A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitis
- Conditions
- Eosinophilic Esophagitis (EoE)MedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-003226-23-BE
- Lead Sponsor
- Arena Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 96
Key Inclusion Criteria (Full Inclusion Criteria Are Provided in the Protocol)
• 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Key Exclusion Criteria (Full Exclusion Criteria Are Provided in the Protocol)
• 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, eosinophilic gastritis 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 polyangiitis (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 that substantially contribute to dysphagia (eg, histologically active Barrett’s esophagitis, active, 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of etrasimod on esophageal eosinophilia in adult subjects with active EoE<br>To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo in adult subjects with active EoE<br>To select an etrasimod dose based on efficacy and safety for continued development;Secondary Objective: To evaluate the effect of etrasimod on dysphagia symptoms in adult subjects with active EoE;Primary end point(s): Percent change from Baseline in esophageal PEC at Week 16;Timepoint(s) of evaluation of this end point: Week 16<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Absolute change from Baseline in DSQ score at Week 16<br>• Absolute change from Baseline in esophageal PEC at Week 16<br>• Proportion of subjects with esophageal PEC < 15 eos/hpf at Week 16<br>• Proportion of subjects with esophageal PEC = 6 eos/hpf at Week 16;Timepoint(s) of evaluation of this end point: Week 16