A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— VOYAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682639
• Other study ID #: APD334-206
• Secondary ID: C50410092020-003
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Etrasimod
Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.
• Placebo
Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.
• Etrasimod
Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.

Locations

Country	Name	City	State
Australia	MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons (OCT Facility)	Bellfield
Australia	Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )	Birtinya
Australia	Sunshine University Private Hospital	Birtinya	Queensland
Australia	Eastern Clinical Research Unit	Box Hill	Victoria
Australia	Eastern Health	Box Hill	Victoria
Australia	Box Hill Eye Surgeons (OCT Facility)	Box Hill North	Victoria
Australia	Mater Misericordiae Ltd	Brisbane South	Queensland
Australia	Buderim Eye Centre (OCT Facility)	Buderim	Queensland
Australia	Retina Specialists Victoria (OCT Facility)	Camberwell	Victoria
Australia	Elizabeth Specialist Suites (PFT Facility)	Elizabeth Vale	South Australia
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Lyell McEwin Hospital.	Elizabeth Vale	South Australia
Australia	The Northern Hospital	Epping	Victoria
Australia	Footscray Hospital	Footscray	Victoria
Australia	Dr Shiran DeSilva Respiratory Clinic	Mackay	Queensland
Australia	Mackay Discount Drug Store	Mackay	Queensland
Australia	Mater Misericordiae Hospital	Mackay	Queensland
Australia	Queensland X-Ray	Mackay	Queensland
Australia	Vision Eye Institute Mackay	Mackay	Queensland
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	Vision Eye Institute	Melbourne	Victoria
Australia	Modbury Hospital (OCT Facility)	Modbury	South Australia
Australia	Coral Sea Clinical Research Institute	North Mackay	Queensland
Belgium	AZ St Lucas Brugge	Brugge
Belgium	AZ Delta	Roeselare
Belgium	Centre Hospitalier Wallonie Picarde (CHWAPI)	Tournai
Canada	Mount Sinai Services Inc. Dr George Charames	Toronto	Ontario
Germany	Precision for Medicine GmbH	Berlin
Netherlands	Amsterdam UMC, location AMC	Amsterdam
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Miguel Servet	Zaragoza
Switzerland	Universitätsspital Zürich	Zurich
Switzerland	University Hospital Zurich	Zurich
Switzerland	Universtätsspital Zürich	Zurich
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Peachtree Allergy and Asthma Clinica - Pulmonary Function Test	Atlanta	Georgia
United States	Piedmont Hospital- DLCO	Atlanta	Georgia
United States	Ross Eyecare - Opthalmoscopy and OCT	Atlanta	Georgia
United States	Clinical Research Center of Alabama, LLC	Birmingham	Alabama
United States	GastroHealth - St. Vincent's East	Birmingham	Alabama
United States	RecioMed Clinical Research Network, Inc	Boynton Beach	Florida
United States	Steelgate	Bradenton	Florida
United States	Allied Health Clinical Research Organization, LLC (IP Address)	Brick	New Jersey
United States	Del Negro & Senft Eye Associates	Brick	New Jersey
United States	Seashore Surgical Institute	Brick	New Jersey
United States	Shore Pulmonary, PA	Brick	New Jersey
United States	West Shore Endoscopy Center	Camp Hill	Pennsylvania
United States	Clinical and Translational Research Center Outpatient Unit	Chapel Hill	North Carolina
United States	lnvestigational Drug Services, University of North Carolina Hospitals (IP storage address)	Chapel Hill	North Carolina
United States	UNC Clinical Research Eastowne	Chapel Hill	North Carolina
United States	UNC Endoscopy Center at Meadowmont	Chapel Hill	North Carolina
United States	UNC Hospitals Pulmonary Function Lab (PFT and DLCO procedures only)	Chapel Hill	North Carolina
United States	UNC Hospitals Pulmonary Specialty Clinic (PFT and DLCO procedures only)	Chapel Hill	North Carolina
United States	UNC Kittner Eye Center (OCT procedure only)	Chapel Hill	North Carolina
United States	University of North Carolina - Memorial Hospital	Chapel Hill	North Carolina
United States	Geauga Sleep Center (PFT Only)	Chardon	Ohio
United States	Chesapeake Pulmonary and Critical Care Medicine (PFT Only)	Chesapeake	Virginia
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Gastroenterology Associates of Tidewater - Endoscopy Center	Chesapeake	Virginia
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cincinnati Eye Institute (ophthalmic and OCT exams)	Cincinnati	Ohio
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Gastro Health Research	Cincinnati	Ohio
United States	Leon A. Reid, III, M.D. (OCT)	Cincinnati	Ohio
United States	Leon A. Reid, III, M.D. (OCT)	Cincinnati	Ohio
United States	New Horizons Clinical Research (PFT)	Cincinnati	Ohio
United States	Ohio GI and Liver Institute	Cincinnati	Ohio
United States	Tristate Endoscopy Center (Endoscopy)	Cincinnati	Ohio
United States	UC Health Hoxworth (ophthalmic and OCT only)	Cincinnati	Ohio
United States	UC Health Physicians Office Clifton (where subjects seen)	Cincinnati	Ohio
United States	UC Health Pulmonary (PFT Location)	Cincinnati	Ohio
United States	UC Health Pulmonary (Pulmonary Function Testing)	Cincinnati	Ohio
United States	UC Health/Division of Digestive Diseases (where subjects seen)	Cincinnati	Ohio
United States	University Endoscopy Center (Endoscopy location)	Cincinnati	Ohio
United States	University of Cincinnati Medical Center Diagnostic Center (Endoscopy location)	Cincinnati	Ohio
United States	Bay Area Chest Physicians, P.A., - Pulmonary Function Test	Clearwater	Florida
United States	Gastro Florida (Regulatory & Administrative Duties)	Clearwater	Florida
United States	MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)	Clearwater	Florida
United States	Northwood Vision Optical Coherence Tomography (OCT)	Clearwater	Florida
United States	Safety Harbor Surgery Center	Clearwater	Florida
United States	West Coast Endoscopy	Clearwater	Florida
United States	West Coast Endoscopy Center	Clearwater	Florida
United States	Erdey Searcy Eye Group	Columbus	Ohio
United States	Beraja Medical Institute (OCT)	Coral Gables	Florida
United States	Bayfront Health Seven Rivers (Liver Biopsy Location)	Crystal River	Florida
United States	Citrus Surgery and Endoscopy Center (EGD Location)	Crystal River	Florida
United States	Digestive Health Center (Endoscopy)	Dallas	Texas
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	Atlanta Endoscopy Center LTD	Decatur	Georgia
United States	Georgia Eye Partners	Decatur	Georgia
United States	Pulmonary & Sleep Specialist	Decatur	Georgia
United States	Digestive Health Specialists	Dothan	Alabama
United States	Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)	Dothan	Alabama
United States	Dothan Surgery Center (Colonoscopy Location)	Dothan	Alabama
United States	Flowers Hospital (PFT Procedure Only)	Dothan	Alabama
United States	Pulmonary Associates (PFT Procedure Only, Second Location )	Dothan	Alabama
United States	Ohio Gastroenterology Group	Dublin	Ohio
United States	Duke Eye Center	Durham	North Carolina
United States	Duke Medical Plaza North Duke Street	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Investigational Drug Services (Pharmacy)	Durham	North Carolina
United States	Coastal Research Institute	Fayetteville	North Carolina
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Harman Eye Center (OCT only)	Forest	Virginia
United States	Isight Vision Care	Fountain Valley	California
United States	Mile Square Surgery Center	Fountain Valley	California
United States	Pulmonary & Sleep Consultants	Fountain Valley	California
United States	Allied Health Clinical Research Organization, LLC	Freehold	New Jersey
United States	Paragon Rx Clinical, Inc.	Garden Grove	California
United States	Glen Endoscopy Center (Endoscopy Facility)	Glenview	Illinois
United States	GI Alliance (PFT)	Gurnee	Illinois
United States	Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)	Gurnee	Illinois
United States	Medical Eye Services LTD (Ophthalmoscopy with OCT)	Gurnee	Illinois
United States	Farrel Opthalmology(OCT only)	Harrisburg	Pennsylvania
United States	Harrisburg Eye Associates (OCT only)	Harrisburg	Pennsylvania
United States	Medical Arts Allergy,PC (PFT Only)	Harrisburg	Pennsylvania
United States	Susquehanna Research Group, LLC	Harrisburg	Pennsylvania
United States	Advanced Eye Center	Hialeah	Florida
United States	UNC Gastroenterology at Hillsborough	Hillsborough	North Carolina
United States	Precision for Medicine	Houston	Texas
United States	Avant Research Associates, LLC	Huntsville	Alabama
United States	Baily Cove Eye Care	Huntsville	Alabama
United States	Crestwood Medical Center	Huntsville	Alabama
United States	Grand Teton Research Group, PLLC	Idaho Falls	Idaho
United States	Grand Teton Surgical Center	Idaho Falls	Idaho
United States	Idaho Falls Pulmonary/ Sleep and Critical Care Specialists (PFT procedure only)	Idaho Falls	Idaho
United States	Premier Eye Care of Eastern Idaho (OCT procedure only)	Idaho Falls	Idaho
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Suncoast Endoscopy Center (EGD Location)	Inverness	Florida
United States	West Coast Eye Institute (OCT Procedure Only)	Inverness	Florida
United States	Clark Memorial Health (PFTs)	Jeffersonville	Indiana
United States	One Anesthesia, AACC Division	Jeffersonville	Indiana
United States	Franklin Woods Community Hospital (PFT Only)	Johnson City	Tennessee
United States	Pulmonary Associates of ET/Jeff Farrow, MD - PFT only	Johnson City	Tennessee
United States	Jupiter Outpatient Surgery Center	Jupiter	Florida
United States	The Regional Eye Center - OCT only	Kingsport	Tennessee
United States	Tri-Cities Gastroenterology	Kingsport	Tennessee
United States	Acadiana Endoscopy Center, Inc	Lafayette	Louisiana
United States	Acadiana Gastroenterology Associates	Lafayette	Louisiana
United States	Combined Gastro Research, LLC	Lafayette	Louisiana
United States	Gastroenterology Clinic of Acadiana (IP address)	Lafayette	Louisiana
United States	Lafayette Family Eye Care	Lafayette	Louisiana
United States	Lafayette General Endoscopy Center	Lafayette	Louisiana
United States	North Shore Endoscopy Center (Endoscopy)	Lake Bluff	Illinois
United States	Inland Pulmonary Specialists [PFT Only]	Lake Elsinore	California
United States	Auzmer Research	Lakeland	Florida
United States	Central Florida Sleep Diagnostic & Treatment Center	Lakeland	Florida
United States	Advanced Endoscopy and Pain Center	Lancaster	California
United States	Advanced Endoscopy and Pain Center - EGD & Biopsy Collection	Lancaster	California
United States	Antelope Valley Eye Care	Lancaster	California
United States	Antelope Valley Eye Care - OCT	Lancaster	California
United States	Antelope Valley Lung and Sleep Institute	Lancaster	California
United States	Apollo Surgery Center	Lancaster	California
United States	AV Pediatrics, Allergy and Family Medicine - PFT, Physical Exams, Lab Reviews, ECG Reviews	Lancaster	California
United States	Gastro Care Institute	Lancaster	California
United States	Jatinder S. Pruthi, MD FACG CPI - Physical Exams, Lab Reviews, ECG Reviews	Lancaster	California
United States	Om Research LLC	Lancaster	California
United States	West Coast Eye Institute (OCT Procedure Only)	Lecanto	Florida
United States	Penn State Health Medical Group - Lemoyne (PFT only)	Lemoyne	Pennsylvania
United States	Quest	Lenexa	Kansas
United States	Libertyville Imaging Center (Diagnostic Imaging)	Libertyville	Illinois
United States	Celerion, Inc.	Lincoln	Nebraska
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Four Seasons Allergy and Asthma	Little Rock	Arkansas
United States	Little Rock Eye Clinic	Little Rock	Arkansas
United States	Premier Gastroenterology	Little Rock	Arkansas
United States	Premier Gastroenterology Endoscopy Center	Little Rock	Arkansas
United States	Advanced Vision Care (OCT)	Los Angeles	California
United States	Clinical Trials Unit	Los Angeles	California
United States	Keck Hospital of USC	Los Angeles	California
United States	USC IDS Pharmacy	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Lynchburg Pulmonary Associates, Inc. (PFT only)	Lynchburg	Virginia
United States	Madison Surgery Center	Madison	Alabama
United States	Great Lakes Medical Research, LLC	Mentor	Ohio
United States	The Endoscopy Center of Lake County	Mentor	Ohio
United States	Juan Barrio, MD (PFT when needed)	Miami	Florida
United States	Research Associates of South Florida	Miami	Florida
United States	Research Associates of South Florida	Miami	Florida
United States	The Endoscopy Center (Endoscopy Procedure)	Miami	Florida
United States	M Health Fairview Clinics and Surgery Center	Minneapolis	Minnesota
United States	M Health Fairview University of Minnesota Medical Center	Minneapolis	Minnesota
United States	University of Minnesota Health Clinical research unit	Minneapolis	Minnesota
United States	University of Minnesota Health Opthalmology Clinic	Minneapolis	Minnesota
United States	United Medical Doctors	Murrieta	California
United States	United Surgery Center Murrieta [Endoscopy Only]	Murrieta	California
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	Vanderbilt GI Endoscopy Lab at One Hundred Oaks	Nashville	Tennessee
United States	Vanderbilt Pulmonary Medicine	Nashville	Tennessee
United States	Vanderbilt University Medical Center - Digestive Disease Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center - GI Research Office	Nashville	Tennessee
United States	Vanderbilt University Medical Center - Heart Station	Nashville	Tennessee
United States	Vanderbilt University Medical Center GI Endoscopy Lab	Nashville	Tennessee
United States	Del Negro & Senft Eye associates	Neptune	New Jersey
United States	Baptist Health Floyd (PFTs)	New Albany	Indiana
United States	Gastroenterology Health Partners, PLLC, (IP)	New Albany	Indiana
United States	John Kenyon Eye Center (OCT)	New Albany	Indiana
United States	One Anesthesia, PLLC	New Albany	Indiana
United States	Physicians Medical Center (Endoscopies)	New Albany	Indiana
United States	CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center-new Braunfels(Endoscopy)	New Braunfels	Texas
United States	Tyrus Schroeder (PFT)	New Braunfels	Texas
United States	Wagner Macula and Retina Center (OCT only)	Norfolk	Virginia
United States	Wagner Macula and Retina Center (OCT only)	Norfolk	Virginia
United States	Norman Endoscopy Center	Norman	Oklahoma
United States	Central Sooner Research	Oklahoma City	Oklahoma
United States	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma
United States	Digestive Disease Specialists, Inc. Endoscopy Lab	Oklahoma City	Oklahoma
United States	Johnston Eye	Oklahoma City	Oklahoma
United States	Pulmonary Physicians of Oklahoma	Oklahoma City	Oklahoma
United States	Retinal Center of Oklahoma	Oklahoma City	Oklahoma
United States	Vitreo Retinal Consultants (OCT only)	Painesville	Ohio
United States	Arizona Retina Institute/ Phoenix Retina Associates(OCT)	Peoria	Arizona
United States	SimonMed Imaging (Imaging)	Peoria	Arizona
United States	Investigational Drug Services	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Eye Place Jenny Fan, OD (OCT Only)	Plano	Texas
United States	Brier Creek Medical Pavilion	Raleigh	North Carolina
United States	Rapid City Medical Center, LLP	Rapid City	South Dakota
United States	Del Negro & Senft eye Associates	Red Bank	New Jersey
United States	Pulmonary Medicine Consultants (PFT with DCLO only)	Richardson	Texas
United States	Florida Eye Specialists and Cataract Institute	Riverview	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Huntsman Cancer Hospital	Salt Lake City	Utah
United States	University of Utah Gastroenterology Division Research	Salt Lake City	Utah
United States	University of Utah Hospital	Salt Lake City	Utah
United States	University Of Utah School Of Medicine	Salt Lake City	Utah
United States	Advanced Imaging	San Marcos	Texas
United States	Central Texas Eye Center (OCT)	San Marcos	Texas
United States	CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center - San Marcos (Endoscopy)	San Marcos	Texas
United States	Dr. Dennis Bassetti, MD	Sebring	Florida
United States	Highlands Eye Institute, P.A.	Sebring	Florida
United States	The Surgery and Endoscopy Center	Sebring	Florida
United States	Arizona Digestive Health - Sun City	Sun City	Arizona
United States	Sun City Endoscopy Center (Endoscopy)	Sun City	Arizona
United States	Ambulatory Surgery Center	Tampa	Florida
United States	Pulmonology & Sleep Disorders	Tampa	Florida
United States	California Eye Professionals [OCT Only]	Temecula	California
United States	United Surgery Center Temecula [Endoscopy Only]	Temecula	California
United States	Cotton O'Neil Clinic (OCT Procedure Only)	Topeka	Kansas
United States	Cotton O'Neil Clinic (PFT Procedure Only)	Topeka	Kansas
United States	Cotton O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Alabama Eye MD	Vestavia Hills	Alabama
United States	Sleep Specialists of Tidewater - Virginia Beach (PFT Only)	Virginia Beach	Virginia
United States	Bay Area Houston Endoscopy Center (Endoscopy)	Webster	Texas
United States	Coastal Eye Associates (OCT)	Webster	Texas
United States	GI Alliance (Patients Seen)	Webster	Texas
United States	Houston Lung and Sleep Clinic, PA (PFT)	Webster	Texas
United States	Tower Health Reading Hospital	West Reading	Pennsylvania
United States	Lake Pulmonary Associates (PFT only)	Willoughby	Ohio
United States	Retina Specialists of Ohio(OCT only)	Willoughby Hills	Ohio
United States	Day Surgery Center	Winter Haven	Florida
United States	Berks Center for Digestive Health	Wyomissing	Pennsylvania
United States	Berks Schuylkill Respiratory Specialists "PFT Procedure Only"	Wyomissing	Pennsylvania
United States	Eye Consultants of Pennsylvania, PC "OCT Procedure Only"	Wyomissing	Pennsylvania
United States	Regional Gastroenterology Associates of Lancaster, Ltd.	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Arena is a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, up to Week 24
Other	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
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16
Secondary	Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16		Week 16
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		Week 16

External Links

•   To obtain contact information for a study center near you, click here.