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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have histologically active eosinophilic esophagitis (EoE) 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 gastroenteritis), 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04682639
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arena Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Arena CT.gov Administrator
Principal Investigator Affiliation Arena Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions

Arms

Experimental: Etrasimod Dose 1

Experimental: Etrasimod Dose 2

Placebo Comparator: Placebo

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

Interventions

Drug: - Etrasimod

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

Drug: - Placebo

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

Drug: - Etrasimod

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dothan, Alabama

Status

Recruiting

Address

Gut P.C., dba Digestive Health Specialists

Dothan, Alabama, 36305

Arizona Digestive Health, Sun City, Arizona

Status

Recruiting

Address

Arizona Digestive Health

Sun City, Arizona, 85351

Premier Gastroenterology, Little Rock, Arkansas

Status

Recruiting

Address

Premier Gastroenterology

Little Rock, Arkansas, 72212

Gastrointestinal Biosciences, Beverly Hills, California

Status

Recruiting

Address

Gastrointestinal Biosciences

Beverly Hills, California, 90067

Alliance Research Institute, Canoga Park, California

Status

Recruiting

Address

Alliance Research Institute

Canoga Park, California, 91304

Paragon Rx Clinical, Inc., Garden Grove, California

Status

Recruiting

Address

Paragon Rx Clinical, Inc.

Garden Grove, California, 92840

Gastro Care Institute, Lancaster, California

Status

Recruiting

Address

Gastro Care Institute

Lancaster, California, 93534

Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

United Medical Doctors, Murrieta, California

Status

Recruiting

Address

United Medical Doctors

Murrieta, California, 92563

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33756

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33761

Grand Teton Research Group, PLLC, Idaho Falls, Idaho

Status

Recruiting

Address

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404

Illinois Gastroenterology Group-Gurnee, Gurnee, Illinois

Status

Recruiting

Address

Illinois Gastroenterology Group-Gurnee

Gurnee, Illinois, 60031

Cotton O' Neil Clinical Research Center, Topeka, Kansas

Status

Recruiting

Address

Cotton O' Neil Clinical Research Center

Topeka, Kansas, 66606

Aventiv Research, Inc, Dublin, Ohio

Status

Recruiting

Address

Aventiv Research, Inc

Dublin, Ohio, 43016

Central Sooner Research, Oklahoma City, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Oklahoma City, Oklahoma, 73118

Susquehanna Research Group, LLC, Harrisburg, Pennsylvania

Status

Recruiting

Address

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110

Tri-Cities Gastroenterology, Kingsport, Tennessee

Status

Recruiting

Address

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663

San Marcos, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants, PLLC

San Marcos, Texas, 78666

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