A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

  • STATUS
    Recruiting
  • End date
    Feb 12, 2023
  • participants needed
    96
  • sponsor
    Arena Pharmaceuticals
Updated on 12 September 2021

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.

Details
Condition Eosinophilic esophagitis
Treatment Placebo, Etrasimod
Clinical Study IdentifierNCT04682639
SponsorArena Pharmaceuticals
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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