A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis (VOYAGE)
Eosinophilic Esophagitis
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic esophagitis, Esophageal eosinophilia, Etrasimod, APD334, EoE, Eosinophilic oesophagitis
Eligibility Criteria
Inclusion Criteria:
- Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils per high powered field (eos/hpf)
- Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks during the Screening period
Inclusion Criteria for the Extension Treatment Period
- Completion of the Week 24 study visit [including esophagogastroduodenoscopy (EGD)]
- Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator
- No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator
- Willing to comply with all study visits and procedures for the Extension Treatment Period
Exclusion Criteria:
- History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study
- Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD
- Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD
Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation:
- Elemental diet
- EoE food trigger elimination diet
- Proton pump inhibitor (PPI) therapy
- Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation
- Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)
- Use of any investigational agent or device within 12 weeks prior to Baseline
- Females who are pregnant
Sites / Locations
- Clinical Research Center of Alabama, LLC
- GastroHealth - St. Vincent's East
- Digestive Health Specialists
- Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)
- Dothan Surgery Center (Colonoscopy Location)
- Pulmonary Associates (PFT Procedure Only, Second Location )
- Flowers Hospital (PFT Procedure Only)
- Avant Research Associates, LLC
- Crestwood Medical Center
- Baily Cove Eye Care
- Madison Surgery Center
- Alabama Eye MD
- Arizona Retina Institute/ Phoenix Retina Associates(OCT)
- SimonMed Imaging (Imaging)
- Arizona Digestive Health - Sun City
- Sun City Endoscopy Center (Endoscopy)
- Little Rock Eye Clinic
- Applied Research Center of Arkansas
- Premier Gastroenterology Endoscopy Center
- Premier Gastroenterology
- Isight Vision Care
- Mile Square Surgery Center
- Pulmonary & Sleep Consultants
- Paragon Rx Clinical, Inc.
- Inland Pulmonary Specialists [PFT Only]
- Advanced Endoscopy and Pain Center - EGD & Biopsy Collection
- Advanced Endoscopy and Pain Center
- Antelope Valley Eye Care - OCT
- Antelope Valley Eye Care
- Antelope Valley Lung and Sleep Institute
- AV Pediatrics, Allergy and Family Medicine - PFT, Physical Exams, Lab Reviews, ECG Reviews
- Gastro Care Institute
- Jatinder S. Pruthi, MD FACG CPI - Physical Exams, Lab Reviews, ECG Reviews
- Om Research LLC
- Keck Hospital of USC
- Advanced Vision Care (OCT)
- United Surgery Center Murrieta [Endoscopy Only]
- United Medical Doctors
- California Eye Professionals [OCT Only]
- United Surgery Center Temecula [Endoscopy Only]
- RecioMed Clinical Research Network, Inc
- Bay Area Chest Physicians, P.A., - Pulmonary Function Test
- West Coast Endoscopy Center
- West Coast Endoscopy
- MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)
- Northwood Vision Optical Coherence Tomography (OCT)
- Safety Harbor Surgery Center
- Gastro Florida (Regulatory & Administrative Duties)
- Advanced Eye Center
- Nature Coast Clinical Research
- West Coast Eye Institute (OCT Procedure Only)
- Suncoast Endoscopy Center (EGD Location)
- Jupiter Outpatient Surgery Center
- Auzmer Research
- West Coast Eye Institute (OCT Procedure Only)
- Research Associates of South Florida
- Dr. Dennis Bassetti, MD
- Highlands Eye Institute, P.A.
- The Surgery and Endoscopy Center
- Ambulatory Surgery Center
- Pulmonology & Sleep Disorders
- Day Surgery Center
- Digestive Healthcare of Georgia
- Peachtree Allergy and Asthma Clinica - Pulmonary Function Test
- Piedmont Hospital- DLCO
- Ross Eyecare - Opthalmoscopy and OCT
- Georgia Eye Partners
- Atlanta Center for Gastroenterology, P.C.
- Atlanta Endoscopy Center LTD
- Pulmonary & Sleep Specialist
- Grand Teton Research Group, PLLC
- Grand Teton Surgical Center
- Idaho Falls Pulmonary/ Sleep and Critical Care Specialists (PFT procedure only)
- Premier Eye Care of Eastern Idaho (OCT procedure only)
- Northwestern University Feinberg School of Medicine
- Glen Endoscopy Center (Endoscopy Facility)
- GI Alliance (PFT)
- Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
- Medical Eye Services LTD (Ophthalmoscopy with OCT)
- North Shore Endoscopy Center (Endoscopy)
- Libertyville Imaging Center (Diagnostic Imaging)
- Clark Memorial Health (PFTs)
- One Anesthesia, AACC Division
- Gastroenterology Health Partners, PLLC, (IP)
- John Kenyon Eye Center (OCT)
- One Anesthesia, PLLC
- Physicians Medical Center (Endoscopies)
- Cotton O'Neil Clinic (OCT Procedure Only)
- Cotton O'Neil Clinic (PFT Procedure Only)
- Cotton O'Neil Clinical Research Center, Digestive Health
- Acadiana Endoscopy Center, Inc
- Acadiana Gastroenterology Associates
- Combined Gastro Research, LLC
- Gastroenterology Clinic of Acadiana (IP address)
- Lafayette General Endoscopy Center
- Lafayette Family Eye Care
- M Health Fairview Clinics and Surgery Center
- M Health Fairview University of Minnesota Medical Center
- University of Minnesota Health Clinical research unit
- University of Minnesota Health Opthalmology Clinic
- Mayo Clinic
- Del Negro & Senft Eye Associates
- Allied Health Clinical Research Organization, LLC (IP Address)
- Seashore Surgical Institute
- Shore Pulmonary, PA
- Allied Health Clinical Research Organization, LLC
- Del Negro & Senft Eye associates
- Del Negro & Senft eye Associates
- lnvestigational Drug Services, University of North Carolina Hospitals (IP storage address)
- UNC Clinical Research Eastowne
- UNC Hospitals Pulmonary Function Lab (PFT and DLCO procedures only)
- University of North Carolina - Memorial Hospital
- UNC Endoscopy Center at Meadowmont
- UNC Hospitals Pulmonary Specialty Clinic (PFT and DLCO procedures only)
- UNC Kittner Eye Center (OCT procedure only)
- Clinical and Translational Research Center Outpatient Unit
- Duke Medical Plaza North Duke Street
- Duke Eye Center
- Duke University Medical Center
- Investigational Drug Services (Pharmacy)
- Cumberland Research Associates, LLC
- UNC Gastroenterology at Hillsborough
- Brier Creek Medical Pavilion
- Geauga Sleep Center (PFT Only)
- Leon A. Reid, III, M.D. (OCT)
- Consultants for Clinical Research
- Ohio GI and Liver Institute
- Tristate Endoscopy Center (Endoscopy)
- UC Health Physicians Office Clifton (where subjects seen)
- University of Cincinnati Medical Center Diagnostic Center (Endoscopy location)
- New Horizons Clinical Research (PFT)
- University Endoscopy Center (Endoscopy location)
- UC Health/Division of Digestive Diseases (where subjects seen)
- Erdey Searcy Eye Group
- Ohio Gastroenterology Group
- Great Lakes Medical Research, LLC
- The Endoscopy Center of Lake County
- Vitreo Retinal Consultants (OCT only)
- Retina Specialists of Ohio(OCT only)
- Lake Pulmonary Associates (PFT only)
- Norman Endoscopy Center
- Digestive Disease Specialists, Inc. Endoscopy Lab
- Digestive Disease Specialists, Inc.
- Pulmonary Physicians of Oklahoma
- Retinal Center of Oklahoma
- Central Sooner Research
- Johnston Eye
- West Shore Endoscopy Center
- Medical Arts Allergy,PC (PFT Only)
- Farrel Opthalmology(OCT only)
- Susquehanna Research Group, LLC
- Harrisburg Eye Associates (OCT only)
- Penn State Health Medical Group - Lemoyne (PFT only)
- Investigational Drug Services
- University of Pennsylvania
- Tower Health Reading Hospital
- Berks Center for Digestive Health
- Berks Schuylkill Respiratory Specialists "PFT Procedure Only"
- Eye Consultants of Pennsylvania, PC "OCT Procedure Only"
- Regional Gastroenterology Associates of Lancaster, Ltd.
- Rapid City Medical Center, LLP
- Pulmonary Associates of ET/Jeff Farrow, MD - PFT only
- The Regional Eye Center - OCT only
- Tri-Cities Gastroenterology
- Vanderbilt GI Endoscopy Lab at One Hundred Oaks
- Vanderbilt University Medical Center - GI Research Office
- Vanderbilt University Medical Center GI Endoscopy Lab
- Vanderbilt Eye Institute
- Vanderbilt Pulmonary Medicine
- Vanderbilt University Medical Center - Digestive Disease Center
- Vanderbilt University Medical Center - Heart Station
- Digestive Health Center (Endoscopy)
- CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center-new Braunfels(Endoscopy)
- Tyrus Schroeder (PFT)
- The Eye Place Jenny Fan, OD (OCT Only)
- Pulmonary Medicine Consultants (PFT with DCLO only)
- Advanced Imaging
- Central Texas Eye Center (OCT)
- CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center - San Marcos (Endoscopy)
- Bay Area Houston Endoscopy Center (Endoscopy)
- Coastal Eye Associates (OCT)
- GI Alliance (Patients Seen)
- Houston Lung and Sleep Clinic, PA (PFT)
- Huntsman Cancer Hospital
- University of Utah Hospital
- University Of Utah School Of Medicine
- Gastroenterology Associates of Tidewater - Endoscopy Center
- Gastroenterology Associates of Tidewater
- Harman Eye Center (OCT only)
- Lynchburg Pulmonary Associates, Inc. (PFT only)
- Blue Ridge Medical Research
- Sunshine University Private Hospital
- Mater Misericordiae Ltd
- Buderim Eye Centre (OCT Facility)
- Dr Shiran DeSilva Respiratory Clinic
- Mackay Discount Drug Store
- Mater Misericordiae Hospital
- Queensland X-Ray
- Vision Eye Institute Mackay
- Coastal Digestive Health
- Coral Sea Clinical Research Institute
- Elizabeth Specialist Suites (PFT Facility)
- Lyell McEwin Hospital.
- Lyell McEwin Hospital
- Modbury Hospital (OCT Facility)
- Box Hill Eye Surgeons (OCT Facility)
- Eastern Clinical Research Unit
- Eastern Health
- Retina Specialists Victoria (OCT Facility)
- The Northern Hospital
- Footscray Hospital
- MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons (OCT Facility)
- Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
- AZ St Lucas Brugge
- AZ Delta
- Centre Hospitalier Wallonie Picarde (CHWAPI)
- Amsterdam UMC, location AMC
- Hospital General Universitario de Alicante
- Hospital Universitario de La Princesa
- Hospital Universitario Miguel Servet
- University Hospital Zurich
- Universitätsspital Zürich
- Universtätsspital Zürich
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Etrasimod Dose 1
Etrasimod Dose 2
Placebo and Etrasimod
Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.