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

May 2, 2024 updated by: Pfizer

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis

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.

Study Overview

Status

Completed

Conditions

Eosinophilic Esophagitis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Bellfield, Australia, 3081
    - MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons (OCT Facility)
  - Birtinya, Australia, 4575
    - Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
- Queensland
  - Birtinya, Queensland, Australia, 4575
    - Sunshine University Private Hospital
  - Brisbane South, Queensland, Australia, 4101
    - Mater Misericordiae Ltd
  - Buderim, Queensland, Australia, 4558
    - Buderim Eye Centre (OCT Facility)
  - Mackay, Queensland, Australia, 4740
    - Dr Shiran DeSilva Respiratory Clinic
  - Mackay, Queensland, Australia, 4740
    - Mackay Discount Drug Store
  - Mackay, Queensland, Australia, 4740
    - Mater Misericordiae Hospital
  - Mackay, Queensland, Australia, 4740
    - Queensland X-Ray
  - Mackay, Queensland, Australia, 4740
    - Vision Eye Institute Mackay
  - Maroochydore, Queensland, Australia, 4558
    - Coastal Digestive Health
  - North Mackay, Queensland, Australia, 4740
    - Coral Sea Clinical Research Institute
- South Australia
  - Elizabeth Vale, South Australia, Australia, 5112
    - Lyell McEwin Hospital
  - Elizabeth Vale, South Australia, Australia, 5112
    - Elizabeth Specialist Suites (PFT Facility)
  - Elizabeth Vale, South Australia, Australia, 5112
    - Lyell McEwin Hospital.
  - Modbury, South Australia, Australia, 5092
    - Modbury Hospital (OCT Facility)
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Eastern Health
  - Box Hill, Victoria, Australia, 3128
    - Eastern Clinical Research Unit
  - Box Hill North, Victoria, Australia, 3129
    - Box Hill Eye Surgeons (OCT Facility)
  - Camberwell, Victoria, Australia, 3124
    - Retina Specialists Victoria (OCT Facility)
  - Epping, Victoria, Australia, 3076
    - The Northern Hospital
  - Footscray, Victoria, Australia, 3011
    - Footscray Hospital
  - Melbourne, Victoria, Australia, 3011
    - Vision Eye Institute
Belgium
- - Brugge, Belgium, 8310
    - AZ St Lucas Brugge
  - Roeselare, Belgium, 8800
    - AZ Delta
  - Tournai, Belgium, 7500
    - Centre Hospitalier Wallonie Picarde (CHWAPI)
Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Services Inc. Dr George Charames
Germany
- - Berlin, Germany, 12489
    - Precision for Medicine GmbH
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Amsterdam UMC, location AMC
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Madrid, Spain, 28006
    - Hospital Universitario de la Princesa
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
Switzerland
- - Zurich, Switzerland, 8091
    - University Hospital Zurich
  - Zurich, Switzerland, CH-8091
    - Universitatsspital Zurich
  - Zurich, Switzerland, CH-8091
    - Universtätsspital Zürich
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Clinical Research Center of Alabama, LLC
  - Birmingham, Alabama, United States, 35235
    - GastroHealth - St. Vincent's East
  - Dothan, Alabama, United States, 36301
    - Digestive Health Specialists
  - Dothan, Alabama, United States, 36301
    - Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)
  - Dothan, Alabama, United States, 36301
    - Dothan Surgery Center (Colonoscopy Location)
  - Dothan, Alabama, United States, 36301
    - Pulmonary Associates (PFT Procedure Only, Second Location )
  - Dothan, Alabama, United States, 36305
    - Flowers Hospital (PFT Procedure Only)
  - Huntsville, Alabama, United States, 35802
    - Avant Research Associates, LLC
  - Huntsville, Alabama, United States, 35802
    - Crestwood Medical Center
  - Huntsville, Alabama, United States, 35803
    - Baily Cove Eye Care
  - Madison, Alabama, United States, 35758
    - Madison Surgery Center
  - Vestavia Hills, Alabama, United States, 35216
    - Alabama Eye MD
- Arizona
  - Peoria, Arizona, United States, 85381
    - Arizona Retina Institute/ Phoenix Retina Associates(OCT)
  - Peoria, Arizona, United States, 85381
    - SimonMed Imaging (Imaging)
  - Sun City, Arizona, United States, 85351
    - Arizona Digestive Health - Sun City
  - Sun City, Arizona, United States, 85351
    - Sun City Endoscopy Center (Endoscopy)
- Arkansas
  - Little Rock, Arkansas, United States, 72212
    - Premier Gastroenterology
  - Little Rock, Arkansas, United States, 72212
    - Applied Research Center of Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Little Rock Eye Clinic
  - Little Rock, Arkansas, United States, 72212
    - Premier Gastroenterology Endoscopy Center
  - Little Rock, Arkansas, United States, 72211
    - Four Seasons Allergy and Asthma
- California
  - Fountain Valley, California, United States, 92708
    - Isight Vision Care
  - Fountain Valley, California, United States, 92708
    - Mile Square Surgery Center
  - Fountain Valley, California, United States, 92708
    - Pulmonary & Sleep Consultants
  - Garden Grove, California, United States, 92840
    - Paragon RX Clinical, Inc.
  - Lake Elsinore, California, United States, 92532
    - Inland Pulmonary Specialists [PFT Only]
  - Lancaster, California, United States, 93534
    - Gastro Care Institute
  - Lancaster, California, United States, 93534
    - Om Research LLC
  - Lancaster, California, United States, 93534
    - Advanced Endoscopy and Pain Center - EGD & Biopsy Collection
  - Lancaster, California, United States, 93534
    - Advanced Endoscopy and Pain Center
  - Lancaster, California, United States, 93534
    - Antelope Valley Eye Care - OCT
  - Lancaster, California, United States, 93534
    - Antelope Valley Eye Care
  - Lancaster, California, United States, 93534
    - Antelope Valley Lung and Sleep Institute
  - Lancaster, California, United States, 93534
    - AV Pediatrics, Allergy and Family Medicine - PFT, Physical Exams, Lab Reviews, ECG Reviews
  - Lancaster, California, United States, 93534
    - Jatinder S. Pruthi, MD FACG CPI - Physical Exams, Lab Reviews, ECG Reviews
  - Lancaster, California, United States, 93534
    - Apollo Surgery Center
  - Los Angeles, California, United States, 90033
    - Keck Hospital of USC
  - Los Angeles, California, United States, 90033
    - USC IDS Pharmacy
  - Los Angeles, California, United States, 90067
    - Advanced Vision Care (OCT)
  - Los Angeles, California, United States, 90033
    - Clinical Trials Unit
  - Murrieta, California, United States, 92563
    - United Medical Doctors
  - Murrieta, California, United States, 92562
    - United Surgery Center Murrieta [Endoscopy Only]
  - Temecula, California, United States, 92591
    - California Eye Professionals [OCT Only]
  - Temecula, California, United States, 92592
    - United Surgery Center Temecula [Endoscopy Only]
- Florida
  - Boynton Beach, Florida, United States, 33472
    - RecioMed Clinical Research Network, Inc
  - Bradenton, Florida, United States, 34203
    - Steelgate
  - Clearwater, Florida, United States, 33756
    - West Coast Endoscopy Center
  - Clearwater, Florida, United States, 33756
    - Bay Area Chest Physicians, P.A., - Pulmonary Function Test
  - Clearwater, Florida, United States, 33756
    - West Coast Endoscopy
  - Clearwater, Florida, United States, 33761
    - MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)
  - Clearwater, Florida, United States, 33761
    - Northwood Vision Optical Coherence Tomography (OCT)
  - Clearwater, Florida, United States, 33761
    - Safety Harbor Surgery Center
  - Clearwater, Florida, United States, 33762
    - Gastro Florida (Regulatory & Administrative Duties)
  - Coral Gables, Florida, United States, 33134
    - Beraja Medical Institute (OCT)
  - Crystal River, Florida, United States, 34429
    - Citrus Surgery and Endoscopy Center (EGD Location)
  - Crystal River, Florida, United States, 34428
    - Bayfront Health Seven Rivers (Liver Biopsy Location)
  - Hialeah, Florida, United States, 33012
    - Advanced Eye Center
  - Inverness, Florida, United States, 34452
    - Nature Coast Clinical Research
  - Inverness, Florida, United States, 34452
    - West Coast Eye Institute (OCT Procedure Only)
  - Inverness, Florida, United States, 34453
    - Suncoast Endoscopy Center (EGD Location)
  - Jupiter, Florida, United States, 33458
    - Jupiter Outpatient Surgery Center
  - Lakeland, Florida, United States, 33813
    - Auzmer Research
  - Lakeland, Florida, United States, 33812
    - Central Florida Sleep Diagnostic & Treatment Center
  - Lecanto, Florida, United States, 34453
    - West Coast Eye Institute (OCT Procedure Only)
  - Miami, Florida, United States, 33156
    - Research Associates of South Florida
  - Miami, Florida, United States, 33134
    - The Endoscopy Center (Endoscopy Procedure)
  - Miami, Florida, United States, 33137
    - Research Associates of South Florida
  - Miami, Florida, United States, 33173
    - Juan Barrio, MD (PFT when needed)
  - Riverview, Florida, United States, 33579
    - Florida Eye Specialists and Cataract Institute
  - Sebring, Florida, United States, 33870
    - Dr. Dennis Bassetti, MD
  - Sebring, Florida, United States, 33870
    - Highlands Eye Institute, P.A.
  - Sebring, Florida, United States, 33870
    - The Surgery and Endoscopy Center
  - Tampa, Florida, United States, 33613
    - Ambulatory Surgery Center
  - Tampa, Florida, United States, 33613
    - Pulmonology & Sleep Disorders
  - Winter Haven, Florida, United States, 33884
    - Day Surgery Center
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Digestive Healthcare of Georgia
  - Atlanta, Georgia, United States, 30309
    - Peachtree Allergy and Asthma Clinica - Pulmonary Function Test
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital- DLCO
  - Atlanta, Georgia, United States, 30324
    - Ross Eyecare - Opthalmoscopy and OCT
  - Decatur, Georgia, United States, 30033
    - Atlanta Center for Gastroenterology, P.C.
  - Decatur, Georgia, United States, 30030
    - Georgia Eye Partners
  - Decatur, Georgia, United States, 30033
    - Atlanta Endoscopy Center LTD
  - Decatur, Georgia, United States, 30033
    - Pulmonary & Sleep Specialist
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Grand Teton Research Group, PLLC
  - Idaho Falls, Idaho, United States, 83404
    - Grand Teton Surgical Center
  - Idaho Falls, Idaho, United States, 83404
    - Idaho Falls Pulmonary/ Sleep and Critical Care Specialists (PFT procedure only)
  - Idaho Falls, Idaho, United States, 83404
    - Premier Eye Care of Eastern Idaho (OCT procedure only)
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University Feinberg School of Medicine
  - Glenview, Illinois, United States, 60026
    - Glen Endoscopy Center (Endoscopy Facility)
  - Gurnee, Illinois, United States, 60031
    - GI Alliance (PFT)
  - Gurnee, Illinois, United States, 60031
    - Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
  - Gurnee, Illinois, United States, 60031
    - Medical Eye Services LTD (Ophthalmoscopy with OCT)
  - Lake Bluff, Illinois, United States, 60044
    - North Shore Endoscopy Center (Endoscopy)
  - Libertyville, Illinois, United States, 60048
    - Libertyville Imaging Center (Diagnostic Imaging)
- Indiana
  - Jeffersonville, Indiana, United States, 47130
    - Clark Memorial Health (PFTs)
  - Jeffersonville, Indiana, United States, 47130
    - One Anesthesia, AACC Division
  - New Albany, Indiana, United States, 47150
    - Gastroenterology Health Partners, PLLC, (IP)
  - New Albany, Indiana, United States, 47150
    - John Kenyon Eye Center (OCT)
  - New Albany, Indiana, United States, 47150
    - One Anesthesia, PLLC
  - New Albany, Indiana, United States, 47150
    - Physicians Medical Center (Endoscopies)
  - New Albany, Indiana, United States, 47150
    - Baptist Health Floyd (PFTs)
- Kansas
  - Lenexa, Kansas, United States, 66219
    - Quest
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Clinic (OCT Procedure Only)
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Clinic (PFT Procedure Only)
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Clinical Research Center, Digestive Health
- Louisiana
  - Lafayette, Louisiana, United States, 70503
    - Acadiana Endoscopy Center, Inc
  - Lafayette, Louisiana, United States, 70503
    - Acadiana Gastroenterology Associates
  - Lafayette, Louisiana, United States, 70503
    - Combined Gastro Research, LLC
  - Lafayette, Louisiana, United States, 70503
    - Gastroenterology Clinic of Acadiana (IP address)
  - Lafayette, Louisiana, United States, 70503
    - Lafayette General Endoscopy Center
  - Lafayette, Louisiana, United States, 70508
    - Lafayette Family Eye Care
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - M Health Fairview University of Minnesota Medical Center
  - Minneapolis, Minnesota, United States, 55455
    - M Health Fairview Clinics and Surgery Center
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota Health Clinical Research Unit
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota Health Opthalmology Clinic
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Nebraska
  - Lincoln, Nebraska, United States, 68502
    - Celerion, Inc.
- New Jersey
  - Brick, New Jersey, United States, 08723
    - Del Negro & Senft eye Associates
  - Brick, New Jersey, United States, 08724
    - Allied Health Clinical Research Organization, LLC (IP Address)
  - Brick, New Jersey, United States, 08724
    - Seashore Surgical Institute
  - Brick, New Jersey, United States, 08724
    - Shore Pulmonary, PA
  - Freehold, New Jersey, United States, 07728
    - Allied Health Clinical Research Organization, LLC
  - Neptune, New Jersey, United States, 07753
    - Del Negro & Senft eye Associates
  - Red Bank, New Jersey, United States, 07701
    - Del Negro & Senft eye Associates
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - lnvestigational Drug Services, University of North Carolina Hospitals (IP storage address)
  - Chapel Hill, North Carolina, United States, 27514
    - UNC Clinical Research Eastowne
  - Chapel Hill, North Carolina, United States, 27514
    - UNC Hospitals Pulmonary Function Lab (PFT and DLCO procedures only)
  - Chapel Hill, North Carolina, United States, 27514
    - University of North Carolina - Memorial Hospital
  - Chapel Hill, North Carolina, United States, 27517
    - UNC Endoscopy Center at Meadowmont
  - Chapel Hill, North Carolina, United States, 27517
    - UNC Hospitals Pulmonary Specialty Clinic (PFT and DLCO procedures only)
  - Chapel Hill, North Carolina, United States, 27517
    - UNC Kittner Eye Center (OCT procedure only)
  - Chapel Hill, North Carolina, United States, 27599-7064
    - Clinical and Translational Research Center Outpatient Unit
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Durham, North Carolina, United States, 27705
    - Duke Eye Center
  - Durham, North Carolina, United States, 27704
    - Duke Medical Plaza North Duke Street
  - Durham, North Carolina, United States, 27710
    - Investigational Drug Services (Pharmacy)
  - Fayetteville, North Carolina, United States, 28304
    - Cumberland Research Associates, LLC
  - Fayetteville, North Carolina, United States, 28304
    - Coastal Research Institute
  - Hillsborough, North Carolina, United States, 27278
    - UNC Gastroenterology at Hillsborough
  - Raleigh, North Carolina, United States, 27617
    - Brier Creek Medical Pavilion
- Ohio
  - Chardon, Ohio, United States, 44024
    - Geauga Sleep Center (PFT Only)
  - Cincinnati, Ohio, United States, 45219
    - Consultants for Clinical Research
  - Cincinnati, Ohio, United States, 45209
    - Leon A. Reid, III, M.D. (OCT)
  - Cincinnati, Ohio, United States, 45219
    - Ohio GI and Liver Institute
  - Cincinnati, Ohio, United States, 45219
    - Tristate Endoscopy Center (Endoscopy)
  - Cincinnati, Ohio, United States, 45219
    - UC Health Physicians Office Clifton (where subjects seen)
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Medical Center Diagnostic Center (Endoscopy location)
  - Cincinnati, Ohio, United States, 45242
    - New Horizons Clinical Research (PFT)
  - Cincinnati, Ohio, United States, 45242
    - University Endoscopy Center (Endoscopy location)
  - Cincinnati, Ohio, United States, 45267
    - UC Health/Division of Digestive Diseases (where subjects seen)
  - Cincinnati, Ohio, United States, 45219
    - Gastro Health Research
  - Cincinnati, Ohio, United States, 45219
    - UC Health Hoxworth (ophthalmic and OCT only)
  - Cincinnati, Ohio, United States, 45219
    - UC Health Pulmonary (PFT Location)
  - Cincinnati, Ohio, United States, 45229
    - UC Health Pulmonary (Pulmonary Function Testing)
  - Cincinnati, Ohio, United States, 45236
    - Leon A. Reid, III, M.D. (OCT)
  - Cincinnati, Ohio, United States, 45219
    - Cincinnati Eye Institute (ophthalmic and OCT exams)
  - Columbus, Ohio, United States, 43213
    - Erdey Searcy Eye Group
  - Dublin, Ohio, United States, 43016
    - Ohio Gastroenterology Group
  - Mentor, Ohio, United States, 44060
    - The Endoscopy Center of Lake County
  - Mentor, Ohio, United States, 44060
    - Great Lakes Medical Research, LLC
  - Painesville, Ohio, United States, 44077
    - Vitreo Retinal Consultants (OCT only)
  - Willoughby, Ohio, United States, 44094
    - Lake Pulmonary Associates (PFT only)
  - Willoughby Hills, Ohio, United States, 44094
    - Retina Specialists of Ohio(OCT only)
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Norman Endoscopy Center
  - Oklahoma City, Oklahoma, United States, 73118
    - Central Sooner Research
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists, Inc.
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists, Inc. Endoscopy Lab
  - Oklahoma City, Oklahoma, United States, 73112
    - Pulmonary Physicians of Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Retinal Center of Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Johnston Eye
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - West Shore Endoscopy Center
  - Harrisburg, Pennsylvania, United States, 17110
    - Susquehanna Research Group, LLC
  - Harrisburg, Pennsylvania, United States, 17109
    - Medical Arts Allergy,PC (PFT Only)
  - Harrisburg, Pennsylvania, United States, 17110
    - Farrel Opthalmology(OCT only)
  - Harrisburg, Pennsylvania, United States, 17111
    - Harrisburg Eye Associates (OCT only)
  - Lemoyne, Pennsylvania, United States, 17043
    - Penn State Health Medical Group - Lemoyne (PFT only)
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Investigational Drug Services
  - West Reading, Pennsylvania, United States, 19611
    - Tower Health Reading Hospital
  - Wyomissing, Pennsylvania, United States, 19610
    - Berks Center for Digestive Health
  - Wyomissing, Pennsylvania, United States, 19610
    - Berks Schuylkill Respiratory Specialists "PFT Procedure Only"
  - Wyomissing, Pennsylvania, United States, 19610
    - Eye Consultants of Pennsylvania, PC "OCT Procedure Only"
  - Wyomissing, Pennsylvania, United States, 19610
    - Regional Gastroenterology Associates of Lancaster, Ltd.
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Medical Center, LLP
- Tennessee
  - Johnson City, Tennessee, United States, 37604
    - Pulmonary Associates of ET/Jeff Farrow, MD - PFT only
  - Johnson City, Tennessee, United States, 37604
    - Franklin Woods Community Hospital (PFT Only)
  - Kingsport, Tennessee, United States, 37663
    - Tri-Cities Gastroenterology
  - Kingsport, Tennessee, United States, 37660
    - The Regional Eye Center - OCT only
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center - Digestive Disease Center
  - Nashville, Tennessee, United States, 37212-1610
    - Vanderbilt University Medical Center - GI Research Office
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center - Heart Station
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt GI Endoscopy Lab at One Hundred Oaks
  - Nashville, Tennessee, United States, 37232-5543
    - Vanderbilt University Medical Center GI Endoscopy Lab
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt Eye Institute
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt Pulmonary Medicine
- Texas
  - Dallas, Texas, United States, 75231
    - Digestive Health Center (Endoscopy)
  - Houston, Texas, United States, 77054
    - Precision for Medicine
  - New Braunfels, Texas, United States, 78130
    - CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center-new Braunfels(Endoscopy)
  - New Braunfels, Texas, United States, 78130
    - Tyrus Schroeder (PFT)
  - Plano, Texas, United States, 75074
    - The Eye Place Jenny Fan, OD (OCT Only)
  - Richardson, Texas, United States, 75082
    - Pulmonary Medicine Consultants (PFT with DCLO only)
  - San Marcos, Texas, United States, 78666
    - Advanced Imaging
  - San Marcos, Texas, United States, 78666
    - Central Texas Eye Center (OCT)
  - San Marcos, Texas, United States, 78666
    - CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center - San Marcos (Endoscopy)
  - Webster, Texas, United States, 77598
    - Bay Area Houston Endoscopy Center (Endoscopy)
  - Webster, Texas, United States, 77598
    - Coastal Eye Associates (OCT)
  - Webster, Texas, United States, 77598
    - GI Alliance (Patients Seen)
  - Webster, Texas, United States, 77598
    - Houston Lung and Sleep Clinic, PA (PFT)
- Utah
  - Salt Lake City, Utah, United States, 84132
    - University of Utah Hospital
  - Salt Lake City, Utah, United States, 84132
    - University of Utah School of Medicine
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Hospital
  - Salt Lake City, Utah, United States, 84108
    - University of Utah Gastroenterology Division Research
- Virginia
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater - Endoscopy Center
  - Chesapeake, Virginia, United States, 23320
    - Chesapeake Pulmonary and Critical Care Medicine (PFT Only)
  - Forest, Virginia, United States, 24551
    - Harman Eye Center (OCT only)
  - Lynchburg, Virginia, United States, 24502
    - Blue Ridge Medical Research
  - Lynchburg, Virginia, United States, 24501
    - Lynchburg Pulmonary Associates, Inc. (PFT only)
  - Norfolk, Virginia, United States, 23322
    - Wagner Macula and Retina Center (OCT only)
  - Norfolk, Virginia, United States, 23502
    - Wagner Macula and Retina Center (OCT only)
  - Virginia Beach, Virginia, United States, 23464
    - Sleep Specialists of Tidewater - Virginia Beach (PFT Only)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Sequential Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etrasimod Dose 1	Drug: Etrasimod Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods. Other Names: APD334 Drug: Etrasimod Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period. Other Names: APD334
Experimental: Etrasimod Dose 2	Drug: Etrasimod Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods. Other Names: APD334 Drug: Etrasimod Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period. Other Names: APD334
Placebo Comparator: Placebo and Etrasimod Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.	Drug: Etrasimod Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods. Other Names: APD334 Drug: Etrasimod Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period. Other Names: APD334 Drug: Placebo Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 Time Frame: 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.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 Time Frame: 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.	Baseline, Week 16
Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 Time Frame: 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.	Baseline, Week 16
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		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 Time Frame: Week 16		Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period Time Frame: 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.	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 Time Frame: 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.	Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Arena is a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

APD334-206
2020-003226-23 (EudraCT Number: CTIS (EU))
C5041009 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Etrasimod

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