A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)
- Conditions
- allergic esophagitisEoE10001708
- Registration Number
- NL-OMON55352
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• A documented diagnosis of EoE by endoscopic biopsy prior to screening, as
demonstrated by intraepithelial eosinophilic infiltration (peak cell count >=15
eosinophils/high power field [eos/hpf]) from at least one esophageal region and
performed after at least 8 weeks of treatment with a high dose proton pump
inhibitor (PPI) regimen. If the patient discontinued PPI therapy, the biopsy
must have been performed within 2 weeks of the date of discontinuation. If a
prior (historical) endoscopic biopsy meeting these criteria is not available
(or no prior biopsy is available), patients who meet other clinical and
laboratory eligibility criteria will undergo treatment with a high dose PPI
regimen for at least 8 weeks during the screening period before their baseline
endoscopy/biopsies.
• Baseline endoscopic biopsies with a demonstration on central reading of
intraepithelial eosinophilic infiltration (peak cell count >=15 eos/hpf) in at
least 2 of the 3 biopsied esophageal regions (proximal, mid, or distal)
• History (by patient report) of an average of at least 2 episodes of dysphagia
(with intake of solids) per week in the 4 weeks prior to screening
• At least 4 episodes of dysphagia in the 2 weeks prior to baseline, documented
via eDiary, at least 2 of which require liquids, coughing or
gagging, vomiting, or medical attention to obtain relief
• Completed at least 11 of 14 days of the Dysphagia Symptom Questionnaire (DSQ)
eDiary data entry in the 2 weeks prior to the baseline visit (visit 3)
• Baseline DSQ score >=10
• Body weight <=40 kg
• Prior participation in a dupilumab clinical trial, or past or current
treatment
with dupilumab
• Initiation or change of a food-elimination diet regimen or re-introduction of
a previously eliminated food group in the 6 weeks prior to screening.
Patients on a food-elimination diet must remain on the same diet throughout
the study.
• Other causes of esophageal eosinophilia or the following conditions:
hypereosinophilic syndrome and eosinophilic granulomatosis with
polyangiitis (Churg-Strauss syndrome)
Note: Patients with eosinophilic gastroenteritis are eligible, provided they
meet other eligibility criteria.
• Active Helicobacter pylori infection
• History of achalasia, Crohn*s disease, ulcerative colitis, celiac disease,
and
prior esophageal surgery
• Any esophageal stricture unable to be passed with a standard, diagnostic,
9 to10 mm upper endoscope or any critical esophageal stricture that requires
dilation at screening
• History of bleeding disorders or esophageal varices
• Treatment with swallowed topical corticosteroids within 8 weeks prior to
baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary endpoints of the study are:<br /><br>-Proportion of patients achieving peak esophageal intraepithelial eosinophil<br /><br>count of <=6 eosinophils per high-power field (eos/hpf) at week 24<br /><br>-Absolute change in Dysphagia Symptom Questionnaire (DSQ) score from baseline<br /><br>to week 24</p><br>
- Secondary Outcome Measures
Name Time Method