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

Completed · Phase 2 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT04682639

Run by

Pfizer

People needed

108

Starts

2020-12-15

Expected to finish

2023-06-30

Last updated by the study team

2024-05-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• GastroHealth - St. Vincent's East — Birmingham, Alabama, United States
• Digestive Health Specialists — Dothan, Alabama, United States
• Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only) — Dothan, Alabama, United States
• Dothan Surgery Center (Colonoscopy Location) — Dothan, Alabama, United States
• Pulmonary Associates (PFT Procedure Only, Second Location ) — Dothan, Alabama, United States
• Flowers Hospital (PFT Procedure Only) — Dothan, Alabama, United States
• Avant Research Associates, LLC — Huntsville, Alabama, United States
• Crestwood Medical Center — Huntsville, Alabama, United States
• Baily Cove Eye Care — Huntsville, Alabama, United States
• Madison Surgery Center — Madison, Alabama, United States
• Alabama Eye MD — Vestavia Hills, Alabama, United States
• Arizona Retina Institute/ Phoenix Retina Associates(OCT) — Peoria, Arizona, United States
• SimonMed Imaging (Imaging) — Peoria, Arizona, United States
• Arizona Digestive Health - Sun City — Sun City, Arizona, United States
• Sun City Endoscopy Center (Endoscopy) — Sun City, Arizona, United States
• Little Rock Eye Clinic — Little Rock, Arkansas, United States
• Four Seasons Allergy and Asthma — Little Rock, Arkansas, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Premier Gastroenterology Endoscopy Center — Little Rock, Arkansas, United States
• Premier Gastroenterology — Little Rock, Arkansas, United States
• Isight Vision Care — Fountain Valley, California, United States
• Mile Square Surgery Center — Fountain Valley, California, United States
• Pulmonary & Sleep Consultants — Fountain Valley, California, United States
• Paragon Rx Clinical, Inc. — Garden Grove, California, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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