Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
Arena is a wholly owned subsidiary of Pfizer
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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 may not be 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:
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
Clareo Health | A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
