Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Eosinophilic Esophagitis Esophageal eosinophilia Etrasimod APD334 EoE Eosinophilic oesophagitis Esophagitis

Eligibility

You can join if…

Open to people ages 18-65

  • 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 CAN'T join 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

Locations

  • University of California at Irvine Medical Center accepting new patients
    Irvine California 92697-7600 United States
  • Paragon Rx Clinical, Inc. withdrawn
    Garden Grove California 92840 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arena Pharmaceuticals
Links
Related Info
ID
NCT04682639
Phase
Phase 2 Eosinophilic Esophagitis Research Study
Study Type
Interventional
Participants
Expecting 96 study participants
Last Updated