A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Etrasimod; Placebo; Etrasimod
Intervention description: Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.; Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.; Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Eosinophilic esophagitis; Esophageal eosinophilia; Etrasimod; APD334; EoE; Eosinophilic oesophagitis

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 Criteria:

          -  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 Criteria:

          -  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:

               1. Elemental diet

               2. EoE food trigger elimination diet

               3. 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