Status:
COMPLETED
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arena is a wholly owned subsidiary of Pfizer
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04682639
Start Date
December 15 2020
End Date
June 30 2023
Last Update
May 6 2024
Active Locations (256)
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1
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States, 35209
2
GastroHealth - St. Vincent's East
Birmingham, Alabama, United States, 35235
3
Digestive Health Specialists
Dothan, Alabama, United States, 36301
4
Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)
Dothan, Alabama, United States, 36301