EoE Eosinophilic Esophagitis
Conditions
Interventions
During the Double-Blind Treatment Period, eligible subjects will be randomized
in a double-blind fashion (3:3:2 ratio) to etrasimod 1 mg, etrasimod 2 mg, or
matching placebo once daily. Subjects who
Sponsors
Arena Pharmaceuticals Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria * Men or women between 18 and 65 years of age at the time of informed consent (IC) * Have an EoE diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of * 15 eosinophils (eos)/high power field (hpf) (~60 eos/mm2) from any level (proximal, mid, or distal) of the esophagus at the Screening esophagogastroduodenoscopy (EGD). * 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 Dysphagia Symptom Questionnaire (DSQ) during the Screening period)
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria * History of any of the following non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic, endoscopic, or symptom endpoints of the study: a. Conditions that substantially contribute to esophageal eosinophilia (eg eosoinophilic, gastroenteritis, or enteritis [ie, eosinophilic duodenitis or colitis] with esophageal involvement, achalasia, hypereosinophilic syndrome, Crohn's disease [CD] with esophageal involvement, esophageal infection [fungal, viral], eosinophilic granulomatosis with polyangitis (formally known as Churg-Strauss Syndrome), pemphigus with esophageal involvement, pill esophagitis, graft versus host disease, Mendelian disorders [eg, Marfan syndrome Type II, hyper-immunoglobulin E (IgE) syndrome, phosphatase and tensin homolog (PTEN) hamartoma tumor syndrome, Netherton syndrome, severe atopy metabolic wasting (SAM) syndrome]) b. Conditions that interfere with the evaluation of the esophagus (eg, esophageal varices with risk of spontaneous bleed, high-grade esophageal stenosis where an 8- to 10-mm endoscope could not pass through the stricture without dilation at the time of Screening EGD) c. Conditions or procedures substantially contribute to dysphagia (eg, histologically active Barrett's, active, esophagitis, erosive esophagitis Los Angeles Grade B or above, significant hiatal hernia [* 4 cm], esophageal resection) * 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. Subjects on any of the following therapy need to stay on a stable regimen during study participation: a. Elemental diet b. EoE food trigger elimination diet c. PPI therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from Baseline in esophageal PEC at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| * Absolute change from Baseline in DSQ score at Week 16 * Absolute change from Baseline in esophageal PEC at Week 16 * Proportion of subjects with esophageal PEC | — |
Countries
Netherlands
Outcome results
None listed