StudyFinder

APD334-206: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis

Recruiting

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.

I'm interested

All
18 Years to 65 Years old
This study is NOT accepting healthy volunteers
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:
• 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

Drug: Etrasimod, Drug: Placebo, Drug: Etrasimod

Eosinophilic Esophagitis

Eosinophilic esophagitis, Esophageal eosinophilia, Etrasimod, APD334, EoE, Eosinophilic oesophagitis, Clinics and Surgery Center (CSC)

Sara Eischen - bengt008@umn.edu
Joshua Sloan
Phase 2
STUDY00012609
NCT04682639
See this study on ClinicalTrials.gov

Back