4 | 0 Participants |
| Placebo Then Etrasimod Any Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 2 | 11 Participants |
| Placebo Then Etrasimod Any Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | TEAE: Grade 1 | 8 Participants |