NCT04682639|CompletedPhase 2ResultsFDA Drug

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

VOYAGE

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

Pfizer ClinicalTrials.gov

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3 other identifiers

APD334-206C50410092020-003226-23

Study Type

interventional

Target

108

Locations

8 countries

Sites

256

Timeline

RegisteredDec 2020

StartedDec 2020

CompletionJun 2023

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

108

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Dec 2020

Geographic Reach

8 countries

256 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

December 15, 2020

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed

4 months until next milestone

Results Posted

Study results publicly available

October 26, 2023

Completed

Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

December 19, 2020

Results QC Date

September 29, 2023

Last Update Submit

May 2, 2024

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic esophagitisEsophageal eosinophiliaEtrasimodAPD334EoEEosinophilic oesophagitis

Outcome Measures

Primary Outcomes (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.
Baseline, Week 16

Secondary Outcomes (4)

Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16
Baseline, Week 16
Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Baseline, Week 16
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at 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
Week 16

Other Outcomes (2)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
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
Baseline up to Week 24

Study Arms (3)

Etrasimod Dose 1

EXPERIMENTAL

Drug: Etrasimod

Etrasimod Dose 2

EXPERIMENTAL

Drug: Etrasimod

Placebo and Etrasimod

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Etrasimod

Interventions

EtrasimodDRUG

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

Also known as: APD334

Etrasimod Dose 1Etrasimod Dose 2

PlaceboDRUG

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

Placebo and Etrasimod

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead
Arena is a wholly owned subsidiary of Pfizercollaborator

Study Sites (256)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209, United States

Location

GastroHealth - St. Vincent's East

Birmingham, Alabama, 35235, United States

Location

Digestive Health Specialists

Dothan, Alabama, 36301, United States

Location

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

Dothan, Alabama, 36301, United States

Location

Dothan Surgery Center (Colonoscopy Location)

Dothan, Alabama, 36301, United States

Location

Pulmonary Associates (PFT Procedure Only, Second Location )

Dothan, Alabama, 36301, United States

Location

Flowers Hospital (PFT Procedure Only)

Dothan, Alabama, 36305, United States

Location

Avant Research Associates, LLC

Huntsville, Alabama, 35802, United States

Location

Crestwood Medical Center

Huntsville, Alabama, 35802, United States

Location

Baily Cove Eye Care

Huntsville, Alabama, 35803, United States

Location

Madison Surgery Center

Madison, Alabama, 35758, United States

Location

Alabama Eye MD

Vestavia Hills, Alabama, 35216, United States

Location

Arizona Retina Institute/ Phoenix Retina Associates(OCT)

Peoria, Arizona, 85381, United States

Location

SimonMed Imaging (Imaging)

Peoria, Arizona, 85381, United States

Location

Arizona Digestive Health - Sun City

Sun City, Arizona, 85351, United States

Location

Sun City Endoscopy Center (Endoscopy)

Sun City, Arizona, 85351, United States

Location

Little Rock Eye Clinic

Little Rock, Arkansas, 72205, United States

Location

Four Seasons Allergy and Asthma

Little Rock, Arkansas, 72211, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Premier Gastroenterology Endoscopy Center

Little Rock, Arkansas, 72212, United States

Location

Premier Gastroenterology

Little Rock, Arkansas, 72212, United States

Location

Isight Vision Care

Fountain Valley, California, 92708, United States

Location

Mile Square Surgery Center

Fountain Valley, California, 92708, United States

Location

Pulmonary & Sleep Consultants

Fountain Valley, California, 92708, United States

Location

Paragon Rx Clinical, Inc.

Garden Grove, California, 92840, United States

Location

Inland Pulmonary Specialists [PFT Only]

Lake Elsinore, California, 92532, United States

Location

Advanced Endoscopy and Pain Center - EGD & Biopsy Collection