AzTrials
AzTrials

Eosinophilic EsophagitisPhase 2VOYAGENCT04682639

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

A Phase 2 study testing Etrasimod in people with Eosinophilic Esophagitis, run by Pfizer at 256 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Eosinophilic Esophagitis
What is being tested?
Etrasimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
256 sitesin 8 countries
Study dates
15 Dec 2020to 30 Jun 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

256 sites in 8 countries.

256 sites in 8 countries

United States221 sites

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Peachtree Allergy and Asthma Clinica - Pulmonary Function Test

    Atlanta, Georgia, 30309

  • Piedmont Hospital- DLCO

    Atlanta, Georgia, 30309

  • Ross Eyecare - Opthalmoscopy and OCT

    Atlanta, Georgia, 30324

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama, 35209

  • GastroHealth - St. Vincent's East

    Birmingham, Alabama, 35235

  • RecioMed Clinical Research Network, Inc

    Boynton Beach, Florida, 33472

  • Steelgate

    Bradenton, Florida, 34203

  • Del Negro & Senft Eye Associates

    Brick, New Jersey, 08723

  • Allied Health Clinical Research Organization, LLC (IP Address)

    Brick, New Jersey, 08724

  • Seashore Surgical Institute

    Brick, New Jersey, 08724

  • Shore Pulmonary, PA

    Brick, New Jersey, 08724

  • West Shore Endoscopy Center

    Camp Hill, Pennsylvania, 17011

  • lnvestigational Drug Services, University of North Carolina Hospitals (IP storage address)

    Chapel Hill, North Carolina, 27514

  • UNC Clinical Research Eastowne

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals Pulmonary Function Lab (PFT and DLCO procedures only)

    Chapel Hill, North Carolina, 27514

  • University of North Carolina - Memorial Hospital

    Chapel Hill, North Carolina, 27514

  • UNC Endoscopy Center at Meadowmont

    Chapel Hill, North Carolina, 27517

  • UNC Hospitals Pulmonary Specialty Clinic (PFT and DLCO procedures only)

    Chapel Hill, North Carolina, 27517

  • UNC Kittner Eye Center (OCT procedure only)

    Chapel Hill, North Carolina, 27517

  • Clinical and Translational Research Center Outpatient Unit

    Chapel Hill, North Carolina, 27599-7064

  • Geauga Sleep Center (PFT Only)

    Chardon, Ohio, 44024

  • Chesapeake Pulmonary and Critical Care Medicine (PFT Only)

    Chesapeake, Virginia, 23320

  • Gastroenterology Associates of Tidewater - Endoscopy Center

    Chesapeake, Virginia, 23320

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Leon A. Reid, III, M.D. (OCT)

    Cincinnati, Ohio, 45209

  • Cincinnati Eye Institute (ophthalmic and OCT exams)

    Cincinnati, Ohio, 45219

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Gastro Health Research

    Cincinnati, Ohio, 45219

  • Ohio GI and Liver Institute

    Cincinnati, Ohio, 45219

  • Tristate Endoscopy Center (Endoscopy)

    Cincinnati, Ohio, 45219

  • UC Health Hoxworth (ophthalmic and OCT only)

    Cincinnati, Ohio, 45219

  • UC Health Physicians Office Clifton (where subjects seen)

    Cincinnati, Ohio, 45219

  • UC Health Pulmonary (PFT Location)

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center Diagnostic Center (Endoscopy location)

    Cincinnati, Ohio, 45219

  • UC Health Pulmonary (Pulmonary Function Testing)

    Cincinnati, Ohio, 45229

  • Leon A. Reid, III, M.D. (OCT)

    Cincinnati, Ohio, 45236

  • New Horizons Clinical Research (PFT)

    Cincinnati, Ohio, 45242

  • University Endoscopy Center (Endoscopy location)

    Cincinnati, Ohio, 45242

  • UC Health/Division of Digestive Diseases (where subjects seen)

    Cincinnati, Ohio, 45267

  • Bay Area Chest Physicians, P.A., - Pulmonary Function Test

    Clearwater, Florida, 33756

  • West Coast Endoscopy Center

    Clearwater, Florida, 33756

  • West Coast Endoscopy

    Clearwater, Florida, 33756

  • MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)

    Clearwater, Florida, 33761

  • Northwood Vision Optical Coherence Tomography (OCT)

    Clearwater, Florida, 33761

  • Safety Harbor Surgery Center

    Clearwater, Florida, 33761

  • Gastro Florida (Regulatory & Administrative Duties)

    Clearwater, Florida, 33762

  • Erdey Searcy Eye Group

    Columbus, Ohio, 43213

  • Beraja Medical Institute (OCT)

    Coral Gables, Florida, 33134

  • Bayfront Health Seven Rivers (Liver Biopsy Location)

    Crystal River, Florida, 34428

  • Citrus Surgery and Endoscopy Center (EGD Location)

    Crystal River, Florida, 34429

  • Digestive Health Center (Endoscopy)

    Dallas, Texas, 75231

  • Georgia Eye Partners

    Decatur, Georgia, 30030

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Atlanta Endoscopy Center LTD

    Decatur, Georgia, 30033

  • Pulmonary & Sleep Specialist

    Decatur, Georgia, 30033

  • Digestive Health Specialists

    Dothan, Alabama, 36301

  • Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)

    Dothan, Alabama, 36301

  • Dothan Surgery Center (Colonoscopy Location)

    Dothan, Alabama, 36301

  • Pulmonary Associates (PFT Procedure Only, Second Location )

    Dothan, Alabama, 36301

  • Flowers Hospital (PFT Procedure Only)

    Dothan, Alabama, 36305

  • Ohio Gastroenterology Group

    Dublin, Ohio, 43016

  • Duke Medical Plaza North Duke Street

    Durham, North Carolina, 27704

  • Duke Eye Center

    Durham, North Carolina, 27705

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Investigational Drug Services (Pharmacy)

    Durham, North Carolina, 27710

  • Coastal Research Institute

    Fayetteville, North Carolina, 28304

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Harman Eye Center (OCT only)

    Forest, Virginia, 24551

  • Isight Vision Care

    Fountain Valley, California, 92708

  • Mile Square Surgery Center

    Fountain Valley, California, 92708

  • Pulmonary & Sleep Consultants

    Fountain Valley, California, 92708

  • Allied Health Clinical Research Organization, LLC

    Freehold, New Jersey, 07728

  • Paragon Rx Clinical, Inc.

    Garden Grove, California, 92840

  • Glen Endoscopy Center (Endoscopy Facility)

    Glenview, Illinois, 60026

  • GI Alliance (PFT)

    Gurnee, Illinois, 60031

  • Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)

    Gurnee, Illinois, 60031

  • Medical Eye Services LTD (Ophthalmoscopy with OCT)

    Gurnee, Illinois, 60031

  • Medical Arts Allergy,PC (PFT Only)

    Harrisburg, Pennsylvania, 17109

  • Farrel Opthalmology(OCT only)

    Harrisburg, Pennsylvania, 17110

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110

  • Harrisburg Eye Associates (OCT only)

    Harrisburg, Pennsylvania, 17111

  • Advanced Eye Center

    Hialeah, Florida, 33012

  • UNC Gastroenterology at Hillsborough

    Hillsborough, North Carolina, 27278

  • Precision for Medicine

    Houston, Texas, 77054

  • Avant Research Associates, LLC

    Huntsville, Alabama, 35802

  • Crestwood Medical Center

    Huntsville, Alabama, 35802

  • Baily Cove Eye Care

    Huntsville, Alabama, 35803

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404

  • Grand Teton Surgical Center

    Idaho Falls, Idaho, 83404

  • Idaho Falls Pulmonary/ Sleep and Critical Care Specialists (PFT procedure only)

    Idaho Falls, Idaho, 83404

  • Premier Eye Care of Eastern Idaho (OCT procedure only)

    Idaho Falls, Idaho, 83404

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • West Coast Eye Institute (OCT Procedure Only)

    Inverness, Florida, 34452

  • Suncoast Endoscopy Center (EGD Location)

    Inverness, Florida, 34453

  • Clark Memorial Health (PFTs)

    Jeffersonville, Indiana, 47130

  • One Anesthesia, AACC Division

    Jeffersonville, Indiana, 47130

  • Franklin Woods Community Hospital (PFT Only)

    Johnson City, Tennessee, 37604

  • Pulmonary Associates of ET/Jeff Farrow, MD - PFT only

    Johnson City, Tennessee, 37604

  • Jupiter Outpatient Surgery Center

    Jupiter, Florida, 33458

  • The Regional Eye Center - OCT only

    Kingsport, Tennessee, 37660

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663

  • Acadiana Endoscopy Center, Inc

    Lafayette, Louisiana, 70503

  • Acadiana Gastroenterology Associates

    Lafayette, Louisiana, 70503

  • Combined Gastro Research, LLC

    Lafayette, Louisiana, 70503

  • Gastroenterology Clinic of Acadiana (IP address)

    Lafayette, Louisiana, 70503

  • Lafayette General Endoscopy Center

    Lafayette, Louisiana, 70503

  • Lafayette Family Eye Care

    Lafayette, Louisiana, 70508

  • North Shore Endoscopy Center (Endoscopy)

    Lake Bluff, Illinois, 60044

  • Inland Pulmonary Specialists [PFT Only]

    Lake Elsinore, California, 92532

  • Central Florida Sleep Diagnostic & Treatment Center

    Lakeland, Florida, 33812

  • Auzmer Research

    Lakeland, Florida, 33813

  • Advanced Endoscopy and Pain Center - EGD & Biopsy Collection

    Lancaster, California, 93534

  • Advanced Endoscopy and Pain Center

    Lancaster, California, 93534

  • Antelope Valley Eye Care - OCT

    Lancaster, California, 93534

  • Antelope Valley Eye Care

    Lancaster, California, 93534

  • Antelope Valley Lung and Sleep Institute

    Lancaster, California, 93534

  • Apollo Surgery Center

    Lancaster, California, 93534

  • AV Pediatrics, Allergy and Family Medicine - PFT, Physical Exams, Lab Reviews, ECG Reviews

    Lancaster, California, 93534

  • Gastro Care Institute

    Lancaster, California, 93534

  • Jatinder S. Pruthi, MD FACG CPI - Physical Exams, Lab Reviews, ECG Reviews

    Lancaster, California, 93534

  • Om Research LLC

    Lancaster, California, 93534

  • West Coast Eye Institute (OCT Procedure Only)

    Lecanto, Florida, 34453

  • Penn State Health Medical Group - Lemoyne (PFT only)

    Lemoyne, Pennsylvania, 17043

  • Quest

    Lenexa, Kansas, 66219

  • Libertyville Imaging Center (Diagnostic Imaging)

    Libertyville, Illinois, 60048

  • Celerion, Inc.

    Lincoln, Nebraska, 68502

  • Little Rock Eye Clinic

    Little Rock, Arkansas, 72205

  • Four Seasons Allergy and Asthma

    Little Rock, Arkansas, 72211

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Premier Gastroenterology Endoscopy Center

    Little Rock, Arkansas, 72212

  • Premier Gastroenterology

    Little Rock, Arkansas, 72212

  • Clinical Trials Unit

    Los Angeles, California, 90033

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • USC IDS Pharmacy

    Los Angeles, California, 90033

  • Advanced Vision Care (OCT)

    Los Angeles, California, 90067

  • Lynchburg Pulmonary Associates, Inc. (PFT only)

    Lynchburg, Virginia, 24501

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Madison Surgery Center

    Madison, Alabama, 35758

  • Great Lakes Medical Research, LLC

    Mentor, Ohio, 44060

  • The Endoscopy Center of Lake County

    Mentor, Ohio, 44060

  • The Endoscopy Center (Endoscopy Procedure)

    Miami, Florida, 33134

  • Research Associates of South Florida

    Miami, Florida, 33137

  • Research Associates of South Florida

    Miami, Florida, 33156

  • Juan Barrio, MD (PFT when needed)

    Miami, Florida, 33173

  • M Health Fairview Clinics and Surgery Center

    Minneapolis, Minnesota, 55455

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • University of Minnesota Health Clinical research unit

    Minneapolis, Minnesota, 55455

  • University of Minnesota Health Opthalmology Clinic

    Minneapolis, Minnesota, 55455

  • United Surgery Center Murrieta [Endoscopy Only]

    Murrieta, California, 92562

  • United Medical Doctors

    Murrieta, California, 92563

  • Vanderbilt GI Endoscopy Lab at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University Medical Center - GI Research Office

    Nashville, Tennessee, 37212-1610

  • Vanderbilt University Medical Center GI Endoscopy Lab

    Nashville, Tennessee, 37232-5543

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232

  • Vanderbilt Pulmonary Medicine

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - Digestive Disease Center

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - Heart Station

    Nashville, Tennessee, 37232

  • Del Negro & Senft Eye associates

    Neptune City, New Jersey, 07753

  • Baptist Health Floyd (PFTs)

    New Albany, Indiana, 47150

  • Gastroenterology Health Partners, PLLC, (IP)

    New Albany, Indiana, 47150

  • John Kenyon Eye Center (OCT)

    New Albany, Indiana, 47150

  • One Anesthesia, PLLC

    New Albany, Indiana, 47150

  • Physicians Medical Center (Endoscopies)

    New Albany, Indiana, 47150

  • CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center-new Braunfels(Endoscopy)

    New Braunfels, Texas, 78130

  • Tyrus Schroeder (PFT)

    New Braunfels, Texas, 78130

  • Wagner Macula and Retina Center (OCT only)

    Norfolk, Virginia, 23322

  • Wagner Macula and Retina Center (OCT only)

    Norfolk, Virginia, 23502

  • Norman Endoscopy Center

    Norman, Oklahoma, 73071

  • Digestive Disease Specialists, Inc. Endoscopy Lab

    Oklahoma City, Oklahoma, 73112

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • Pulmonary Physicians of Oklahoma

    Oklahoma City, Oklahoma, 73112

  • Retinal Center of Oklahoma

    Oklahoma City, Oklahoma, 73112

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73118

  • Johnston Eye

    Oklahoma City, Oklahoma, 73120

  • Vitreo Retinal Consultants (OCT only)

    Painesville, Ohio, 44077

  • Arizona Retina Institute/ Phoenix Retina Associates(OCT)

    Peoria, Arizona, 85381

  • SimonMed Imaging (Imaging)

    Peoria, Arizona, 85381

  • Investigational Drug Services

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The Eye Place Jenny Fan, OD (OCT Only)

    Plano, Texas, 75074

  • Brier Creek Medical Pavilion

    Raleigh, North Carolina, 27617

  • Rapid City Medical Center, LLP

    Rapid City, South Dakota, 57701

  • Del Negro & Senft eye Associates

    Red Bank, New Jersey, 07701

  • Pulmonary Medicine Consultants (PFT with DCLO only)

    Richardson, Texas, 75082

  • Florida Eye Specialists and Cataract Institute

    Riverview, Florida, 33579

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Gastroenterology Division Research

    Salt Lake City, Utah, 84108

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • University Of Utah School Of Medicine

    Salt Lake City, Utah, 84132

  • Advanced Imaging

    San Marcos, Texas, 78666

  • Central Texas Eye Center (OCT)

    San Marcos, Texas, 78666

  • CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center - San Marcos (Endoscopy)

    San Marcos, Texas, 78666

  • Dr. Dennis Bassetti, MD

    Sebring, Florida, 33870

  • Highlands Eye Institute, P.A.

    Sebring, Florida, 33870

  • The Surgery and Endoscopy Center

    Sebring, Florida, 33870

  • Arizona Digestive Health - Sun City

    Sun City, Arizona, 85351

  • Sun City Endoscopy Center (Endoscopy)

    Sun City, Arizona, 85351

  • Ambulatory Surgery Center

    Tampa, Florida, 33613

  • Pulmonology & Sleep Disorders

    Tampa, Florida, 33613

  • California Eye Professionals [OCT Only]

    Temecula, California, 92591

  • United Surgery Center Temecula [Endoscopy Only]

    Temecula, California, 92592

  • Cotton O'Neil Clinic (OCT Procedure Only)

    Topeka, Kansas, 66606

  • Cotton O'Neil Clinic (PFT Procedure Only)

    Topeka, Kansas, 66606

  • Cotton O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • Alabama Eye MD

    Vestavia Hills, Alabama, 35216

  • Sleep Specialists of Tidewater - Virginia Beach (PFT Only)

    Virginia Beach, Virginia, 23464

  • Bay Area Houston Endoscopy Center (Endoscopy)

    Webster, Texas, 77598

  • Coastal Eye Associates (OCT)

    Webster, Texas, 77598

  • GI Alliance (Patients Seen)

    Webster, Texas, 77598

  • Houston Lung and Sleep Clinic, PA (PFT)

    Webster, Texas, 77598

  • Tower Health Reading Hospital

    West Reading, Pennsylvania, 19611

  • Lake Pulmonary Associates (PFT only)

    Willoughby, Ohio, 44094

  • Retina Specialists of Ohio(OCT only)

    Willoughby Hills, Ohio, 44094

  • Day Surgery Center

    Winter Haven, Florida, 33884

  • Berks Center for Digestive Health

    Wyomissing, Pennsylvania, 19610

  • Berks Schuylkill Respiratory Specialists "PFT Procedure Only"

    Wyomissing, Pennsylvania, 19610

  • Eye Consultants of Pennsylvania, PC "OCT Procedure Only"

    Wyomissing, Pennsylvania, 19610

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Australia23 sites

  • MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons (OCT Facility)

    Bellfield, 3081

  • Sunshine University Private Hospital

    Birtinya, Queensland, 4575

  • Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )

    Birtinya, 4575

  • Eastern Clinical Research Unit

    Box Hill, Victoria, 3128

  • Eastern Health

    Box Hill, Victoria, 3128

  • Box Hill Eye Surgeons (OCT Facility)

    Box Hill North, Victoria, 3129

  • Mater Misericordiae Ltd

    Brisbane South, Queensland, 4101

  • Buderim Eye Centre (OCT Facility)

    Buderim, Queensland, 4558

  • Retina Specialists Victoria (OCT Facility)

    Camberwell, Victoria, 3124

  • Elizabeth Specialist Suites (PFT Facility)

    Elizabeth Vale, South Australia, 5112

  • Lyell McEwin Hospital.

    Elizabeth Vale, South Australia, 5112

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • The Northern Hospital

    Epping, Victoria, 3076

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Dr Shiran DeSilva Respiratory Clinic

    Mackay, Queensland, 4740

  • Mackay Discount Drug Store

    Mackay, Queensland, 4740

  • Mater Misericordiae Hospital

    Mackay, Queensland, 4740

  • Queensland X-Ray

    Mackay, Queensland, 4740

  • Vision Eye Institute Mackay

    Mackay, Queensland, 4740

  • Coastal Digestive Health

    Maroochydore, Queensland, 4558

  • Vision Eye Institute

    Melbourne, Victoria, 3011

  • Modbury Hospital (OCT Facility)

    Modbury, South Australia, 5092

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland, 4740

Other trials in Australia

Belgium3 sites

  • AZ St Lucas Brugge

    Bruges, 8310

  • AZ Delta

    Roeselare, 8800

  • Centre Hospitalier Wallonie Picarde (CHWAPI)

    Tournai, 7500

Other trials in Belgium

Spain3 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Switzerland3 sites

  • University Hospital Zurich

    Zurich, 8091

  • Universitätsspital Zürich

    Zurich, CH-8091

  • Universtätsspital Zürich

    Zurich, CH-8091

Other trials in Switzerland

Canada1 site

  • Mount Sinai Services Inc. Dr George Charames

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Germany1 site

  • Precision for Medicine GmbH

    Berlin, 12489

Other trials in Germany

Netherlands1 site

  • Amsterdam UMC, location AMC

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

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

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.

Being tested
Etrasimod, Placebo
Keywords
Eosinophilic esophagitis, Esophageal eosinophilia, Etrasimod, APD334, EoE, Eosinophilic oesophagitis
Medical subject headings
Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrasimodDrug

    Also called APD334

    Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.

  • PlaceboDrug

    Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.

  • EtrasimodDrug

    Also called APD334

    Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.

Study groups in NCT04682639
Study groupRoleWhat they receive
Etrasimod Dose 1ExperimentalNot described
Receives: Drug: Etrasimod
Etrasimod Dose 2ExperimentalNot described
Receives: Drug: Etrasimod
Placebo and EtrasimodPlacebo comparatorParticipants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.
Receives: Drug: Placebo; Drug: Etrasimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 16

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, Week 16

  2. 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.

    Measured: Baseline, Week 16

  3. Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16

    Measured: Week 16

  4. Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion30 Sep 2022
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04682639
Sponsor's protocol ID
APD334-206
Other IDs
C5041009, 2020-003226-23
Acronym
VOYAGE
Status last verified
May 2024
First submitted
19 Dec 2020
Last updated
6 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Dellon ES, Collins MH, Bredenoord AJ, Philpott H, Biedermann L, Dulcine M, Nguyen-Cleary T, Su C, Yu J, Tan H, Cataldi F, Wu J, Wang W, Clax P, Woolcott JC, Hirano I. Etrasimod as a treatment for eosinophilic oesophagitis (VOYAGE): a double-blind, placebo-controlled, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2025 Jul;10(7):622-633. doi: 10.1016/S2468-1253(25)00062-7. Epub 2025 May 14.

    PubMed 40381637

  • 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.

    PubMed 39575597

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etrasimod in people with Eosinophilic Esophagitis, run by Pfizer at 256 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, Australia, Belgium, Spain, Switzerland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04682639, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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