A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis
- Conditions
- EoEEosinophilic Esophagitis10017969
- Registration Number
- NL-OMON52257
- Lead Sponsor
- Arena Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percent change from Baseline in esophageal PEC at Week 16</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Absolute change from Baseline in DSQ score at Week 16<br /><br>* Absolute change from Baseline in esophageal PEC at Week 16<br /><br>* Proportion of subjects with esophageal PEC < 15 eos/hpf at Week 16<br /><br>* Proportion of subjects with esophageal PEC * 6 eos/hpf at Week 16</p><br>