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 Etrasimod Dose 1 Etrasimod Dose 2

Eligibility

You can join if…

Open to people ages 18-65

  • 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

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 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:
  • 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. accepting new patients
    Garden Grove California 92840 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arena Pharmaceuticals
ID
NCT04682639
Phase
Phase 2
Study Type
Interventional
Last Updated