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

NCT ID: NCT04682639

Last Updated: 2024-05-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Etrasimod Dose 1

Group Type EXPERIMENTAL

Etrasimod

Intervention Type DRUG

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

Etrasimod Dose 2

Group Type EXPERIMENTAL

Etrasimod

Intervention Type DRUG

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

Placebo and Etrasimod

Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Etrasimod

Intervention Type DRUG

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

Interventions

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Etrasimod

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Etrasimod

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

Intervention Type DRUG

Other Intervention Names

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APD334 APD334

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arena is a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Universtätsspital Zürich

Zurich, , Switzerland

Site Status

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Site Status

GastroHealth - St. Vincent's East

Birmingham, Alabama, United States

Site Status

Digestive Health Specialists

Dothan, Alabama, United States

Site Status

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

Dothan, Alabama, United States

Site Status

Dothan Surgery Center (Colonoscopy Location)

Dothan, Alabama, United States

Site Status

Pulmonary Associates (PFT Procedure Only, Second Location )

Dothan, Alabama, United States

Site Status

Flowers Hospital (PFT Procedure Only)

Dothan, Alabama, United States

Site Status

Avant Research Associates, LLC

Huntsville, Alabama, United States

Site Status

Crestwood Medical Center

Huntsville, Alabama, United States

Site Status

Baily Cove Eye Care

Huntsville, Alabama, United States

Site Status

Madison Surgery Center

Madison, Alabama, United States

Site Status

Alabama Eye MD

Vestavia Hills, Alabama, United States

Site Status

Arizona Retina Institute/ Phoenix Retina Associates(OCT)

Peoria, Arizona, United States

Site Status

SimonMed Imaging (Imaging)

Peoria, Arizona, United States

Site Status

Arizona Digestive Health - Sun City

Sun City, Arizona, United States

Site Status

Sun City Endoscopy Center (Endoscopy)

Sun City, Arizona, United States

Site Status

Little Rock Eye Clinic

Little Rock, Arkansas, United States

Site Status

Four Seasons Allergy and Asthma

Little Rock, Arkansas, United States

Site Status

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Site Status

Premier Gastroenterology Endoscopy Center

Little Rock, Arkansas, United States

Site Status

Premier Gastroenterology

Little Rock, Arkansas, United States

Site Status

Isight Vision Care

Fountain Valley, California, United States

Site Status

Mile Square Surgery Center

Fountain Valley, California, United States

Site Status

Pulmonary & Sleep Consultants

Fountain Valley, California, United States

Site Status

Paragon Rx Clinical, Inc.

Garden Grove, California, United States

Site Status

Inland Pulmonary Specialists [PFT Only]

Lake Elsinore, California, United States

Site Status

Advanced Endoscopy and Pain Center - EGD & Biopsy Collection

Lancaster, California, United States

Site Status

Advanced Endoscopy and Pain Center

Lancaster, California, United States

Site Status

Antelope Valley Eye Care - OCT

Lancaster, California, United States

Site Status

Antelope Valley Eye Care

Lancaster, California, United States

Site Status

Antelope Valley Lung and Sleep Institute

Lancaster, California, United States

Site Status

Apollo Surgery Center

Lancaster, California, United States

Site Status

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

Lancaster, California, United States

Site Status

Gastro Care Institute

Lancaster, California, United States

Site Status

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

Lancaster, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Clinical Trials Unit

Los Angeles, California, United States

Site Status

Keck Hospital of USC

Los Angeles, California, United States

Site Status

USC IDS Pharmacy

Los Angeles, California, United States

Site Status

Advanced Vision Care (OCT)

Los Angeles, California, United States

Site Status

United Surgery Center Murrieta [Endoscopy Only]

Murrieta, California, United States

Site Status

United Medical Doctors

Murrieta, California, United States

Site Status

California Eye Professionals [OCT Only]

Temecula, California, United States

Site Status

United Surgery Center Temecula [Endoscopy Only]

Temecula, California, United States

Site Status

RecioMed Clinical Research Network, Inc

Boynton Beach, Florida, United States

Site Status

Steelgate

Bradenton, Florida, United States

Site Status

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

Clearwater, Florida, United States

Site Status

West Coast Endoscopy Center

Clearwater, Florida, United States

Site Status

West Coast Endoscopy

Clearwater, Florida, United States

Site Status

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

Clearwater, Florida, United States

Site Status

Northwood Vision Optical Coherence Tomography (OCT)

Clearwater, Florida, United States

Site Status

Safety Harbor Surgery Center

Clearwater, Florida, United States

Site Status

Gastro Florida (Regulatory & Administrative Duties)

Clearwater, Florida, United States

Site Status

Beraja Medical Institute (OCT)

Coral Gables, Florida, United States

Site Status

Bayfront Health Seven Rivers (Liver Biopsy Location)

Crystal River, Florida, United States

Site Status

Citrus Surgery and Endoscopy Center (EGD Location)

Crystal River, Florida, United States

Site Status

Advanced Eye Center

Hialeah, Florida, United States

Site Status

Nature Coast Clinical Research

Inverness, Florida, United States

Site Status

West Coast Eye Institute (OCT Procedure Only)

Inverness, Florida, United States

Site Status

Suncoast Endoscopy Center (EGD Location)

Inverness, Florida, United States

Site Status

Jupiter Outpatient Surgery Center

Jupiter, Florida, United States

Site Status

Central Florida Sleep Diagnostic & Treatment Center

Lakeland, Florida, United States

Site Status

Auzmer Research

Lakeland, Florida, United States

Site Status

West Coast Eye Institute (OCT Procedure Only)

Lecanto, Florida, United States

Site Status

The Endoscopy Center (Endoscopy Procedure)

Miami, Florida, United States

Site Status

Research Associates of South Florida

Miami, Florida, United States

Site Status

Research Associates of South Florida

Miami, Florida, United States

Site Status

Juan Barrio, MD (PFT when needed)

Miami, Florida, United States

Site Status

Florida Eye Specialists and Cataract Institute

Riverview, Florida, United States

Site Status

Dr. Dennis Bassetti, MD

Sebring, Florida, United States

Site Status

Highlands Eye Institute, P.A.

Sebring, Florida, United States

Site Status

The Surgery and Endoscopy Center

Sebring, Florida, United States

Site Status

Ambulatory Surgery Center

Tampa, Florida, United States

Site Status

Pulmonology & Sleep Disorders

Tampa, Florida, United States

Site Status

Day Surgery Center

Winter Haven, Florida, United States

Site Status

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Site Status

Peachtree Allergy and Asthma Clinica - Pulmonary Function Test

Atlanta, Georgia, United States

Site Status

Piedmont Hospital- DLCO

Atlanta, Georgia, United States

Site Status

Ross Eyecare - Opthalmoscopy and OCT

Atlanta, Georgia, United States

Site Status

Georgia Eye Partners

Decatur, Georgia, United States

Site Status

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, United States

Site Status

Atlanta Endoscopy Center LTD

Decatur, Georgia, United States

Site Status

Pulmonary & Sleep Specialist

Decatur, Georgia, United States

Site Status

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Site Status

Grand Teton Surgical Center

Idaho Falls, Idaho, United States

Site Status

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

Idaho Falls, Idaho, United States

Site Status

Premier Eye Care of Eastern Idaho (OCT procedure only)

Idaho Falls, Idaho, United States

Site Status

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Glen Endoscopy Center (Endoscopy Facility)

Glenview, Illinois, United States

Site Status

GI Alliance (PFT)

Gurnee, Illinois, United States

Site Status

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

Gurnee, Illinois, United States

Site Status

Medical Eye Services LTD (Ophthalmoscopy with OCT)

Gurnee, Illinois, United States

Site Status

North Shore Endoscopy Center (Endoscopy)

Lake Bluff, Illinois, United States

Site Status

Libertyville Imaging Center (Diagnostic Imaging)

Libertyville, Illinois, United States

Site Status

Clark Memorial Health (PFTs)

Jeffersonville, Indiana, United States

Site Status

One Anesthesia, AACC Division

Jeffersonville, Indiana, United States

Site Status

Baptist Health Floyd (PFTs)

New Albany, Indiana, United States

Site Status

Gastroenterology Health Partners, PLLC, (IP)

New Albany, Indiana, United States

Site Status

John Kenyon Eye Center (OCT)

New Albany, Indiana, United States

Site Status

One Anesthesia, PLLC

New Albany, Indiana, United States

Site Status

Physicians Medical Center (Endoscopies)

New Albany, Indiana, United States

Site Status

Quest

Lenexa, Kansas, United States

Site Status

Cotton O'Neil Clinic (OCT Procedure Only)

Topeka, Kansas, United States

Site Status

Cotton O'Neil Clinic (PFT Procedure Only)

Topeka, Kansas, United States

Site Status

Cotton O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, United States

Site Status

Acadiana Endoscopy Center, Inc

Lafayette, Louisiana, United States

Site Status

Acadiana Gastroenterology Associates

Lafayette, Louisiana, United States

Site Status

Combined Gastro Research, LLC

Lafayette, Louisiana, United States

Site Status

Gastroenterology Clinic of Acadiana (IP address)

Lafayette, Louisiana, United States

Site Status

Lafayette General Endoscopy Center

Lafayette, Louisiana, United States

Site Status

Lafayette Family Eye Care

Lafayette, Louisiana, United States

Site Status

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, United States

Site Status

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Health Clinical research unit

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Health Opthalmology Clinic

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Celerion, Inc.

Lincoln, Nebraska, United States

Site Status

Del Negro & Senft Eye Associates

Brick, New Jersey, United States

Site Status

Allied Health Clinical Research Organization, LLC (IP Address)

Brick, New Jersey, United States

Site Status

Seashore Surgical Institute

Brick, New Jersey, United States

Site Status

Shore Pulmonary, PA

Brick, New Jersey, United States

Site Status

Allied Health Clinical Research Organization, LLC

Freehold, New Jersey, United States

Site Status

Del Negro & Senft Eye associates

Neptune City, New Jersey, United States

Site Status

Del Negro & Senft eye Associates

Red Bank, New Jersey, United States

Site Status

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

Chapel Hill, North Carolina, United States

Site Status

UNC Clinical Research Eastowne

Chapel Hill, North Carolina, United States

Site Status

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

Chapel Hill, North Carolina, United States

Site Status

University of North Carolina - Memorial Hospital

Chapel Hill, North Carolina, United States

Site Status

UNC Endoscopy Center at Meadowmont

Chapel Hill, North Carolina, United States

Site Status

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

Chapel Hill, North Carolina, United States

Site Status

UNC Kittner Eye Center (OCT procedure only)

Chapel Hill, North Carolina, United States

Site Status

Clinical and Translational Research Center Outpatient Unit

Chapel Hill, North Carolina, United States

Site Status

Duke Medical Plaza North Duke Street

Durham, North Carolina, United States

Site Status

Duke Eye Center

Durham, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Investigational Drug Services (Pharmacy)

Durham, North Carolina, United States

Site Status

Coastal Research Institute

Fayetteville, North Carolina, United States

Site Status

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Site Status

UNC Gastroenterology at Hillsborough

Hillsborough, North Carolina, United States

Site Status

Brier Creek Medical Pavilion

Raleigh, North Carolina, United States

Site Status

Geauga Sleep Center (PFT Only)

Chardon, Ohio, United States

Site Status

Leon A. Reid, III, M.D. (OCT)

Cincinnati, Ohio, United States

Site Status

Cincinnati Eye Institute (ophthalmic and OCT exams)

Cincinnati, Ohio, United States

Site Status

Consultants for Clinical Research

Cincinnati, Ohio, United States

Site Status

Gastro Health Research

Cincinnati, Ohio, United States

Site Status

Ohio GI and Liver Institute

Cincinnati, Ohio, United States

Site Status

Tristate Endoscopy Center (Endoscopy)

Cincinnati, Ohio, United States

Site Status

UC Health Hoxworth (ophthalmic and OCT only)

Cincinnati, Ohio, United States

Site Status

UC Health Physicians Office Clifton (where subjects seen)

Cincinnati, Ohio, United States

Site Status

UC Health Pulmonary (PFT Location)

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Medical Center Diagnostic Center (Endoscopy location)

Cincinnati, Ohio, United States

Site Status

UC Health Pulmonary (Pulmonary Function Testing)

Cincinnati, Ohio, United States

Site Status

Leon A. Reid, III, M.D. (OCT)

Cincinnati, Ohio, United States

Site Status

New Horizons Clinical Research (PFT)

Cincinnati, Ohio, United States

Site Status

University Endoscopy Center (Endoscopy location)

Cincinnati, Ohio, United States

Site Status

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

Cincinnati, Ohio, United States

Site Status

Erdey Searcy Eye Group

Columbus, Ohio, United States

Site Status

Ohio Gastroenterology Group

Dublin, Ohio, United States

Site Status

Great Lakes Medical Research, LLC

Mentor, Ohio, United States

Site Status

The Endoscopy Center of Lake County

Mentor, Ohio, United States

Site Status

Vitreo Retinal Consultants (OCT only)

Painesville, Ohio, United States

Site Status

Lake Pulmonary Associates (PFT only)

Willoughby, Ohio, United States

Site Status

Retina Specialists of Ohio(OCT only)

Willoughby Hills, Ohio, United States

Site Status

Norman Endoscopy Center

Norman, Oklahoma, United States

Site Status

Digestive Disease Specialists, Inc. Endoscopy Lab

Oklahoma City, Oklahoma, United States

Site Status

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States

Site Status

Pulmonary Physicians of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Retinal Center of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Central Sooner Research

Oklahoma City, Oklahoma, United States

Site Status

Johnston Eye

Oklahoma City, Oklahoma, United States

Site Status

West Shore Endoscopy Center

Camp Hill, Pennsylvania, United States

Site Status

Medical Arts Allergy,PC (PFT Only)

Harrisburg, Pennsylvania, United States

Site Status

Farrel Opthalmology(OCT only)

Harrisburg, Pennsylvania, United States

Site Status

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, United States

Site Status

Harrisburg Eye Associates (OCT only)

Harrisburg, Pennsylvania, United States

Site Status

Penn State Health Medical Group - Lemoyne (PFT only)

Lemoyne, Pennsylvania, United States

Site Status

Investigational Drug Services

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Tower Health Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Berks Center for Digestive Health

Wyomissing, Pennsylvania, United States

Site Status

Berks Schuylkill Respiratory Specialists "PFT Procedure Only"

Wyomissing, Pennsylvania, United States

Site Status

Eye Consultants of Pennsylvania, PC "OCT Procedure Only"

Wyomissing, Pennsylvania, United States

Site Status

Regional Gastroenterology Associates of Lancaster, Ltd.

Wyomissing, Pennsylvania, United States

Site Status

Rapid City Medical Center, LLP

Rapid City, South Dakota, United States

Site Status

Franklin Woods Community Hospital (PFT Only)

Johnson City, Tennessee, United States

Site Status

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

Johnson City, Tennessee, United States

Site Status

The Regional Eye Center - OCT only

Kingsport, Tennessee, United States

Site Status

Tri-Cities Gastroenterology

Kingsport, Tennessee, United States

Site Status

Vanderbilt GI Endoscopy Lab at One Hundred Oaks

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - GI Research Office

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center GI Endoscopy Lab

Nashville, Tennessee, United States

Site Status

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Site Status

Vanderbilt Pulmonary Medicine

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Digestive Disease Center

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Heart Station

Nashville, Tennessee, United States

Site Status

Digestive Health Center (Endoscopy)

Dallas, Texas, United States

Site Status

Precision for Medicine

Houston, Texas, United States

Site Status

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

New Braunfels, Texas, United States

Site Status

Tyrus Schroeder (PFT)

New Braunfels, Texas, United States

Site Status

The Eye Place Jenny Fan, OD (OCT Only)

Plano, Texas, United States

Site Status

Pulmonary Medicine Consultants (PFT with DCLO only)

Richardson, Texas, United States

Site Status

Advanced Imaging

San Marcos, Texas, United States

Site Status

Central Texas Eye Center (OCT)

San Marcos, Texas, United States

Site Status

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

San Marcos, Texas, United States

Site Status

Bay Area Houston Endoscopy Center (Endoscopy)

Webster, Texas, United States

Site Status

Coastal Eye Associates (OCT)

Webster, Texas, United States

Site Status

GI Alliance (Patients Seen)

Webster, Texas, United States

Site Status

Houston Lung and Sleep Clinic, PA (PFT)

Webster, Texas, United States

Site Status

University of Utah Gastroenterology Division Research

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Hospital

Salt Lake City, Utah, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

University Of Utah School Of Medicine

Salt Lake City, Utah, United States

Site Status

Chesapeake Pulmonary and Critical Care Medicine (PFT Only)

Chesapeake, Virginia, United States

Site Status

Gastroenterology Associates of Tidewater - Endoscopy Center

Chesapeake, Virginia, United States

Site Status

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Site Status

Harman Eye Center (OCT only)

Forest, Virginia, United States

Site Status

Lynchburg Pulmonary Associates, Inc. (PFT only)

Lynchburg, Virginia, United States

Site Status

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Site Status

Wagner Macula and Retina Center (OCT only)

Norfolk, Virginia, United States

Site Status

Wagner Macula and Retina Center (OCT only)

Norfolk, Virginia, United States

Site Status

Sleep Specialists of Tidewater - Virginia Beach (PFT Only)

Virginia Beach, Virginia, United States

Site Status

Sunshine University Private Hospital

Birtinya, Queensland, Australia

Site Status

Mater Misericordiae Ltd

Brisbane South, Queensland, Australia

Site Status

Buderim Eye Centre (OCT Facility)

Buderim, Queensland, Australia

Site Status

Dr Shiran DeSilva Respiratory Clinic

Mackay, Queensland, Australia

Site Status

Mackay Discount Drug Store

Mackay, Queensland, Australia

Site Status

Mater Misericordiae Hospital

Mackay, Queensland, Australia

Site Status

Queensland X-Ray

Mackay, Queensland, Australia

Site Status

Vision Eye Institute Mackay

Mackay, Queensland, Australia

Site Status

Coastal Digestive Health

Maroochydore, Queensland, Australia

Site Status

Coral Sea Clinical Research Institute

North Mackay, Queensland, Australia

Site Status

Elizabeth Specialist Suites (PFT Facility)

Elizabeth Vale, South Australia, Australia

Site Status

Lyell McEwin Hospital.

Elizabeth Vale, South Australia, Australia

Site Status

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Site Status

Modbury Hospital (OCT Facility)

Modbury, South Australia, Australia

Site Status

Eastern Clinical Research Unit

Box Hill, Victoria, Australia

Site Status

Eastern Health

Box Hill, Victoria, Australia

Site Status

Box Hill Eye Surgeons (OCT Facility)

Box Hill North, Victoria, Australia

Site Status

Retina Specialists Victoria (OCT Facility)

Camberwell, Victoria, Australia

Site Status

The Northern Hospital

Epping, Victoria, Australia

Site Status

Footscray Hospital

Footscray, Victoria, Australia

Site Status

Vision Eye Institute

Melbourne, Victoria, Australia

Site Status

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

Bellfield, , Australia

Site Status

Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )

Birtinya, , Australia

Site Status

AZ St Lucas Brugge

Bruges, , Belgium

Site Status

AZ Delta

Roeselare, , Belgium

Site Status

Centre Hospitalier Wallonie Picarde (CHWAPI)

Tournai, , Belgium

Site Status

Mount Sinai Services Inc. Dr George Charames

Toronto, Ontario, Canada

Site Status

Precision for Medicine GmbH

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Canada Germany Netherlands Spain Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40381637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39575597 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

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Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=APD334-206

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Other Identifiers

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C5041009

Identifier Type: OTHER

Identifier Source: secondary_id

2020-003226-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APD334-206

Identifier Type: -

Identifier Source: org_study_id

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