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APD334-206


Title A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis
Therapeutic Area Eosinophilic Esophagitis
Principal Investigator John Leung, MD
Min Age 18 Years
Max Age 65 Years
Gender All
Contact Selma Sinanovic
617-636-2392
ssinanovic@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04682639

Overview

The purpose of this study is to assess an investigational drug called etrasimod in the treatment of eosinophilic esophagitis (EoE). This study is being done to find out which dose of etrasimod works best and which is the safest dose for people with EoE. The study will also look at how etrasimod works, and whether it will reduce the number of eosinophils in the esophagus and help improve the pain or difficulty of swallowing in people with EoE.

Study Details

Inclusion Criteria

  • Men or women between 18 to 65 years of age at the time of informed consent (IC)
  • Have histologically active EoE with an esophageal PEC of ≥ 15 eos/hpf (~60 eos/mm2) from any level (proximal, mid, or distal) of the esophagus at the Screening EGD. Eosinophilia must be isolated to the esophagus.
  • 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 (as documented using the DSQ during the Screening period)

Exclusion Criteria

  • Undergone dilation of an esophageal stricture within 12 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. Subjects on any of the following therapy need to stay on a stable regimen during study participation:
    • Elemental diet
    • EoE food trigger elimination diet
    • PPI therapy
  • Have a serious infection that requires hospitalization or treatment with intravenous (IV) medications within 4 weeks prior to Baseline

Study Requirements

Throughout this study subjects will have 5 EKG’s, 5 pulmonary function tests, 5 Ophthalmoscopy with OCT, 4 endoscopies, and 11 blood draws